Key clinical point: Doses of 200 mg lasmiditan and 75 mg rimegepant had the lowest numbers needed to treat (NNT) to achieve immediate and sustained pain freedom, respectively, whereas 25 mg ubrogepant had higher numbers needed to harm (NNH) for nausea and dizziness in acute treatment for migraine.

Major finding: Compared with placebo, 200 mg lasmiditan had the lowest NNT for immediate pain freedom at 2 hours (NNT 7; 95% credible interval [CrI] 5-9) and 75 mg rimegepant had the lowest NNT for sustained pain freedom at 2-24 hours (NNT 7; 95% CrI 5-12); although statistically insignificant, 25 mg ubrogepant had a high NNH for dizziness and nausea.

Study details: Findings are from a fixed-effects Bayesian network meta-analysis of five phase 3 randomized controlled trials including 10,060 patients with migraine who received lasmiditan, rimegepant, ubrogepant, or placebo for acute treatment.

Disclosures: This study was supported by Biohaven Pharmaceuticals. Seven authors declared being employees of and owning stock or stock options in Biohaven or a company funded by Biohaven.

Source: Johnston K et al. Rimegepant, ubrogepant, and lasmiditan in the acute treatment of migraine examining the benefit-risk profile using number needed to treat/harm. Clin J Pain. 2022;38(11):680-685  (Sep 26). Doi: 10.1097/AJP.0000000000001072

Key clinical point: Doses of 200 mg lasmiditan and 75 mg rimegepant had the lowest numbers needed to treat (NNT) to achieve immediate and sustained pain freedom, respectively, whereas 25 mg ubrogepant had higher numbers needed to harm (NNH) for nausea and dizziness in acute treatment for migraine.

Major finding: Compared with placebo, 200 mg lasmiditan had the lowest NNT for immediate pain freedom at 2 hours (NNT 7; 95% credible interval [CrI] 5-9) and 75 mg rimegepant had the lowest NNT for sustained pain freedom at 2-24 hours (NNT 7; 95% CrI 5-12); although statistically insignificant, 25 mg ubrogepant had a high NNH for dizziness and nausea.

Study details: Findings are from a fixed-effects Bayesian network meta-analysis of five phase 3 randomized controlled trials including 10,060 patients with migraine who received lasmiditan, rimegepant, ubrogepant, or placebo for acute treatment.

Disclosures: This study was supported by Biohaven Pharmaceuticals. Seven authors declared being employees of and owning stock or stock options in Biohaven or a company funded by Biohaven.

Source: Johnston K et al. Rimegepant, ubrogepant, and lasmiditan in the acute treatment of migraine examining the benefit-risk profile using number needed to treat/harm. Clin J Pain. 2022;38(11):680-685  (Sep 26). Doi: 10.1097/AJP.0000000000001072

Key clinical point: Doses of 200 mg lasmiditan and 75 mg rimegepant had the lowest numbers needed to treat (NNT) to achieve immediate and sustained pain freedom, respectively, whereas 25 mg ubrogepant had higher numbers needed to harm (NNH) for nausea and dizziness in acute treatment for migraine.

Major finding: Compared with placebo, 200 mg lasmiditan had the lowest NNT for immediate pain freedom at 2 hours (NNT 7; 95% credible interval [CrI] 5-9) and 75 mg rimegepant had the lowest NNT for sustained pain freedom at 2-24 hours (NNT 7; 95% CrI 5-12); although statistically insignificant, 25 mg ubrogepant had a high NNH for dizziness and nausea.

Study details: Findings are from a fixed-effects Bayesian network meta-analysis of five phase 3 randomized controlled trials including 10,060 patients with migraine who received lasmiditan, rimegepant, ubrogepant, or placebo for acute treatment.

Disclosures: This study was supported by Biohaven Pharmaceuticals. Seven authors declared being employees of and owning stock or stock options in Biohaven or a company funded by Biohaven.

Source: Johnston K et al. Rimegepant, ubrogepant, and lasmiditan in the acute treatment of migraine examining the benefit-risk profile using number needed to treat/harm. Clin J Pain. 2022;38(11):680-685  (Sep 26). Doi: 10.1097/AJP.0000000000001072

Key clinical point: At the onset of attack, many patients with migraine with aura (MwA) experience stroke-like symptoms, whereas many patients with acute ischemic stroke (AIS) experience migraine-like symptoms, highlighting the need for additional clinical investigation for careful differential diagnosis.

Major finding: Migraine-like irritative sensations were experienced by 32.1% and 35.2% of patients with stroke who experienced visual disturbances and sensory disturbances, respectively, whereas stroke-like symptoms were reported by 12.0% and 31.4% of patients with MwA who experienced visual disturbances and sensory disturbances, respectively.

Study details: Findings are from a questionnaire-based observational study including 343 patients with MwA and 350 patients with AIS.

Disclosures: This study was supported by Swiss Heart Foundation. Several authors reported receiving research support, grants, personal fees, speaker fees, consulting or advisory support from Swiss Heart Foundation or other sources.

Source: Scutelnic A et al. Migraine aura-like symptoms at onset of stroke and stroke-like symptoms in migraine with aura. Front Neurol. 2022;13:1004058 (Sep 14). Doi: 10.3389/fneur.2022.1004058

Key clinical point: At the onset of attack, many patients with migraine with aura (MwA) experience stroke-like symptoms, whereas many patients with acute ischemic stroke (AIS) experience migraine-like symptoms, highlighting the need for additional clinical investigation for careful differential diagnosis.

Major finding: Migraine-like irritative sensations were experienced by 32.1% and 35.2% of patients with stroke who experienced visual disturbances and sensory disturbances, respectively, whereas stroke-like symptoms were reported by 12.0% and 31.4% of patients with MwA who experienced visual disturbances and sensory disturbances, respectively.

Study details: Findings are from a questionnaire-based observational study including 343 patients with MwA and 350 patients with AIS.

Disclosures: This study was supported by Swiss Heart Foundation. Several authors reported receiving research support, grants, personal fees, speaker fees, consulting or advisory support from Swiss Heart Foundation or other sources.

Source: Scutelnic A et al. Migraine aura-like symptoms at onset of stroke and stroke-like symptoms in migraine with aura. Front Neurol. 2022;13:1004058 (Sep 14). Doi: 10.3389/fneur.2022.1004058

Key clinical point: At the onset of attack, many patients with migraine with aura (MwA) experience stroke-like symptoms, whereas many patients with acute ischemic stroke (AIS) experience migraine-like symptoms, highlighting the need for additional clinical investigation for careful differential diagnosis.

Major finding: Migraine-like irritative sensations were experienced by 32.1% and 35.2% of patients with stroke who experienced visual disturbances and sensory disturbances, respectively, whereas stroke-like symptoms were reported by 12.0% and 31.4% of patients with MwA who experienced visual disturbances and sensory disturbances, respectively.

Study details: Findings are from a questionnaire-based observational study including 343 patients with MwA and 350 patients with AIS.

Disclosures: This study was supported by Swiss Heart Foundation. Several authors reported receiving research support, grants, personal fees, speaker fees, consulting or advisory support from Swiss Heart Foundation or other sources.

Source: Scutelnic A et al. Migraine aura-like symptoms at onset of stroke and stroke-like symptoms in migraine with aura. Front Neurol. 2022;13:1004058 (Sep 14). Doi: 10.3389/fneur.2022.1004058

Key clinical point: Galcanezumab demonstrated persistent efficacy in improving migraine features and disability scores and was well tolerated over 1 year in real-life patients with high frequency episodic migraine (HFEM) or chronic migraine (CM).

Major finding: The monthly migraine days (MMD) significantly reduced in patients with HFEM (from 11.5 ± 3.5 to 5.5 ± 5.5) and CM (from 19.3 ± 5.8 to 7.4 ± 5.9; both P < .00001) over 12 months along with a significant decrease in pain intensity, monthly acute medication intake, Headache Impact Test-6, and Migraine Disability Assessment questionnaire scores (all P < .00001). Overall, 56.5% of patients presented with a response rate of ≥50% reduction in MMD for 9 cumulative months. No serious adverse events were reported.

Study details: Findings are from a prospective ongoing study including 191 patients with HFEM or CM who received galcanezumab and completed the 12 months of observation since galcanezumab initiation.

Disclosures: This study was supported by Campus Bio-Medico University. Several authors reported receiving grants or honoraria from various sources.

Source: Vernieri F et al for the GARLIT Study Group. Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study. Eur J Neurol. 2022 (Sep 13). Doi: 10.1111/ene.15563

Key clinical point: Galcanezumab demonstrated persistent efficacy in improving migraine features and disability scores and was well tolerated over 1 year in real-life patients with high frequency episodic migraine (HFEM) or chronic migraine (CM).

Major finding: The monthly migraine days (MMD) significantly reduced in patients with HFEM (from 11.5 ± 3.5 to 5.5 ± 5.5) and CM (from 19.3 ± 5.8 to 7.4 ± 5.9; both P < .00001) over 12 months along with a significant decrease in pain intensity, monthly acute medication intake, Headache Impact Test-6, and Migraine Disability Assessment questionnaire scores (all P < .00001). Overall, 56.5% of patients presented with a response rate of ≥50% reduction in MMD for 9 cumulative months. No serious adverse events were reported.

Study details: Findings are from a prospective ongoing study including 191 patients with HFEM or CM who received galcanezumab and completed the 12 months of observation since galcanezumab initiation.

Disclosures: This study was supported by Campus Bio-Medico University. Several authors reported receiving grants or honoraria from various sources.

Source: Vernieri F et al for the GARLIT Study Group. Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study. Eur J Neurol. 2022 (Sep 13). Doi: 10.1111/ene.15563

Key clinical point: Galcanezumab demonstrated persistent efficacy in improving migraine features and disability scores and was well tolerated over 1 year in real-life patients with high frequency episodic migraine (HFEM) or chronic migraine (CM).

Major finding: The monthly migraine days (MMD) significantly reduced in patients with HFEM (from 11.5 ± 3.5 to 5.5 ± 5.5) and CM (from 19.3 ± 5.8 to 7.4 ± 5.9; both P < .00001) over 12 months along with a significant decrease in pain intensity, monthly acute medication intake, Headache Impact Test-6, and Migraine Disability Assessment questionnaire scores (all P < .00001). Overall, 56.5% of patients presented with a response rate of ≥50% reduction in MMD for 9 cumulative months. No serious adverse events were reported.

Study details: Findings are from a prospective ongoing study including 191 patients with HFEM or CM who received galcanezumab and completed the 12 months of observation since galcanezumab initiation.

Disclosures: This study was supported by Campus Bio-Medico University. Several authors reported receiving grants or honoraria from various sources.

Source: Vernieri F et al for the GARLIT Study Group. Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study. Eur J Neurol. 2022 (Sep 13). Doi: 10.1111/ene.15563

Key clinical point: Meta-analysis on 10 years of real-world data confirmed the efficacy of onabotulinumtoxinA as a preventive treatment for chronic migraine.

Major finding: At week 24, onabotulinumtoxinA reduced the number of headache days per month (mean change from baseline [MCFB] −10.64; 95% CI −12.31 to −8.97), with a ≥50% reduction in migraine days response rate of 46.57% (95% CI 29.50%-63.65%) and improvements in total Headache Impact Test-6 score (MCFB −11.70; 95% CI −13.86 to −9.54) and Migraine-Specific Quality of Life v2.1 score (MCFB 23.60; 95% CI 21.56-25.64). The improvements were maintained till 52 weeks.

Study details: Findings are from a systematic review and meta-analysis of 44 studies including patients with chronic migraine who received onabotulinumtoxinA.

Disclosures: This study was supported by AbbVie. M Lanteri-Minet reported receiving personal fees and grants from various sources. Four authors declared being employees of AbbVie or working for a consultancy company commissioned by AbbVie or holding stock options in GSK and AbbVie.

Source: Lanteri-Minet M et al. Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data. Cephalalgia. 2022 (Sep 8). Doi: 10.1177/03331024221123058

Key clinical point: Meta-analysis on 10 years of real-world data confirmed the efficacy of onabotulinumtoxinA as a preventive treatment for chronic migraine.

Major finding: At week 24, onabotulinumtoxinA reduced the number of headache days per month (mean change from baseline [MCFB] −10.64; 95% CI −12.31 to −8.97), with a ≥50% reduction in migraine days response rate of 46.57% (95% CI 29.50%-63.65%) and improvements in total Headache Impact Test-6 score (MCFB −11.70; 95% CI −13.86 to −9.54) and Migraine-Specific Quality of Life v2.1 score (MCFB 23.60; 95% CI 21.56-25.64). The improvements were maintained till 52 weeks.

Study details: Findings are from a systematic review and meta-analysis of 44 studies including patients with chronic migraine who received onabotulinumtoxinA.

Disclosures: This study was supported by AbbVie. M Lanteri-Minet reported receiving personal fees and grants from various sources. Four authors declared being employees of AbbVie or working for a consultancy company commissioned by AbbVie or holding stock options in GSK and AbbVie.

Source: Lanteri-Minet M et al. Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data. Cephalalgia. 2022 (Sep 8). Doi: 10.1177/03331024221123058

Key clinical point: Meta-analysis on 10 years of real-world data confirmed the efficacy of onabotulinumtoxinA as a preventive treatment for chronic migraine.

Major finding: At week 24, onabotulinumtoxinA reduced the number of headache days per month (mean change from baseline [MCFB] −10.64; 95% CI −12.31 to −8.97), with a ≥50% reduction in migraine days response rate of 46.57% (95% CI 29.50%-63.65%) and improvements in total Headache Impact Test-6 score (MCFB −11.70; 95% CI −13.86 to −9.54) and Migraine-Specific Quality of Life v2.1 score (MCFB 23.60; 95% CI 21.56-25.64). The improvements were maintained till 52 weeks.

Study details: Findings are from a systematic review and meta-analysis of 44 studies including patients with chronic migraine who received onabotulinumtoxinA.

Disclosures: This study was supported by AbbVie. M Lanteri-Minet reported receiving personal fees and grants from various sources. Four authors declared being employees of AbbVie or working for a consultancy company commissioned by AbbVie or holding stock options in GSK and AbbVie.

Source: Lanteri-Minet M et al. Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data. Cephalalgia. 2022 (Sep 8). Doi: 10.1177/03331024221123058

Key clinical point: Patients with migraine treated with anti-calcitonin gene-related peptide (anti-CGRP) receptor monoclonal antibodies (mAb), erenumab and fremanezumab, reported an increase in systolic and diastolic blood pressure, with most having blood pressure within normal limits but some requiring antihypertensive treatment.

Major finding: At 3 months, patients treated with erenumab or fremanezumab reported a significant increase in systolic (change from baseline [Δ] 5.0 mm Hg; P < .001) and diastolic (Δ 3.3 mm Hg; P < .001) blood pressure, with sustained effects over 1 year of follow-up (P < .001). Antihypertensive treatment was required by 3.7% of patients treated with erenumab.

Study details: This prospective follow-up study included 196 patients with migraine who previously failed ≥4 migraine preventive treatments and received erenumab or fremanezumab and 109 patients with migraine who did not use any migraine prophylactic medication.

Disclosures: This study did not receive any targeted funding. AM van den Brink and GM Terwindt reported receiving independent, consultancy, or industry support from various sources.

Source: de Vries Lentsch S et al. Blood pressure in migraine patients treated with monoclonal anti-CGRP (receptor) antibodies: A prospective follow-up study. Neurology. 2022 (Oct 4). Doi: 10.1212/WNL.0000000000201008

Key clinical point: Patients with migraine treated with anti-calcitonin gene-related peptide (anti-CGRP) receptor monoclonal antibodies (mAb), erenumab and fremanezumab, reported an increase in systolic and diastolic blood pressure, with most having blood pressure within normal limits but some requiring antihypertensive treatment.

Major finding: At 3 months, patients treated with erenumab or fremanezumab reported a significant increase in systolic (change from baseline [Δ] 5.0 mm Hg; P < .001) and diastolic (Δ 3.3 mm Hg; P < .001) blood pressure, with sustained effects over 1 year of follow-up (P < .001). Antihypertensive treatment was required by 3.7% of patients treated with erenumab.

Study details: This prospective follow-up study included 196 patients with migraine who previously failed ≥4 migraine preventive treatments and received erenumab or fremanezumab and 109 patients with migraine who did not use any migraine prophylactic medication.

Disclosures: This study did not receive any targeted funding. AM van den Brink and GM Terwindt reported receiving independent, consultancy, or industry support from various sources.

Source: de Vries Lentsch S et al. Blood pressure in migraine patients treated with monoclonal anti-CGRP (receptor) antibodies: A prospective follow-up study. Neurology. 2022 (Oct 4). Doi: 10.1212/WNL.0000000000201008

Key clinical point: Patients with migraine treated with anti-calcitonin gene-related peptide (anti-CGRP) receptor monoclonal antibodies (mAb), erenumab and fremanezumab, reported an increase in systolic and diastolic blood pressure, with most having blood pressure within normal limits but some requiring antihypertensive treatment.

Major finding: At 3 months, patients treated with erenumab or fremanezumab reported a significant increase in systolic (change from baseline [Δ] 5.0 mm Hg; P < .001) and diastolic (Δ 3.3 mm Hg; P < .001) blood pressure, with sustained effects over 1 year of follow-up (P < .001). Antihypertensive treatment was required by 3.7% of patients treated with erenumab.

Study details: This prospective follow-up study included 196 patients with migraine who previously failed ≥4 migraine preventive treatments and received erenumab or fremanezumab and 109 patients with migraine who did not use any migraine prophylactic medication.

Disclosures: This study did not receive any targeted funding. AM van den Brink and GM Terwindt reported receiving independent, consultancy, or industry support from various sources.

Source: de Vries Lentsch S et al. Blood pressure in migraine patients treated with monoclonal anti-CGRP (receptor) antibodies: A prospective follow-up study. Neurology. 2022 (Oct 4). Doi: 10.1212/WNL.0000000000201008

Three months after the World Health Organization declared monkeypox a public health emergency, clinical presentations and vaccination strategies are evolving.

New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.

Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.

Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.

Shift away from White men

Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.

“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.

In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.

“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.

No sustained spread outside MSM

Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.

However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.

“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”

She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.

“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.

Severe cases among immunocompromised

Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.

Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”

Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.

She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.

Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”

Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.

Differences from past epidemics

Dr. Titanji said the current outbreak has some differences from historic outbreaks.

The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.

There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.

The scope of suspected cases has also broadened, with changing clinical features.

“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.

Expanding the case definition will help identify who should be tested.

“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”

Vaccine strategy has evolved

Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.

Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”

It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.

Early data from the CDC indicate that the Jynneos vaccine is effective.

In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.

“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.

Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”

Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.

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

Three months after the World Health Organization declared monkeypox a public health emergency, clinical presentations and vaccination strategies are evolving.

New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.

Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.

Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.

Shift away from White men

Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.

“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.

In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.

“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.

No sustained spread outside MSM

Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.

However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.

“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”

She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.

“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.

Severe cases among immunocompromised

Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.

Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”

Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.

She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.

Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”

Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.

Differences from past epidemics

Dr. Titanji said the current outbreak has some differences from historic outbreaks.

The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.

There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.

The scope of suspected cases has also broadened, with changing clinical features.

“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.

Expanding the case definition will help identify who should be tested.

“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”

Vaccine strategy has evolved

Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.

Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”

It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.

Early data from the CDC indicate that the Jynneos vaccine is effective.

In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.

“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.

Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”

Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.

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

Three months after the World Health Organization declared monkeypox a public health emergency, clinical presentations and vaccination strategies are evolving.

New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.

Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.

Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.

Shift away from White men

Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.

“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.

In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.

“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.

No sustained spread outside MSM

Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.

However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.

“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”

She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.

“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.

Severe cases among immunocompromised

Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.

Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”

Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.

She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.

Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”

Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.

Differences from past epidemics

Dr. Titanji said the current outbreak has some differences from historic outbreaks.

The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.

There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.

The scope of suspected cases has also broadened, with changing clinical features.

“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.

Expanding the case definition will help identify who should be tested.

“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”

Vaccine strategy has evolved

Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.

Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”

It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.

Early data from the CDC indicate that the Jynneos vaccine is effective.

In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.

“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.

Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”

Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.

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

Preexisting statin use may help protect hospitalized patients with COVID-19 against negative outcomes, including death, a large retrospective analysis suggests.

Compared with patients who didn’t take statins, statin users had better health outcomes. For those who used these medications, the researchers saw lower mortality, lower clinical severity, and shorter hospital stays, aligning with previous observational studies, said lead author Ettore Crimi, MD, of the University of Central Florida, Orlando, and colleagues in their abstract, which was part of the agenda for the Anesthesiology annual meeting.

They attributed these clinical improvements to the pleiotropic – non–cholesterol lowering – effects of statins.

“[These] benefits of statins have been reported since the 1990s,” Dr. Crimi said in an interview. “Statin treatment has been associated with a marked reduction of markers of inflammation, such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), interleukin-6 (IL-6), ferritin, and white blood cell count, among others.”

He noted that these effects have been studied in an array of conditions, including cancer, autoimmune diseases, chronic inflammatory disease, and in the perioperative setting, and with infectious diseases, including COVID-19.

In those previous studies, “preexisting statin use was protective among hospitalized COVID-19 patients, but a large, multicenter cohort study has not been reported in the United States,” Dr. Crimi and his colleagues wrote in their abstract.

To address this knowledge gap, they turned to electronic medical records from 38,875 patients hospitalized with COVID-19 from January to September 2020. Almost one-third of the population (n = 11,533) were using statins prior to hospitalization, while the remainder (n = 27,342) were nonusers.

The primary outcome was all-cause mortality. Secondary outcomes included death from COVID-19, along with a variety of severe complications. While the analysis did account for a range of potentially confounding variables, the effects of different SARS-CoV-2 variants and new therapeutics were not considered. Vaccines were not yet available at the time the data were collected.

Statin users had a 31% lower rate of all-cause mortality (odds ratio, 0.69; 95% confidence interval, 0.64-0.75; P = .001) and a 37% reduced rate of death from COVID-19 (OR, 0.63; 95% CI, 0.58-0.69; P = .001).

A litany of other secondary variables also favored statin users, including reduced rates of discharge to hospice (OR, 0.79), ICU admission (OR, 0.69), severe acute respiratory distress syndrome (ARDs; OR, 0.72), critical ARDs (OR, 0.57), mechanical ventilation (OR, 0.60), severe sepsis with septic shock (OR, 0.66), and thrombosis (OR, 0.46). Statin users also had, on average, shorter hospital stays and briefer mechanical ventilation.

“Our study showed a strong association between preexisting statin use and reduced mortality and morbidity rates in hospitalized COVID-19 patients,” the investigators concluded. “Pleiotropic benefits of statins could be repurposed for COVID-19 illness.”

Prospective studies needed before practice changes

How to best use statins against COVID-19, if at all, remains unclear, Dr. Crimi said, as initiation upon infection has generated mixed results in other studies, possibly because of statin pharmacodynamics. Cholesterol normalization can take about 6 weeks, so other benefits may track a similar timeline.

“The delayed onset of statins’ pleiotropic effects may likely fail to keep pace with the rapidly progressive, devastating COVID-19 disease,” Dr. Crimi said. “Therefore, initiating statins for an acute disease may not be an ideal first-line treatment.”

Stronger data are on the horizon, he added, noting that 19 federally funded prospective trials are underway to better understand the relationship between statins and COVID-19.

Daniel Rader, MD, of the University of Pennsylvania, Philadelphia, said the present findings are “not especially notable” because they “mostly confirm previous studies, but in a large U.S. cohort.”

Dr. Rader, who wrote about the potential repurposing of statins for COVID-19 back in the first year of the pandemic (Cell Metab. 2020 Aug 4;32[2]:145-7), agreed with the investigators that recommending changes to clinical practice would be imprudent until randomized controlled data confirm the benefits of initiating statins in patients with active COVID-19.

“More research on the impact of cellular cholesterol metabolism on SARS-CoV-2 infection of cells and generation of inflammation would also be of interest,” he added.

The investigators disclosed no competing interests. Dr. Rader disclosed relationships with Novartis, Pfizer, Verve, and others.

Preexisting statin use may help protect hospitalized patients with COVID-19 against negative outcomes, including death, a large retrospective analysis suggests.

Compared with patients who didn’t take statins, statin users had better health outcomes. For those who used these medications, the researchers saw lower mortality, lower clinical severity, and shorter hospital stays, aligning with previous observational studies, said lead author Ettore Crimi, MD, of the University of Central Florida, Orlando, and colleagues in their abstract, which was part of the agenda for the Anesthesiology annual meeting.

They attributed these clinical improvements to the pleiotropic – non–cholesterol lowering – effects of statins.

“[These] benefits of statins have been reported since the 1990s,” Dr. Crimi said in an interview. “Statin treatment has been associated with a marked reduction of markers of inflammation, such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), interleukin-6 (IL-6), ferritin, and white blood cell count, among others.”

He noted that these effects have been studied in an array of conditions, including cancer, autoimmune diseases, chronic inflammatory disease, and in the perioperative setting, and with infectious diseases, including COVID-19.

In those previous studies, “preexisting statin use was protective among hospitalized COVID-19 patients, but a large, multicenter cohort study has not been reported in the United States,” Dr. Crimi and his colleagues wrote in their abstract.

To address this knowledge gap, they turned to electronic medical records from 38,875 patients hospitalized with COVID-19 from January to September 2020. Almost one-third of the population (n = 11,533) were using statins prior to hospitalization, while the remainder (n = 27,342) were nonusers.

The primary outcome was all-cause mortality. Secondary outcomes included death from COVID-19, along with a variety of severe complications. While the analysis did account for a range of potentially confounding variables, the effects of different SARS-CoV-2 variants and new therapeutics were not considered. Vaccines were not yet available at the time the data were collected.

Statin users had a 31% lower rate of all-cause mortality (odds ratio, 0.69; 95% confidence interval, 0.64-0.75; P = .001) and a 37% reduced rate of death from COVID-19 (OR, 0.63; 95% CI, 0.58-0.69; P = .001).

A litany of other secondary variables also favored statin users, including reduced rates of discharge to hospice (OR, 0.79), ICU admission (OR, 0.69), severe acute respiratory distress syndrome (ARDs; OR, 0.72), critical ARDs (OR, 0.57), mechanical ventilation (OR, 0.60), severe sepsis with septic shock (OR, 0.66), and thrombosis (OR, 0.46). Statin users also had, on average, shorter hospital stays and briefer mechanical ventilation.

“Our study showed a strong association between preexisting statin use and reduced mortality and morbidity rates in hospitalized COVID-19 patients,” the investigators concluded. “Pleiotropic benefits of statins could be repurposed for COVID-19 illness.”

Prospective studies needed before practice changes

How to best use statins against COVID-19, if at all, remains unclear, Dr. Crimi said, as initiation upon infection has generated mixed results in other studies, possibly because of statin pharmacodynamics. Cholesterol normalization can take about 6 weeks, so other benefits may track a similar timeline.

“The delayed onset of statins’ pleiotropic effects may likely fail to keep pace with the rapidly progressive, devastating COVID-19 disease,” Dr. Crimi said. “Therefore, initiating statins for an acute disease may not be an ideal first-line treatment.”

Stronger data are on the horizon, he added, noting that 19 federally funded prospective trials are underway to better understand the relationship between statins and COVID-19.

Daniel Rader, MD, of the University of Pennsylvania, Philadelphia, said the present findings are “not especially notable” because they “mostly confirm previous studies, but in a large U.S. cohort.”

Dr. Rader, who wrote about the potential repurposing of statins for COVID-19 back in the first year of the pandemic (Cell Metab. 2020 Aug 4;32[2]:145-7), agreed with the investigators that recommending changes to clinical practice would be imprudent until randomized controlled data confirm the benefits of initiating statins in patients with active COVID-19.

“More research on the impact of cellular cholesterol metabolism on SARS-CoV-2 infection of cells and generation of inflammation would also be of interest,” he added.

The investigators disclosed no competing interests. Dr. Rader disclosed relationships with Novartis, Pfizer, Verve, and others.

Preexisting statin use may help protect hospitalized patients with COVID-19 against negative outcomes, including death, a large retrospective analysis suggests.

Compared with patients who didn’t take statins, statin users had better health outcomes. For those who used these medications, the researchers saw lower mortality, lower clinical severity, and shorter hospital stays, aligning with previous observational studies, said lead author Ettore Crimi, MD, of the University of Central Florida, Orlando, and colleagues in their abstract, which was part of the agenda for the Anesthesiology annual meeting.

They attributed these clinical improvements to the pleiotropic – non–cholesterol lowering – effects of statins.

“[These] benefits of statins have been reported since the 1990s,” Dr. Crimi said in an interview. “Statin treatment has been associated with a marked reduction of markers of inflammation, such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), interleukin-6 (IL-6), ferritin, and white blood cell count, among others.”

He noted that these effects have been studied in an array of conditions, including cancer, autoimmune diseases, chronic inflammatory disease, and in the perioperative setting, and with infectious diseases, including COVID-19.

In those previous studies, “preexisting statin use was protective among hospitalized COVID-19 patients, but a large, multicenter cohort study has not been reported in the United States,” Dr. Crimi and his colleagues wrote in their abstract.

To address this knowledge gap, they turned to electronic medical records from 38,875 patients hospitalized with COVID-19 from January to September 2020. Almost one-third of the population (n = 11,533) were using statins prior to hospitalization, while the remainder (n = 27,342) were nonusers.

The primary outcome was all-cause mortality. Secondary outcomes included death from COVID-19, along with a variety of severe complications. While the analysis did account for a range of potentially confounding variables, the effects of different SARS-CoV-2 variants and new therapeutics were not considered. Vaccines were not yet available at the time the data were collected.

Statin users had a 31% lower rate of all-cause mortality (odds ratio, 0.69; 95% confidence interval, 0.64-0.75; P = .001) and a 37% reduced rate of death from COVID-19 (OR, 0.63; 95% CI, 0.58-0.69; P = .001).

A litany of other secondary variables also favored statin users, including reduced rates of discharge to hospice (OR, 0.79), ICU admission (OR, 0.69), severe acute respiratory distress syndrome (ARDs; OR, 0.72), critical ARDs (OR, 0.57), mechanical ventilation (OR, 0.60), severe sepsis with septic shock (OR, 0.66), and thrombosis (OR, 0.46). Statin users also had, on average, shorter hospital stays and briefer mechanical ventilation.

“Our study showed a strong association between preexisting statin use and reduced mortality and morbidity rates in hospitalized COVID-19 patients,” the investigators concluded. “Pleiotropic benefits of statins could be repurposed for COVID-19 illness.”

Prospective studies needed before practice changes

How to best use statins against COVID-19, if at all, remains unclear, Dr. Crimi said, as initiation upon infection has generated mixed results in other studies, possibly because of statin pharmacodynamics. Cholesterol normalization can take about 6 weeks, so other benefits may track a similar timeline.

“The delayed onset of statins’ pleiotropic effects may likely fail to keep pace with the rapidly progressive, devastating COVID-19 disease,” Dr. Crimi said. “Therefore, initiating statins for an acute disease may not be an ideal first-line treatment.”

Stronger data are on the horizon, he added, noting that 19 federally funded prospective trials are underway to better understand the relationship between statins and COVID-19.

Daniel Rader, MD, of the University of Pennsylvania, Philadelphia, said the present findings are “not especially notable” because they “mostly confirm previous studies, but in a large U.S. cohort.”

Dr. Rader, who wrote about the potential repurposing of statins for COVID-19 back in the first year of the pandemic (Cell Metab. 2020 Aug 4;32[2]:145-7), agreed with the investigators that recommending changes to clinical practice would be imprudent until randomized controlled data confirm the benefits of initiating statins in patients with active COVID-19.

“More research on the impact of cellular cholesterol metabolism on SARS-CoV-2 infection of cells and generation of inflammation would also be of interest,” he added.

The investigators disclosed no competing interests. Dr. Rader disclosed relationships with Novartis, Pfizer, Verve, and others.

Mind and body practices, especially yoga, improve glycemic control in type 2 diabetes to a similar extent as medications such as metformin, new research shows.

“To our knowledge, this is the first study that has looked across different modalities of mind-body interventions and the first to show that there is a very consistent effect on A1c regardless of which modality you use,” senior author, Richard Watanabe, PhD, professor of biostatistics, Keck School of Medicine of the University of Southern California, Los Angeles, told this news organization.

none needed

Regularity of yoga practice makes the difference

A total of 28 studies of patients with type 2 diabetes published between 1993 and 2022 were included in the meta-analysis. In all studies, patients who were taking insulin or had any medical complications of diabetes were excluded.

A significant mean reduction in A1c of 0.84% was observed across the board for all types of mindfulness interventions (P < .0001).

For mindfulness-based stress reduction, A1c was reduced by 0.48% (P = 0.03), while the practice of qigong – a coordinated body-posture movement – was associated with a 0.66% drop in A1c (P = .01). For meditation, A1c dropped by 0.50% (P = .64).

However, the largest drop in A1c was seen with yoga, where it fell by 1.00% (P < .0001) – about the same degree of glycemic control achieved with metformin, the authors point out.  

Indeed, for every additional day of yoga practiced per week, mean A1c differed by –0.22% (P = .46) between those who engaged in mind-body interventions and those who did not.

There was also a reduction in fasting blood glucose (FBG) with yoga and other practices. “The mean change in FBG was consistent with the mean change in A1c at –22.81 mg/dL (P < .0001),” the authors continue.

The researchers found that the duration of yoga didn’t matter but the frequency did, so it’s the regularity “with which you do yoga that makes the difference,” Dr. Watanabe said.

Dr. Watanabe and his coauthors also point out that because most patients were actively receiving metformin before and throughout the studies, the observed effect of mind and body practices on A1c represents an additional reduction beyond that of medication.

“This raises the question [as to] whether mind and body practices could be useful when initiated early in the course of diabetes therapy along with conventional lifestyle treatments,” they suggest.

While more research is needed to study this specifically, “our results suggest that these mind-body practices might be a good preventative measure,” Dr. Watanabe noted. Mind-body practices may also effectively prevent type 2 diabetes in at-risk patients, the authors propose.
 

Does meditation help alleviate psychological distress?

How mind-body practices work to improve glycemic control isn’t clear, but one possible theory is that patients experience a decrease in psychological distress when they undertake such practices and in so doing, may be more compliant with their prescribed treatment regimen.

A few of the studies analyzed showed that mind-body work resulted in a significant decrease in serum cortisol, the stress hormone that could plausibly mediate the benefit of mind and body practices through reduced inflammation.

In addition, “people with diabetes live with what we call ‘diabetes distress,’ ” Dr. Watanabe explained.

“Management of blood glucose is very stressful. You have to watch what you eat, you have to measure your glucose, and for the average person, that gets stressful. And that stress just contributes to the difficulty of controlling blood glucose,” he noted.

The authors have reported no relevant financial relationships.

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

Mind and body practices, especially yoga, improve glycemic control in type 2 diabetes to a similar extent as medications such as metformin, new research shows.

“To our knowledge, this is the first study that has looked across different modalities of mind-body interventions and the first to show that there is a very consistent effect on A1c regardless of which modality you use,” senior author, Richard Watanabe, PhD, professor of biostatistics, Keck School of Medicine of the University of Southern California, Los Angeles, told this news organization.

none needed

Regularity of yoga practice makes the difference

A total of 28 studies of patients with type 2 diabetes published between 1993 and 2022 were included in the meta-analysis. In all studies, patients who were taking insulin or had any medical complications of diabetes were excluded.

A significant mean reduction in A1c of 0.84% was observed across the board for all types of mindfulness interventions (P < .0001).

For mindfulness-based stress reduction, A1c was reduced by 0.48% (P = 0.03), while the practice of qigong – a coordinated body-posture movement – was associated with a 0.66% drop in A1c (P = .01). For meditation, A1c dropped by 0.50% (P = .64).

However, the largest drop in A1c was seen with yoga, where it fell by 1.00% (P < .0001) – about the same degree of glycemic control achieved with metformin, the authors point out.  

Indeed, for every additional day of yoga practiced per week, mean A1c differed by –0.22% (P = .46) between those who engaged in mind-body interventions and those who did not.

There was also a reduction in fasting blood glucose (FBG) with yoga and other practices. “The mean change in FBG was consistent with the mean change in A1c at –22.81 mg/dL (P < .0001),” the authors continue.

The researchers found that the duration of yoga didn’t matter but the frequency did, so it’s the regularity “with which you do yoga that makes the difference,” Dr. Watanabe said.

Dr. Watanabe and his coauthors also point out that because most patients were actively receiving metformin before and throughout the studies, the observed effect of mind and body practices on A1c represents an additional reduction beyond that of medication.

“This raises the question [as to] whether mind and body practices could be useful when initiated early in the course of diabetes therapy along with conventional lifestyle treatments,” they suggest.

While more research is needed to study this specifically, “our results suggest that these mind-body practices might be a good preventative measure,” Dr. Watanabe noted. Mind-body practices may also effectively prevent type 2 diabetes in at-risk patients, the authors propose.
 

Does meditation help alleviate psychological distress?

How mind-body practices work to improve glycemic control isn’t clear, but one possible theory is that patients experience a decrease in psychological distress when they undertake such practices and in so doing, may be more compliant with their prescribed treatment regimen.

A few of the studies analyzed showed that mind-body work resulted in a significant decrease in serum cortisol, the stress hormone that could plausibly mediate the benefit of mind and body practices through reduced inflammation.

In addition, “people with diabetes live with what we call ‘diabetes distress,’ ” Dr. Watanabe explained.

“Management of blood glucose is very stressful. You have to watch what you eat, you have to measure your glucose, and for the average person, that gets stressful. And that stress just contributes to the difficulty of controlling blood glucose,” he noted.

The authors have reported no relevant financial relationships.

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

Mind and body practices, especially yoga, improve glycemic control in type 2 diabetes to a similar extent as medications such as metformin, new research shows.

“To our knowledge, this is the first study that has looked across different modalities of mind-body interventions and the first to show that there is a very consistent effect on A1c regardless of which modality you use,” senior author, Richard Watanabe, PhD, professor of biostatistics, Keck School of Medicine of the University of Southern California, Los Angeles, told this news organization.

none needed

Regularity of yoga practice makes the difference

A total of 28 studies of patients with type 2 diabetes published between 1993 and 2022 were included in the meta-analysis. In all studies, patients who were taking insulin or had any medical complications of diabetes were excluded.

A significant mean reduction in A1c of 0.84% was observed across the board for all types of mindfulness interventions (P < .0001).

For mindfulness-based stress reduction, A1c was reduced by 0.48% (P = 0.03), while the practice of qigong – a coordinated body-posture movement – was associated with a 0.66% drop in A1c (P = .01). For meditation, A1c dropped by 0.50% (P = .64).

However, the largest drop in A1c was seen with yoga, where it fell by 1.00% (P < .0001) – about the same degree of glycemic control achieved with metformin, the authors point out.  

Indeed, for every additional day of yoga practiced per week, mean A1c differed by –0.22% (P = .46) between those who engaged in mind-body interventions and those who did not.

There was also a reduction in fasting blood glucose (FBG) with yoga and other practices. “The mean change in FBG was consistent with the mean change in A1c at –22.81 mg/dL (P < .0001),” the authors continue.

The researchers found that the duration of yoga didn’t matter but the frequency did, so it’s the regularity “with which you do yoga that makes the difference,” Dr. Watanabe said.

Dr. Watanabe and his coauthors also point out that because most patients were actively receiving metformin before and throughout the studies, the observed effect of mind and body practices on A1c represents an additional reduction beyond that of medication.

“This raises the question [as to] whether mind and body practices could be useful when initiated early in the course of diabetes therapy along with conventional lifestyle treatments,” they suggest.

While more research is needed to study this specifically, “our results suggest that these mind-body practices might be a good preventative measure,” Dr. Watanabe noted. Mind-body practices may also effectively prevent type 2 diabetes in at-risk patients, the authors propose.
 

Does meditation help alleviate psychological distress?

How mind-body practices work to improve glycemic control isn’t clear, but one possible theory is that patients experience a decrease in psychological distress when they undertake such practices and in so doing, may be more compliant with their prescribed treatment regimen.

A few of the studies analyzed showed that mind-body work resulted in a significant decrease in serum cortisol, the stress hormone that could plausibly mediate the benefit of mind and body practices through reduced inflammation.

In addition, “people with diabetes live with what we call ‘diabetes distress,’ ” Dr. Watanabe explained.

“Management of blood glucose is very stressful. You have to watch what you eat, you have to measure your glucose, and for the average person, that gets stressful. And that stress just contributes to the difficulty of controlling blood glucose,” he noted.

The authors have reported no relevant financial relationships.

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

MONTREAL – Systemic treatment of atopic dermatitis (AD) boosts mood in addition to relieving skin symptoms, according to a prospective, real-world, clinical cohort study presented at the annual meeting of the International Society of Atopic Dermatitis.

“Randomized, controlled, phase 3 studies have shown that systemic treatment of AD reduces depressive symptoms, but whether this holds true in real-world cohorts remains to be shown,” said study investigator Lina Ivert, MD, PhD, of the dermatology and venereology unit in the department of medicine at the Karolinska Institutet, Stockholm.

The study used data from SwedAD, a newly launched web-based Swedish national registry of patients with AD on systemic treatment between June 2017 and August 2021. Participants were followed at 6 and 12 months for the primary outcome of depressive symptoms using the Montgomery–Åsberg Depression Rating Scale–self-report (MADRS-S). Secondary outcomes included the Eczema Area and Severity Index (EASI) score, Patient-Oriented Eczema Measure (POEM), the Dermatology Life Quality Index (DLQI), and pruritus visual analog scale/numeric rating scale (VAS/NRS).

At baseline, 120 patients (median age, 39 years; 57.5% men) were started on dupilumab (n = 91), methotrexate (26), or cyclosporin (3). Although almost half had no depression at baseline, mild depression was present in 29.2%, with moderate and severe depression in 20% and 4.2%, respectively.

Among 59 patients with 6-month follow-up data (48 on dupilumab, 10 on methotrexate, 1 on cyclosporin), all nine depressive symptoms in MADRS-S improved significantly, with reduced sleep improving the most (from a median of 3 points to a median of 1 point). Similarly, overall MADRS-S scores improved (from a median of 14 points to a median of 5; P < .001), as did EASI scores (from a median of 20.5 to 2), POEM scores (from a median of 22 to 6), DLQI (from a median of 15 to 3), and pruritus scores (from a median of 7.1 to 1.8; all P < .001).

The analysis also found a strong correlation between the MADRS-S score and all of the secondary outcomes (P < .001 for all). All these improvements remained significant among the 36 patients with 12-month follow-up data.

“The median MADRS-S reduction also remained when we excluded eight patients who were on antidepressants during the study period, so these results cannot be explained by psychiatric medication,” noted Dr. Ivert, adding that three patients with severe suicide ideation at baseline improved their MADRS-S suicide item to less than 2 points. “So, this study taught us to look at the suicide item score and not only the total MADRS-S score,” she commented.

Comparing patients treated with dupilumab with those treated with methotrexate, the analysis showed that though baseline median MADRS-S scores did not differ significantly between them, there was a significant 6-month reduction in the dupilumab group but not in the methotrexate group.

Asked to comment on the findings, moderator Marissa Joseph, MD, a pediatric dermatologist at the University of Toronto, said that “the mental health effects of inflammatory skin conditions like atopic dermatitis are well known, but whether or not they are well explored in the patient-physician interaction is a whole other scenario.” There are time constraints, she said, adding, “it sometimes takes some deep-diving ... but exploring those types of symptoms is something we need to do more of, and the severity of the disease and reasons for treatment are not just what you can see.”

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

MONTREAL – Systemic treatment of atopic dermatitis (AD) boosts mood in addition to relieving skin symptoms, according to a prospective, real-world, clinical cohort study presented at the annual meeting of the International Society of Atopic Dermatitis.

“Randomized, controlled, phase 3 studies have shown that systemic treatment of AD reduces depressive symptoms, but whether this holds true in real-world cohorts remains to be shown,” said study investigator Lina Ivert, MD, PhD, of the dermatology and venereology unit in the department of medicine at the Karolinska Institutet, Stockholm.

The study used data from SwedAD, a newly launched web-based Swedish national registry of patients with AD on systemic treatment between June 2017 and August 2021. Participants were followed at 6 and 12 months for the primary outcome of depressive symptoms using the Montgomery–Åsberg Depression Rating Scale–self-report (MADRS-S). Secondary outcomes included the Eczema Area and Severity Index (EASI) score, Patient-Oriented Eczema Measure (POEM), the Dermatology Life Quality Index (DLQI), and pruritus visual analog scale/numeric rating scale (VAS/NRS).

At baseline, 120 patients (median age, 39 years; 57.5% men) were started on dupilumab (n = 91), methotrexate (26), or cyclosporin (3). Although almost half had no depression at baseline, mild depression was present in 29.2%, with moderate and severe depression in 20% and 4.2%, respectively.

Among 59 patients with 6-month follow-up data (48 on dupilumab, 10 on methotrexate, 1 on cyclosporin), all nine depressive symptoms in MADRS-S improved significantly, with reduced sleep improving the most (from a median of 3 points to a median of 1 point). Similarly, overall MADRS-S scores improved (from a median of 14 points to a median of 5; P < .001), as did EASI scores (from a median of 20.5 to 2), POEM scores (from a median of 22 to 6), DLQI (from a median of 15 to 3), and pruritus scores (from a median of 7.1 to 1.8; all P < .001).

The analysis also found a strong correlation between the MADRS-S score and all of the secondary outcomes (P < .001 for all). All these improvements remained significant among the 36 patients with 12-month follow-up data.

“The median MADRS-S reduction also remained when we excluded eight patients who were on antidepressants during the study period, so these results cannot be explained by psychiatric medication,” noted Dr. Ivert, adding that three patients with severe suicide ideation at baseline improved their MADRS-S suicide item to less than 2 points. “So, this study taught us to look at the suicide item score and not only the total MADRS-S score,” she commented.

Comparing patients treated with dupilumab with those treated with methotrexate, the analysis showed that though baseline median MADRS-S scores did not differ significantly between them, there was a significant 6-month reduction in the dupilumab group but not in the methotrexate group.

Asked to comment on the findings, moderator Marissa Joseph, MD, a pediatric dermatologist at the University of Toronto, said that “the mental health effects of inflammatory skin conditions like atopic dermatitis are well known, but whether or not they are well explored in the patient-physician interaction is a whole other scenario.” There are time constraints, she said, adding, “it sometimes takes some deep-diving ... but exploring those types of symptoms is something we need to do more of, and the severity of the disease and reasons for treatment are not just what you can see.”

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

MONTREAL – Systemic treatment of atopic dermatitis (AD) boosts mood in addition to relieving skin symptoms, according to a prospective, real-world, clinical cohort study presented at the annual meeting of the International Society of Atopic Dermatitis.

“Randomized, controlled, phase 3 studies have shown that systemic treatment of AD reduces depressive symptoms, but whether this holds true in real-world cohorts remains to be shown,” said study investigator Lina Ivert, MD, PhD, of the dermatology and venereology unit in the department of medicine at the Karolinska Institutet, Stockholm.

The study used data from SwedAD, a newly launched web-based Swedish national registry of patients with AD on systemic treatment between June 2017 and August 2021. Participants were followed at 6 and 12 months for the primary outcome of depressive symptoms using the Montgomery–Åsberg Depression Rating Scale–self-report (MADRS-S). Secondary outcomes included the Eczema Area and Severity Index (EASI) score, Patient-Oriented Eczema Measure (POEM), the Dermatology Life Quality Index (DLQI), and pruritus visual analog scale/numeric rating scale (VAS/NRS).

At baseline, 120 patients (median age, 39 years; 57.5% men) were started on dupilumab (n = 91), methotrexate (26), or cyclosporin (3). Although almost half had no depression at baseline, mild depression was present in 29.2%, with moderate and severe depression in 20% and 4.2%, respectively.

Among 59 patients with 6-month follow-up data (48 on dupilumab, 10 on methotrexate, 1 on cyclosporin), all nine depressive symptoms in MADRS-S improved significantly, with reduced sleep improving the most (from a median of 3 points to a median of 1 point). Similarly, overall MADRS-S scores improved (from a median of 14 points to a median of 5; P < .001), as did EASI scores (from a median of 20.5 to 2), POEM scores (from a median of 22 to 6), DLQI (from a median of 15 to 3), and pruritus scores (from a median of 7.1 to 1.8; all P < .001).

The analysis also found a strong correlation between the MADRS-S score and all of the secondary outcomes (P < .001 for all). All these improvements remained significant among the 36 patients with 12-month follow-up data.

“The median MADRS-S reduction also remained when we excluded eight patients who were on antidepressants during the study period, so these results cannot be explained by psychiatric medication,” noted Dr. Ivert, adding that three patients with severe suicide ideation at baseline improved their MADRS-S suicide item to less than 2 points. “So, this study taught us to look at the suicide item score and not only the total MADRS-S score,” she commented.

Comparing patients treated with dupilumab with those treated with methotrexate, the analysis showed that though baseline median MADRS-S scores did not differ significantly between them, there was a significant 6-month reduction in the dupilumab group but not in the methotrexate group.

Asked to comment on the findings, moderator Marissa Joseph, MD, a pediatric dermatologist at the University of Toronto, said that “the mental health effects of inflammatory skin conditions like atopic dermatitis are well known, but whether or not they are well explored in the patient-physician interaction is a whole other scenario.” There are time constraints, she said, adding, “it sometimes takes some deep-diving ... but exploring those types of symptoms is something we need to do more of, and the severity of the disease and reasons for treatment are not just what you can see.”

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

WASHINGTON – Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

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

WASHINGTON – Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

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

WASHINGTON – Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

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