Pharmacology

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

A version of this article first appeared on Medscape.com.

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

A version of this article first appeared on Medscape.com.

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

A version of this article first appeared on Medscape.com.

The persistent shortage of dacarbazine has led to an “acute and unprecedented crisis” in the treatment of patients with advanced classical Hodgkin lymphoma, experts say.

Dacarbazine, an essential part of the four-drug standard of care for managing Hodgkin lymphoma, has been in short supply since last summer, prompting experts to search for a viable substitute.

In a recent review, oncologists scoured decades of data to find the best alternatives for a range of scenarios. For fit adults younger than 60, the group recommends the seven-drug regimen BEACOPP – bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone.

“Among all available regimens,” BEACOPP has “the most robust evidence” as a substitute for the four-drug standard ABVD, which includes doxorubicin, bleomycin, vinblastine, and dacarbazine, Pallawi Torka, MD, a hematologic oncologist at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and colleagues wrote in JCO Oncology Practice.

Last October, the Food and Drug Administration posted a notice about the dacarbazine shortage. According to the notice, the shortage occurred because of “manufacturing delays” and a “demand increase” affecting three companies supplying the U.S. market – Fresenius Kabi USA, Hikma Pharmaceuticals, and Teva. In an update issued May 4, the FDA said that 100-mg and 200-mg vials of the drug are now available from Fresenius. An update from April 8 said that 200-mg vials were available from Hikma.

Dacarbazine is hardly the only oncology drug to fall into short supply. Recent data show that shortages of oncology drugs have become more common in the United States in recent years, particularly generic drugs and those targeting hematologic malignancies.

In a recent national survey of oncology pharmacists, researchers found that almost two-thirds of institutions reported at least one drug shortage in the past month, representing a 34% increase between 2018 and 2019.

“This shortage of [dacarbazine] is not the first shortage of oncolytic drugs, and it certainly will not be the last,” Nicole Soriano, PharmD, hematology/oncology clinical pharmacist at Northwestern Memorial Hospital, Chicago, and colleagues wrote in a commentary accompanying the review.

According to Dr. Soriano and coauthors, “some studies have found that shortages are significant across many oncology disciplines and may lead to delays, changes in therapy, interference with clinical research, increased risk of medication errors, adverse outcomes, and increased costs.”
 

Finding a substitute

In the current analysis, Dr. Torka and her team conducted an exhaustive literature review in which they examined studies going back decades.

The authors highlight more than 10 alternative regimens for treating advanced classical Hodgkin lymphoma. They also provide a detailed treatment algorithm to help oncologists choose the best option for their individual patients as well as strategies for reintegrating ABVD into patient care should the supply of dacarbazine return to normal.

The first considerations: Can patients tolerate intensive chemotherapy, and are patients younger than 60?

For fit adults younger than 60, Dr. Torka and colleagues conclude that the BEACOPP regimen is the “preferred” option. In trials comparing ABVD to BEACOPP, both regimens demonstrated similar overall survival. And while BEACOPP may provide slightly “better disease control,” this approach may also come with greater toxicities in the short and long term, compared with ABVD, depending on the dosing strategy.

The authors also propose an alternative treatment strategy in case the supply of dacarbazine returns to normal mid-treatment. In this scenario, patients could receive an escalated BEACOPP regimen for two cycles and then undergo an interim positron-emission tomography scan. If the scan is negative and dacarbazine is available, the patient’s regimen could be deescalated to ABVD for four cycles without affecting disease control.

For pediatric patients, the authors recommend the ABVE-PC regimen, which includes six drugs – doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide. Data show that the 5-year overall survival among pediatric patients receiving ABVE-PC is 95%.

Stanford V-C – cyclophosphamide, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide, and prednisone – is another “acceptable approach” for pediatric patients, the authors noted.

For older patients with advanced disease or those unfit for intensive chemotherapy, the authors suggest evaluating them for fitness for anthracyclines to determine whether doxorubicin, in particular, is an option.

The researchers suggest one of the following three strategies for those who are doxorubicin-eligible: PVAG (prednisone, vinblastine, doxorubicin, and gemcitabine), CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), or EVA (etoposide, vinblastine, and doxorubicin).

For those unfit for anthracyclines, the options include COPP (cyclophosphamide, vincristine, procarbazine, and prednisone) or ChlVPP (chlorambucil, vinblastine, procarbazine, and prednisone).

For frail patients who are ineligible for chemotherapy, the team recommends brentuximab alone or in combination with nivolumab.

Given the limited availability of dacarbazine, the authors say that the “current supply should be triaged to prioritize patients whose therapy cannot be changed and those without alternative acceptable options.”

To stretch available dacarbazine supplies as much as possible, the researchers and editorialists advocate for rounding doses within 5%-10% of the prescribed dose.

For example, Dr. Torka and colleagues explained, rounding a dose from 750 mg down to 700 mg would save one vial of dacarbazine.

Vial sharing and using drugs beyond their use dates by compounding with closed-system transfer devices are other strategies to preserve the existing supply of dacarbazine.

The goal of this review “is to give as many patients as possible the most optimal and efficacious therapy even with the strain on supply,” the editorialists wrote.

No funding for the study was reported. Dr. Torka is an adviser for Genentech, ADC Therapeutics, and TG Therapeutics. Dr. Soriano has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The persistent shortage of dacarbazine has led to an “acute and unprecedented crisis” in the treatment of patients with advanced classical Hodgkin lymphoma, experts say.

Dacarbazine, an essential part of the four-drug standard of care for managing Hodgkin lymphoma, has been in short supply since last summer, prompting experts to search for a viable substitute.

In a recent review, oncologists scoured decades of data to find the best alternatives for a range of scenarios. For fit adults younger than 60, the group recommends the seven-drug regimen BEACOPP – bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone.

“Among all available regimens,” BEACOPP has “the most robust evidence” as a substitute for the four-drug standard ABVD, which includes doxorubicin, bleomycin, vinblastine, and dacarbazine, Pallawi Torka, MD, a hematologic oncologist at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and colleagues wrote in JCO Oncology Practice.

Last October, the Food and Drug Administration posted a notice about the dacarbazine shortage. According to the notice, the shortage occurred because of “manufacturing delays” and a “demand increase” affecting three companies supplying the U.S. market – Fresenius Kabi USA, Hikma Pharmaceuticals, and Teva. In an update issued May 4, the FDA said that 100-mg and 200-mg vials of the drug are now available from Fresenius. An update from April 8 said that 200-mg vials were available from Hikma.

Dacarbazine is hardly the only oncology drug to fall into short supply. Recent data show that shortages of oncology drugs have become more common in the United States in recent years, particularly generic drugs and those targeting hematologic malignancies.

In a recent national survey of oncology pharmacists, researchers found that almost two-thirds of institutions reported at least one drug shortage in the past month, representing a 34% increase between 2018 and 2019.

“This shortage of [dacarbazine] is not the first shortage of oncolytic drugs, and it certainly will not be the last,” Nicole Soriano, PharmD, hematology/oncology clinical pharmacist at Northwestern Memorial Hospital, Chicago, and colleagues wrote in a commentary accompanying the review.

According to Dr. Soriano and coauthors, “some studies have found that shortages are significant across many oncology disciplines and may lead to delays, changes in therapy, interference with clinical research, increased risk of medication errors, adverse outcomes, and increased costs.”
 

Finding a substitute

In the current analysis, Dr. Torka and her team conducted an exhaustive literature review in which they examined studies going back decades.

The authors highlight more than 10 alternative regimens for treating advanced classical Hodgkin lymphoma. They also provide a detailed treatment algorithm to help oncologists choose the best option for their individual patients as well as strategies for reintegrating ABVD into patient care should the supply of dacarbazine return to normal.

The first considerations: Can patients tolerate intensive chemotherapy, and are patients younger than 60?

For fit adults younger than 60, Dr. Torka and colleagues conclude that the BEACOPP regimen is the “preferred” option. In trials comparing ABVD to BEACOPP, both regimens demonstrated similar overall survival. And while BEACOPP may provide slightly “better disease control,” this approach may also come with greater toxicities in the short and long term, compared with ABVD, depending on the dosing strategy.

The authors also propose an alternative treatment strategy in case the supply of dacarbazine returns to normal mid-treatment. In this scenario, patients could receive an escalated BEACOPP regimen for two cycles and then undergo an interim positron-emission tomography scan. If the scan is negative and dacarbazine is available, the patient’s regimen could be deescalated to ABVD for four cycles without affecting disease control.

For pediatric patients, the authors recommend the ABVE-PC regimen, which includes six drugs – doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide. Data show that the 5-year overall survival among pediatric patients receiving ABVE-PC is 95%.

Stanford V-C – cyclophosphamide, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide, and prednisone – is another “acceptable approach” for pediatric patients, the authors noted.

For older patients with advanced disease or those unfit for intensive chemotherapy, the authors suggest evaluating them for fitness for anthracyclines to determine whether doxorubicin, in particular, is an option.

The researchers suggest one of the following three strategies for those who are doxorubicin-eligible: PVAG (prednisone, vinblastine, doxorubicin, and gemcitabine), CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), or EVA (etoposide, vinblastine, and doxorubicin).

For those unfit for anthracyclines, the options include COPP (cyclophosphamide, vincristine, procarbazine, and prednisone) or ChlVPP (chlorambucil, vinblastine, procarbazine, and prednisone).

For frail patients who are ineligible for chemotherapy, the team recommends brentuximab alone or in combination with nivolumab.

Given the limited availability of dacarbazine, the authors say that the “current supply should be triaged to prioritize patients whose therapy cannot be changed and those without alternative acceptable options.”

To stretch available dacarbazine supplies as much as possible, the researchers and editorialists advocate for rounding doses within 5%-10% of the prescribed dose.

For example, Dr. Torka and colleagues explained, rounding a dose from 750 mg down to 700 mg would save one vial of dacarbazine.

Vial sharing and using drugs beyond their use dates by compounding with closed-system transfer devices are other strategies to preserve the existing supply of dacarbazine.

The goal of this review “is to give as many patients as possible the most optimal and efficacious therapy even with the strain on supply,” the editorialists wrote.

No funding for the study was reported. Dr. Torka is an adviser for Genentech, ADC Therapeutics, and TG Therapeutics. Dr. Soriano has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The persistent shortage of dacarbazine has led to an “acute and unprecedented crisis” in the treatment of patients with advanced classical Hodgkin lymphoma, experts say.

Dacarbazine, an essential part of the four-drug standard of care for managing Hodgkin lymphoma, has been in short supply since last summer, prompting experts to search for a viable substitute.

In a recent review, oncologists scoured decades of data to find the best alternatives for a range of scenarios. For fit adults younger than 60, the group recommends the seven-drug regimen BEACOPP – bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone.

“Among all available regimens,” BEACOPP has “the most robust evidence” as a substitute for the four-drug standard ABVD, which includes doxorubicin, bleomycin, vinblastine, and dacarbazine, Pallawi Torka, MD, a hematologic oncologist at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and colleagues wrote in JCO Oncology Practice.

Last October, the Food and Drug Administration posted a notice about the dacarbazine shortage. According to the notice, the shortage occurred because of “manufacturing delays” and a “demand increase” affecting three companies supplying the U.S. market – Fresenius Kabi USA, Hikma Pharmaceuticals, and Teva. In an update issued May 4, the FDA said that 100-mg and 200-mg vials of the drug are now available from Fresenius. An update from April 8 said that 200-mg vials were available from Hikma.

Dacarbazine is hardly the only oncology drug to fall into short supply. Recent data show that shortages of oncology drugs have become more common in the United States in recent years, particularly generic drugs and those targeting hematologic malignancies.

In a recent national survey of oncology pharmacists, researchers found that almost two-thirds of institutions reported at least one drug shortage in the past month, representing a 34% increase between 2018 and 2019.

“This shortage of [dacarbazine] is not the first shortage of oncolytic drugs, and it certainly will not be the last,” Nicole Soriano, PharmD, hematology/oncology clinical pharmacist at Northwestern Memorial Hospital, Chicago, and colleagues wrote in a commentary accompanying the review.

According to Dr. Soriano and coauthors, “some studies have found that shortages are significant across many oncology disciplines and may lead to delays, changes in therapy, interference with clinical research, increased risk of medication errors, adverse outcomes, and increased costs.”
 

Finding a substitute

In the current analysis, Dr. Torka and her team conducted an exhaustive literature review in which they examined studies going back decades.

The authors highlight more than 10 alternative regimens for treating advanced classical Hodgkin lymphoma. They also provide a detailed treatment algorithm to help oncologists choose the best option for their individual patients as well as strategies for reintegrating ABVD into patient care should the supply of dacarbazine return to normal.

The first considerations: Can patients tolerate intensive chemotherapy, and are patients younger than 60?

For fit adults younger than 60, Dr. Torka and colleagues conclude that the BEACOPP regimen is the “preferred” option. In trials comparing ABVD to BEACOPP, both regimens demonstrated similar overall survival. And while BEACOPP may provide slightly “better disease control,” this approach may also come with greater toxicities in the short and long term, compared with ABVD, depending on the dosing strategy.

The authors also propose an alternative treatment strategy in case the supply of dacarbazine returns to normal mid-treatment. In this scenario, patients could receive an escalated BEACOPP regimen for two cycles and then undergo an interim positron-emission tomography scan. If the scan is negative and dacarbazine is available, the patient’s regimen could be deescalated to ABVD for four cycles without affecting disease control.

For pediatric patients, the authors recommend the ABVE-PC regimen, which includes six drugs – doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide. Data show that the 5-year overall survival among pediatric patients receiving ABVE-PC is 95%.

Stanford V-C – cyclophosphamide, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide, and prednisone – is another “acceptable approach” for pediatric patients, the authors noted.

For older patients with advanced disease or those unfit for intensive chemotherapy, the authors suggest evaluating them for fitness for anthracyclines to determine whether doxorubicin, in particular, is an option.

The researchers suggest one of the following three strategies for those who are doxorubicin-eligible: PVAG (prednisone, vinblastine, doxorubicin, and gemcitabine), CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), or EVA (etoposide, vinblastine, and doxorubicin).

For those unfit for anthracyclines, the options include COPP (cyclophosphamide, vincristine, procarbazine, and prednisone) or ChlVPP (chlorambucil, vinblastine, procarbazine, and prednisone).

For frail patients who are ineligible for chemotherapy, the team recommends brentuximab alone or in combination with nivolumab.

Given the limited availability of dacarbazine, the authors say that the “current supply should be triaged to prioritize patients whose therapy cannot be changed and those without alternative acceptable options.”

To stretch available dacarbazine supplies as much as possible, the researchers and editorialists advocate for rounding doses within 5%-10% of the prescribed dose.

For example, Dr. Torka and colleagues explained, rounding a dose from 750 mg down to 700 mg would save one vial of dacarbazine.

Vial sharing and using drugs beyond their use dates by compounding with closed-system transfer devices are other strategies to preserve the existing supply of dacarbazine.

The goal of this review “is to give as many patients as possible the most optimal and efficacious therapy even with the strain on supply,” the editorialists wrote.

No funding for the study was reported. Dr. Torka is an adviser for Genentech, ADC Therapeutics, and TG Therapeutics. Dr. Soriano has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Seven physicians were among 12 medical professionals charged today by the U.S. Department of Justice with opioid distribution offenses.

In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.

The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.

“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
 

Medical professionals, others across six states charged

One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:

• Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
• Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
• Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
• Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
• Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
• Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
• Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
• Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
• Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.

Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.

The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.

“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.

“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.

A version of this article first appeared on Medscape.com.

Seven physicians were among 12 medical professionals charged today by the U.S. Department of Justice with opioid distribution offenses.

In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.

The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.

“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
 

Medical professionals, others across six states charged

One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:

• Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
• Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
• Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
• Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
• Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
• Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
• Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
• Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
• Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.

Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.

The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.

“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.

“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.

A version of this article first appeared on Medscape.com.

Seven physicians were among 12 medical professionals charged today by the U.S. Department of Justice with opioid distribution offenses.

In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.

The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.

“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
 

Medical professionals, others across six states charged

One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:

• Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
• Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
• Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
• Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
• Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
• Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
• Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
• Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
• Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.

Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.

The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.

“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.

“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.

A version of this article first appeared on Medscape.com.

Is fear of missing an infection – call it “FOMI” – leading you to overprescribe antibiotics to your patients?   

Inappropriate use of antibiotics can result in adverse events and toxicity, superinfections such as Clostridioides difficile and Methicillin-resistant Staphylococcus aureus, excess mortality and costs, and resistance to the drugs.   

All that has been well-known for years, and antibiotic resistance has become a leading public health concern. So why are physicians continuing to overprescribe the drugs?

Speaking at the 2022 annual Internal Medicine Meeting of the American College of Physicians, James “Brad” Cutrell, MD, medical director of antimicrobial stewardship, University of Texas Southwestern Medical Center, Dallas, said clinicians in the United States and elsewhere appear to be falling into a three-part fallacy when it comes to using the drugs: fear of “missing an infection,” coupled with patient expectations that they will leave the office with a prescription and combined with an overemphasis on the potential benefit to the individual at the expense of the risk to society of antibiotic resistance.

Antibiotics are the only drugs that lose their efficacy for all patients over time the more they are used. “For example, if I give a beta blocker to a patient, it’s not going to affect other patients down the road,” Dr. Cutrell said. “It’s not going to lose its efficacy.”

“What we need in medicine is a new culture around antibiotic use,” Dr. Cutrell added. “We need more respect for the dangers of antibiotic misuse and to have confidence in [their] benefits and when they can be used wisely.”
 

Rampant misuse

Outpatient prescriptions account for at least 60% of antibiotic use in the United States. The rate is even higher in other countries, Dr. Cutrell said during a presentation at the 2022 annual Internal Medicine Meeting of the American College of Physicians.

“About 10% of adult visits and 20% of pediatric visits will result in an antibiotic prescription,” said Dr. Cutrell, noting that prescribing patterns vary widely across the country, with as much as a three-fold difference in some locations. But at least 30% of outpatient antibiotic prescriptions are inappropriately ordered, he said.

“When we look at acute respiratory infections, upwards of 50% are not indicated at all,” he said. Imagine, he added, if the same error rate applied to other medical practices: “What if surgeons were only right 50% of the time, or if the oncologist was only giving the right treatment 50% of the time?”

The most recent Antibiotic Threats Report from the U.S. Centers for Disease Control and Prevention estimated that antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and about 36,000 deaths annually in the United States alone.
 

How to be a better steward

The core elements for antimicrobial stewardship in the outpatient setting, according to Dr. Cutrell, include making a commitment to optimize prescribing, implementing at least one policy or practice to improve prescribing, monitoring prescribing practices and offering feedback to clinicians, and educating both patients and clinicians.

All that is similar to in-patient stewardship, he said, but outpatient clinicians face a few unique challenges. “Patients are lower acuity, and there is less diagnostic data, and program resources and time are more limited,” he said. Patient satisfaction is also a major driver, and it is also more difficult to measure and track ambulatory antibiotic use.

Interventions have been identified, however, that can help improve stewardship. One is auditing and feedback with peers. “Another [is] commitment posters, which can be placed around the clinic, and that helps set the culture,” he said. “Clinical education and practice guidelines are also important.”

Clinicians should also:

• Observe antibiotic best practices
• Optimize antibiotic selection and dosing
• Practice effective diagnostic stewardship
• Use the shortest duration of therapy necessary
• Avoid antibiotics for inappropriate indications
• Educate patients on when antibiotics are needed
• Follow and become good antibiotic stewardship mentors

“Multiple antibiotic stewardship interventions are effective, particularly those focused on behavioral interventions,” Dr. Cutrell said. “Every provider should follow antibiotic ‘best practices’ and other simple steps to prescribe antibiotics more wisely and to improve patient care.”

Dr. Cutrell reported financial relationships with Gilead Sciences and Regeneron Pharmaceuticals.

A version of this article first appeared on Medscape.com.

Is fear of missing an infection – call it “FOMI” – leading you to overprescribe antibiotics to your patients?   

Inappropriate use of antibiotics can result in adverse events and toxicity, superinfections such as Clostridioides difficile and Methicillin-resistant Staphylococcus aureus, excess mortality and costs, and resistance to the drugs.   

All that has been well-known for years, and antibiotic resistance has become a leading public health concern. So why are physicians continuing to overprescribe the drugs?

Speaking at the 2022 annual Internal Medicine Meeting of the American College of Physicians, James “Brad” Cutrell, MD, medical director of antimicrobial stewardship, University of Texas Southwestern Medical Center, Dallas, said clinicians in the United States and elsewhere appear to be falling into a three-part fallacy when it comes to using the drugs: fear of “missing an infection,” coupled with patient expectations that they will leave the office with a prescription and combined with an overemphasis on the potential benefit to the individual at the expense of the risk to society of antibiotic resistance.

Antibiotics are the only drugs that lose their efficacy for all patients over time the more they are used. “For example, if I give a beta blocker to a patient, it’s not going to affect other patients down the road,” Dr. Cutrell said. “It’s not going to lose its efficacy.”

“What we need in medicine is a new culture around antibiotic use,” Dr. Cutrell added. “We need more respect for the dangers of antibiotic misuse and to have confidence in [their] benefits and when they can be used wisely.”
 

Rampant misuse

Outpatient prescriptions account for at least 60% of antibiotic use in the United States. The rate is even higher in other countries, Dr. Cutrell said during a presentation at the 2022 annual Internal Medicine Meeting of the American College of Physicians.

“About 10% of adult visits and 20% of pediatric visits will result in an antibiotic prescription,” said Dr. Cutrell, noting that prescribing patterns vary widely across the country, with as much as a three-fold difference in some locations. But at least 30% of outpatient antibiotic prescriptions are inappropriately ordered, he said.

“When we look at acute respiratory infections, upwards of 50% are not indicated at all,” he said. Imagine, he added, if the same error rate applied to other medical practices: “What if surgeons were only right 50% of the time, or if the oncologist was only giving the right treatment 50% of the time?”

The most recent Antibiotic Threats Report from the U.S. Centers for Disease Control and Prevention estimated that antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and about 36,000 deaths annually in the United States alone.
 

How to be a better steward

The core elements for antimicrobial stewardship in the outpatient setting, according to Dr. Cutrell, include making a commitment to optimize prescribing, implementing at least one policy or practice to improve prescribing, monitoring prescribing practices and offering feedback to clinicians, and educating both patients and clinicians.

All that is similar to in-patient stewardship, he said, but outpatient clinicians face a few unique challenges. “Patients are lower acuity, and there is less diagnostic data, and program resources and time are more limited,” he said. Patient satisfaction is also a major driver, and it is also more difficult to measure and track ambulatory antibiotic use.

Interventions have been identified, however, that can help improve stewardship. One is auditing and feedback with peers. “Another [is] commitment posters, which can be placed around the clinic, and that helps set the culture,” he said. “Clinical education and practice guidelines are also important.”

Clinicians should also:

• Observe antibiotic best practices
• Optimize antibiotic selection and dosing
• Practice effective diagnostic stewardship
• Use the shortest duration of therapy necessary
• Avoid antibiotics for inappropriate indications
• Educate patients on when antibiotics are needed
• Follow and become good antibiotic stewardship mentors

“Multiple antibiotic stewardship interventions are effective, particularly those focused on behavioral interventions,” Dr. Cutrell said. “Every provider should follow antibiotic ‘best practices’ and other simple steps to prescribe antibiotics more wisely and to improve patient care.”

Dr. Cutrell reported financial relationships with Gilead Sciences and Regeneron Pharmaceuticals.

A version of this article first appeared on Medscape.com.

Is fear of missing an infection – call it “FOMI” – leading you to overprescribe antibiotics to your patients?   

Inappropriate use of antibiotics can result in adverse events and toxicity, superinfections such as Clostridioides difficile and Methicillin-resistant Staphylococcus aureus, excess mortality and costs, and resistance to the drugs.   

All that has been well-known for years, and antibiotic resistance has become a leading public health concern. So why are physicians continuing to overprescribe the drugs?

Speaking at the 2022 annual Internal Medicine Meeting of the American College of Physicians, James “Brad” Cutrell, MD, medical director of antimicrobial stewardship, University of Texas Southwestern Medical Center, Dallas, said clinicians in the United States and elsewhere appear to be falling into a three-part fallacy when it comes to using the drugs: fear of “missing an infection,” coupled with patient expectations that they will leave the office with a prescription and combined with an overemphasis on the potential benefit to the individual at the expense of the risk to society of antibiotic resistance.

Antibiotics are the only drugs that lose their efficacy for all patients over time the more they are used. “For example, if I give a beta blocker to a patient, it’s not going to affect other patients down the road,” Dr. Cutrell said. “It’s not going to lose its efficacy.”

“What we need in medicine is a new culture around antibiotic use,” Dr. Cutrell added. “We need more respect for the dangers of antibiotic misuse and to have confidence in [their] benefits and when they can be used wisely.”
 

Rampant misuse

Outpatient prescriptions account for at least 60% of antibiotic use in the United States. The rate is even higher in other countries, Dr. Cutrell said during a presentation at the 2022 annual Internal Medicine Meeting of the American College of Physicians.

“About 10% of adult visits and 20% of pediatric visits will result in an antibiotic prescription,” said Dr. Cutrell, noting that prescribing patterns vary widely across the country, with as much as a three-fold difference in some locations. But at least 30% of outpatient antibiotic prescriptions are inappropriately ordered, he said.

“When we look at acute respiratory infections, upwards of 50% are not indicated at all,” he said. Imagine, he added, if the same error rate applied to other medical practices: “What if surgeons were only right 50% of the time, or if the oncologist was only giving the right treatment 50% of the time?”

The most recent Antibiotic Threats Report from the U.S. Centers for Disease Control and Prevention estimated that antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and about 36,000 deaths annually in the United States alone.
 

How to be a better steward

The core elements for antimicrobial stewardship in the outpatient setting, according to Dr. Cutrell, include making a commitment to optimize prescribing, implementing at least one policy or practice to improve prescribing, monitoring prescribing practices and offering feedback to clinicians, and educating both patients and clinicians.

All that is similar to in-patient stewardship, he said, but outpatient clinicians face a few unique challenges. “Patients are lower acuity, and there is less diagnostic data, and program resources and time are more limited,” he said. Patient satisfaction is also a major driver, and it is also more difficult to measure and track ambulatory antibiotic use.

Interventions have been identified, however, that can help improve stewardship. One is auditing and feedback with peers. “Another [is] commitment posters, which can be placed around the clinic, and that helps set the culture,” he said. “Clinical education and practice guidelines are also important.”

Clinicians should also:

• Observe antibiotic best practices
• Optimize antibiotic selection and dosing
• Practice effective diagnostic stewardship
• Use the shortest duration of therapy necessary
• Avoid antibiotics for inappropriate indications
• Educate patients on when antibiotics are needed
• Follow and become good antibiotic stewardship mentors

“Multiple antibiotic stewardship interventions are effective, particularly those focused on behavioral interventions,” Dr. Cutrell said. “Every provider should follow antibiotic ‘best practices’ and other simple steps to prescribe antibiotics more wisely and to improve patient care.”

Dr. Cutrell reported financial relationships with Gilead Sciences and Regeneron Pharmaceuticals.

A version of this article first appeared on Medscape.com.

New research suggests physicians face a Herculean task to get Americans with atherosclerotic cardiovascular disease (ASCVD) to take high-intensity statins, despite multiple professional guidelines giving the therapy their highest level recommendation.

Results from more 600,000 commercially insured patients with established ASCVD showed:

• Only one in five patients (22.5%) were taking a high-intensity statin.
• 27.6% were taking a low- or moderate-intensity statin.
• One-half (49.9%) were not taking any statin.

“It’s embarrassing,” senior author Christopher B. Granger, MD, Duke Clinical Research Institute, Durham, N.C., told this news organization. “It should be embarrassing for anybody in health care that we do such a terrible job with something so simple and effective.”

The results were published in the Journal of the American College of Cardiology.

Statins have been shown to reduce the risk for ASCVD events by about 30%, with an added 15% reduction with a high-intensity formulation. The class I recommendation for high-intensity statin use in ASCVD patients younger than 75 years in the 2013 American College of Cardiology/American Heart Association cholesterol guidelines prompted a jump in prescriptions that plateaued by 2017.

A class II recommendation was added to the 2018 guideline update for high-intensity statins in adults older than 75 years with ASCVD. But underuse persists, despite falling prices with generic availability and initiatives to improve statin adoption, the authors noted.

“There are a lot of barriers for patients to statin use, including the misinformation on the Internet and elsewhere that statins have all kinds of side effects,” Dr. Granger said. “They have uncommon side effects, but when we look at it carefully, only about 10% of patients, even with statin intolerance, have true intolerance.”

Efforts are needed to better understand and address these barriers, particularly for younger and female patients, he noted.

In multivariate analyses, patients who were middle-aged (odds ratio, 2.66) or at least 75 years of age (OR, 2.09) were more than twice as likely as patients younger than 45 years to be on any statin.

Not surprisingly, women were 30% less likely than men to receive a statin (OR, 0.70), Dr. Granger said. A high Charlson comorbidity score (OR, 0.72) and peripheral artery disease (OR, 0.55) also reduced the odds of a statin prescription.

Among statin users, middle-aged (OR, 0.83) and older (OR, 0.44) patients were less likely to be on a high-intensity statin, as were women (OR, 0.68) and patients with peripheral artery disease (OR, 0.43).

Visiting a cardiologist in the previous 12 months, however, increased the odds a patient was on a high-intensity statin (OR, 1.21), as did the use of other LDL-cholesterol-lowering drugs (OR, 1.44).

“With no evidence of heterogeneity in efficacy by sex, ongoing work must not only address misperceptions and barriers to the prescription of high-intensity statins in women, but also further understand (and address) differences in tolerability, which may be related to sex-based variation in statin metabolism,” wrote the authors, led by Adam J. Nelson, MBBS, MBA, MPH, also from Duke.

The study involved 601,934 patients (mean age, 67.5 years) who had a diagnosis of ASCVD between Jan. 31, 2018, and an index date of Jan. 31, 2019, and were enrolled in the HealthCore Integrated Research Environment database.

Two-thirds (70.9%) of patients visited a cardiologist in the 12 months prior to the index date, and three-fourths (81.3%) visited a primary care provider.

Pharmacy claims for the 12 months after the index date showed 82.8% of high-intensity users at index achieved coverage for at least 75% of days. Those with the least adherence (< 50% of days covered) included younger patients, as well as those with chronic kidney disease or depression.

“We need implementation research. What are the tools and the methods that we can use to improve the proportion of patients who are having the life-saving benefits from statins?” Dr. Granger said.

He noted that the team has submitted a National Institutes of Health grant to try to use pharmacists, as a mechanism within the context of health systems and payer systems, to improve the appropriate use of statins in a randomized trial. “I think that’s a win.”

Salim S. Virani, MD, PhD, Baylor College of Medicine, and Michael DeBakey VA Medical Center, Houston, and colleagues point out in a related editorial that the rates of statin usage in the study are “considerably lower” than in other contemporary studies, where about 80% and 50% of ASCVD patients are receiving statins and high-intensity statins, respectively.

Possible explanations are the use of rule-out codes, a short medication fill window from the index date, or issues with medication capture, they said. “Nevertheless, the findings are largely consistent with other work highlighting low use of statin therapy.”

The editorialists said social media, statin-related adverse effects, and therapeutic inertia are key drivers of non–guideline-concordant statin use. Possible solutions include improving guideline dissemination, leveraging team-based care, using smart clinical decision-support tools at the point of care, and identifying trustworthy and easily understood sources of information for patients.

“We can only hope that the fate of statin therapy is not repeated with sodium-glucose cotranspoerter-2 inhibitors or glucagon-like peptide-1 receptor agonists in another 30 years, or worse yet, that continued gaps in statin therapy use in patients with ASCVD persist 30 years from now,” Dr. Virani and colleagues concluded.

A sliver of optimism?

A research letter by Colantonio et al. in the same issue of JACC points to some positive steps, at least among patients having a myocardial infarction (MI). It reported that the percentage of patients who received a high-intensity statin as their first statin prescription 30 days after MI jumped from 30.7% in the first quarter of 2011 to 78.6% in the fourth quarter of 2019.

Similar increases were reported by race/ethnicity, despite statin use previously shown to be lower among non-Hispanic Black patients with ASCVD. In each calendar year, however, high-intensity statin therapy was lower among patients older than 75 years and among women.

Dr. Granger disclosed ties with Boehringer Ingelheim, Bristol Myers Squibb, Janssen Pharmaceuticals, Pfizer, AKROS, Apple, AstraZeneca, Daiichi Sankyo, Food and Drug Administration, GlaxoSmithKline, Medtronic Foundation, Novartis Pharmaceuticals, AbbVie, Bayer, Boston Scientific, CeleCor Therapeutics, Correvio, Espero BioPharma, Medscape, Medtronic, Merck, National Institutes of Health, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Virani disclosed ties with the Department of Veterans Affairs, the National Institutes of Health, the World Heart Federation, and the Jooma and Tahir Family, and the American College of Cardiology.

A version of this article first appeared on Medscape.com.

New research suggests physicians face a Herculean task to get Americans with atherosclerotic cardiovascular disease (ASCVD) to take high-intensity statins, despite multiple professional guidelines giving the therapy their highest level recommendation.

Results from more 600,000 commercially insured patients with established ASCVD showed:

• Only one in five patients (22.5%) were taking a high-intensity statin.
• 27.6% were taking a low- or moderate-intensity statin.
• One-half (49.9%) were not taking any statin.

“It’s embarrassing,” senior author Christopher B. Granger, MD, Duke Clinical Research Institute, Durham, N.C., told this news organization. “It should be embarrassing for anybody in health care that we do such a terrible job with something so simple and effective.”

The results were published in the Journal of the American College of Cardiology.

Statins have been shown to reduce the risk for ASCVD events by about 30%, with an added 15% reduction with a high-intensity formulation. The class I recommendation for high-intensity statin use in ASCVD patients younger than 75 years in the 2013 American College of Cardiology/American Heart Association cholesterol guidelines prompted a jump in prescriptions that plateaued by 2017.

A class II recommendation was added to the 2018 guideline update for high-intensity statins in adults older than 75 years with ASCVD. But underuse persists, despite falling prices with generic availability and initiatives to improve statin adoption, the authors noted.

“There are a lot of barriers for patients to statin use, including the misinformation on the Internet and elsewhere that statins have all kinds of side effects,” Dr. Granger said. “They have uncommon side effects, but when we look at it carefully, only about 10% of patients, even with statin intolerance, have true intolerance.”

Efforts are needed to better understand and address these barriers, particularly for younger and female patients, he noted.

In multivariate analyses, patients who were middle-aged (odds ratio, 2.66) or at least 75 years of age (OR, 2.09) were more than twice as likely as patients younger than 45 years to be on any statin.

Not surprisingly, women were 30% less likely than men to receive a statin (OR, 0.70), Dr. Granger said. A high Charlson comorbidity score (OR, 0.72) and peripheral artery disease (OR, 0.55) also reduced the odds of a statin prescription.

Among statin users, middle-aged (OR, 0.83) and older (OR, 0.44) patients were less likely to be on a high-intensity statin, as were women (OR, 0.68) and patients with peripheral artery disease (OR, 0.43).

Visiting a cardiologist in the previous 12 months, however, increased the odds a patient was on a high-intensity statin (OR, 1.21), as did the use of other LDL-cholesterol-lowering drugs (OR, 1.44).

“With no evidence of heterogeneity in efficacy by sex, ongoing work must not only address misperceptions and barriers to the prescription of high-intensity statins in women, but also further understand (and address) differences in tolerability, which may be related to sex-based variation in statin metabolism,” wrote the authors, led by Adam J. Nelson, MBBS, MBA, MPH, also from Duke.

The study involved 601,934 patients (mean age, 67.5 years) who had a diagnosis of ASCVD between Jan. 31, 2018, and an index date of Jan. 31, 2019, and were enrolled in the HealthCore Integrated Research Environment database.

Two-thirds (70.9%) of patients visited a cardiologist in the 12 months prior to the index date, and three-fourths (81.3%) visited a primary care provider.

Pharmacy claims for the 12 months after the index date showed 82.8% of high-intensity users at index achieved coverage for at least 75% of days. Those with the least adherence (< 50% of days covered) included younger patients, as well as those with chronic kidney disease or depression.

“We need implementation research. What are the tools and the methods that we can use to improve the proportion of patients who are having the life-saving benefits from statins?” Dr. Granger said.

He noted that the team has submitted a National Institutes of Health grant to try to use pharmacists, as a mechanism within the context of health systems and payer systems, to improve the appropriate use of statins in a randomized trial. “I think that’s a win.”

Salim S. Virani, MD, PhD, Baylor College of Medicine, and Michael DeBakey VA Medical Center, Houston, and colleagues point out in a related editorial that the rates of statin usage in the study are “considerably lower” than in other contemporary studies, where about 80% and 50% of ASCVD patients are receiving statins and high-intensity statins, respectively.

Possible explanations are the use of rule-out codes, a short medication fill window from the index date, or issues with medication capture, they said. “Nevertheless, the findings are largely consistent with other work highlighting low use of statin therapy.”

The editorialists said social media, statin-related adverse effects, and therapeutic inertia are key drivers of non–guideline-concordant statin use. Possible solutions include improving guideline dissemination, leveraging team-based care, using smart clinical decision-support tools at the point of care, and identifying trustworthy and easily understood sources of information for patients.

“We can only hope that the fate of statin therapy is not repeated with sodium-glucose cotranspoerter-2 inhibitors or glucagon-like peptide-1 receptor agonists in another 30 years, or worse yet, that continued gaps in statin therapy use in patients with ASCVD persist 30 years from now,” Dr. Virani and colleagues concluded.

A sliver of optimism?

A research letter by Colantonio et al. in the same issue of JACC points to some positive steps, at least among patients having a myocardial infarction (MI). It reported that the percentage of patients who received a high-intensity statin as their first statin prescription 30 days after MI jumped from 30.7% in the first quarter of 2011 to 78.6% in the fourth quarter of 2019.

Similar increases were reported by race/ethnicity, despite statin use previously shown to be lower among non-Hispanic Black patients with ASCVD. In each calendar year, however, high-intensity statin therapy was lower among patients older than 75 years and among women.

Dr. Granger disclosed ties with Boehringer Ingelheim, Bristol Myers Squibb, Janssen Pharmaceuticals, Pfizer, AKROS, Apple, AstraZeneca, Daiichi Sankyo, Food and Drug Administration, GlaxoSmithKline, Medtronic Foundation, Novartis Pharmaceuticals, AbbVie, Bayer, Boston Scientific, CeleCor Therapeutics, Correvio, Espero BioPharma, Medscape, Medtronic, Merck, National Institutes of Health, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Virani disclosed ties with the Department of Veterans Affairs, the National Institutes of Health, the World Heart Federation, and the Jooma and Tahir Family, and the American College of Cardiology.

A version of this article first appeared on Medscape.com.

New research suggests physicians face a Herculean task to get Americans with atherosclerotic cardiovascular disease (ASCVD) to take high-intensity statins, despite multiple professional guidelines giving the therapy their highest level recommendation.

Results from more 600,000 commercially insured patients with established ASCVD showed:

• Only one in five patients (22.5%) were taking a high-intensity statin.
• 27.6% were taking a low- or moderate-intensity statin.
• One-half (49.9%) were not taking any statin.

“It’s embarrassing,” senior author Christopher B. Granger, MD, Duke Clinical Research Institute, Durham, N.C., told this news organization. “It should be embarrassing for anybody in health care that we do such a terrible job with something so simple and effective.”

The results were published in the Journal of the American College of Cardiology.

Statins have been shown to reduce the risk for ASCVD events by about 30%, with an added 15% reduction with a high-intensity formulation. The class I recommendation for high-intensity statin use in ASCVD patients younger than 75 years in the 2013 American College of Cardiology/American Heart Association cholesterol guidelines prompted a jump in prescriptions that plateaued by 2017.

A class II recommendation was added to the 2018 guideline update for high-intensity statins in adults older than 75 years with ASCVD. But underuse persists, despite falling prices with generic availability and initiatives to improve statin adoption, the authors noted.

“There are a lot of barriers for patients to statin use, including the misinformation on the Internet and elsewhere that statins have all kinds of side effects,” Dr. Granger said. “They have uncommon side effects, but when we look at it carefully, only about 10% of patients, even with statin intolerance, have true intolerance.”

Efforts are needed to better understand and address these barriers, particularly for younger and female patients, he noted.

In multivariate analyses, patients who were middle-aged (odds ratio, 2.66) or at least 75 years of age (OR, 2.09) were more than twice as likely as patients younger than 45 years to be on any statin.

Not surprisingly, women were 30% less likely than men to receive a statin (OR, 0.70), Dr. Granger said. A high Charlson comorbidity score (OR, 0.72) and peripheral artery disease (OR, 0.55) also reduced the odds of a statin prescription.

Among statin users, middle-aged (OR, 0.83) and older (OR, 0.44) patients were less likely to be on a high-intensity statin, as were women (OR, 0.68) and patients with peripheral artery disease (OR, 0.43).

Visiting a cardiologist in the previous 12 months, however, increased the odds a patient was on a high-intensity statin (OR, 1.21), as did the use of other LDL-cholesterol-lowering drugs (OR, 1.44).

“With no evidence of heterogeneity in efficacy by sex, ongoing work must not only address misperceptions and barriers to the prescription of high-intensity statins in women, but also further understand (and address) differences in tolerability, which may be related to sex-based variation in statin metabolism,” wrote the authors, led by Adam J. Nelson, MBBS, MBA, MPH, also from Duke.

The study involved 601,934 patients (mean age, 67.5 years) who had a diagnosis of ASCVD between Jan. 31, 2018, and an index date of Jan. 31, 2019, and were enrolled in the HealthCore Integrated Research Environment database.

Two-thirds (70.9%) of patients visited a cardiologist in the 12 months prior to the index date, and three-fourths (81.3%) visited a primary care provider.

Pharmacy claims for the 12 months after the index date showed 82.8% of high-intensity users at index achieved coverage for at least 75% of days. Those with the least adherence (< 50% of days covered) included younger patients, as well as those with chronic kidney disease or depression.

“We need implementation research. What are the tools and the methods that we can use to improve the proportion of patients who are having the life-saving benefits from statins?” Dr. Granger said.

He noted that the team has submitted a National Institutes of Health grant to try to use pharmacists, as a mechanism within the context of health systems and payer systems, to improve the appropriate use of statins in a randomized trial. “I think that’s a win.”

Salim S. Virani, MD, PhD, Baylor College of Medicine, and Michael DeBakey VA Medical Center, Houston, and colleagues point out in a related editorial that the rates of statin usage in the study are “considerably lower” than in other contemporary studies, where about 80% and 50% of ASCVD patients are receiving statins and high-intensity statins, respectively.

Possible explanations are the use of rule-out codes, a short medication fill window from the index date, or issues with medication capture, they said. “Nevertheless, the findings are largely consistent with other work highlighting low use of statin therapy.”

The editorialists said social media, statin-related adverse effects, and therapeutic inertia are key drivers of non–guideline-concordant statin use. Possible solutions include improving guideline dissemination, leveraging team-based care, using smart clinical decision-support tools at the point of care, and identifying trustworthy and easily understood sources of information for patients.

“We can only hope that the fate of statin therapy is not repeated with sodium-glucose cotranspoerter-2 inhibitors or glucagon-like peptide-1 receptor agonists in another 30 years, or worse yet, that continued gaps in statin therapy use in patients with ASCVD persist 30 years from now,” Dr. Virani and colleagues concluded.

A sliver of optimism?

A research letter by Colantonio et al. in the same issue of JACC points to some positive steps, at least among patients having a myocardial infarction (MI). It reported that the percentage of patients who received a high-intensity statin as their first statin prescription 30 days after MI jumped from 30.7% in the first quarter of 2011 to 78.6% in the fourth quarter of 2019.

Similar increases were reported by race/ethnicity, despite statin use previously shown to be lower among non-Hispanic Black patients with ASCVD. In each calendar year, however, high-intensity statin therapy was lower among patients older than 75 years and among women.

Dr. Granger disclosed ties with Boehringer Ingelheim, Bristol Myers Squibb, Janssen Pharmaceuticals, Pfizer, AKROS, Apple, AstraZeneca, Daiichi Sankyo, Food and Drug Administration, GlaxoSmithKline, Medtronic Foundation, Novartis Pharmaceuticals, AbbVie, Bayer, Boston Scientific, CeleCor Therapeutics, Correvio, Espero BioPharma, Medscape, Medtronic, Merck, National Institutes of Health, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Virani disclosed ties with the Department of Veterans Affairs, the National Institutes of Health, the World Heart Federation, and the Jooma and Tahir Family, and the American College of Cardiology.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.

Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.

Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.

The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.

Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.

The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).

Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.

Read the complete prescribing information here.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.

Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.

Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.

The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.

Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.

The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).

Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.

Read the complete prescribing information here.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.

Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.

Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.

The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.

Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.

The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).

Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.

Read the complete prescribing information here.

A version of this article first appeared on Medscape.com.

LISBON – Two-thirds of antibiotic prescriptions written for Black patients and more than half of antibiotic prescriptions for Hispanic/Latinx patients are inappropriate, according to data from a study of antibiotic prescribing habits in U.S. doctors’ offices, hospital clinics, and emergency departments.

Eric Young, PharmD, PhD, from the University of Texas at Austin, and UT Health, San Antonio, presented his work as a poster at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022.

“We were really surprised mainly by the racial findings, because Black patients have the highest overall and the highest inappropriate prescribing of antibiotics,” he told this news organization. “There was also a difference seen for age [across all ethnicities].”

Pediatric patients were found to have high overall prescribing but, notably, the lowest inappropriate prescribing among all the patient groups, reported Dr. Young. “This is interesting because oftentimes we think the more antibiotics are prescribed, then surely the greater the inappropriate prescribing would be too, but pediatricians actually have one of the lowest rates of inappropriate antibiotic prescribing. They do a great job.”

The study included more than 7 billion patient visits, 11.3% of which involved an antibiotic prescription.

The rate of antibiotic prescribing was 122 per 1,000 visits in Black patients and 139 per 1,000 visits in Hispanic patients, while in White patients, the rate was 109 per 1,000 visits. The rate was 114 per 1,000 visits in patients younger than 18 years and 170 per 1,000 visits in females.

Dr. Young found that almost 64% of antibiotic prescriptions written for Black patients and 58% for Hispanic patients were inappropriate. For White patients, the rate of inappropriate antibiotic prescribing was 56%. Similarly, 74% of prescriptions dispensed to patients aged 65 years and older and 58% to males were deemed inappropriate.

Kajal Bhakta, PharmD, BCACP, ambulatory care clinical pharmacist, University Health System, UT Health Science Center San Antonio, who was not involved in the study, pointed out that antibiotics are frequently prescribed without confirmation of an infection, owing to the fact that the verification process may delay care, especially in the outpatient setting.

Dr. Bhakta said that overprescribing in the elderly population and in certain ethnic groups was “likely due to socioeconomic and cultural factors. These prescribing methods may lead to unnecessary drug side effects and/or antimicrobial resistance.”

Regarding the patient-doctor consultation process, she pointed out that “older patients may have trouble describing their symptoms, and when those symptoms remain unresolved, providers may be more inclined to prescribe antibiotics to help.”

Sometimes overprescribing can occur because of the logistics involved in getting to the doctor’s office in the outpatient setting. “Sometimes patients struggle with transportation, as two separate trips to the doctor and pharmacy may not be feasible. Additionally, these same patients may have limited access to health care and therefore may use an urgent care facility for their acute infection–like symptoms,” Dr. Bhakta explained.

Dr. Young, who is of Asian descent, first became interested in disparities in health care when he noticed that ethnic minority groups showed greater hesitancy toward COVID-19 vaccination. “I noticed that there weren’t many Asians involved in previous trials and realized at this point that disparities were rampant.”

Dr. Young had been involved in investigating the overall use and the inappropriate use of antibiotics across the whole U.S. population when his interest in health disparities prompted him to study these patterns in specific demographic groups.

“Most previous data are derived from inpatient studies where the physician is giving the antibiotics,” said Dr. Young, who looked specifically at outpatient prescribing.

Dr. Young used prescribing data from the Centers for Disease Control and Prevention’s National Ambulatory Medical Care Survey, which covers more than 5.7 billion adult (aged 18 and older) and 1.3 billion child visits to outpatient practices between 2009 and 2016 across all 50 U.S. states and Washington, D.C.

He gathered patient data on ICD-9-CM and ICD-10 diagnostic codes for infections and for diagnoses that “appeared like infections.” All of the patients who were included had received at least one oral antibiotic. Antibiotic prescribing was defined as visits that included an antibiotic per 1,000 total patient visits.

On the basis of previous research, Dr. Young and his colleagues then determined whether each antibiotic prescription was appropriate, possibly appropriate, or inappropriate. Patient demographics included age (younger than 18 years, 18-64 years, and older than 64 years), sex (male or female), race, and ethnicity (White, Black, more than one race, Hispanic/Latinx, and other). These data were used to evaluate overall and inappropriate use.

“The health care community needs to be really careful with the judicious use of antibiotics,” Dr. Young said. “We have good guidelines on antimicrobial stewardship both in the inpatient and outpatient settings, but sometimes we overlook the disparities and cultural implications held by some patients.”

Typical examples of socioeconomic and cultural factors at play included patients not being able to afford the antibiotics, having limited access to care, or not returning for a follow-up visit for whatever reason.

“Patients of Black and Hispanic descent often don’t have the same degree of established care that many White patients have,” Dr. Young noted.

In the future, Dr. Young wants to conduct research into whether patients are actually taking their prescribed antibiotics, as well as their outcomes. For example, he would like to investigate whether rates of antibiotic resistance or Clostridioides difficile infection are higher among Black patients.

Dr. Young and Dr. Bhakta have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LISBON – Two-thirds of antibiotic prescriptions written for Black patients and more than half of antibiotic prescriptions for Hispanic/Latinx patients are inappropriate, according to data from a study of antibiotic prescribing habits in U.S. doctors’ offices, hospital clinics, and emergency departments.

Eric Young, PharmD, PhD, from the University of Texas at Austin, and UT Health, San Antonio, presented his work as a poster at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022.

“We were really surprised mainly by the racial findings, because Black patients have the highest overall and the highest inappropriate prescribing of antibiotics,” he told this news organization. “There was also a difference seen for age [across all ethnicities].”

Pediatric patients were found to have high overall prescribing but, notably, the lowest inappropriate prescribing among all the patient groups, reported Dr. Young. “This is interesting because oftentimes we think the more antibiotics are prescribed, then surely the greater the inappropriate prescribing would be too, but pediatricians actually have one of the lowest rates of inappropriate antibiotic prescribing. They do a great job.”

The study included more than 7 billion patient visits, 11.3% of which involved an antibiotic prescription.

The rate of antibiotic prescribing was 122 per 1,000 visits in Black patients and 139 per 1,000 visits in Hispanic patients, while in White patients, the rate was 109 per 1,000 visits. The rate was 114 per 1,000 visits in patients younger than 18 years and 170 per 1,000 visits in females.

Dr. Young found that almost 64% of antibiotic prescriptions written for Black patients and 58% for Hispanic patients were inappropriate. For White patients, the rate of inappropriate antibiotic prescribing was 56%. Similarly, 74% of prescriptions dispensed to patients aged 65 years and older and 58% to males were deemed inappropriate.

Kajal Bhakta, PharmD, BCACP, ambulatory care clinical pharmacist, University Health System, UT Health Science Center San Antonio, who was not involved in the study, pointed out that antibiotics are frequently prescribed without confirmation of an infection, owing to the fact that the verification process may delay care, especially in the outpatient setting.

Dr. Bhakta said that overprescribing in the elderly population and in certain ethnic groups was “likely due to socioeconomic and cultural factors. These prescribing methods may lead to unnecessary drug side effects and/or antimicrobial resistance.”

Regarding the patient-doctor consultation process, she pointed out that “older patients may have trouble describing their symptoms, and when those symptoms remain unresolved, providers may be more inclined to prescribe antibiotics to help.”

Sometimes overprescribing can occur because of the logistics involved in getting to the doctor’s office in the outpatient setting. “Sometimes patients struggle with transportation, as two separate trips to the doctor and pharmacy may not be feasible. Additionally, these same patients may have limited access to health care and therefore may use an urgent care facility for their acute infection–like symptoms,” Dr. Bhakta explained.

Dr. Young, who is of Asian descent, first became interested in disparities in health care when he noticed that ethnic minority groups showed greater hesitancy toward COVID-19 vaccination. “I noticed that there weren’t many Asians involved in previous trials and realized at this point that disparities were rampant.”

Dr. Young had been involved in investigating the overall use and the inappropriate use of antibiotics across the whole U.S. population when his interest in health disparities prompted him to study these patterns in specific demographic groups.

“Most previous data are derived from inpatient studies where the physician is giving the antibiotics,” said Dr. Young, who looked specifically at outpatient prescribing.

Dr. Young used prescribing data from the Centers for Disease Control and Prevention’s National Ambulatory Medical Care Survey, which covers more than 5.7 billion adult (aged 18 and older) and 1.3 billion child visits to outpatient practices between 2009 and 2016 across all 50 U.S. states and Washington, D.C.

He gathered patient data on ICD-9-CM and ICD-10 diagnostic codes for infections and for diagnoses that “appeared like infections.” All of the patients who were included had received at least one oral antibiotic. Antibiotic prescribing was defined as visits that included an antibiotic per 1,000 total patient visits.

On the basis of previous research, Dr. Young and his colleagues then determined whether each antibiotic prescription was appropriate, possibly appropriate, or inappropriate. Patient demographics included age (younger than 18 years, 18-64 years, and older than 64 years), sex (male or female), race, and ethnicity (White, Black, more than one race, Hispanic/Latinx, and other). These data were used to evaluate overall and inappropriate use.

“The health care community needs to be really careful with the judicious use of antibiotics,” Dr. Young said. “We have good guidelines on antimicrobial stewardship both in the inpatient and outpatient settings, but sometimes we overlook the disparities and cultural implications held by some patients.”

Typical examples of socioeconomic and cultural factors at play included patients not being able to afford the antibiotics, having limited access to care, or not returning for a follow-up visit for whatever reason.

“Patients of Black and Hispanic descent often don’t have the same degree of established care that many White patients have,” Dr. Young noted.

In the future, Dr. Young wants to conduct research into whether patients are actually taking their prescribed antibiotics, as well as their outcomes. For example, he would like to investigate whether rates of antibiotic resistance or Clostridioides difficile infection are higher among Black patients.

Dr. Young and Dr. Bhakta have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LISBON – Two-thirds of antibiotic prescriptions written for Black patients and more than half of antibiotic prescriptions for Hispanic/Latinx patients are inappropriate, according to data from a study of antibiotic prescribing habits in U.S. doctors’ offices, hospital clinics, and emergency departments.

Eric Young, PharmD, PhD, from the University of Texas at Austin, and UT Health, San Antonio, presented his work as a poster at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022.

“We were really surprised mainly by the racial findings, because Black patients have the highest overall and the highest inappropriate prescribing of antibiotics,” he told this news organization. “There was also a difference seen for age [across all ethnicities].”

Pediatric patients were found to have high overall prescribing but, notably, the lowest inappropriate prescribing among all the patient groups, reported Dr. Young. “This is interesting because oftentimes we think the more antibiotics are prescribed, then surely the greater the inappropriate prescribing would be too, but pediatricians actually have one of the lowest rates of inappropriate antibiotic prescribing. They do a great job.”

The study included more than 7 billion patient visits, 11.3% of which involved an antibiotic prescription.

The rate of antibiotic prescribing was 122 per 1,000 visits in Black patients and 139 per 1,000 visits in Hispanic patients, while in White patients, the rate was 109 per 1,000 visits. The rate was 114 per 1,000 visits in patients younger than 18 years and 170 per 1,000 visits in females.

Dr. Young found that almost 64% of antibiotic prescriptions written for Black patients and 58% for Hispanic patients were inappropriate. For White patients, the rate of inappropriate antibiotic prescribing was 56%. Similarly, 74% of prescriptions dispensed to patients aged 65 years and older and 58% to males were deemed inappropriate.

Kajal Bhakta, PharmD, BCACP, ambulatory care clinical pharmacist, University Health System, UT Health Science Center San Antonio, who was not involved in the study, pointed out that antibiotics are frequently prescribed without confirmation of an infection, owing to the fact that the verification process may delay care, especially in the outpatient setting.

Dr. Bhakta said that overprescribing in the elderly population and in certain ethnic groups was “likely due to socioeconomic and cultural factors. These prescribing methods may lead to unnecessary drug side effects and/or antimicrobial resistance.”

Regarding the patient-doctor consultation process, she pointed out that “older patients may have trouble describing their symptoms, and when those symptoms remain unresolved, providers may be more inclined to prescribe antibiotics to help.”

Sometimes overprescribing can occur because of the logistics involved in getting to the doctor’s office in the outpatient setting. “Sometimes patients struggle with transportation, as two separate trips to the doctor and pharmacy may not be feasible. Additionally, these same patients may have limited access to health care and therefore may use an urgent care facility for their acute infection–like symptoms,” Dr. Bhakta explained.

Dr. Young, who is of Asian descent, first became interested in disparities in health care when he noticed that ethnic minority groups showed greater hesitancy toward COVID-19 vaccination. “I noticed that there weren’t many Asians involved in previous trials and realized at this point that disparities were rampant.”

Dr. Young had been involved in investigating the overall use and the inappropriate use of antibiotics across the whole U.S. population when his interest in health disparities prompted him to study these patterns in specific demographic groups.

“Most previous data are derived from inpatient studies where the physician is giving the antibiotics,” said Dr. Young, who looked specifically at outpatient prescribing.

Dr. Young used prescribing data from the Centers for Disease Control and Prevention’s National Ambulatory Medical Care Survey, which covers more than 5.7 billion adult (aged 18 and older) and 1.3 billion child visits to outpatient practices between 2009 and 2016 across all 50 U.S. states and Washington, D.C.

He gathered patient data on ICD-9-CM and ICD-10 diagnostic codes for infections and for diagnoses that “appeared like infections.” All of the patients who were included had received at least one oral antibiotic. Antibiotic prescribing was defined as visits that included an antibiotic per 1,000 total patient visits.

On the basis of previous research, Dr. Young and his colleagues then determined whether each antibiotic prescription was appropriate, possibly appropriate, or inappropriate. Patient demographics included age (younger than 18 years, 18-64 years, and older than 64 years), sex (male or female), race, and ethnicity (White, Black, more than one race, Hispanic/Latinx, and other). These data were used to evaluate overall and inappropriate use.

“The health care community needs to be really careful with the judicious use of antibiotics,” Dr. Young said. “We have good guidelines on antimicrobial stewardship both in the inpatient and outpatient settings, but sometimes we overlook the disparities and cultural implications held by some patients.”

Typical examples of socioeconomic and cultural factors at play included patients not being able to afford the antibiotics, having limited access to care, or not returning for a follow-up visit for whatever reason.

“Patients of Black and Hispanic descent often don’t have the same degree of established care that many White patients have,” Dr. Young noted.

In the future, Dr. Young wants to conduct research into whether patients are actually taking their prescribed antibiotics, as well as their outcomes. For example, he would like to investigate whether rates of antibiotic resistance or Clostridioides difficile infection are higher among Black patients.

Dr. Young and Dr. Bhakta have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LISBON – During the pandemic, critical and acute care hospitals with medium and high rates of antimicrobial resistance (AMR) showed significant increases in antibiotic prescriptions and longer durations of antibiotic treatment among all hospital admissions, and also in those patients who were bacterial culture negative, according to a large U.S.-based study.

The analysis across 271 U.S. hospitals also showed that AMR rates were significantly higher for pathogens during the pandemic period, compared with the prepandemic period in patients who were tested for SARS-CoV-2, and highest in SARS-CoV-2–positive patients.

More than a third of SARS-CoV-2–positive patients who were prescribed antibiotics were bacterial culture negative.

Findings of the study were presented by Vikas Gupta, PharmD, director of medical affairs at medical technology firm Becton Dickinson, at this year’s European Congress of Clinical Microbiology & Infectious Diseases. He conducted the study jointly with Karri Bauer, PharmD, from Merck Sharp & Dohme, Kenilworth, N.J., and colleagues.

“There are differences in AMR that go beyond COVID-positive admissions,” Dr. Gupta told this news organization. “There is opportunity for improvement especially with those hospitalized patients who had a negative culture result, or no culture collected.”

“We found a higher percentage of COVID-positive admissions that were prescribed antibacterial therapy even in those having [tested negative for bacteria] or no culture result,” said Dr. Gupta. “Our data also shows that the percentage of admissions with duration of antibacterial therapy over 3 days was significantly higher in COVID-positive but culture-negative/no culture patients, compared to other groups evaluated.”

Of all admissions prescribed antibiotics during the pandemic, 57.8% of SARS-CoV-2–positive patients were prescribed antibiotics whereas 88.1% of SARS-CoV-2–positive admissions were bacterial culture negative/no culture. Overall, prepandemic, 35% of admissions were prescribed antibiotics.

Duration of antibiotic therapy in the prepandemic era was an average of 3.5 days, compared with an average of 3.8 days overall in the pandemic and 5.7 days in patients who tested positive for SARS-CoV-2. Similarly, the percentage of patients who were bacterial culture negative or had no culture and received antibiotic therapy for more than 72 hours was 17.6% in the prepandemic era, compared with 19.2% overall in the pandemic era, and 41.1% in patients who tested positive for COVID-19.  

Dr. Gupta and Dr. Bauer wanted to look at all patients admitted to hospitals segmented by SARS-CoV-2 positive, negative, and not tested, to get a sense of how much antibiotic use there was and how long patients were on antibiotics. “We ultimately want to optimize and not overuse antibiotics and prescribe them for right period of time,” said Dr. Gupta.

“To date, there has been no conclusive evidence about the suggestion that the pandemic has led to increased AMR rates, so we aimed to evaluate the pandemic’s impact on AMR and antibiotic use across U.S. hospitals,” he explained.

The multicenter, retrospective cohort analysis made use of BD’s infection surveillance platform (BD HealthSight Infection Advisor with MedMined Insights) and was conducted across 271 U.S. critical access/acute care facilities, representing approximately 10%-13% of U.S. hospital admissions. It included all hospitalized patients with more than 1 day of in-patient admission. Patients were considered SARS-CoV-2 positive by polymerase chain reaction test or antigen test either 7 days or less prior to or within 14 days of admission.

Patients were categorized as hospitalized during the “prepandemic” period (July 1, 2019 through February 29, 2020) and the “pandemic” period (March 1, 2020 through Oct. 30, 2021) and were stratified based on their SARS-CoV-2 result. 

Investigators included all hospital admissions with an AMR event (first positive culture for select gram-negative or gram-positive pathogens that were reported as nonsusceptible across blood, urine, respiratory, intra-abdominal, skin/wound, and other sources).

The investigators calculated AMR rates at the patient-admission level and defined per 100 admissions. Also, they further evaluated AMR rates based on community onset (defined as culture collected ≤2 days from admission) or hospital onset (>2 days from admission). Finally, AMR rates were determined according to whether they related to prepandemic or pandemic periods. 

Hospitals were also categorized according to their AMR rates as low (<25%), medium (25%-75%), and high (>75%). 

Overall AMR rates were lower in the pandemic period, compared with the prepandemic period. However, reported Dr.Gupta, for hospital-onset pathogens specifically, AMR rates were significantly higher overall in the pandemic period and mostly driven by admissions tested for SARS-CoV-2 (whether positive or negative).

Hospitals with high AMR rates also tended to have more SARS-CoV-2 positive admissions (6.1% in high-AMR hospitals vs. 3% in low-AMR hospitals). The highest antibiotic-prescribing rates and highest duration of antibiotic use was also seen in those hospitals with highest AMR rates. 

Of the SARS-CoV-2 patients who were bacterial culture negative/no culture and were prescribed antibiotics, 36.5% were in hospitals with a high AMR rate. “Roughly one-third of patients without culture evidence of a bacterial infection were prescribed antibiotics in hospitals with a high AMR rate,” said Dr. Gupta.

The researchers wanted to tease out whether hospitals with high, moderate, or low AMR rates look different with respect to antibiotic-prescribing patterns. During the pandemic period, they found that hospitals with high and medium AMR rates experienced significant increases in antibiotic prescriptions and longer durations. Prepandemic, the overall hospital-onset AMR rate was 0.8 per 100 admissions, whereas during the pandemic this rose to 1.4 per 100 admissions in high-AMR hospitals and dropped to 0.4 in low-AMR hospitals.

SARS-CoV-2–positive admission rates were higher in facilities with medium (5.6%) and high AMR (6.1%) rates than those with low (3%) AMR rates. “We found that those with medium and high AMR rates were more likely to have COVID-positive admissions than facilities with low AMR rates,” Dr. Gupta said. “It appears as if COVID is contributing to AMR in the facilities.”

Asked for independent comment, Jason C. Gallagher, PharmD, BCPS, clinical professor at Temple University School of Pharmacy in Philadelphia, said in an interview, “It is not surprising that there was more antimicrobial resistance in patients with COVID than those without. Even though antibiotics do not work for COVID, they are often prescribed, and antibiotic use is a major risk factor for antimicrobial resistance. This is likely because clinicians are sometimes concerned about coinfections with bacteria (which are rare) and because hospitalized patients with severe COVID can acquire other infections as they are treated.”
 

Antibiotic stewardship programs

Antibiotic stewardship programs have been highly stressed during the pandemic, so the researchers hope their data support the need for better antibiotic stewardship practices during pandemic surges when control is more challenging.

Dr. Gupta explained that they were seeing interesting associations that can inform antimicrobial stewardship programs and teams. “We are not trying to imply causality,” he stressed.

It is a common practice for stewardship teams to evaluate the need for continuation of antibiotic therapy at 3 days, especially in patients who are culture negative or did not have a culture collected.

“Antibiotic time-out at 3 days is a recommended practice to evaluate for continuing antibiotic therapy based on the patient’s condition and culture results,” he said. “This is what made our study unique because we wanted to look at what percentage of admissions were prescribed antibiotics beyond 3 days and compare to the prepandemic period.”

Session moderator Evangelos J. Giamarellos-Bourboulis, MD, PhD, an assistant professor of internal medicine and infectious diseases, University of Athens, Greece, thanked Dr. Gupta for his “eloquent presentation” and sought to clarify whether the data “refer to antimicrobial use that was empirical or whether use was in hospitals with high AMR rates, or whether the approach was driven through microbiology?”

Dr. Gupta replied that this was why they evaluated the negative-culture and no-culture patients. “We wanted to get a measure of antibacterial use in this population too,” he said. “Definitely, there is empirical therapy as well as definitive therapy, but I think the negative and no-culture group provide a reference point where we see similar signals and trends to that of the overall population.”

An audience member also addressed a question to Dr. Gupta: “Did you look at the patient population, because in many cases, during COVID, these patients may have been more severe than in the prepandemic period?”

Dr. Gupta replied: “In our manuscript we’ve done an analysis where we adjusted for patient-level facility and regional-level factors. There are definitely differences in the patient populations but overall, these are pretty sick patients when we look at the level of severity overall.”

Dr. Gupta is an employee of and a shareholder in Becton Dickinson. Dr. Bauer is an employee of and a shareholder in Merck. Dr. Gallagher consults for many pharmaceutical companies including Merck.

Dr. Giamarellos-Bourboulis disclosed honoraria (paid to the University of Athens) from Abbott CH, Brahms Thermo Fisher GMBH Germany, GlaxoSmithKline, and Sobi; serving as a consultant for Abbott CH, Fab’nTech, InflaRx GmbH, UCB, Sobi, and Xbiotech; research grants (paid to the Hellenic Institute for the Study of Sepsis) from Abbott CH, BioMerieux France, Johnson & Johnson, MSD, Sobi, Thermo Fisher Brahms GmbH; and EU research funding: Horizon 2020 ITN European Sepsis Academy (granted to the University of Athens); Horizon 2020 ImmunoSep and RISinCOVID (granted to the Hellenic Institute for the Study of Sepsis); Horizon Health EPIC-CROWN-2 (granted to the Hellenic Institute for the Study of Sepsis).

A version of this article first appeared on Medscape.com.

LISBON – During the pandemic, critical and acute care hospitals with medium and high rates of antimicrobial resistance (AMR) showed significant increases in antibiotic prescriptions and longer durations of antibiotic treatment among all hospital admissions, and also in those patients who were bacterial culture negative, according to a large U.S.-based study.

The analysis across 271 U.S. hospitals also showed that AMR rates were significantly higher for pathogens during the pandemic period, compared with the prepandemic period in patients who were tested for SARS-CoV-2, and highest in SARS-CoV-2–positive patients.

More than a third of SARS-CoV-2–positive patients who were prescribed antibiotics were bacterial culture negative.

Findings of the study were presented by Vikas Gupta, PharmD, director of medical affairs at medical technology firm Becton Dickinson, at this year’s European Congress of Clinical Microbiology & Infectious Diseases. He conducted the study jointly with Karri Bauer, PharmD, from Merck Sharp & Dohme, Kenilworth, N.J., and colleagues.

“There are differences in AMR that go beyond COVID-positive admissions,” Dr. Gupta told this news organization. “There is opportunity for improvement especially with those hospitalized patients who had a negative culture result, or no culture collected.”

“We found a higher percentage of COVID-positive admissions that were prescribed antibacterial therapy even in those having [tested negative for bacteria] or no culture result,” said Dr. Gupta. “Our data also shows that the percentage of admissions with duration of antibacterial therapy over 3 days was significantly higher in COVID-positive but culture-negative/no culture patients, compared to other groups evaluated.”

Of all admissions prescribed antibiotics during the pandemic, 57.8% of SARS-CoV-2–positive patients were prescribed antibiotics whereas 88.1% of SARS-CoV-2–positive admissions were bacterial culture negative/no culture. Overall, prepandemic, 35% of admissions were prescribed antibiotics.

Duration of antibiotic therapy in the prepandemic era was an average of 3.5 days, compared with an average of 3.8 days overall in the pandemic and 5.7 days in patients who tested positive for SARS-CoV-2. Similarly, the percentage of patients who were bacterial culture negative or had no culture and received antibiotic therapy for more than 72 hours was 17.6% in the prepandemic era, compared with 19.2% overall in the pandemic era, and 41.1% in patients who tested positive for COVID-19.  

Dr. Gupta and Dr. Bauer wanted to look at all patients admitted to hospitals segmented by SARS-CoV-2 positive, negative, and not tested, to get a sense of how much antibiotic use there was and how long patients were on antibiotics. “We ultimately want to optimize and not overuse antibiotics and prescribe them for right period of time,” said Dr. Gupta.

“To date, there has been no conclusive evidence about the suggestion that the pandemic has led to increased AMR rates, so we aimed to evaluate the pandemic’s impact on AMR and antibiotic use across U.S. hospitals,” he explained.

The multicenter, retrospective cohort analysis made use of BD’s infection surveillance platform (BD HealthSight Infection Advisor with MedMined Insights) and was conducted across 271 U.S. critical access/acute care facilities, representing approximately 10%-13% of U.S. hospital admissions. It included all hospitalized patients with more than 1 day of in-patient admission. Patients were considered SARS-CoV-2 positive by polymerase chain reaction test or antigen test either 7 days or less prior to or within 14 days of admission.

Patients were categorized as hospitalized during the “prepandemic” period (July 1, 2019 through February 29, 2020) and the “pandemic” period (March 1, 2020 through Oct. 30, 2021) and were stratified based on their SARS-CoV-2 result. 

Investigators included all hospital admissions with an AMR event (first positive culture for select gram-negative or gram-positive pathogens that were reported as nonsusceptible across blood, urine, respiratory, intra-abdominal, skin/wound, and other sources).

The investigators calculated AMR rates at the patient-admission level and defined per 100 admissions. Also, they further evaluated AMR rates based on community onset (defined as culture collected ≤2 days from admission) or hospital onset (>2 days from admission). Finally, AMR rates were determined according to whether they related to prepandemic or pandemic periods. 

Hospitals were also categorized according to their AMR rates as low (<25%), medium (25%-75%), and high (>75%). 

Overall AMR rates were lower in the pandemic period, compared with the prepandemic period. However, reported Dr.Gupta, for hospital-onset pathogens specifically, AMR rates were significantly higher overall in the pandemic period and mostly driven by admissions tested for SARS-CoV-2 (whether positive or negative).

Hospitals with high AMR rates also tended to have more SARS-CoV-2 positive admissions (6.1% in high-AMR hospitals vs. 3% in low-AMR hospitals). The highest antibiotic-prescribing rates and highest duration of antibiotic use was also seen in those hospitals with highest AMR rates. 

Of the SARS-CoV-2 patients who were bacterial culture negative/no culture and were prescribed antibiotics, 36.5% were in hospitals with a high AMR rate. “Roughly one-third of patients without culture evidence of a bacterial infection were prescribed antibiotics in hospitals with a high AMR rate,” said Dr. Gupta.

The researchers wanted to tease out whether hospitals with high, moderate, or low AMR rates look different with respect to antibiotic-prescribing patterns. During the pandemic period, they found that hospitals with high and medium AMR rates experienced significant increases in antibiotic prescriptions and longer durations. Prepandemic, the overall hospital-onset AMR rate was 0.8 per 100 admissions, whereas during the pandemic this rose to 1.4 per 100 admissions in high-AMR hospitals and dropped to 0.4 in low-AMR hospitals.

SARS-CoV-2–positive admission rates were higher in facilities with medium (5.6%) and high AMR (6.1%) rates than those with low (3%) AMR rates. “We found that those with medium and high AMR rates were more likely to have COVID-positive admissions than facilities with low AMR rates,” Dr. Gupta said. “It appears as if COVID is contributing to AMR in the facilities.”

Asked for independent comment, Jason C. Gallagher, PharmD, BCPS, clinical professor at Temple University School of Pharmacy in Philadelphia, said in an interview, “It is not surprising that there was more antimicrobial resistance in patients with COVID than those without. Even though antibiotics do not work for COVID, they are often prescribed, and antibiotic use is a major risk factor for antimicrobial resistance. This is likely because clinicians are sometimes concerned about coinfections with bacteria (which are rare) and because hospitalized patients with severe COVID can acquire other infections as they are treated.”
 

Antibiotic stewardship programs

Antibiotic stewardship programs have been highly stressed during the pandemic, so the researchers hope their data support the need for better antibiotic stewardship practices during pandemic surges when control is more challenging.

Dr. Gupta explained that they were seeing interesting associations that can inform antimicrobial stewardship programs and teams. “We are not trying to imply causality,” he stressed.

It is a common practice for stewardship teams to evaluate the need for continuation of antibiotic therapy at 3 days, especially in patients who are culture negative or did not have a culture collected.

“Antibiotic time-out at 3 days is a recommended practice to evaluate for continuing antibiotic therapy based on the patient’s condition and culture results,” he said. “This is what made our study unique because we wanted to look at what percentage of admissions were prescribed antibiotics beyond 3 days and compare to the prepandemic period.”

Session moderator Evangelos J. Giamarellos-Bourboulis, MD, PhD, an assistant professor of internal medicine and infectious diseases, University of Athens, Greece, thanked Dr. Gupta for his “eloquent presentation” and sought to clarify whether the data “refer to antimicrobial use that was empirical or whether use was in hospitals with high AMR rates, or whether the approach was driven through microbiology?”

Dr. Gupta replied that this was why they evaluated the negative-culture and no-culture patients. “We wanted to get a measure of antibacterial use in this population too,” he said. “Definitely, there is empirical therapy as well as definitive therapy, but I think the negative and no-culture group provide a reference point where we see similar signals and trends to that of the overall population.”

An audience member also addressed a question to Dr. Gupta: “Did you look at the patient population, because in many cases, during COVID, these patients may have been more severe than in the prepandemic period?”

Dr. Gupta replied: “In our manuscript we’ve done an analysis where we adjusted for patient-level facility and regional-level factors. There are definitely differences in the patient populations but overall, these are pretty sick patients when we look at the level of severity overall.”

Dr. Gupta is an employee of and a shareholder in Becton Dickinson. Dr. Bauer is an employee of and a shareholder in Merck. Dr. Gallagher consults for many pharmaceutical companies including Merck.

Dr. Giamarellos-Bourboulis disclosed honoraria (paid to the University of Athens) from Abbott CH, Brahms Thermo Fisher GMBH Germany, GlaxoSmithKline, and Sobi; serving as a consultant for Abbott CH, Fab’nTech, InflaRx GmbH, UCB, Sobi, and Xbiotech; research grants (paid to the Hellenic Institute for the Study of Sepsis) from Abbott CH, BioMerieux France, Johnson & Johnson, MSD, Sobi, Thermo Fisher Brahms GmbH; and EU research funding: Horizon 2020 ITN European Sepsis Academy (granted to the University of Athens); Horizon 2020 ImmunoSep and RISinCOVID (granted to the Hellenic Institute for the Study of Sepsis); Horizon Health EPIC-CROWN-2 (granted to the Hellenic Institute for the Study of Sepsis).

A version of this article first appeared on Medscape.com.

LISBON – During the pandemic, critical and acute care hospitals with medium and high rates of antimicrobial resistance (AMR) showed significant increases in antibiotic prescriptions and longer durations of antibiotic treatment among all hospital admissions, and also in those patients who were bacterial culture negative, according to a large U.S.-based study.

The analysis across 271 U.S. hospitals also showed that AMR rates were significantly higher for pathogens during the pandemic period, compared with the prepandemic period in patients who were tested for SARS-CoV-2, and highest in SARS-CoV-2–positive patients.

More than a third of SARS-CoV-2–positive patients who were prescribed antibiotics were bacterial culture negative.

Findings of the study were presented by Vikas Gupta, PharmD, director of medical affairs at medical technology firm Becton Dickinson, at this year’s European Congress of Clinical Microbiology & Infectious Diseases. He conducted the study jointly with Karri Bauer, PharmD, from Merck Sharp & Dohme, Kenilworth, N.J., and colleagues.

“There are differences in AMR that go beyond COVID-positive admissions,” Dr. Gupta told this news organization. “There is opportunity for improvement especially with those hospitalized patients who had a negative culture result, or no culture collected.”

“We found a higher percentage of COVID-positive admissions that were prescribed antibacterial therapy even in those having [tested negative for bacteria] or no culture result,” said Dr. Gupta. “Our data also shows that the percentage of admissions with duration of antibacterial therapy over 3 days was significantly higher in COVID-positive but culture-negative/no culture patients, compared to other groups evaluated.”

Of all admissions prescribed antibiotics during the pandemic, 57.8% of SARS-CoV-2–positive patients were prescribed antibiotics whereas 88.1% of SARS-CoV-2–positive admissions were bacterial culture negative/no culture. Overall, prepandemic, 35% of admissions were prescribed antibiotics.

Duration of antibiotic therapy in the prepandemic era was an average of 3.5 days, compared with an average of 3.8 days overall in the pandemic and 5.7 days in patients who tested positive for SARS-CoV-2. Similarly, the percentage of patients who were bacterial culture negative or had no culture and received antibiotic therapy for more than 72 hours was 17.6% in the prepandemic era, compared with 19.2% overall in the pandemic era, and 41.1% in patients who tested positive for COVID-19.  

Dr. Gupta and Dr. Bauer wanted to look at all patients admitted to hospitals segmented by SARS-CoV-2 positive, negative, and not tested, to get a sense of how much antibiotic use there was and how long patients were on antibiotics. “We ultimately want to optimize and not overuse antibiotics and prescribe them for right period of time,” said Dr. Gupta.

“To date, there has been no conclusive evidence about the suggestion that the pandemic has led to increased AMR rates, so we aimed to evaluate the pandemic’s impact on AMR and antibiotic use across U.S. hospitals,” he explained.

The multicenter, retrospective cohort analysis made use of BD’s infection surveillance platform (BD HealthSight Infection Advisor with MedMined Insights) and was conducted across 271 U.S. critical access/acute care facilities, representing approximately 10%-13% of U.S. hospital admissions. It included all hospitalized patients with more than 1 day of in-patient admission. Patients were considered SARS-CoV-2 positive by polymerase chain reaction test or antigen test either 7 days or less prior to or within 14 days of admission.

Patients were categorized as hospitalized during the “prepandemic” period (July 1, 2019 through February 29, 2020) and the “pandemic” period (March 1, 2020 through Oct. 30, 2021) and were stratified based on their SARS-CoV-2 result. 

Investigators included all hospital admissions with an AMR event (first positive culture for select gram-negative or gram-positive pathogens that were reported as nonsusceptible across blood, urine, respiratory, intra-abdominal, skin/wound, and other sources).

The investigators calculated AMR rates at the patient-admission level and defined per 100 admissions. Also, they further evaluated AMR rates based on community onset (defined as culture collected ≤2 days from admission) or hospital onset (>2 days from admission). Finally, AMR rates were determined according to whether they related to prepandemic or pandemic periods. 

Hospitals were also categorized according to their AMR rates as low (<25%), medium (25%-75%), and high (>75%). 

Overall AMR rates were lower in the pandemic period, compared with the prepandemic period. However, reported Dr.Gupta, for hospital-onset pathogens specifically, AMR rates were significantly higher overall in the pandemic period and mostly driven by admissions tested for SARS-CoV-2 (whether positive or negative).

Hospitals with high AMR rates also tended to have more SARS-CoV-2 positive admissions (6.1% in high-AMR hospitals vs. 3% in low-AMR hospitals). The highest antibiotic-prescribing rates and highest duration of antibiotic use was also seen in those hospitals with highest AMR rates. 

Of the SARS-CoV-2 patients who were bacterial culture negative/no culture and were prescribed antibiotics, 36.5% were in hospitals with a high AMR rate. “Roughly one-third of patients without culture evidence of a bacterial infection were prescribed antibiotics in hospitals with a high AMR rate,” said Dr. Gupta.

The researchers wanted to tease out whether hospitals with high, moderate, or low AMR rates look different with respect to antibiotic-prescribing patterns. During the pandemic period, they found that hospitals with high and medium AMR rates experienced significant increases in antibiotic prescriptions and longer durations. Prepandemic, the overall hospital-onset AMR rate was 0.8 per 100 admissions, whereas during the pandemic this rose to 1.4 per 100 admissions in high-AMR hospitals and dropped to 0.4 in low-AMR hospitals.

SARS-CoV-2–positive admission rates were higher in facilities with medium (5.6%) and high AMR (6.1%) rates than those with low (3%) AMR rates. “We found that those with medium and high AMR rates were more likely to have COVID-positive admissions than facilities with low AMR rates,” Dr. Gupta said. “It appears as if COVID is contributing to AMR in the facilities.”

Asked for independent comment, Jason C. Gallagher, PharmD, BCPS, clinical professor at Temple University School of Pharmacy in Philadelphia, said in an interview, “It is not surprising that there was more antimicrobial resistance in patients with COVID than those without. Even though antibiotics do not work for COVID, they are often prescribed, and antibiotic use is a major risk factor for antimicrobial resistance. This is likely because clinicians are sometimes concerned about coinfections with bacteria (which are rare) and because hospitalized patients with severe COVID can acquire other infections as they are treated.”
 

Antibiotic stewardship programs

Antibiotic stewardship programs have been highly stressed during the pandemic, so the researchers hope their data support the need for better antibiotic stewardship practices during pandemic surges when control is more challenging.

Dr. Gupta explained that they were seeing interesting associations that can inform antimicrobial stewardship programs and teams. “We are not trying to imply causality,” he stressed.

It is a common practice for stewardship teams to evaluate the need for continuation of antibiotic therapy at 3 days, especially in patients who are culture negative or did not have a culture collected.

“Antibiotic time-out at 3 days is a recommended practice to evaluate for continuing antibiotic therapy based on the patient’s condition and culture results,” he said. “This is what made our study unique because we wanted to look at what percentage of admissions were prescribed antibiotics beyond 3 days and compare to the prepandemic period.”

Session moderator Evangelos J. Giamarellos-Bourboulis, MD, PhD, an assistant professor of internal medicine and infectious diseases, University of Athens, Greece, thanked Dr. Gupta for his “eloquent presentation” and sought to clarify whether the data “refer to antimicrobial use that was empirical or whether use was in hospitals with high AMR rates, or whether the approach was driven through microbiology?”

Dr. Gupta replied that this was why they evaluated the negative-culture and no-culture patients. “We wanted to get a measure of antibacterial use in this population too,” he said. “Definitely, there is empirical therapy as well as definitive therapy, but I think the negative and no-culture group provide a reference point where we see similar signals and trends to that of the overall population.”

An audience member also addressed a question to Dr. Gupta: “Did you look at the patient population, because in many cases, during COVID, these patients may have been more severe than in the prepandemic period?”

Dr. Gupta replied: “In our manuscript we’ve done an analysis where we adjusted for patient-level facility and regional-level factors. There are definitely differences in the patient populations but overall, these are pretty sick patients when we look at the level of severity overall.”

Dr. Gupta is an employee of and a shareholder in Becton Dickinson. Dr. Bauer is an employee of and a shareholder in Merck. Dr. Gallagher consults for many pharmaceutical companies including Merck.

Dr. Giamarellos-Bourboulis disclosed honoraria (paid to the University of Athens) from Abbott CH, Brahms Thermo Fisher GMBH Germany, GlaxoSmithKline, and Sobi; serving as a consultant for Abbott CH, Fab’nTech, InflaRx GmbH, UCB, Sobi, and Xbiotech; research grants (paid to the Hellenic Institute for the Study of Sepsis) from Abbott CH, BioMerieux France, Johnson & Johnson, MSD, Sobi, Thermo Fisher Brahms GmbH; and EU research funding: Horizon 2020 ITN European Sepsis Academy (granted to the University of Athens); Horizon 2020 ImmunoSep and RISinCOVID (granted to the Hellenic Institute for the Study of Sepsis); Horizon Health EPIC-CROWN-2 (granted to the Hellenic Institute for the Study of Sepsis).

A version of this article first appeared on Medscape.com.

The U.S. Preventive Services Task Force has published a final recommendation statement on aspirin use to prevent cardiovascular disease.

The statement advises against starting aspirin for the primary prevention of cardiovascular disease in individuals aged 60 years or older.

For people aged 40-59 years, the USPSTF suggests that aspirin could be considered in those at increased risk of cardiovascular disease (10-year risk of 10% or greater) but that the decision should be individualized.

It notes that in the 40-59 age group, evidence indicates that the net benefit of aspirin use is small, and that persons who are not at increased risk for bleeding are more likely to benefit.

It adds that these recommendations apply only to people who do not have a history of cardiovascular disease and are not already taking daily aspirin.

The USPSTF statement was published online in the Journal of the American Medical Association. It is accompanied by an evidence review, a modeling study, a patient page, and an editorial.

A draft version of the recommendation statement, evidence review, and modeling report were previously available for public comment. The final recommendation statement is consistent with the draft version.

The task force concludes that there is adequate evidence that low-dose aspirin has a small benefit to reduce risk for cardiovascular events (nonfatal myocardial infarction and stroke) in adults 40 years or older who have no history of cardiovascular disease but are at increased cardiovascular risk.

Evidence shows that the absolute magnitude of benefit increases with increasing 10-year cardiovascular risk and that the magnitude of the lifetime benefits is greater when aspirin is initiated at a younger age.

But it adds that there is also adequate evidence that aspirin use in adults increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke. The USPSTF determined that the magnitude of the harms is small overall but increases in older age groups, particularly in adults older than 60 years.

For patients who are eligible and choose to start taking aspirin, the benefits become smaller with advancing age, and data suggest that clinicians and patients should consider stopping aspirin use around age 75 years, the statement advises.

It also says that evidence is unclear whether aspirin use reduces the risk of colorectal cancer incidence or mortality.

USPSTF vice chair Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston, told this news organization that these recommendations apply only to patients not taking aspirin already and who have no evidence of existing cardiovascular disease.

“In adults aged 60 or over we do not recommend starting aspirin for primary prevention. That is because in this age group the risk of bleeding outweighs the cardiovascular benefit,” he said.

“For adults aged 40-59 years with a greater than 10% predicted risk of cardiovascular disease, there appears to be a net benefit from taking aspirin, but this net benefit is relatively small and will vary with other factors such as magnitude of cardiovascular and bleeding risk. People should talk to their physician about these factors and whether to take aspirin or not,” he added.      

Dr. Barry noted that these recommendations do not apply to people who are already taking aspirin for primary prevention. “These people need to talk to their physicians about whether they should continue. They need to review the reasons why they started aspirin in the first place, and they need to have their bleeding risk evaluated. Someone who has taken aspirin long term without any bleeding complications has a lower risk of future bleeding complications,” he said.

The task force recommends an aspirin dose of 81 mg daily for those people deciding to take aspirin for primary prevention.    

“There is an abundance of evidence that less than 100 mg a day is enough. The lower the dose the lower the bleeding risk. So, the most convenient dose is the widely available 81-mg baby aspirin tablet,” Dr. Barry noted. “While enteric coated products are meant to reduce gastric irritation, the data do not show any difference in bleeding risk between various aspirin formulations,” he added.

Dr. Barry pointed out that aspirin is just one tool for reducing cardiovascular risk.

“People can reduce their risk significantly in many other ways including taking regular exercise, eating a healthy diet, controlling blood pressure and diabetes, and taking statins if they are at increased cardiovascular risk.”

He noted that recent trials have suggested that aspirin has only a marginal value over and above all these other factors. And the risk reduction with aspirin is smaller than with some other interventions.

“For example, aspirin is associated with a 12% reduction in MI whereas statins are associated with a 25%-30% reduction. Statins are a more powerful tool in reducing cardiovascular risk than aspirin, so perhaps people should consider taking statins first. The benefit of aspirin may be smaller in individuals already taking a statin, and clinicians need to think about the big picture,” Dr. Barry said.

He explained that physicians need to evaluate the cardiovascular and bleeding risk in each individual patient. “While there are widely available tools to estimate cardiovascular risk, there are no easy tools yet available to evaluate bleeding risk, so physicians need to consider clinical factors such as history of peptic ulcers.”

He suggests for the many people who have an average bleeding risk, then personal preference may come into play. “In the 40-59 age group, the benefits and harms of aspirin are pretty well-balanced. For the average person we think there may be a small net benefit, but this is small enough for personal preference to be considered as well.”
 

Pendulum swinging away from aspirin use

In an editorial accompanying publication of the task force statement in JAMA, Allan S. Brett, MD, clinical professor of internal medicine at the University of Colorado at Denver, Aurora, explains that the USPSTF recommendations on aspirin use for primary prevention of cardiovascular disease have changed numerous times over the past 30 years, with the last update in 2016 narrowing the eligible population.

In the new recommendation statement, “the pendulum has swung further away from aspirin prophylaxis for primary prevention: The guideline does not recommend routine preventive aspirin for anyone,” Dr. Brett notes.

He points out that an important development between the 2016 and current version was the publication in 2018 of three large placebo-controlled randomized clinical trials of primary prevention with aspirin – ARRIVE, ASPREE and ASCEND – which taken together “cast doubt about net benefit for aspirin prophylaxis in current practice.”

Asked how physicians should go about “individualizing” the decision on the use of aspirin in the 40-59 age group at increased cardiovascular risk, Dr. Brett suggests that some patents will have a general philosophy of medical care of “don’t prescribe medication for me unless there is strong evidence to support it,” while others may favor preventive interventions even in borderline cases.

But he notes that many patients have no strong general preferences and often ask a trusted clinician to decide for them. “For such patients, the best approach is for clinicians to be knowledgeable about the data on primary prevention with aspirin. Close reading of the new USPSTF guideline and its companion evidence review, and becoming familiar with the three more recent aspirin trials, is a good way to prepare for these clinical encounters,” he concludes.
 

A cardiologist’s view

Commenting on the task force statement for this news organization, Andrew Freeman, MD, a cardiologist at National Jewish Health, Denver, noted that cardiology societies are already making similar recommendations on aspirin use in primary prevention. “The American College of Cardiology prevention guidelines have been giving similar advice for a couple of years now. It takes a few years for professional societies to catch up with each other,” he said.

“Over the last few years, it has become obvious that the benefit of aspirin is not really very positive until a patient has had a cardiovascular event. In primary prevention, it doesn’t become beneficial unless they are at quite a high risk of having an event,” Dr. Freeman noted.

“In general, most cardiologists are now telling people that, despite what they may have been told in the past, they don’t need to be on aspirin unless they have had a cardiovascular event,” he added. “Our understanding has changed over the years and the weight of evidence has now become clear that the risk of bleeding is not insignificant.”

Dr. Freeman agreed with the shared decision-making advocated for patients in the 40-59 age group. “If a patient is particularly worried about a family history of heart disease, taking aspirin may make some sense, but for most people who have not had a cardiovascular event, the net benefit is very low and gets lower with age as the bleeding risk increases,” he said.  

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

A version of this article first appeared on Medscape.com.

The U.S. Preventive Services Task Force has published a final recommendation statement on aspirin use to prevent cardiovascular disease.

The statement advises against starting aspirin for the primary prevention of cardiovascular disease in individuals aged 60 years or older.

For people aged 40-59 years, the USPSTF suggests that aspirin could be considered in those at increased risk of cardiovascular disease (10-year risk of 10% or greater) but that the decision should be individualized.

It notes that in the 40-59 age group, evidence indicates that the net benefit of aspirin use is small, and that persons who are not at increased risk for bleeding are more likely to benefit.

It adds that these recommendations apply only to people who do not have a history of cardiovascular disease and are not already taking daily aspirin.

The USPSTF statement was published online in the Journal of the American Medical Association. It is accompanied by an evidence review, a modeling study, a patient page, and an editorial.

A draft version of the recommendation statement, evidence review, and modeling report were previously available for public comment. The final recommendation statement is consistent with the draft version.

The task force concludes that there is adequate evidence that low-dose aspirin has a small benefit to reduce risk for cardiovascular events (nonfatal myocardial infarction and stroke) in adults 40 years or older who have no history of cardiovascular disease but are at increased cardiovascular risk.

Evidence shows that the absolute magnitude of benefit increases with increasing 10-year cardiovascular risk and that the magnitude of the lifetime benefits is greater when aspirin is initiated at a younger age.

But it adds that there is also adequate evidence that aspirin use in adults increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke. The USPSTF determined that the magnitude of the harms is small overall but increases in older age groups, particularly in adults older than 60 years.

For patients who are eligible and choose to start taking aspirin, the benefits become smaller with advancing age, and data suggest that clinicians and patients should consider stopping aspirin use around age 75 years, the statement advises.

It also says that evidence is unclear whether aspirin use reduces the risk of colorectal cancer incidence or mortality.

USPSTF vice chair Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston, told this news organization that these recommendations apply only to patients not taking aspirin already and who have no evidence of existing cardiovascular disease.

“In adults aged 60 or over we do not recommend starting aspirin for primary prevention. That is because in this age group the risk of bleeding outweighs the cardiovascular benefit,” he said.

“For adults aged 40-59 years with a greater than 10% predicted risk of cardiovascular disease, there appears to be a net benefit from taking aspirin, but this net benefit is relatively small and will vary with other factors such as magnitude of cardiovascular and bleeding risk. People should talk to their physician about these factors and whether to take aspirin or not,” he added.      

Dr. Barry noted that these recommendations do not apply to people who are already taking aspirin for primary prevention. “These people need to talk to their physicians about whether they should continue. They need to review the reasons why they started aspirin in the first place, and they need to have their bleeding risk evaluated. Someone who has taken aspirin long term without any bleeding complications has a lower risk of future bleeding complications,” he said.

The task force recommends an aspirin dose of 81 mg daily for those people deciding to take aspirin for primary prevention.    

“There is an abundance of evidence that less than 100 mg a day is enough. The lower the dose the lower the bleeding risk. So, the most convenient dose is the widely available 81-mg baby aspirin tablet,” Dr. Barry noted. “While enteric coated products are meant to reduce gastric irritation, the data do not show any difference in bleeding risk between various aspirin formulations,” he added.

Dr. Barry pointed out that aspirin is just one tool for reducing cardiovascular risk.

“People can reduce their risk significantly in many other ways including taking regular exercise, eating a healthy diet, controlling blood pressure and diabetes, and taking statins if they are at increased cardiovascular risk.”

He noted that recent trials have suggested that aspirin has only a marginal value over and above all these other factors. And the risk reduction with aspirin is smaller than with some other interventions.

“For example, aspirin is associated with a 12% reduction in MI whereas statins are associated with a 25%-30% reduction. Statins are a more powerful tool in reducing cardiovascular risk than aspirin, so perhaps people should consider taking statins first. The benefit of aspirin may be smaller in individuals already taking a statin, and clinicians need to think about the big picture,” Dr. Barry said.

He explained that physicians need to evaluate the cardiovascular and bleeding risk in each individual patient. “While there are widely available tools to estimate cardiovascular risk, there are no easy tools yet available to evaluate bleeding risk, so physicians need to consider clinical factors such as history of peptic ulcers.”

He suggests for the many people who have an average bleeding risk, then personal preference may come into play. “In the 40-59 age group, the benefits and harms of aspirin are pretty well-balanced. For the average person we think there may be a small net benefit, but this is small enough for personal preference to be considered as well.”
 

Pendulum swinging away from aspirin use

In an editorial accompanying publication of the task force statement in JAMA, Allan S. Brett, MD, clinical professor of internal medicine at the University of Colorado at Denver, Aurora, explains that the USPSTF recommendations on aspirin use for primary prevention of cardiovascular disease have changed numerous times over the past 30 years, with the last update in 2016 narrowing the eligible population.

In the new recommendation statement, “the pendulum has swung further away from aspirin prophylaxis for primary prevention: The guideline does not recommend routine preventive aspirin for anyone,” Dr. Brett notes.

He points out that an important development between the 2016 and current version was the publication in 2018 of three large placebo-controlled randomized clinical trials of primary prevention with aspirin – ARRIVE, ASPREE and ASCEND – which taken together “cast doubt about net benefit for aspirin prophylaxis in current practice.”

Asked how physicians should go about “individualizing” the decision on the use of aspirin in the 40-59 age group at increased cardiovascular risk, Dr. Brett suggests that some patents will have a general philosophy of medical care of “don’t prescribe medication for me unless there is strong evidence to support it,” while others may favor preventive interventions even in borderline cases.

But he notes that many patients have no strong general preferences and often ask a trusted clinician to decide for them. “For such patients, the best approach is for clinicians to be knowledgeable about the data on primary prevention with aspirin. Close reading of the new USPSTF guideline and its companion evidence review, and becoming familiar with the three more recent aspirin trials, is a good way to prepare for these clinical encounters,” he concludes.
 

A cardiologist’s view

Commenting on the task force statement for this news organization, Andrew Freeman, MD, a cardiologist at National Jewish Health, Denver, noted that cardiology societies are already making similar recommendations on aspirin use in primary prevention. “The American College of Cardiology prevention guidelines have been giving similar advice for a couple of years now. It takes a few years for professional societies to catch up with each other,” he said.

“Over the last few years, it has become obvious that the benefit of aspirin is not really very positive until a patient has had a cardiovascular event. In primary prevention, it doesn’t become beneficial unless they are at quite a high risk of having an event,” Dr. Freeman noted.

“In general, most cardiologists are now telling people that, despite what they may have been told in the past, they don’t need to be on aspirin unless they have had a cardiovascular event,” he added. “Our understanding has changed over the years and the weight of evidence has now become clear that the risk of bleeding is not insignificant.”

Dr. Freeman agreed with the shared decision-making advocated for patients in the 40-59 age group. “If a patient is particularly worried about a family history of heart disease, taking aspirin may make some sense, but for most people who have not had a cardiovascular event, the net benefit is very low and gets lower with age as the bleeding risk increases,” he said.  

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

A version of this article first appeared on Medscape.com.

The U.S. Preventive Services Task Force has published a final recommendation statement on aspirin use to prevent cardiovascular disease.

The statement advises against starting aspirin for the primary prevention of cardiovascular disease in individuals aged 60 years or older.

For people aged 40-59 years, the USPSTF suggests that aspirin could be considered in those at increased risk of cardiovascular disease (10-year risk of 10% or greater) but that the decision should be individualized.

It notes that in the 40-59 age group, evidence indicates that the net benefit of aspirin use is small, and that persons who are not at increased risk for bleeding are more likely to benefit.

It adds that these recommendations apply only to people who do not have a history of cardiovascular disease and are not already taking daily aspirin.

The USPSTF statement was published online in the Journal of the American Medical Association. It is accompanied by an evidence review, a modeling study, a patient page, and an editorial.

A draft version of the recommendation statement, evidence review, and modeling report were previously available for public comment. The final recommendation statement is consistent with the draft version.

The task force concludes that there is adequate evidence that low-dose aspirin has a small benefit to reduce risk for cardiovascular events (nonfatal myocardial infarction and stroke) in adults 40 years or older who have no history of cardiovascular disease but are at increased cardiovascular risk.

Evidence shows that the absolute magnitude of benefit increases with increasing 10-year cardiovascular risk and that the magnitude of the lifetime benefits is greater when aspirin is initiated at a younger age.

But it adds that there is also adequate evidence that aspirin use in adults increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke. The USPSTF determined that the magnitude of the harms is small overall but increases in older age groups, particularly in adults older than 60 years.

For patients who are eligible and choose to start taking aspirin, the benefits become smaller with advancing age, and data suggest that clinicians and patients should consider stopping aspirin use around age 75 years, the statement advises.

It also says that evidence is unclear whether aspirin use reduces the risk of colorectal cancer incidence or mortality.

USPSTF vice chair Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston, told this news organization that these recommendations apply only to patients not taking aspirin already and who have no evidence of existing cardiovascular disease.

“In adults aged 60 or over we do not recommend starting aspirin for primary prevention. That is because in this age group the risk of bleeding outweighs the cardiovascular benefit,” he said.

“For adults aged 40-59 years with a greater than 10% predicted risk of cardiovascular disease, there appears to be a net benefit from taking aspirin, but this net benefit is relatively small and will vary with other factors such as magnitude of cardiovascular and bleeding risk. People should talk to their physician about these factors and whether to take aspirin or not,” he added.      

Dr. Barry noted that these recommendations do not apply to people who are already taking aspirin for primary prevention. “These people need to talk to their physicians about whether they should continue. They need to review the reasons why they started aspirin in the first place, and they need to have their bleeding risk evaluated. Someone who has taken aspirin long term without any bleeding complications has a lower risk of future bleeding complications,” he said.

The task force recommends an aspirin dose of 81 mg daily for those people deciding to take aspirin for primary prevention.    

“There is an abundance of evidence that less than 100 mg a day is enough. The lower the dose the lower the bleeding risk. So, the most convenient dose is the widely available 81-mg baby aspirin tablet,” Dr. Barry noted. “While enteric coated products are meant to reduce gastric irritation, the data do not show any difference in bleeding risk between various aspirin formulations,” he added.

Dr. Barry pointed out that aspirin is just one tool for reducing cardiovascular risk.

“People can reduce their risk significantly in many other ways including taking regular exercise, eating a healthy diet, controlling blood pressure and diabetes, and taking statins if they are at increased cardiovascular risk.”

He noted that recent trials have suggested that aspirin has only a marginal value over and above all these other factors. And the risk reduction with aspirin is smaller than with some other interventions.

“For example, aspirin is associated with a 12% reduction in MI whereas statins are associated with a 25%-30% reduction. Statins are a more powerful tool in reducing cardiovascular risk than aspirin, so perhaps people should consider taking statins first. The benefit of aspirin may be smaller in individuals already taking a statin, and clinicians need to think about the big picture,” Dr. Barry said.

He explained that physicians need to evaluate the cardiovascular and bleeding risk in each individual patient. “While there are widely available tools to estimate cardiovascular risk, there are no easy tools yet available to evaluate bleeding risk, so physicians need to consider clinical factors such as history of peptic ulcers.”

He suggests for the many people who have an average bleeding risk, then personal preference may come into play. “In the 40-59 age group, the benefits and harms of aspirin are pretty well-balanced. For the average person we think there may be a small net benefit, but this is small enough for personal preference to be considered as well.”
 

Pendulum swinging away from aspirin use

In an editorial accompanying publication of the task force statement in JAMA, Allan S. Brett, MD, clinical professor of internal medicine at the University of Colorado at Denver, Aurora, explains that the USPSTF recommendations on aspirin use for primary prevention of cardiovascular disease have changed numerous times over the past 30 years, with the last update in 2016 narrowing the eligible population.

In the new recommendation statement, “the pendulum has swung further away from aspirin prophylaxis for primary prevention: The guideline does not recommend routine preventive aspirin for anyone,” Dr. Brett notes.

He points out that an important development between the 2016 and current version was the publication in 2018 of three large placebo-controlled randomized clinical trials of primary prevention with aspirin – ARRIVE, ASPREE and ASCEND – which taken together “cast doubt about net benefit for aspirin prophylaxis in current practice.”

Asked how physicians should go about “individualizing” the decision on the use of aspirin in the 40-59 age group at increased cardiovascular risk, Dr. Brett suggests that some patents will have a general philosophy of medical care of “don’t prescribe medication for me unless there is strong evidence to support it,” while others may favor preventive interventions even in borderline cases.

But he notes that many patients have no strong general preferences and often ask a trusted clinician to decide for them. “For such patients, the best approach is for clinicians to be knowledgeable about the data on primary prevention with aspirin. Close reading of the new USPSTF guideline and its companion evidence review, and becoming familiar with the three more recent aspirin trials, is a good way to prepare for these clinical encounters,” he concludes.
 

A cardiologist’s view

Commenting on the task force statement for this news organization, Andrew Freeman, MD, a cardiologist at National Jewish Health, Denver, noted that cardiology societies are already making similar recommendations on aspirin use in primary prevention. “The American College of Cardiology prevention guidelines have been giving similar advice for a couple of years now. It takes a few years for professional societies to catch up with each other,” he said.

“Over the last few years, it has become obvious that the benefit of aspirin is not really very positive until a patient has had a cardiovascular event. In primary prevention, it doesn’t become beneficial unless they are at quite a high risk of having an event,” Dr. Freeman noted.

“In general, most cardiologists are now telling people that, despite what they may have been told in the past, they don’t need to be on aspirin unless they have had a cardiovascular event,” he added. “Our understanding has changed over the years and the weight of evidence has now become clear that the risk of bleeding is not insignificant.”

Dr. Freeman agreed with the shared decision-making advocated for patients in the 40-59 age group. “If a patient is particularly worried about a family history of heart disease, taking aspirin may make some sense, but for most people who have not had a cardiovascular event, the net benefit is very low and gets lower with age as the bleeding risk increases,” he said.  

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

A version of this article first appeared on Medscape.com.