Ovarian Cancer Blood Test Accuracy Rates Improved

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SAN DIEGO — Refinements to an experimental blood test for ovarian cancer have made it 97.5% sensitive and 99.7% specific for this rare, hard-to-detect disease, Dr. Aliza L. Leiser reported at the annual meeting of the Society of Gynecologic Oncologists.

“This test can discriminate between disease-free women and early cancer patients,” Dr. Leiser said in a presentation of validation studies conducted with serum samples from 160 newly diagnosed ovarian cancer patients and 365 healthy controls.

The investigators have started a prospective longitudinal trial to evaluate the screening tool in high-risk patients. Dr. Leiser, of Yale University, New Haven, Conn., said the group hopes to enroll 250–300 women. Participants are to submit blood samples every 3 months and undergo frequent transvaginal ultrasound and CA-125 screening.

Two years ago, Dr. Gil Mor of Yale's department of obstetrics, gynecology, and reproductive medicine announced that he and his colleagues had achieved 95% specificity, 95% sensitivity, 95% positive predictive value, and 94% negative predictive value with a four-protein blood test (Proc. Natl. Acad. Sci. U.S.A. 2005 May [Epub doi:10.1073/pnas.0502178102]). The test was considered highly promising, but the investigators said it had to be made at least 99.6% specific to avoid a high false-positive rate in the general population.

The revised test adds two more proteins—macrophage inhibitory factor and CA-125—to the original four-protein set of leptin, prolactin, osteopontin, and insulinlike growth factor II. Using bead-based multiplex technology, it determines levels of all six biomarkers simultaneously from a single blood sample. The new test also had a positive predictive value of 99.3% and a negative predictive value of 99.2% in the validation studies. It misclassified four stage I-II cancers; all stage III-IV cancers were identified correctly.

Applying these results to a 1 in 2,500 incidence of ovarian cancer in the general population, Dr. Leiser said its positive predictive value would be 12.6% and its negative predictive value 99.2%. She said the test is 91% sensitive for stage I-II disease and 100% sensitive for stage III-IV disease.

In a discussion of the study, Dr. Laura J. Havrilesky, of Duke University, Durham, N.C., noted, however, that only 24% of ovarian cancers in the validation studies were stage I-II cancers. “The test is useful only if it results in reduction of disease-related mortality, and this would be best achieved if it results in detection of the early-stage cancers.”

Dr. Leiser said that finding a sufficient number of early-stage patients is difficult because the disease is rarely detected when it is most treatable. She said her group is soliciting samples from other centers to expand the validation studies to a larger pool of patients with early-stage disease. The group also is trying the test in 1,200 healthy controls and 500 patients with other cancers and inflammatory conditions that might affect expression of the same biomarkers. The results so far have been negative in all patients with endometrial cancer, she said.

For information on submitting blood samples for testing, visit www.yaleobgyn.org/oncology/ovarian_cancer.html

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SAN DIEGO — Refinements to an experimental blood test for ovarian cancer have made it 97.5% sensitive and 99.7% specific for this rare, hard-to-detect disease, Dr. Aliza L. Leiser reported at the annual meeting of the Society of Gynecologic Oncologists.

“This test can discriminate between disease-free women and early cancer patients,” Dr. Leiser said in a presentation of validation studies conducted with serum samples from 160 newly diagnosed ovarian cancer patients and 365 healthy controls.

The investigators have started a prospective longitudinal trial to evaluate the screening tool in high-risk patients. Dr. Leiser, of Yale University, New Haven, Conn., said the group hopes to enroll 250–300 women. Participants are to submit blood samples every 3 months and undergo frequent transvaginal ultrasound and CA-125 screening.

Two years ago, Dr. Gil Mor of Yale's department of obstetrics, gynecology, and reproductive medicine announced that he and his colleagues had achieved 95% specificity, 95% sensitivity, 95% positive predictive value, and 94% negative predictive value with a four-protein blood test (Proc. Natl. Acad. Sci. U.S.A. 2005 May [Epub doi:10.1073/pnas.0502178102]). The test was considered highly promising, but the investigators said it had to be made at least 99.6% specific to avoid a high false-positive rate in the general population.

The revised test adds two more proteins—macrophage inhibitory factor and CA-125—to the original four-protein set of leptin, prolactin, osteopontin, and insulinlike growth factor II. Using bead-based multiplex technology, it determines levels of all six biomarkers simultaneously from a single blood sample. The new test also had a positive predictive value of 99.3% and a negative predictive value of 99.2% in the validation studies. It misclassified four stage I-II cancers; all stage III-IV cancers were identified correctly.

Applying these results to a 1 in 2,500 incidence of ovarian cancer in the general population, Dr. Leiser said its positive predictive value would be 12.6% and its negative predictive value 99.2%. She said the test is 91% sensitive for stage I-II disease and 100% sensitive for stage III-IV disease.

In a discussion of the study, Dr. Laura J. Havrilesky, of Duke University, Durham, N.C., noted, however, that only 24% of ovarian cancers in the validation studies were stage I-II cancers. “The test is useful only if it results in reduction of disease-related mortality, and this would be best achieved if it results in detection of the early-stage cancers.”

Dr. Leiser said that finding a sufficient number of early-stage patients is difficult because the disease is rarely detected when it is most treatable. She said her group is soliciting samples from other centers to expand the validation studies to a larger pool of patients with early-stage disease. The group also is trying the test in 1,200 healthy controls and 500 patients with other cancers and inflammatory conditions that might affect expression of the same biomarkers. The results so far have been negative in all patients with endometrial cancer, she said.

For information on submitting blood samples for testing, visit www.yaleobgyn.org/oncology/ovarian_cancer.html

SAN DIEGO — Refinements to an experimental blood test for ovarian cancer have made it 97.5% sensitive and 99.7% specific for this rare, hard-to-detect disease, Dr. Aliza L. Leiser reported at the annual meeting of the Society of Gynecologic Oncologists.

“This test can discriminate between disease-free women and early cancer patients,” Dr. Leiser said in a presentation of validation studies conducted with serum samples from 160 newly diagnosed ovarian cancer patients and 365 healthy controls.

The investigators have started a prospective longitudinal trial to evaluate the screening tool in high-risk patients. Dr. Leiser, of Yale University, New Haven, Conn., said the group hopes to enroll 250–300 women. Participants are to submit blood samples every 3 months and undergo frequent transvaginal ultrasound and CA-125 screening.

Two years ago, Dr. Gil Mor of Yale's department of obstetrics, gynecology, and reproductive medicine announced that he and his colleagues had achieved 95% specificity, 95% sensitivity, 95% positive predictive value, and 94% negative predictive value with a four-protein blood test (Proc. Natl. Acad. Sci. U.S.A. 2005 May [Epub doi:10.1073/pnas.0502178102]). The test was considered highly promising, but the investigators said it had to be made at least 99.6% specific to avoid a high false-positive rate in the general population.

The revised test adds two more proteins—macrophage inhibitory factor and CA-125—to the original four-protein set of leptin, prolactin, osteopontin, and insulinlike growth factor II. Using bead-based multiplex technology, it determines levels of all six biomarkers simultaneously from a single blood sample. The new test also had a positive predictive value of 99.3% and a negative predictive value of 99.2% in the validation studies. It misclassified four stage I-II cancers; all stage III-IV cancers were identified correctly.

Applying these results to a 1 in 2,500 incidence of ovarian cancer in the general population, Dr. Leiser said its positive predictive value would be 12.6% and its negative predictive value 99.2%. She said the test is 91% sensitive for stage I-II disease and 100% sensitive for stage III-IV disease.

In a discussion of the study, Dr. Laura J. Havrilesky, of Duke University, Durham, N.C., noted, however, that only 24% of ovarian cancers in the validation studies were stage I-II cancers. “The test is useful only if it results in reduction of disease-related mortality, and this would be best achieved if it results in detection of the early-stage cancers.”

Dr. Leiser said that finding a sufficient number of early-stage patients is difficult because the disease is rarely detected when it is most treatable. She said her group is soliciting samples from other centers to expand the validation studies to a larger pool of patients with early-stage disease. The group also is trying the test in 1,200 healthy controls and 500 patients with other cancers and inflammatory conditions that might affect expression of the same biomarkers. The results so far have been negative in all patients with endometrial cancer, she said.

For information on submitting blood samples for testing, visit www.yaleobgyn.org/oncology/ovarian_cancer.html

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Medications for Addictions Are Safer and More Effective

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Medications for Addictions Are Safer and More Effective

TUCSON, ARIZ. — Antiaddiction medications are becoming safer, more effective, and less prone to cause relapse, Dr. Michael E. Scott told clinicians at a psychopharmacology conference sponsored by the University of Arizona.

Not all patients remain abstinent on the new medications targeting neurotransmitters, but relapses tend to be shorter and less frequent, said Dr. Scott, medical director of the Sierra Tucson treatment center and a professor at the University of Arizona, Tucson.

“Success can be harm reduction, improvement in quality of life, and decrease in relapse severity,” he said, urging greater use of pharmacotherapy.

Patient selection and education are important with these agents, according to Dr. Scott. Compliance can be a problem, and objections from addiction professionals committed to abstinence programs as well as from some family members need to be addressed.

“A medication is not the same as a drug. … A medication is a therapeutic thing, and education is important. The patient needs to know the difference,” he said, adding, “Those early in recovery are less likely to understand medication. Those later in recovery are at greater risk of relapse. You need to know where they are.”

Alcohol Withdrawal

Dr. Scott favored benzodiazepines as the cheapest, safest, most effective therapies for alcohol withdrawal. Four drugs have been approved for treatment: disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), and naltrexone IM (Vivitrol).

Disulfiram works best in patients who are motivated, intelligent, and not impulsive, according to Dr. Scott. He said evidence does not support its use as a single agent to promote abstinence but suggests it can reduce drinking days and works well with cognitive behavioral therapy. He gives it to people in recovery programs.

Studies have shown oral naltrexone (approved for alcohol and opiate dependence) can delay relapses and reduce heavy drinking. “This drug, while it does not protract abstinence, it does help if someone slips to get them back into recovery,” Dr. Scott said.

Compliance is a major problem, however. He called it abysmal and suggested the best candidates for naltrexone therapy are patients mandated to treatment—for example, airline pilots and physicians in recovery.

Intramuscular naltrexone received U.S. Food and Drug Administration approval for alcohol dependence in 2006. Dr. Scott said physicians are still learning how to use it, but the once-a-month injections make compliance less of an issue. Patient selection is complicated, he noted, in that naltrexone IV has an extensive list of serious side effects, including suicidality and depression.

Compliance also is an issue with acamprosate, he continued, calling its three-times-a-day dosing requirement a fantasy. “It is too difficult a challenge for patients who are compliance-poor to begin with,” he said.

Acamprosate seems to promote abstinence, however, and has been shown to work well with naltrexone. “I think we are going to find the combination is better,” Dr. Scott said. “I think it's the trend where polypharmacy of addiction is going to be the norm rather than the exception.”

Opiate Detox

There is no clear choice of opiate detoxification regimen, according to Dr. Scott. Buprenor- phine is a new option that only physicians can prescribe and only if they are licensed after taking a one-day training program. “Even if you are not interested in addiction medicine, you do get addicts and opiate dependents in your practice,” he said, encouraging physicians to become licensed.

He discouraged another new approach, however: rapid/ultrarapid detoxification in which naloxone and naltrexone are administered under general anesthesia. “This is not a life-threatening illness. You don't want to kill your patients,” he said.

The treatment options include naltrexone, nalmefene (Revex), methadone, levo-alpha-acetylmethadol (LAAM), and buprenorphine.

Dr. Scott said that to make sure a patient is opiate-free before starting naltrexone or nalmefene, and he warned again that compliance is a major obstacle. Methadone is effective, he said, but LAAM has received a black-box warning and is not recommended.

Buprenorphine is available by itself as Subutex or in combination with naloxone as Suboxone. Dr. Scott said both are effective but Suboxone can precipitate withdrawal and should not be used in pregnant women. Buprenorphine should not be used with benzodiazepine; the combination can be fatal.

Helping Smokers

Nicotine replacement, bupropion (Zyban), nortriptyline, and clonidine can help 1 more person out of 14 to quit smoking—an absolute benefit of 7%, according to Dr. Scott. Clonidine has serious side effects, however, and he suggested nicotine replacement products might be underdosed.

Dr. Scott said a newly approved medication called varenicline (Chantix) might be more effective. “We are using it a lot more,” he said. “Patients seem to like it. It is fairly easy to take.”

 

 

'A medication is not the same as a drug. [It] is a therapeutic thing…. The patient needs to know the difference.' DR. SCOTT

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TUCSON, ARIZ. — Antiaddiction medications are becoming safer, more effective, and less prone to cause relapse, Dr. Michael E. Scott told clinicians at a psychopharmacology conference sponsored by the University of Arizona.

Not all patients remain abstinent on the new medications targeting neurotransmitters, but relapses tend to be shorter and less frequent, said Dr. Scott, medical director of the Sierra Tucson treatment center and a professor at the University of Arizona, Tucson.

“Success can be harm reduction, improvement in quality of life, and decrease in relapse severity,” he said, urging greater use of pharmacotherapy.

Patient selection and education are important with these agents, according to Dr. Scott. Compliance can be a problem, and objections from addiction professionals committed to abstinence programs as well as from some family members need to be addressed.

“A medication is not the same as a drug. … A medication is a therapeutic thing, and education is important. The patient needs to know the difference,” he said, adding, “Those early in recovery are less likely to understand medication. Those later in recovery are at greater risk of relapse. You need to know where they are.”

Alcohol Withdrawal

Dr. Scott favored benzodiazepines as the cheapest, safest, most effective therapies for alcohol withdrawal. Four drugs have been approved for treatment: disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), and naltrexone IM (Vivitrol).

Disulfiram works best in patients who are motivated, intelligent, and not impulsive, according to Dr. Scott. He said evidence does not support its use as a single agent to promote abstinence but suggests it can reduce drinking days and works well with cognitive behavioral therapy. He gives it to people in recovery programs.

Studies have shown oral naltrexone (approved for alcohol and opiate dependence) can delay relapses and reduce heavy drinking. “This drug, while it does not protract abstinence, it does help if someone slips to get them back into recovery,” Dr. Scott said.

Compliance is a major problem, however. He called it abysmal and suggested the best candidates for naltrexone therapy are patients mandated to treatment—for example, airline pilots and physicians in recovery.

Intramuscular naltrexone received U.S. Food and Drug Administration approval for alcohol dependence in 2006. Dr. Scott said physicians are still learning how to use it, but the once-a-month injections make compliance less of an issue. Patient selection is complicated, he noted, in that naltrexone IV has an extensive list of serious side effects, including suicidality and depression.

Compliance also is an issue with acamprosate, he continued, calling its three-times-a-day dosing requirement a fantasy. “It is too difficult a challenge for patients who are compliance-poor to begin with,” he said.

Acamprosate seems to promote abstinence, however, and has been shown to work well with naltrexone. “I think we are going to find the combination is better,” Dr. Scott said. “I think it's the trend where polypharmacy of addiction is going to be the norm rather than the exception.”

Opiate Detox

There is no clear choice of opiate detoxification regimen, according to Dr. Scott. Buprenor- phine is a new option that only physicians can prescribe and only if they are licensed after taking a one-day training program. “Even if you are not interested in addiction medicine, you do get addicts and opiate dependents in your practice,” he said, encouraging physicians to become licensed.

He discouraged another new approach, however: rapid/ultrarapid detoxification in which naloxone and naltrexone are administered under general anesthesia. “This is not a life-threatening illness. You don't want to kill your patients,” he said.

The treatment options include naltrexone, nalmefene (Revex), methadone, levo-alpha-acetylmethadol (LAAM), and buprenorphine.

Dr. Scott said that to make sure a patient is opiate-free before starting naltrexone or nalmefene, and he warned again that compliance is a major obstacle. Methadone is effective, he said, but LAAM has received a black-box warning and is not recommended.

Buprenorphine is available by itself as Subutex or in combination with naloxone as Suboxone. Dr. Scott said both are effective but Suboxone can precipitate withdrawal and should not be used in pregnant women. Buprenorphine should not be used with benzodiazepine; the combination can be fatal.

Helping Smokers

Nicotine replacement, bupropion (Zyban), nortriptyline, and clonidine can help 1 more person out of 14 to quit smoking—an absolute benefit of 7%, according to Dr. Scott. Clonidine has serious side effects, however, and he suggested nicotine replacement products might be underdosed.

Dr. Scott said a newly approved medication called varenicline (Chantix) might be more effective. “We are using it a lot more,” he said. “Patients seem to like it. It is fairly easy to take.”

 

 

'A medication is not the same as a drug. [It] is a therapeutic thing…. The patient needs to know the difference.' DR. SCOTT

TUCSON, ARIZ. — Antiaddiction medications are becoming safer, more effective, and less prone to cause relapse, Dr. Michael E. Scott told clinicians at a psychopharmacology conference sponsored by the University of Arizona.

Not all patients remain abstinent on the new medications targeting neurotransmitters, but relapses tend to be shorter and less frequent, said Dr. Scott, medical director of the Sierra Tucson treatment center and a professor at the University of Arizona, Tucson.

“Success can be harm reduction, improvement in quality of life, and decrease in relapse severity,” he said, urging greater use of pharmacotherapy.

Patient selection and education are important with these agents, according to Dr. Scott. Compliance can be a problem, and objections from addiction professionals committed to abstinence programs as well as from some family members need to be addressed.

“A medication is not the same as a drug. … A medication is a therapeutic thing, and education is important. The patient needs to know the difference,” he said, adding, “Those early in recovery are less likely to understand medication. Those later in recovery are at greater risk of relapse. You need to know where they are.”

Alcohol Withdrawal

Dr. Scott favored benzodiazepines as the cheapest, safest, most effective therapies for alcohol withdrawal. Four drugs have been approved for treatment: disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), and naltrexone IM (Vivitrol).

Disulfiram works best in patients who are motivated, intelligent, and not impulsive, according to Dr. Scott. He said evidence does not support its use as a single agent to promote abstinence but suggests it can reduce drinking days and works well with cognitive behavioral therapy. He gives it to people in recovery programs.

Studies have shown oral naltrexone (approved for alcohol and opiate dependence) can delay relapses and reduce heavy drinking. “This drug, while it does not protract abstinence, it does help if someone slips to get them back into recovery,” Dr. Scott said.

Compliance is a major problem, however. He called it abysmal and suggested the best candidates for naltrexone therapy are patients mandated to treatment—for example, airline pilots and physicians in recovery.

Intramuscular naltrexone received U.S. Food and Drug Administration approval for alcohol dependence in 2006. Dr. Scott said physicians are still learning how to use it, but the once-a-month injections make compliance less of an issue. Patient selection is complicated, he noted, in that naltrexone IV has an extensive list of serious side effects, including suicidality and depression.

Compliance also is an issue with acamprosate, he continued, calling its three-times-a-day dosing requirement a fantasy. “It is too difficult a challenge for patients who are compliance-poor to begin with,” he said.

Acamprosate seems to promote abstinence, however, and has been shown to work well with naltrexone. “I think we are going to find the combination is better,” Dr. Scott said. “I think it's the trend where polypharmacy of addiction is going to be the norm rather than the exception.”

Opiate Detox

There is no clear choice of opiate detoxification regimen, according to Dr. Scott. Buprenor- phine is a new option that only physicians can prescribe and only if they are licensed after taking a one-day training program. “Even if you are not interested in addiction medicine, you do get addicts and opiate dependents in your practice,” he said, encouraging physicians to become licensed.

He discouraged another new approach, however: rapid/ultrarapid detoxification in which naloxone and naltrexone are administered under general anesthesia. “This is not a life-threatening illness. You don't want to kill your patients,” he said.

The treatment options include naltrexone, nalmefene (Revex), methadone, levo-alpha-acetylmethadol (LAAM), and buprenorphine.

Dr. Scott said that to make sure a patient is opiate-free before starting naltrexone or nalmefene, and he warned again that compliance is a major obstacle. Methadone is effective, he said, but LAAM has received a black-box warning and is not recommended.

Buprenorphine is available by itself as Subutex or in combination with naloxone as Suboxone. Dr. Scott said both are effective but Suboxone can precipitate withdrawal and should not be used in pregnant women. Buprenorphine should not be used with benzodiazepine; the combination can be fatal.

Helping Smokers

Nicotine replacement, bupropion (Zyban), nortriptyline, and clonidine can help 1 more person out of 14 to quit smoking—an absolute benefit of 7%, according to Dr. Scott. Clonidine has serious side effects, however, and he suggested nicotine replacement products might be underdosed.

Dr. Scott said a newly approved medication called varenicline (Chantix) might be more effective. “We are using it a lot more,” he said. “Patients seem to like it. It is fairly easy to take.”

 

 

'A medication is not the same as a drug. [It] is a therapeutic thing…. The patient needs to know the difference.' DR. SCOTT

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Gyn. Oncologists Improve Survival in Ovarian Ca

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SAN DIEGO — A retrospective study of 1,491 Northern Californians diagnosed with ovarian cancer from 1994 to 1996 determined that women with the disease were likely to live significantly longer if treated by a gynecologic oncologist.

Women in the care of these cancer subspecialists had a 5-year survival rate of 39%, Dr. John K. Chan reported at the annual meeting of the Society of Gynecologic Oncologists. In comparison, 30% of women treated by other physicians survived 5 years in the study of patients in the California Cancer Registry.

“Treatment by a gynecologic oncologist is an independent prognostic factor for improved survival,” said Dr. Chan, newly appointed director of gynecologic oncology at the University of California, San Francisco.

He worked on the study while serving as a faculty member at Stanford (Calif.) University.

Dr. Chan and his colleagues attributed the survival advantage to gynecologic oncologists doing more primary surgery with appropriate staging and giving more chemotherapy. Nearly all the patients in subspecialist care had primary surgery (92%) and chemotherapy (90%), compared with 69% and 70% of those treated by other physicians.

In addition, the women who did not go to a gynecologic oncologist were four times more likely to have unstaged cancers (8% vs. 2%).

“We're just doing the standard treatment—what the guidelines recommend that we do, and what all the national organizations and all the studies prove is efficacious. It is nothing magical,” Dr. Chan said in an interview after his presentation.

He noted that the findings are consistent with many smaller studies that have shown better outcomes in patients treated by gynecologic oncologists. Drawing patients from multiple institutions, the new study provides more demographic detail, he said. Investigators augmented registry data with chemotherapy information from a medical record review and a physician survey.

Despite the extensive literature favoring treatment by gynecologic oncologists, two-thirds of the patients were treated by “others,” a group that was not broken down but is presumed to include general surgeons and ob.gyns. Though the proportion of patients receiving subspecialist care increased from 28% to 36% during the period studied, it was still only 34% overall. Compared with the larger group of women treated by other physicians, the women in the care of gynecologic oncologists were more affluent, more educated, and more often from urban areas. Poorer patients, especially those from rural areas, were less likely to see a gynecologic oncologist.

Looking for factors associated with suboptimal treatment of higher-risk, early-stage cancers, the investigators found 21% of younger patients (up to age 55) with stage IC-II cancers did not receive chemotherapy. They also reported that only 39% of poorer patients and 38% of patients with early-grade tumors received chemotherapy.

“Younger patients who did not receive appropriate treatment were more likely to be classified as poor, less likely to be treated by a gynecologic oncologist, and had more early-grade cancers,” Dr. Chan said, calling for more patient and physician education “to ensure that patients are appropriately referred to subspecialists to achieve comprehensive care.”

In a discussion of the study, Dr. Barbara Goff, secretary-treasurer of the society, reviewed the medical literature and asked why some women still have their procedures by surgeons other than gynecologic oncologists. The society needs to go beyond “preaching to the choir” and become more aggressive in educating other physicians about the importance of referring cancer patients to gynecologic oncologists, said Dr. Goff of the University of Washington, Seattle.

“We need to do a better job of promoting this agenda,” she said.

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SAN DIEGO — A retrospective study of 1,491 Northern Californians diagnosed with ovarian cancer from 1994 to 1996 determined that women with the disease were likely to live significantly longer if treated by a gynecologic oncologist.

Women in the care of these cancer subspecialists had a 5-year survival rate of 39%, Dr. John K. Chan reported at the annual meeting of the Society of Gynecologic Oncologists. In comparison, 30% of women treated by other physicians survived 5 years in the study of patients in the California Cancer Registry.

“Treatment by a gynecologic oncologist is an independent prognostic factor for improved survival,” said Dr. Chan, newly appointed director of gynecologic oncology at the University of California, San Francisco.

He worked on the study while serving as a faculty member at Stanford (Calif.) University.

Dr. Chan and his colleagues attributed the survival advantage to gynecologic oncologists doing more primary surgery with appropriate staging and giving more chemotherapy. Nearly all the patients in subspecialist care had primary surgery (92%) and chemotherapy (90%), compared with 69% and 70% of those treated by other physicians.

In addition, the women who did not go to a gynecologic oncologist were four times more likely to have unstaged cancers (8% vs. 2%).

“We're just doing the standard treatment—what the guidelines recommend that we do, and what all the national organizations and all the studies prove is efficacious. It is nothing magical,” Dr. Chan said in an interview after his presentation.

He noted that the findings are consistent with many smaller studies that have shown better outcomes in patients treated by gynecologic oncologists. Drawing patients from multiple institutions, the new study provides more demographic detail, he said. Investigators augmented registry data with chemotherapy information from a medical record review and a physician survey.

Despite the extensive literature favoring treatment by gynecologic oncologists, two-thirds of the patients were treated by “others,” a group that was not broken down but is presumed to include general surgeons and ob.gyns. Though the proportion of patients receiving subspecialist care increased from 28% to 36% during the period studied, it was still only 34% overall. Compared with the larger group of women treated by other physicians, the women in the care of gynecologic oncologists were more affluent, more educated, and more often from urban areas. Poorer patients, especially those from rural areas, were less likely to see a gynecologic oncologist.

Looking for factors associated with suboptimal treatment of higher-risk, early-stage cancers, the investigators found 21% of younger patients (up to age 55) with stage IC-II cancers did not receive chemotherapy. They also reported that only 39% of poorer patients and 38% of patients with early-grade tumors received chemotherapy.

“Younger patients who did not receive appropriate treatment were more likely to be classified as poor, less likely to be treated by a gynecologic oncologist, and had more early-grade cancers,” Dr. Chan said, calling for more patient and physician education “to ensure that patients are appropriately referred to subspecialists to achieve comprehensive care.”

In a discussion of the study, Dr. Barbara Goff, secretary-treasurer of the society, reviewed the medical literature and asked why some women still have their procedures by surgeons other than gynecologic oncologists. The society needs to go beyond “preaching to the choir” and become more aggressive in educating other physicians about the importance of referring cancer patients to gynecologic oncologists, said Dr. Goff of the University of Washington, Seattle.

“We need to do a better job of promoting this agenda,” she said.

SAN DIEGO — A retrospective study of 1,491 Northern Californians diagnosed with ovarian cancer from 1994 to 1996 determined that women with the disease were likely to live significantly longer if treated by a gynecologic oncologist.

Women in the care of these cancer subspecialists had a 5-year survival rate of 39%, Dr. John K. Chan reported at the annual meeting of the Society of Gynecologic Oncologists. In comparison, 30% of women treated by other physicians survived 5 years in the study of patients in the California Cancer Registry.

“Treatment by a gynecologic oncologist is an independent prognostic factor for improved survival,” said Dr. Chan, newly appointed director of gynecologic oncology at the University of California, San Francisco.

He worked on the study while serving as a faculty member at Stanford (Calif.) University.

Dr. Chan and his colleagues attributed the survival advantage to gynecologic oncologists doing more primary surgery with appropriate staging and giving more chemotherapy. Nearly all the patients in subspecialist care had primary surgery (92%) and chemotherapy (90%), compared with 69% and 70% of those treated by other physicians.

In addition, the women who did not go to a gynecologic oncologist were four times more likely to have unstaged cancers (8% vs. 2%).

“We're just doing the standard treatment—what the guidelines recommend that we do, and what all the national organizations and all the studies prove is efficacious. It is nothing magical,” Dr. Chan said in an interview after his presentation.

He noted that the findings are consistent with many smaller studies that have shown better outcomes in patients treated by gynecologic oncologists. Drawing patients from multiple institutions, the new study provides more demographic detail, he said. Investigators augmented registry data with chemotherapy information from a medical record review and a physician survey.

Despite the extensive literature favoring treatment by gynecologic oncologists, two-thirds of the patients were treated by “others,” a group that was not broken down but is presumed to include general surgeons and ob.gyns. Though the proportion of patients receiving subspecialist care increased from 28% to 36% during the period studied, it was still only 34% overall. Compared with the larger group of women treated by other physicians, the women in the care of gynecologic oncologists were more affluent, more educated, and more often from urban areas. Poorer patients, especially those from rural areas, were less likely to see a gynecologic oncologist.

Looking for factors associated with suboptimal treatment of higher-risk, early-stage cancers, the investigators found 21% of younger patients (up to age 55) with stage IC-II cancers did not receive chemotherapy. They also reported that only 39% of poorer patients and 38% of patients with early-grade tumors received chemotherapy.

“Younger patients who did not receive appropriate treatment were more likely to be classified as poor, less likely to be treated by a gynecologic oncologist, and had more early-grade cancers,” Dr. Chan said, calling for more patient and physician education “to ensure that patients are appropriately referred to subspecialists to achieve comprehensive care.”

In a discussion of the study, Dr. Barbara Goff, secretary-treasurer of the society, reviewed the medical literature and asked why some women still have their procedures by surgeons other than gynecologic oncologists. The society needs to go beyond “preaching to the choir” and become more aggressive in educating other physicians about the importance of referring cancer patients to gynecologic oncologists, said Dr. Goff of the University of Washington, Seattle.

“We need to do a better job of promoting this agenda,” she said.

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Apnea Linked to Atrial Fibrillation Before Age 65

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SCOTTSDALE, ARIZ. – Obesity and obstructive sleep apnea are independent risk factors for atrial fibrillation in patients younger than 65 years of age, but not in older patients, according to a retrospective cohort study of 3,542 people who had sleep studies at the Mayo Clinic in Rochester, Minn.

Heart failure was the only independent predictor of new-onset atrial fibrillation for people 65 years of age and older in the study, which followed patients a mean of 4.7 years after an initial polysomnography.

“The ability of sleep apnea to predict the development of atrial fibrillation was dependent on the age of the patient. If they were more than 65, and they were in sinus rhythm when you did the sleep study, they didn't get atrial fibrillation,” Dr. Virend K. Somers, a coinvestigator, said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

None of the patients had atrial fibrillation before or at the time of the screenings, conducted in 1987–2003, for possible sleep disorders. All told, 133 people developed atrial fibrillation at some point after undergoing polysomnography (J. Am. Coll. Cardiol. 2007;49:565–71).

Obstructive sleep apnea was diagnosed in 2,626 people (74%), and the investigators reported it was a strong predictor (hazard ratio 2.18) of future atrial fibrillation. A total of 4.3% of patients with obstructive sleep apnea but only 2.1% without the disorder were subsequently diagnosed with atrial fibrillation.

An age-stratified analysis showed patients younger than 65 years were more vulnerable to atrial fibrillation, however, and had more risk factors. The most significant was lower oxygen levels at night (hazard ratio 3.29), but age (2.04), male gender (2.66), coronary artery disease (2.66), and body mass index (1.07) also were predictors. In older patients, heart failure had a hazard ratio of 7.68.

Why the older patients were less susceptible to atrial fibrillation is unclear, according to the authors. Dr. Somers, a professor of medicine at the Mayo Clinic, speculated that the older patients probably had undiagnosed apnea for many years.

“If you have sleep apnea and you last to 65–70 years without developing atrial fibrillation, you are going to be okay–you are going to live longer,” he said. “But if you are susceptible to the damage that sleep apnea does to your cardiovascular system, you will develop atrial fibrillation earlier on.”

Dr. Somers is a consultant for Cardiac Concepts and is coinvestigator on a grant from the ResMed Foundation, which funded the study. The present study, for which the lead author is Dr. Apoor Gami, follows earlier research at the Mayo Clinic that showed an association between obstructive sleep apnea and atrial fibrillation.

In one study, Dr. Gami, Dr. Somers, and coinvestigators found obstructive sleep apnea was “strikingly more prevalent” (odds ratio 2.19) in atrial fibrillation patients than in general cardiology patients. About half (49%) of 151 patients who underwent electrocardioversion for atrial fibrillation had obstructive sleep apnea vs. about a third (32%) of 312 patients treated for other heart conditions (Circulation 2004;110:364–7).

In a study of patients who underwent electrocardioversion, Dr. Somers' group found atrial fibrillation was more likely to recur if obstructive sleep apnea was not treated (Circulation 2003;107:2589–94). Within 12 months, 82% of 27 untreated or inadequately treated apnea patients had their apnea recur, vs. 42% of 12 apnea patients treated with continuous positive airway pressure and 53% of the control group.

Dr. Somers noted that risk doubled in the apnea population when the condition went untreated, and in the 25 apnea patients who received no treatment, nocturnal oxygen saturation fell to lower levels in patients who had a recurrence of atrial fibrillation.

Does Sleep Apnea Treatment Prevent Heart Disease?

Despite presenting strong evidence of an association between obstructive sleep apnea and cardiovascular disease, Dr. Somers was careful not to say that treating the sleep disorder would prevent heart disease.

“Beyond lowering blood pressure and perhaps increasing EF [ejection fraction] in people with heart failure, treating sleep apnea has not been proven to prevent any cardiovascular end points,” he said.

“We have no evidence that treating sleep apnea will prevent a cardiac death, a heart attack, a stroke, or anything,” he said. “All we have now are soft end points–blood pressure, [and] heart rate.”

Many markers of heart disease–notably hypertension, elevated levels of C-reactive protein, and systemic inflammation–occur with sleep apnea, according to Dr. Somers. Consequently, he maintained, it makes sense that an untreated apnea could lead to cardiovascular disease.

Moreover, in addition to his work showing a link with atrial fibrillation, he cited studies associating sleep disorders with hypertension, sudden cardiac death, and heart failure. Among these findings, he noted the following:

 

 

▸ Apnea can cause hypertension, and hypertension becomes worse if apnea is not treated (N. Engl. J. Med. 2000;342:1378–84).

▸ Obstructive sleep apnea patients were two to three times more likely to have a first-degree relative who died of a heart attack or suddenly of an unexplained cause, according to a review of 500 people by Dr. Somers and his colleagues.

▸ Although 6 a.m.–11 a.m. is the peak time for sudden cardiac deaths in the general population, 46% of the sudden cardiac deaths in people with obstructive sleep apnea occurred between midnight and 6 a.m. (N. Engl. J. Med. 2005;352:1206–14).

About 10% of heart failure patients have obstructive sleep apnea and 40% have central sleep apnea, Dr. Somers added, attributing the data to studies conducted during the 1990s. “Since then,” he said, “patients are substantially fatter, and we think there are more obstructive apneas in heart failure patients than there used to be.”

Although Dr. Somers believes in treating sleep disorders to prevent heart disease, he added that his colleagues in cardiology won't be convinced until cause and effect is proved.

As for randomized controlled trials providing that proof, a major obstacle emerged in a question from the audience at the meeting. Institutional review boards are not likely to approve a trial that allows a sleep disorder to go untreated because the patient is randomized to a control group.

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SCOTTSDALE, ARIZ. – Obesity and obstructive sleep apnea are independent risk factors for atrial fibrillation in patients younger than 65 years of age, but not in older patients, according to a retrospective cohort study of 3,542 people who had sleep studies at the Mayo Clinic in Rochester, Minn.

Heart failure was the only independent predictor of new-onset atrial fibrillation for people 65 years of age and older in the study, which followed patients a mean of 4.7 years after an initial polysomnography.

“The ability of sleep apnea to predict the development of atrial fibrillation was dependent on the age of the patient. If they were more than 65, and they were in sinus rhythm when you did the sleep study, they didn't get atrial fibrillation,” Dr. Virend K. Somers, a coinvestigator, said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

None of the patients had atrial fibrillation before or at the time of the screenings, conducted in 1987–2003, for possible sleep disorders. All told, 133 people developed atrial fibrillation at some point after undergoing polysomnography (J. Am. Coll. Cardiol. 2007;49:565–71).

Obstructive sleep apnea was diagnosed in 2,626 people (74%), and the investigators reported it was a strong predictor (hazard ratio 2.18) of future atrial fibrillation. A total of 4.3% of patients with obstructive sleep apnea but only 2.1% without the disorder were subsequently diagnosed with atrial fibrillation.

An age-stratified analysis showed patients younger than 65 years were more vulnerable to atrial fibrillation, however, and had more risk factors. The most significant was lower oxygen levels at night (hazard ratio 3.29), but age (2.04), male gender (2.66), coronary artery disease (2.66), and body mass index (1.07) also were predictors. In older patients, heart failure had a hazard ratio of 7.68.

Why the older patients were less susceptible to atrial fibrillation is unclear, according to the authors. Dr. Somers, a professor of medicine at the Mayo Clinic, speculated that the older patients probably had undiagnosed apnea for many years.

“If you have sleep apnea and you last to 65–70 years without developing atrial fibrillation, you are going to be okay–you are going to live longer,” he said. “But if you are susceptible to the damage that sleep apnea does to your cardiovascular system, you will develop atrial fibrillation earlier on.”

Dr. Somers is a consultant for Cardiac Concepts and is coinvestigator on a grant from the ResMed Foundation, which funded the study. The present study, for which the lead author is Dr. Apoor Gami, follows earlier research at the Mayo Clinic that showed an association between obstructive sleep apnea and atrial fibrillation.

In one study, Dr. Gami, Dr. Somers, and coinvestigators found obstructive sleep apnea was “strikingly more prevalent” (odds ratio 2.19) in atrial fibrillation patients than in general cardiology patients. About half (49%) of 151 patients who underwent electrocardioversion for atrial fibrillation had obstructive sleep apnea vs. about a third (32%) of 312 patients treated for other heart conditions (Circulation 2004;110:364–7).

In a study of patients who underwent electrocardioversion, Dr. Somers' group found atrial fibrillation was more likely to recur if obstructive sleep apnea was not treated (Circulation 2003;107:2589–94). Within 12 months, 82% of 27 untreated or inadequately treated apnea patients had their apnea recur, vs. 42% of 12 apnea patients treated with continuous positive airway pressure and 53% of the control group.

Dr. Somers noted that risk doubled in the apnea population when the condition went untreated, and in the 25 apnea patients who received no treatment, nocturnal oxygen saturation fell to lower levels in patients who had a recurrence of atrial fibrillation.

Does Sleep Apnea Treatment Prevent Heart Disease?

Despite presenting strong evidence of an association between obstructive sleep apnea and cardiovascular disease, Dr. Somers was careful not to say that treating the sleep disorder would prevent heart disease.

“Beyond lowering blood pressure and perhaps increasing EF [ejection fraction] in people with heart failure, treating sleep apnea has not been proven to prevent any cardiovascular end points,” he said.

“We have no evidence that treating sleep apnea will prevent a cardiac death, a heart attack, a stroke, or anything,” he said. “All we have now are soft end points–blood pressure, [and] heart rate.”

Many markers of heart disease–notably hypertension, elevated levels of C-reactive protein, and systemic inflammation–occur with sleep apnea, according to Dr. Somers. Consequently, he maintained, it makes sense that an untreated apnea could lead to cardiovascular disease.

Moreover, in addition to his work showing a link with atrial fibrillation, he cited studies associating sleep disorders with hypertension, sudden cardiac death, and heart failure. Among these findings, he noted the following:

 

 

▸ Apnea can cause hypertension, and hypertension becomes worse if apnea is not treated (N. Engl. J. Med. 2000;342:1378–84).

▸ Obstructive sleep apnea patients were two to three times more likely to have a first-degree relative who died of a heart attack or suddenly of an unexplained cause, according to a review of 500 people by Dr. Somers and his colleagues.

▸ Although 6 a.m.–11 a.m. is the peak time for sudden cardiac deaths in the general population, 46% of the sudden cardiac deaths in people with obstructive sleep apnea occurred between midnight and 6 a.m. (N. Engl. J. Med. 2005;352:1206–14).

About 10% of heart failure patients have obstructive sleep apnea and 40% have central sleep apnea, Dr. Somers added, attributing the data to studies conducted during the 1990s. “Since then,” he said, “patients are substantially fatter, and we think there are more obstructive apneas in heart failure patients than there used to be.”

Although Dr. Somers believes in treating sleep disorders to prevent heart disease, he added that his colleagues in cardiology won't be convinced until cause and effect is proved.

As for randomized controlled trials providing that proof, a major obstacle emerged in a question from the audience at the meeting. Institutional review boards are not likely to approve a trial that allows a sleep disorder to go untreated because the patient is randomized to a control group.

SCOTTSDALE, ARIZ. – Obesity and obstructive sleep apnea are independent risk factors for atrial fibrillation in patients younger than 65 years of age, but not in older patients, according to a retrospective cohort study of 3,542 people who had sleep studies at the Mayo Clinic in Rochester, Minn.

Heart failure was the only independent predictor of new-onset atrial fibrillation for people 65 years of age and older in the study, which followed patients a mean of 4.7 years after an initial polysomnography.

“The ability of sleep apnea to predict the development of atrial fibrillation was dependent on the age of the patient. If they were more than 65, and they were in sinus rhythm when you did the sleep study, they didn't get atrial fibrillation,” Dr. Virend K. Somers, a coinvestigator, said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

None of the patients had atrial fibrillation before or at the time of the screenings, conducted in 1987–2003, for possible sleep disorders. All told, 133 people developed atrial fibrillation at some point after undergoing polysomnography (J. Am. Coll. Cardiol. 2007;49:565–71).

Obstructive sleep apnea was diagnosed in 2,626 people (74%), and the investigators reported it was a strong predictor (hazard ratio 2.18) of future atrial fibrillation. A total of 4.3% of patients with obstructive sleep apnea but only 2.1% without the disorder were subsequently diagnosed with atrial fibrillation.

An age-stratified analysis showed patients younger than 65 years were more vulnerable to atrial fibrillation, however, and had more risk factors. The most significant was lower oxygen levels at night (hazard ratio 3.29), but age (2.04), male gender (2.66), coronary artery disease (2.66), and body mass index (1.07) also were predictors. In older patients, heart failure had a hazard ratio of 7.68.

Why the older patients were less susceptible to atrial fibrillation is unclear, according to the authors. Dr. Somers, a professor of medicine at the Mayo Clinic, speculated that the older patients probably had undiagnosed apnea for many years.

“If you have sleep apnea and you last to 65–70 years without developing atrial fibrillation, you are going to be okay–you are going to live longer,” he said. “But if you are susceptible to the damage that sleep apnea does to your cardiovascular system, you will develop atrial fibrillation earlier on.”

Dr. Somers is a consultant for Cardiac Concepts and is coinvestigator on a grant from the ResMed Foundation, which funded the study. The present study, for which the lead author is Dr. Apoor Gami, follows earlier research at the Mayo Clinic that showed an association between obstructive sleep apnea and atrial fibrillation.

In one study, Dr. Gami, Dr. Somers, and coinvestigators found obstructive sleep apnea was “strikingly more prevalent” (odds ratio 2.19) in atrial fibrillation patients than in general cardiology patients. About half (49%) of 151 patients who underwent electrocardioversion for atrial fibrillation had obstructive sleep apnea vs. about a third (32%) of 312 patients treated for other heart conditions (Circulation 2004;110:364–7).

In a study of patients who underwent electrocardioversion, Dr. Somers' group found atrial fibrillation was more likely to recur if obstructive sleep apnea was not treated (Circulation 2003;107:2589–94). Within 12 months, 82% of 27 untreated or inadequately treated apnea patients had their apnea recur, vs. 42% of 12 apnea patients treated with continuous positive airway pressure and 53% of the control group.

Dr. Somers noted that risk doubled in the apnea population when the condition went untreated, and in the 25 apnea patients who received no treatment, nocturnal oxygen saturation fell to lower levels in patients who had a recurrence of atrial fibrillation.

Does Sleep Apnea Treatment Prevent Heart Disease?

Despite presenting strong evidence of an association between obstructive sleep apnea and cardiovascular disease, Dr. Somers was careful not to say that treating the sleep disorder would prevent heart disease.

“Beyond lowering blood pressure and perhaps increasing EF [ejection fraction] in people with heart failure, treating sleep apnea has not been proven to prevent any cardiovascular end points,” he said.

“We have no evidence that treating sleep apnea will prevent a cardiac death, a heart attack, a stroke, or anything,” he said. “All we have now are soft end points–blood pressure, [and] heart rate.”

Many markers of heart disease–notably hypertension, elevated levels of C-reactive protein, and systemic inflammation–occur with sleep apnea, according to Dr. Somers. Consequently, he maintained, it makes sense that an untreated apnea could lead to cardiovascular disease.

Moreover, in addition to his work showing a link with atrial fibrillation, he cited studies associating sleep disorders with hypertension, sudden cardiac death, and heart failure. Among these findings, he noted the following:

 

 

▸ Apnea can cause hypertension, and hypertension becomes worse if apnea is not treated (N. Engl. J. Med. 2000;342:1378–84).

▸ Obstructive sleep apnea patients were two to three times more likely to have a first-degree relative who died of a heart attack or suddenly of an unexplained cause, according to a review of 500 people by Dr. Somers and his colleagues.

▸ Although 6 a.m.–11 a.m. is the peak time for sudden cardiac deaths in the general population, 46% of the sudden cardiac deaths in people with obstructive sleep apnea occurred between midnight and 6 a.m. (N. Engl. J. Med. 2005;352:1206–14).

About 10% of heart failure patients have obstructive sleep apnea and 40% have central sleep apnea, Dr. Somers added, attributing the data to studies conducted during the 1990s. “Since then,” he said, “patients are substantially fatter, and we think there are more obstructive apneas in heart failure patients than there used to be.”

Although Dr. Somers believes in treating sleep disorders to prevent heart disease, he added that his colleagues in cardiology won't be convinced until cause and effect is proved.

As for randomized controlled trials providing that proof, a major obstacle emerged in a question from the audience at the meeting. Institutional review boards are not likely to approve a trial that allows a sleep disorder to go untreated because the patient is randomized to a control group.

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Bupropion as Adjunct to Patch Yields Long-Term Results

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PARIS – Enhancing a smoking cessation program with a daily dose of bupropion enabled a small group of schizophrenia patients to stay off nicotine in a randomized, placebo-controlled trial reported by Dr. Tony P. George at the annual congress of the European College of Neuropsychopharmacology.

All patients received 10 weeks of behavioral therapy during which they wore a transdermal nicotine patch 24 hours a day. In addition, 27 patients took 300 mg of bupropion SR daily, while 27 patients received a placebo.

At the conclusion of the intervention, 30% of the bupropion group and 5% of the placebo group had quit smoking. Six months later, 20% of the patients given bupropion were still not smoking. Not one member of the placebo group was able to stay off cigarettes that long.

“It is possible to get these difficult-to-treat patients to quit–more so in the short term, but also in the long term,” said Dr. George, recently appointed professor and chair of addiction psychiatry at the University of Toronto.

“This is very exciting to us,” he added. “This conclusion seems to be superior to the patch alone for short- and long-term outcomes.”

The research was done at Yale University, New Haven, Conn., where Dr. George had conducted previous studies of cognitive-behavioral therapy and the nicotine patch as smoking cessation strategies for patients with schizophrenia.

The National Institute on Drug Abuse funded the new trial. Dr. George presented preliminary results in Paris. However, he said that enrollment was nearly complete and that he did not expect any significant changes in the outcomes.

Patients in both arms of the study were about 40 years old on average and smoked about 24 cigarettes per day.

Schizophrenia patients have much higher rates of smoking and nicotine dependence than does the general population, according to Dr. George. They also have much more difficulty quitting smoking for reasons that may be related to the disorder. His earlier work suggests, for example, that cigarette smoking can enhance prefrontal cortical dopamine function and visual spatial memory in those with schizophrenia.

Nonetheless, Dr. George said in an interview at the meeting that many patients are highly motivated to quit because of the impact on their health–in particular, the risk of early death from cancer and cardiovascular diseases.

“It [nicotine] is helping them in the short term, but it is going to kill them in the end,” he said.

Dr. George said he plans to look at other nicotinic acetylcholine receptor agents in future studies as well as atomoxetine and the role of genetic polymorphisms in moderating treatment response.

“Developing better treatments will depend on the pathophysiologic relationship between smoking and the disorder itself–and possibly other disorders,” Dr. George said.

ELSEVIER GLOBAL MEDICAL NEWS

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PARIS – Enhancing a smoking cessation program with a daily dose of bupropion enabled a small group of schizophrenia patients to stay off nicotine in a randomized, placebo-controlled trial reported by Dr. Tony P. George at the annual congress of the European College of Neuropsychopharmacology.

All patients received 10 weeks of behavioral therapy during which they wore a transdermal nicotine patch 24 hours a day. In addition, 27 patients took 300 mg of bupropion SR daily, while 27 patients received a placebo.

At the conclusion of the intervention, 30% of the bupropion group and 5% of the placebo group had quit smoking. Six months later, 20% of the patients given bupropion were still not smoking. Not one member of the placebo group was able to stay off cigarettes that long.

“It is possible to get these difficult-to-treat patients to quit–more so in the short term, but also in the long term,” said Dr. George, recently appointed professor and chair of addiction psychiatry at the University of Toronto.

“This is very exciting to us,” he added. “This conclusion seems to be superior to the patch alone for short- and long-term outcomes.”

The research was done at Yale University, New Haven, Conn., where Dr. George had conducted previous studies of cognitive-behavioral therapy and the nicotine patch as smoking cessation strategies for patients with schizophrenia.

The National Institute on Drug Abuse funded the new trial. Dr. George presented preliminary results in Paris. However, he said that enrollment was nearly complete and that he did not expect any significant changes in the outcomes.

Patients in both arms of the study were about 40 years old on average and smoked about 24 cigarettes per day.

Schizophrenia patients have much higher rates of smoking and nicotine dependence than does the general population, according to Dr. George. They also have much more difficulty quitting smoking for reasons that may be related to the disorder. His earlier work suggests, for example, that cigarette smoking can enhance prefrontal cortical dopamine function and visual spatial memory in those with schizophrenia.

Nonetheless, Dr. George said in an interview at the meeting that many patients are highly motivated to quit because of the impact on their health–in particular, the risk of early death from cancer and cardiovascular diseases.

“It [nicotine] is helping them in the short term, but it is going to kill them in the end,” he said.

Dr. George said he plans to look at other nicotinic acetylcholine receptor agents in future studies as well as atomoxetine and the role of genetic polymorphisms in moderating treatment response.

“Developing better treatments will depend on the pathophysiologic relationship between smoking and the disorder itself–and possibly other disorders,” Dr. George said.

ELSEVIER GLOBAL MEDICAL NEWS

PARIS – Enhancing a smoking cessation program with a daily dose of bupropion enabled a small group of schizophrenia patients to stay off nicotine in a randomized, placebo-controlled trial reported by Dr. Tony P. George at the annual congress of the European College of Neuropsychopharmacology.

All patients received 10 weeks of behavioral therapy during which they wore a transdermal nicotine patch 24 hours a day. In addition, 27 patients took 300 mg of bupropion SR daily, while 27 patients received a placebo.

At the conclusion of the intervention, 30% of the bupropion group and 5% of the placebo group had quit smoking. Six months later, 20% of the patients given bupropion were still not smoking. Not one member of the placebo group was able to stay off cigarettes that long.

“It is possible to get these difficult-to-treat patients to quit–more so in the short term, but also in the long term,” said Dr. George, recently appointed professor and chair of addiction psychiatry at the University of Toronto.

“This is very exciting to us,” he added. “This conclusion seems to be superior to the patch alone for short- and long-term outcomes.”

The research was done at Yale University, New Haven, Conn., where Dr. George had conducted previous studies of cognitive-behavioral therapy and the nicotine patch as smoking cessation strategies for patients with schizophrenia.

The National Institute on Drug Abuse funded the new trial. Dr. George presented preliminary results in Paris. However, he said that enrollment was nearly complete and that he did not expect any significant changes in the outcomes.

Patients in both arms of the study were about 40 years old on average and smoked about 24 cigarettes per day.

Schizophrenia patients have much higher rates of smoking and nicotine dependence than does the general population, according to Dr. George. They also have much more difficulty quitting smoking for reasons that may be related to the disorder. His earlier work suggests, for example, that cigarette smoking can enhance prefrontal cortical dopamine function and visual spatial memory in those with schizophrenia.

Nonetheless, Dr. George said in an interview at the meeting that many patients are highly motivated to quit because of the impact on their health–in particular, the risk of early death from cancer and cardiovascular diseases.

“It [nicotine] is helping them in the short term, but it is going to kill them in the end,” he said.

Dr. George said he plans to look at other nicotinic acetylcholine receptor agents in future studies as well as atomoxetine and the role of genetic polymorphisms in moderating treatment response.

“Developing better treatments will depend on the pathophysiologic relationship between smoking and the disorder itself–and possibly other disorders,” Dr. George said.

ELSEVIER GLOBAL MEDICAL NEWS

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New Detox Medications Lessen Risk of Relapse

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TUCSON, ARIZ. – Antiaddiction medications are becoming safer, more effective, and less prone to cause relapse, Dr. Michael E. Scott told clinicians at a psychopharmacology conference sponsored by the University of Arizona.

Not all patients remain abstinent on the new medications targeting neurotransmitters, but relapses tend to be shorter and less frequent, said Dr. Scott, medical director of the Sierra Tucson treatment center and a professor at the University of Arizona, Tucson.

“Success can be harm reduction, improvement in quality of life, and decrease in relapse severity,” he said, urging greater use of pharmacotherapy.

Patient selection and education are important, according to Dr. Scott. Compliance can be a problem, and objections from addiction professionals committed to abstinence programs as well as from some family members must be addressed.

“A medication is not the same as a drug. … A medication is a therapeutic thing, and education is important. The patient needs to know the difference,” he said, adding, “Those early in recovery are less likely to understand medication. Those later in recovery are at greater risk of relapse. You need to know where they are.”

Alcohol Withdrawal

Dr. Scott favored benzodiazepines as the cheapest, safest, most effective therapies for alcohol withdrawal. Four drugs have been approved for treatment: disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), and naltrexone IM (Vivitrol).

Disulfiram works best in patients who are motivated, intelligent, and not impulsive, according to Dr. Scott. He said evidence does not support its use as a single agent to promote abstinence but suggests it can reduce drinking days and works well with cognitive-behavioral therapy. He gives it to people in recovery programs.

Studies have shown oral naltrexone (approved for alcohol and opiate dependence) can delay relapses and reduce heavy drinking. Compliance is a major problem, however. He called it abysmal and suggested the best candidates for naltrexone therapy are patients mandated to treatment–for example, airline pilots and physicians in recovery.

Intramuscular naltrexone received U.S. Food and Drug Administration approval for alcohol dependence in 2006. Dr. Scott said physicians are still learning how to use it, but the once-a-month injections make compliance less of an issue. Patient selection is complicated, he noted, in that naltrexone IV has an extensive list of serious side effects, including suicidality and depression.

Compliance also is an issue with acamprosate, he continued, calling its three-times-a-day dosing requirement a fantasy. “It is too difficult a challenge for patients who are compliance-poor to begin with,” he said.

Acamprosate seems to promote abstinence, however, and has been shown to work well with naltrexone. “I think we are going to find the combination is better,” Dr. Scott said. “I think it's the trend where polypharmacy of addiction is going to be the norm rather than the exception.”

Opiate Detoxification

There's no clear choice of opiate detoxification regimen, according to Dr. Scott. Buprenorphine is a new option that only physicians can prescribe and only if they are licensed after taking a 1-day training program. “Even if you are not interested in addiction medicine, you do get addicts and opiate dependents in your practice,” he said, encouraging physicians to become licensed.

He discouraged another new approach, however: rapid/ultrarapid detoxification in which naloxone and naltrexone are administered under general anesthesia. “This is not a life-threatening illness. You don't want to kill your patients,” he said.

Treatment options include naltrexone, nalmefene (Revex), methadone, levo-alpha-acetylmethadol (LAAM), and buprenorphine. Dr. Scott said to make sure a patient is opiate-free before starting naltrexone or nalmefene, and he warned again that compliance is a major obstacle. Methadone is effective, he said, but LAAM has received a black box warning and is not recommended.

Buprenorphine is available by itself as Subutex or in combination with naloxone as Suboxone. Dr. Scott said both are effective but Suboxone can precipitate withdrawal and should not be used in pregnant women. Buprenorphine should not be used with benzodiazepine; the combination can be fatal.

Helping Smokers

Nicotine replacement, bupropion (Zyban), nortriptyline, and clonidine can help 1 more person out of 14 to quit smoking–an absolute benefit of 7%, according to Dr. Scott. Clonidine has serious side effects, however, and he suggested nicotine replacement products might be underdosed.

Dr. Scott said a newly approved medication called varenicline (Chantix) might be more effective. “Patients seem to like it. It is fairly easy to take.”

A medication is not the same as a drug, and the patient needs to know the difference. DR. SCOTT

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TUCSON, ARIZ. – Antiaddiction medications are becoming safer, more effective, and less prone to cause relapse, Dr. Michael E. Scott told clinicians at a psychopharmacology conference sponsored by the University of Arizona.

Not all patients remain abstinent on the new medications targeting neurotransmitters, but relapses tend to be shorter and less frequent, said Dr. Scott, medical director of the Sierra Tucson treatment center and a professor at the University of Arizona, Tucson.

“Success can be harm reduction, improvement in quality of life, and decrease in relapse severity,” he said, urging greater use of pharmacotherapy.

Patient selection and education are important, according to Dr. Scott. Compliance can be a problem, and objections from addiction professionals committed to abstinence programs as well as from some family members must be addressed.

“A medication is not the same as a drug. … A medication is a therapeutic thing, and education is important. The patient needs to know the difference,” he said, adding, “Those early in recovery are less likely to understand medication. Those later in recovery are at greater risk of relapse. You need to know where they are.”

Alcohol Withdrawal

Dr. Scott favored benzodiazepines as the cheapest, safest, most effective therapies for alcohol withdrawal. Four drugs have been approved for treatment: disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), and naltrexone IM (Vivitrol).

Disulfiram works best in patients who are motivated, intelligent, and not impulsive, according to Dr. Scott. He said evidence does not support its use as a single agent to promote abstinence but suggests it can reduce drinking days and works well with cognitive-behavioral therapy. He gives it to people in recovery programs.

Studies have shown oral naltrexone (approved for alcohol and opiate dependence) can delay relapses and reduce heavy drinking. Compliance is a major problem, however. He called it abysmal and suggested the best candidates for naltrexone therapy are patients mandated to treatment–for example, airline pilots and physicians in recovery.

Intramuscular naltrexone received U.S. Food and Drug Administration approval for alcohol dependence in 2006. Dr. Scott said physicians are still learning how to use it, but the once-a-month injections make compliance less of an issue. Patient selection is complicated, he noted, in that naltrexone IV has an extensive list of serious side effects, including suicidality and depression.

Compliance also is an issue with acamprosate, he continued, calling its three-times-a-day dosing requirement a fantasy. “It is too difficult a challenge for patients who are compliance-poor to begin with,” he said.

Acamprosate seems to promote abstinence, however, and has been shown to work well with naltrexone. “I think we are going to find the combination is better,” Dr. Scott said. “I think it's the trend where polypharmacy of addiction is going to be the norm rather than the exception.”

Opiate Detoxification

There's no clear choice of opiate detoxification regimen, according to Dr. Scott. Buprenorphine is a new option that only physicians can prescribe and only if they are licensed after taking a 1-day training program. “Even if you are not interested in addiction medicine, you do get addicts and opiate dependents in your practice,” he said, encouraging physicians to become licensed.

He discouraged another new approach, however: rapid/ultrarapid detoxification in which naloxone and naltrexone are administered under general anesthesia. “This is not a life-threatening illness. You don't want to kill your patients,” he said.

Treatment options include naltrexone, nalmefene (Revex), methadone, levo-alpha-acetylmethadol (LAAM), and buprenorphine. Dr. Scott said to make sure a patient is opiate-free before starting naltrexone or nalmefene, and he warned again that compliance is a major obstacle. Methadone is effective, he said, but LAAM has received a black box warning and is not recommended.

Buprenorphine is available by itself as Subutex or in combination with naloxone as Suboxone. Dr. Scott said both are effective but Suboxone can precipitate withdrawal and should not be used in pregnant women. Buprenorphine should not be used with benzodiazepine; the combination can be fatal.

Helping Smokers

Nicotine replacement, bupropion (Zyban), nortriptyline, and clonidine can help 1 more person out of 14 to quit smoking–an absolute benefit of 7%, according to Dr. Scott. Clonidine has serious side effects, however, and he suggested nicotine replacement products might be underdosed.

Dr. Scott said a newly approved medication called varenicline (Chantix) might be more effective. “Patients seem to like it. It is fairly easy to take.”

A medication is not the same as a drug, and the patient needs to know the difference. DR. SCOTT

TUCSON, ARIZ. – Antiaddiction medications are becoming safer, more effective, and less prone to cause relapse, Dr. Michael E. Scott told clinicians at a psychopharmacology conference sponsored by the University of Arizona.

Not all patients remain abstinent on the new medications targeting neurotransmitters, but relapses tend to be shorter and less frequent, said Dr. Scott, medical director of the Sierra Tucson treatment center and a professor at the University of Arizona, Tucson.

“Success can be harm reduction, improvement in quality of life, and decrease in relapse severity,” he said, urging greater use of pharmacotherapy.

Patient selection and education are important, according to Dr. Scott. Compliance can be a problem, and objections from addiction professionals committed to abstinence programs as well as from some family members must be addressed.

“A medication is not the same as a drug. … A medication is a therapeutic thing, and education is important. The patient needs to know the difference,” he said, adding, “Those early in recovery are less likely to understand medication. Those later in recovery are at greater risk of relapse. You need to know where they are.”

Alcohol Withdrawal

Dr. Scott favored benzodiazepines as the cheapest, safest, most effective therapies for alcohol withdrawal. Four drugs have been approved for treatment: disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), and naltrexone IM (Vivitrol).

Disulfiram works best in patients who are motivated, intelligent, and not impulsive, according to Dr. Scott. He said evidence does not support its use as a single agent to promote abstinence but suggests it can reduce drinking days and works well with cognitive-behavioral therapy. He gives it to people in recovery programs.

Studies have shown oral naltrexone (approved for alcohol and opiate dependence) can delay relapses and reduce heavy drinking. Compliance is a major problem, however. He called it abysmal and suggested the best candidates for naltrexone therapy are patients mandated to treatment–for example, airline pilots and physicians in recovery.

Intramuscular naltrexone received U.S. Food and Drug Administration approval for alcohol dependence in 2006. Dr. Scott said physicians are still learning how to use it, but the once-a-month injections make compliance less of an issue. Patient selection is complicated, he noted, in that naltrexone IV has an extensive list of serious side effects, including suicidality and depression.

Compliance also is an issue with acamprosate, he continued, calling its three-times-a-day dosing requirement a fantasy. “It is too difficult a challenge for patients who are compliance-poor to begin with,” he said.

Acamprosate seems to promote abstinence, however, and has been shown to work well with naltrexone. “I think we are going to find the combination is better,” Dr. Scott said. “I think it's the trend where polypharmacy of addiction is going to be the norm rather than the exception.”

Opiate Detoxification

There's no clear choice of opiate detoxification regimen, according to Dr. Scott. Buprenorphine is a new option that only physicians can prescribe and only if they are licensed after taking a 1-day training program. “Even if you are not interested in addiction medicine, you do get addicts and opiate dependents in your practice,” he said, encouraging physicians to become licensed.

He discouraged another new approach, however: rapid/ultrarapid detoxification in which naloxone and naltrexone are administered under general anesthesia. “This is not a life-threatening illness. You don't want to kill your patients,” he said.

Treatment options include naltrexone, nalmefene (Revex), methadone, levo-alpha-acetylmethadol (LAAM), and buprenorphine. Dr. Scott said to make sure a patient is opiate-free before starting naltrexone or nalmefene, and he warned again that compliance is a major obstacle. Methadone is effective, he said, but LAAM has received a black box warning and is not recommended.

Buprenorphine is available by itself as Subutex or in combination with naloxone as Suboxone. Dr. Scott said both are effective but Suboxone can precipitate withdrawal and should not be used in pregnant women. Buprenorphine should not be used with benzodiazepine; the combination can be fatal.

Helping Smokers

Nicotine replacement, bupropion (Zyban), nortriptyline, and clonidine can help 1 more person out of 14 to quit smoking–an absolute benefit of 7%, according to Dr. Scott. Clonidine has serious side effects, however, and he suggested nicotine replacement products might be underdosed.

Dr. Scott said a newly approved medication called varenicline (Chantix) might be more effective. “Patients seem to like it. It is fairly easy to take.”

A medication is not the same as a drug, and the patient needs to know the difference. DR. SCOTT

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Is Your Apnea Patient at Risk for a Car Accident?

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SCOTTSDALE, ARIZ. — Evidence-based medicine provides no easy answers for a physician who must decide whether to report an obstructive sleep apnea patient to the state department of motor vehicles, according to Dr. Brian A. Boehlecke.

Numerous studies have failed to identify a method for determining which individuals with obstructive sleep apnea are more likely to have motor vehicle accidents, he said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

“There is no correlation between symptoms and objective measures of vigilance or performance,” said Dr. Boehlecke, a professor of medicine at the University of North Carolina in Chapel Hill, reviewing one of many studies with similar findings.

People with the disorder are more likely to be in a motor vehicle accident, he said, but the overall risk is low. In one report, patients had more crashes than did a control group during a 3-year period (odds ratio 2.6). Some patients had two and three crashes, but most did not have any accidents, and no physiologic markers predicted which patients were at greater risk (Am. J. Respir. Crit. Care Med. 1998;158:18–22).

How a person responds to sleep loss varies from individual to individual, Dr. Boehlecke said.

In study after study, objective measures such as scores on the Epworth Sleepiness Scale, Karolinska Sleepiness Scale, respiratory disturbance index, and the apnea-hypopnea index did not predict reaction time or driving performance.

He cited a U.S. Department of Transportation-commissioned review of the literature from 1960 to 2000 (Report No. DOT HS 809 690). The author concluded that commonly used measures of sleep apnea severity “are not very useful” in identifying people at risk for crashes.

In a more recent trial, 20 obstructive sleep apnea patients and 40 controls took a battery of tests, including a driving simulator (Eur. Respir. J. 2005;25:75–80). Dr. Boehlecke said that almost all the apnea patients had some impairment of vigilance or attention, but no one test predicted ability to remain awake and attentive.

Effectiveness of measures to counteract night drowsiness also is highly variable, according to Dr. Boehlecke. Drinking caffeine or taking a nap helped most participants in another study, but the effects ranged widely among individuals (Ann. Intern. Med. 2006;144:785–91.)

Dr. Boehlecke referred physicians treating sleep apnea patients to recommendations of the American Thoracic Society (Am. J. Respir. Crit. Care Med. 1994;150:1463–73) and a statement on commercial drivers from a Joint Task Force of the American College of Chest Physicians, the American College of Occupational and Environmental Medicine, and the National Sleep Foundation (Chest 2006;130:902–5).

The thoracic society calls on physicians to know the applicable laws in their state, to give high-risk drivers a warning of risk, and to report high-risk drivers who insist on driving before being treated for obstructive sleep apnea or who fail to comply with treatment.

Dr. Boehlecke noted that the joint statement gives an apnea-hypopnea index of 5 or more during titration and 10 or more, “depending on clinical findings,” as objective measures for when commercial drivers should be allowed to return to work. He questioned whether the thresholds were realistic given the inconclusive literature. It also calls for evaluation of compliance with treatment.

In the absence of an easy method for predicting when a patient poses a danger, he urged physicians to rely on their clinical judgment.

Two important considerations, he suggested, are whether the patient perceives a risk and whether he or she is willing to take actions to reduce it, such as treatment.

In North Carolina the law does not require him to report obstructive sleep apnea patients who pose a risk. Nonetheless, he reported a school bus driver who told him she “needs to work.” Her license was suspended while he confirmed the diagnosis, and it was reinstated after she started treatment.

“You've got to live with yourself, and do what you think is right,” Dr. Boehlecke said. “Don't be afraid to use your clinical judgment because nothing is a strong predictor of risk.”

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SCOTTSDALE, ARIZ. — Evidence-based medicine provides no easy answers for a physician who must decide whether to report an obstructive sleep apnea patient to the state department of motor vehicles, according to Dr. Brian A. Boehlecke.

Numerous studies have failed to identify a method for determining which individuals with obstructive sleep apnea are more likely to have motor vehicle accidents, he said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

“There is no correlation between symptoms and objective measures of vigilance or performance,” said Dr. Boehlecke, a professor of medicine at the University of North Carolina in Chapel Hill, reviewing one of many studies with similar findings.

People with the disorder are more likely to be in a motor vehicle accident, he said, but the overall risk is low. In one report, patients had more crashes than did a control group during a 3-year period (odds ratio 2.6). Some patients had two and three crashes, but most did not have any accidents, and no physiologic markers predicted which patients were at greater risk (Am. J. Respir. Crit. Care Med. 1998;158:18–22).

How a person responds to sleep loss varies from individual to individual, Dr. Boehlecke said.

In study after study, objective measures such as scores on the Epworth Sleepiness Scale, Karolinska Sleepiness Scale, respiratory disturbance index, and the apnea-hypopnea index did not predict reaction time or driving performance.

He cited a U.S. Department of Transportation-commissioned review of the literature from 1960 to 2000 (Report No. DOT HS 809 690). The author concluded that commonly used measures of sleep apnea severity “are not very useful” in identifying people at risk for crashes.

In a more recent trial, 20 obstructive sleep apnea patients and 40 controls took a battery of tests, including a driving simulator (Eur. Respir. J. 2005;25:75–80). Dr. Boehlecke said that almost all the apnea patients had some impairment of vigilance or attention, but no one test predicted ability to remain awake and attentive.

Effectiveness of measures to counteract night drowsiness also is highly variable, according to Dr. Boehlecke. Drinking caffeine or taking a nap helped most participants in another study, but the effects ranged widely among individuals (Ann. Intern. Med. 2006;144:785–91.)

Dr. Boehlecke referred physicians treating sleep apnea patients to recommendations of the American Thoracic Society (Am. J. Respir. Crit. Care Med. 1994;150:1463–73) and a statement on commercial drivers from a Joint Task Force of the American College of Chest Physicians, the American College of Occupational and Environmental Medicine, and the National Sleep Foundation (Chest 2006;130:902–5).

The thoracic society calls on physicians to know the applicable laws in their state, to give high-risk drivers a warning of risk, and to report high-risk drivers who insist on driving before being treated for obstructive sleep apnea or who fail to comply with treatment.

Dr. Boehlecke noted that the joint statement gives an apnea-hypopnea index of 5 or more during titration and 10 or more, “depending on clinical findings,” as objective measures for when commercial drivers should be allowed to return to work. He questioned whether the thresholds were realistic given the inconclusive literature. It also calls for evaluation of compliance with treatment.

In the absence of an easy method for predicting when a patient poses a danger, he urged physicians to rely on their clinical judgment.

Two important considerations, he suggested, are whether the patient perceives a risk and whether he or she is willing to take actions to reduce it, such as treatment.

In North Carolina the law does not require him to report obstructive sleep apnea patients who pose a risk. Nonetheless, he reported a school bus driver who told him she “needs to work.” Her license was suspended while he confirmed the diagnosis, and it was reinstated after she started treatment.

“You've got to live with yourself, and do what you think is right,” Dr. Boehlecke said. “Don't be afraid to use your clinical judgment because nothing is a strong predictor of risk.”

SCOTTSDALE, ARIZ. — Evidence-based medicine provides no easy answers for a physician who must decide whether to report an obstructive sleep apnea patient to the state department of motor vehicles, according to Dr. Brian A. Boehlecke.

Numerous studies have failed to identify a method for determining which individuals with obstructive sleep apnea are more likely to have motor vehicle accidents, he said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

“There is no correlation between symptoms and objective measures of vigilance or performance,” said Dr. Boehlecke, a professor of medicine at the University of North Carolina in Chapel Hill, reviewing one of many studies with similar findings.

People with the disorder are more likely to be in a motor vehicle accident, he said, but the overall risk is low. In one report, patients had more crashes than did a control group during a 3-year period (odds ratio 2.6). Some patients had two and three crashes, but most did not have any accidents, and no physiologic markers predicted which patients were at greater risk (Am. J. Respir. Crit. Care Med. 1998;158:18–22).

How a person responds to sleep loss varies from individual to individual, Dr. Boehlecke said.

In study after study, objective measures such as scores on the Epworth Sleepiness Scale, Karolinska Sleepiness Scale, respiratory disturbance index, and the apnea-hypopnea index did not predict reaction time or driving performance.

He cited a U.S. Department of Transportation-commissioned review of the literature from 1960 to 2000 (Report No. DOT HS 809 690). The author concluded that commonly used measures of sleep apnea severity “are not very useful” in identifying people at risk for crashes.

In a more recent trial, 20 obstructive sleep apnea patients and 40 controls took a battery of tests, including a driving simulator (Eur. Respir. J. 2005;25:75–80). Dr. Boehlecke said that almost all the apnea patients had some impairment of vigilance or attention, but no one test predicted ability to remain awake and attentive.

Effectiveness of measures to counteract night drowsiness also is highly variable, according to Dr. Boehlecke. Drinking caffeine or taking a nap helped most participants in another study, but the effects ranged widely among individuals (Ann. Intern. Med. 2006;144:785–91.)

Dr. Boehlecke referred physicians treating sleep apnea patients to recommendations of the American Thoracic Society (Am. J. Respir. Crit. Care Med. 1994;150:1463–73) and a statement on commercial drivers from a Joint Task Force of the American College of Chest Physicians, the American College of Occupational and Environmental Medicine, and the National Sleep Foundation (Chest 2006;130:902–5).

The thoracic society calls on physicians to know the applicable laws in their state, to give high-risk drivers a warning of risk, and to report high-risk drivers who insist on driving before being treated for obstructive sleep apnea or who fail to comply with treatment.

Dr. Boehlecke noted that the joint statement gives an apnea-hypopnea index of 5 or more during titration and 10 or more, “depending on clinical findings,” as objective measures for when commercial drivers should be allowed to return to work. He questioned whether the thresholds were realistic given the inconclusive literature. It also calls for evaluation of compliance with treatment.

In the absence of an easy method for predicting when a patient poses a danger, he urged physicians to rely on their clinical judgment.

Two important considerations, he suggested, are whether the patient perceives a risk and whether he or she is willing to take actions to reduce it, such as treatment.

In North Carolina the law does not require him to report obstructive sleep apnea patients who pose a risk. Nonetheless, he reported a school bus driver who told him she “needs to work.” Her license was suspended while he confirmed the diagnosis, and it was reinstated after she started treatment.

“You've got to live with yourself, and do what you think is right,” Dr. Boehlecke said. “Don't be afraid to use your clinical judgment because nothing is a strong predictor of risk.”

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Fontan Procedure Completed via Stenting

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STOCKHOLM — Physicians in Saudi Arabia are using catheterization instead of surgery to complete the Fontan procedure in infants born with a univentricular heart, Dr. Ahmad Sallehuddin reported at a meeting of the European Association for Cardio-Thoracic Surgery.

Nine of 16 children have successfully completed a modified form of the multistage intervention, according to preliminary results presented by Dr. Sallehuddin, a consultant cardiac surgeon at King Faisal Specialist Hospital and Research Center in Riyadh. Stenting was not possible in one child, who was converted to surgery. The other six in his report awaited the final step.

At 21 months of follow-up, there were no procedural mortalities or late deaths. Mean oxygen saturation was 92.7%, and ECG revealed no gradients across the stents that were inserted. One child underwent scheduled dilation of a stent from 12 mm to 18 mm at 1 year of age.

“Fontan completion without surgery is possible in selected patients with single ventricles,” Dr. Sallehuddin said at the conclusion of his plenary presentation at the meeting, which was held with the European Society of Thoracic Surgeons.

During an interview after his talk, Dr. Sallehuddin said he and his colleagues are trying to minimize the risks inherent in the multistage Fontan procedure by moving the final stage from the operating room to the catheter lab. “The patients do not need another wound. They do not need to be on coronary bypass,” he said. “They require less care. They go home.”

The experimental technique does not eliminate surgery in the complex repair. From June 2003 to February 2006, all 16 infants underwent bidirectional Glenn procedures in preparation for Fontan procedures. Fourteen of the children had one or two previous surgeries. One patient had a concomitant total anomalous pulmonary venous drainage repair; another required a Damus-Kaye-Stansel anastomosis.

The nine boys and seven girls had various forms of univentricular heart. All were older than 3 months and weighed more than 5 kg at the time of the Glenn procedure. Their mean age was 12.5 months, and their mean weight was 7.5 kg.

During the surgical stage, Dr. Sallehuddin's team used a Gore-Tex vascular tube between 14 mm and 16 mm in diameter to create an intra-arterial lateral tunnel. They patched the cardiac end of the superior vena cava and fenestrated the tunnel with a single aperture 10 mm-14 mm in diameter.

When the infants were older than 10 months and weighed more than 9 kg, the surgical team completed the Fontan procedure with general anesthesia in the cath lab. The mean age at this point was 20 months, and the mean weight was 11 kg.

Physicians pierced the autologous pericardial patch with radiofrequency energy and gained femoral access by dilating the patch with a balloon. They deployed a stent mounted on a second balloon across the patch and closed the fenestrations with an occlusion device. Whereas the mean diameter of the aperture had been 11.8 mm at the conclusion of the surgical preparation, it was 7.9 mm at the time of completion.

Dr. Sallehuddin reported the average fluoroscopy time was 41 minutes, and the mean procedural time was 212 minutes. The increase in oxygen saturation was significant: from 83% before stenting to 93% afterward. Pulmonary artery pressures were normal before and after: 15 mm Hg and 19 mm Hg, respectively. The nine stents were dilated to 14.4 mm on average.

Comparison of the catheter experience with a report of the surgical completion at the same institution showed hospital and intensive care unit stays were shorter with catheterization: 6 days vs. 14.9 days and 1 day vs. 4.7 days, respectively.

'The patients do not need another wound. They do not need to be on coronary bypass. They require less care.' DR. SALLEHUDDIN

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STOCKHOLM — Physicians in Saudi Arabia are using catheterization instead of surgery to complete the Fontan procedure in infants born with a univentricular heart, Dr. Ahmad Sallehuddin reported at a meeting of the European Association for Cardio-Thoracic Surgery.

Nine of 16 children have successfully completed a modified form of the multistage intervention, according to preliminary results presented by Dr. Sallehuddin, a consultant cardiac surgeon at King Faisal Specialist Hospital and Research Center in Riyadh. Stenting was not possible in one child, who was converted to surgery. The other six in his report awaited the final step.

At 21 months of follow-up, there were no procedural mortalities or late deaths. Mean oxygen saturation was 92.7%, and ECG revealed no gradients across the stents that were inserted. One child underwent scheduled dilation of a stent from 12 mm to 18 mm at 1 year of age.

“Fontan completion without surgery is possible in selected patients with single ventricles,” Dr. Sallehuddin said at the conclusion of his plenary presentation at the meeting, which was held with the European Society of Thoracic Surgeons.

During an interview after his talk, Dr. Sallehuddin said he and his colleagues are trying to minimize the risks inherent in the multistage Fontan procedure by moving the final stage from the operating room to the catheter lab. “The patients do not need another wound. They do not need to be on coronary bypass,” he said. “They require less care. They go home.”

The experimental technique does not eliminate surgery in the complex repair. From June 2003 to February 2006, all 16 infants underwent bidirectional Glenn procedures in preparation for Fontan procedures. Fourteen of the children had one or two previous surgeries. One patient had a concomitant total anomalous pulmonary venous drainage repair; another required a Damus-Kaye-Stansel anastomosis.

The nine boys and seven girls had various forms of univentricular heart. All were older than 3 months and weighed more than 5 kg at the time of the Glenn procedure. Their mean age was 12.5 months, and their mean weight was 7.5 kg.

During the surgical stage, Dr. Sallehuddin's team used a Gore-Tex vascular tube between 14 mm and 16 mm in diameter to create an intra-arterial lateral tunnel. They patched the cardiac end of the superior vena cava and fenestrated the tunnel with a single aperture 10 mm-14 mm in diameter.

When the infants were older than 10 months and weighed more than 9 kg, the surgical team completed the Fontan procedure with general anesthesia in the cath lab. The mean age at this point was 20 months, and the mean weight was 11 kg.

Physicians pierced the autologous pericardial patch with radiofrequency energy and gained femoral access by dilating the patch with a balloon. They deployed a stent mounted on a second balloon across the patch and closed the fenestrations with an occlusion device. Whereas the mean diameter of the aperture had been 11.8 mm at the conclusion of the surgical preparation, it was 7.9 mm at the time of completion.

Dr. Sallehuddin reported the average fluoroscopy time was 41 minutes, and the mean procedural time was 212 minutes. The increase in oxygen saturation was significant: from 83% before stenting to 93% afterward. Pulmonary artery pressures were normal before and after: 15 mm Hg and 19 mm Hg, respectively. The nine stents were dilated to 14.4 mm on average.

Comparison of the catheter experience with a report of the surgical completion at the same institution showed hospital and intensive care unit stays were shorter with catheterization: 6 days vs. 14.9 days and 1 day vs. 4.7 days, respectively.

'The patients do not need another wound. They do not need to be on coronary bypass. They require less care.' DR. SALLEHUDDIN

STOCKHOLM — Physicians in Saudi Arabia are using catheterization instead of surgery to complete the Fontan procedure in infants born with a univentricular heart, Dr. Ahmad Sallehuddin reported at a meeting of the European Association for Cardio-Thoracic Surgery.

Nine of 16 children have successfully completed a modified form of the multistage intervention, according to preliminary results presented by Dr. Sallehuddin, a consultant cardiac surgeon at King Faisal Specialist Hospital and Research Center in Riyadh. Stenting was not possible in one child, who was converted to surgery. The other six in his report awaited the final step.

At 21 months of follow-up, there were no procedural mortalities or late deaths. Mean oxygen saturation was 92.7%, and ECG revealed no gradients across the stents that were inserted. One child underwent scheduled dilation of a stent from 12 mm to 18 mm at 1 year of age.

“Fontan completion without surgery is possible in selected patients with single ventricles,” Dr. Sallehuddin said at the conclusion of his plenary presentation at the meeting, which was held with the European Society of Thoracic Surgeons.

During an interview after his talk, Dr. Sallehuddin said he and his colleagues are trying to minimize the risks inherent in the multistage Fontan procedure by moving the final stage from the operating room to the catheter lab. “The patients do not need another wound. They do not need to be on coronary bypass,” he said. “They require less care. They go home.”

The experimental technique does not eliminate surgery in the complex repair. From June 2003 to February 2006, all 16 infants underwent bidirectional Glenn procedures in preparation for Fontan procedures. Fourteen of the children had one or two previous surgeries. One patient had a concomitant total anomalous pulmonary venous drainage repair; another required a Damus-Kaye-Stansel anastomosis.

The nine boys and seven girls had various forms of univentricular heart. All were older than 3 months and weighed more than 5 kg at the time of the Glenn procedure. Their mean age was 12.5 months, and their mean weight was 7.5 kg.

During the surgical stage, Dr. Sallehuddin's team used a Gore-Tex vascular tube between 14 mm and 16 mm in diameter to create an intra-arterial lateral tunnel. They patched the cardiac end of the superior vena cava and fenestrated the tunnel with a single aperture 10 mm-14 mm in diameter.

When the infants were older than 10 months and weighed more than 9 kg, the surgical team completed the Fontan procedure with general anesthesia in the cath lab. The mean age at this point was 20 months, and the mean weight was 11 kg.

Physicians pierced the autologous pericardial patch with radiofrequency energy and gained femoral access by dilating the patch with a balloon. They deployed a stent mounted on a second balloon across the patch and closed the fenestrations with an occlusion device. Whereas the mean diameter of the aperture had been 11.8 mm at the conclusion of the surgical preparation, it was 7.9 mm at the time of completion.

Dr. Sallehuddin reported the average fluoroscopy time was 41 minutes, and the mean procedural time was 212 minutes. The increase in oxygen saturation was significant: from 83% before stenting to 93% afterward. Pulmonary artery pressures were normal before and after: 15 mm Hg and 19 mm Hg, respectively. The nine stents were dilated to 14.4 mm on average.

Comparison of the catheter experience with a report of the surgical completion at the same institution showed hospital and intensive care unit stays were shorter with catheterization: 6 days vs. 14.9 days and 1 day vs. 4.7 days, respectively.

'The patients do not need another wound. They do not need to be on coronary bypass. They require less care.' DR. SALLEHUDDIN

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Stabilizing Glucose Didn't Help in Acute Stroke Trial

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SAN FRANCISCO — Stabilizing glucose levels in acute stroke patients failed to reduce mortality or influence survival with severe disability at 90 days in a large randomized controlled trial presented at the 32nd International Stroke Conference.

Patients treated with a continuous infusion of glucose, insulin, and potassium (GIK) had significant reductions in glucose levels and blood pressure but received no benefit in outcomes, compared with a control group given a saline solution, Dr. Christopher Gray reported.

The reduction in blood pressure surprised investigators of the United Kingdom Glucose Insulin in Stroke (GIST-UK) study. The finding suggests that tight glucose control might be harmful to stroke patients, said Dr. Gray of the Newcastle University School of Clinical Medical Sciences in Sunderland, England.

“We may have inadvertently explained why lower glucose levels confer benefit in [acute myocardial infarction],” he said at a press briefing prior to his presentation at the meeting, which was sponsored by the American Stroke Association.

Reduced blood pressure “was not something we expected,” said Dr. Gray, chief investigator of GIST-UK. Other studies of glucose levels in myocardial infarction have not reported changes in blood pressure.

Although hyperglycemia is associated with greater mortality in stroke patients, he emphasized that tight glucose control has not been shown to be safe in stroke patients who are not diabetic. “It may be intensive glucose lowering is not associated with benefit,” he said. “It may be associated with risk.”

Regarding stepped-up efforts to control glucose in intensive care units, Dr. Gray added in an interview that “for stroke patients with mild to moderate elevations in glucose, we should leave well enough alone.”

GIST-UK randomized 933 acute stroke patients presenting with cerebral infarction or intracerebral hemorrhage at 21 centers from 1998 to 2006. It enrolled less than half of the intended trial population, but Dr. Gray said the results were statistically valid.

All patients had mild to moderate elevations in plasma glucose levels (6.1–17.0 mmol/L). Insulin-dependent diabetics were excluded, he said, because assigning them to a control arm would have been unethical.

The trial randomized 464 patients to a variable continuous infusion (100 mL/hr for 24 hours) of a 10% glucose solution supplemented with insulin and potassium chloride. They were monitored every 2 hours in an effort to maintain capillary glucose at 4–7 mmol/L. Another 469 patients were randomized to a saline solution with no attempt to stabilize glucose levels.

The GIK treatment resulted in a significant overall reduction in mean blood glucose of 0.57 mmol/L over 24 hours. It also produced a significant overall reduction in mean blood pressure of 9.03 mm Hg over 24 hours. With the saline solution, glucose levels fell spontaneously but by a smaller amount, Dr. Gray reported.

At 90 days post treatment, 139 patients (30%) in the GIK arm and 128 patients (27.3%) in the control arm had died. The difference was not significant, but it favored the saline solution. The impact on survival without severe disability also was not significantly different between the two groups.

The investigators looked at patients who had the greatest reductions in glucose levels to see whether reductions greater than the modest improvements in the study would have been beneficial. “Those patients who died had the greatest reduction in glucose level,” Dr. Gray said.

In an interview, press briefing moderator Dr. Philip Gorelick said the results of study—the first to test tight glycemic control in acute stroke patients—departed from findings in other recent trials showing benefits for critical care patients in intensive care units. “I don't think we can leave this issue yet. I think we need more studies,” said Dr. Gorelick, the John S. Garvin professor and head of neurology and rehabilitation at the University of Illinois at Chicago.

'For stroke patients with mild to moderate elevations in glucose, we should leave well enough alone.' DR. GRAY

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SAN FRANCISCO — Stabilizing glucose levels in acute stroke patients failed to reduce mortality or influence survival with severe disability at 90 days in a large randomized controlled trial presented at the 32nd International Stroke Conference.

Patients treated with a continuous infusion of glucose, insulin, and potassium (GIK) had significant reductions in glucose levels and blood pressure but received no benefit in outcomes, compared with a control group given a saline solution, Dr. Christopher Gray reported.

The reduction in blood pressure surprised investigators of the United Kingdom Glucose Insulin in Stroke (GIST-UK) study. The finding suggests that tight glucose control might be harmful to stroke patients, said Dr. Gray of the Newcastle University School of Clinical Medical Sciences in Sunderland, England.

“We may have inadvertently explained why lower glucose levels confer benefit in [acute myocardial infarction],” he said at a press briefing prior to his presentation at the meeting, which was sponsored by the American Stroke Association.

Reduced blood pressure “was not something we expected,” said Dr. Gray, chief investigator of GIST-UK. Other studies of glucose levels in myocardial infarction have not reported changes in blood pressure.

Although hyperglycemia is associated with greater mortality in stroke patients, he emphasized that tight glucose control has not been shown to be safe in stroke patients who are not diabetic. “It may be intensive glucose lowering is not associated with benefit,” he said. “It may be associated with risk.”

Regarding stepped-up efforts to control glucose in intensive care units, Dr. Gray added in an interview that “for stroke patients with mild to moderate elevations in glucose, we should leave well enough alone.”

GIST-UK randomized 933 acute stroke patients presenting with cerebral infarction or intracerebral hemorrhage at 21 centers from 1998 to 2006. It enrolled less than half of the intended trial population, but Dr. Gray said the results were statistically valid.

All patients had mild to moderate elevations in plasma glucose levels (6.1–17.0 mmol/L). Insulin-dependent diabetics were excluded, he said, because assigning them to a control arm would have been unethical.

The trial randomized 464 patients to a variable continuous infusion (100 mL/hr for 24 hours) of a 10% glucose solution supplemented with insulin and potassium chloride. They were monitored every 2 hours in an effort to maintain capillary glucose at 4–7 mmol/L. Another 469 patients were randomized to a saline solution with no attempt to stabilize glucose levels.

The GIK treatment resulted in a significant overall reduction in mean blood glucose of 0.57 mmol/L over 24 hours. It also produced a significant overall reduction in mean blood pressure of 9.03 mm Hg over 24 hours. With the saline solution, glucose levels fell spontaneously but by a smaller amount, Dr. Gray reported.

At 90 days post treatment, 139 patients (30%) in the GIK arm and 128 patients (27.3%) in the control arm had died. The difference was not significant, but it favored the saline solution. The impact on survival without severe disability also was not significantly different between the two groups.

The investigators looked at patients who had the greatest reductions in glucose levels to see whether reductions greater than the modest improvements in the study would have been beneficial. “Those patients who died had the greatest reduction in glucose level,” Dr. Gray said.

In an interview, press briefing moderator Dr. Philip Gorelick said the results of study—the first to test tight glycemic control in acute stroke patients—departed from findings in other recent trials showing benefits for critical care patients in intensive care units. “I don't think we can leave this issue yet. I think we need more studies,” said Dr. Gorelick, the John S. Garvin professor and head of neurology and rehabilitation at the University of Illinois at Chicago.

'For stroke patients with mild to moderate elevations in glucose, we should leave well enough alone.' DR. GRAY

SAN FRANCISCO — Stabilizing glucose levels in acute stroke patients failed to reduce mortality or influence survival with severe disability at 90 days in a large randomized controlled trial presented at the 32nd International Stroke Conference.

Patients treated with a continuous infusion of glucose, insulin, and potassium (GIK) had significant reductions in glucose levels and blood pressure but received no benefit in outcomes, compared with a control group given a saline solution, Dr. Christopher Gray reported.

The reduction in blood pressure surprised investigators of the United Kingdom Glucose Insulin in Stroke (GIST-UK) study. The finding suggests that tight glucose control might be harmful to stroke patients, said Dr. Gray of the Newcastle University School of Clinical Medical Sciences in Sunderland, England.

“We may have inadvertently explained why lower glucose levels confer benefit in [acute myocardial infarction],” he said at a press briefing prior to his presentation at the meeting, which was sponsored by the American Stroke Association.

Reduced blood pressure “was not something we expected,” said Dr. Gray, chief investigator of GIST-UK. Other studies of glucose levels in myocardial infarction have not reported changes in blood pressure.

Although hyperglycemia is associated with greater mortality in stroke patients, he emphasized that tight glucose control has not been shown to be safe in stroke patients who are not diabetic. “It may be intensive glucose lowering is not associated with benefit,” he said. “It may be associated with risk.”

Regarding stepped-up efforts to control glucose in intensive care units, Dr. Gray added in an interview that “for stroke patients with mild to moderate elevations in glucose, we should leave well enough alone.”

GIST-UK randomized 933 acute stroke patients presenting with cerebral infarction or intracerebral hemorrhage at 21 centers from 1998 to 2006. It enrolled less than half of the intended trial population, but Dr. Gray said the results were statistically valid.

All patients had mild to moderate elevations in plasma glucose levels (6.1–17.0 mmol/L). Insulin-dependent diabetics were excluded, he said, because assigning them to a control arm would have been unethical.

The trial randomized 464 patients to a variable continuous infusion (100 mL/hr for 24 hours) of a 10% glucose solution supplemented with insulin and potassium chloride. They were monitored every 2 hours in an effort to maintain capillary glucose at 4–7 mmol/L. Another 469 patients were randomized to a saline solution with no attempt to stabilize glucose levels.

The GIK treatment resulted in a significant overall reduction in mean blood glucose of 0.57 mmol/L over 24 hours. It also produced a significant overall reduction in mean blood pressure of 9.03 mm Hg over 24 hours. With the saline solution, glucose levels fell spontaneously but by a smaller amount, Dr. Gray reported.

At 90 days post treatment, 139 patients (30%) in the GIK arm and 128 patients (27.3%) in the control arm had died. The difference was not significant, but it favored the saline solution. The impact on survival without severe disability also was not significantly different between the two groups.

The investigators looked at patients who had the greatest reductions in glucose levels to see whether reductions greater than the modest improvements in the study would have been beneficial. “Those patients who died had the greatest reduction in glucose level,” Dr. Gray said.

In an interview, press briefing moderator Dr. Philip Gorelick said the results of study—the first to test tight glycemic control in acute stroke patients—departed from findings in other recent trials showing benefits for critical care patients in intensive care units. “I don't think we can leave this issue yet. I think we need more studies,” said Dr. Gorelick, the John S. Garvin professor and head of neurology and rehabilitation at the University of Illinois at Chicago.

'For stroke patients with mild to moderate elevations in glucose, we should leave well enough alone.' DR. GRAY

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Glucose, Lipids Key in Managing Diabetic Stroke : About 1/3 of stroke patients have diabetes, but risk factors such as glucose and lipids are often neglected.

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Glucose, Lipids Key in Managing Diabetic Stroke : About 1/3 of stroke patients have diabetes, but risk factors such as glucose and lipids are often neglected.

SAN FRANCISCO — Stroke and diabetes need to be treated as comorbidities, and physicians treating stroke patients should ensure that their patients receive aggressive lipid management, Dr. Lee H. Schwamm reported at the 32nd International Stroke Conference.

Significant numbers of people with diabetes—both the newly diagnosed and the patients previously treated—leave the hospital after a stroke without treatment plans that met evidence-based guidelines, according to Dr. Schwamm.

“We need to educate people who take care of stroke patients about the comorbidity of diabetes and coronary disease to make sure patients get treatment that is best for their combination of conditions and not just the treatment they present with,” he said.

A review of 159,338 acute stroke and transient ischemic attack patients revealed that 49,066 patients—about 31%–-had diabetes. The diabetic population comprised 46,436 patients whose diabetes was known before admission and 2,630 patients who were diagnosed with diabetes after being admitted for stroke.

Although the proportion of diabetic stroke patients was in line with earlier studies, the actual number of stroke patients who have comorbid diabetes may be higher, said Dr. Schwamm, vice chairman of neurology and director of acute stroke services at Massachusetts General Hospital in Boston. The diagnosis of diabetes is dependent on measurement of HbA1c levels, he said, and many hospitals do not routinely screen stroke patients.

“What is really startling is that [66%] of the patients who were known to be diabetic had no measure of [HbA1c] while in the hospital, which tells you that diabetes was not being addressed in the inpatient setting,” he said during an interview at the conference, which was sponsored by the American Stroke Association.

LDL cholesterol levels, he added, were not found in charts for 42% of the stroke patients who were known to have diabetes.

Despite making up a much smaller proportion of the study population, patients who were newly diagnosed with diabetes had significantly worse control of risk factors than did those who had been treated previously, Dr. Schwamm and his colleagues reported.

The researchers said the average age of participants was 70.5 for 46,436 patients known to have diabetes when admitted and 68.67 for 2,630 patients who were newly diagnosed. The difference was statistically significant with a P value of less than .0001.

The mean LDL cholesterol for newly diagnosed patients was 117.6 mg/dL, compared with 106.1 mg/dL in known diabetics; their average total cholesterol was 192.5 mg/dL, compared with 178.2 mg/dL in the stroke patients previously treated for diabetes. The average HbA1c was 7.87% in the previously diagnosed diabetics and 8.18% in patients who were diagnosed while they were hospitalized for stroke.

Compared with the known diabetics, the newly diagnosed were less likely to be obese (27.2% vs. 31.2%) or have high blood pressure (65.5% vs. 82.5%) but more likely to smoke (19.9% vs. 13.7%). They also had fewer vascular risk factors documented in their records before hospitalization.

Ischemic stroke was more common in the patients who had not previously been diagnosed with diabetes (89% vs. 78%).

Dr. Schwamm said the investigators had no way of knowing why diabetes had not been spotted before hospitalization for stroke in the newly diagnosed group. “If you are recognized as a diabetic, lipid control becomes a very important intervention. So the failure to detect diabetes means you are less likely to have lipid control introduced.”

The patients were drawn from a database of 659 hospitals participating in the American Stroke Association's “Get With the Guidelines” stroke initiative, a quality improvement program aimed at increasing adherence to evidence-based guidelines for treatment of acute stroke and prevention of ischemic stroke.

'The failure to detect diabetes means you are less likely to have lipid control introduced.' DR. SCHWAMM

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SAN FRANCISCO — Stroke and diabetes need to be treated as comorbidities, and physicians treating stroke patients should ensure that their patients receive aggressive lipid management, Dr. Lee H. Schwamm reported at the 32nd International Stroke Conference.

Significant numbers of people with diabetes—both the newly diagnosed and the patients previously treated—leave the hospital after a stroke without treatment plans that met evidence-based guidelines, according to Dr. Schwamm.

“We need to educate people who take care of stroke patients about the comorbidity of diabetes and coronary disease to make sure patients get treatment that is best for their combination of conditions and not just the treatment they present with,” he said.

A review of 159,338 acute stroke and transient ischemic attack patients revealed that 49,066 patients—about 31%–-had diabetes. The diabetic population comprised 46,436 patients whose diabetes was known before admission and 2,630 patients who were diagnosed with diabetes after being admitted for stroke.

Although the proportion of diabetic stroke patients was in line with earlier studies, the actual number of stroke patients who have comorbid diabetes may be higher, said Dr. Schwamm, vice chairman of neurology and director of acute stroke services at Massachusetts General Hospital in Boston. The diagnosis of diabetes is dependent on measurement of HbA1c levels, he said, and many hospitals do not routinely screen stroke patients.

“What is really startling is that [66%] of the patients who were known to be diabetic had no measure of [HbA1c] while in the hospital, which tells you that diabetes was not being addressed in the inpatient setting,” he said during an interview at the conference, which was sponsored by the American Stroke Association.

LDL cholesterol levels, he added, were not found in charts for 42% of the stroke patients who were known to have diabetes.

Despite making up a much smaller proportion of the study population, patients who were newly diagnosed with diabetes had significantly worse control of risk factors than did those who had been treated previously, Dr. Schwamm and his colleagues reported.

The researchers said the average age of participants was 70.5 for 46,436 patients known to have diabetes when admitted and 68.67 for 2,630 patients who were newly diagnosed. The difference was statistically significant with a P value of less than .0001.

The mean LDL cholesterol for newly diagnosed patients was 117.6 mg/dL, compared with 106.1 mg/dL in known diabetics; their average total cholesterol was 192.5 mg/dL, compared with 178.2 mg/dL in the stroke patients previously treated for diabetes. The average HbA1c was 7.87% in the previously diagnosed diabetics and 8.18% in patients who were diagnosed while they were hospitalized for stroke.

Compared with the known diabetics, the newly diagnosed were less likely to be obese (27.2% vs. 31.2%) or have high blood pressure (65.5% vs. 82.5%) but more likely to smoke (19.9% vs. 13.7%). They also had fewer vascular risk factors documented in their records before hospitalization.

Ischemic stroke was more common in the patients who had not previously been diagnosed with diabetes (89% vs. 78%).

Dr. Schwamm said the investigators had no way of knowing why diabetes had not been spotted before hospitalization for stroke in the newly diagnosed group. “If you are recognized as a diabetic, lipid control becomes a very important intervention. So the failure to detect diabetes means you are less likely to have lipid control introduced.”

The patients were drawn from a database of 659 hospitals participating in the American Stroke Association's “Get With the Guidelines” stroke initiative, a quality improvement program aimed at increasing adherence to evidence-based guidelines for treatment of acute stroke and prevention of ischemic stroke.

'The failure to detect diabetes means you are less likely to have lipid control introduced.' DR. SCHWAMM

SAN FRANCISCO — Stroke and diabetes need to be treated as comorbidities, and physicians treating stroke patients should ensure that their patients receive aggressive lipid management, Dr. Lee H. Schwamm reported at the 32nd International Stroke Conference.

Significant numbers of people with diabetes—both the newly diagnosed and the patients previously treated—leave the hospital after a stroke without treatment plans that met evidence-based guidelines, according to Dr. Schwamm.

“We need to educate people who take care of stroke patients about the comorbidity of diabetes and coronary disease to make sure patients get treatment that is best for their combination of conditions and not just the treatment they present with,” he said.

A review of 159,338 acute stroke and transient ischemic attack patients revealed that 49,066 patients—about 31%–-had diabetes. The diabetic population comprised 46,436 patients whose diabetes was known before admission and 2,630 patients who were diagnosed with diabetes after being admitted for stroke.

Although the proportion of diabetic stroke patients was in line with earlier studies, the actual number of stroke patients who have comorbid diabetes may be higher, said Dr. Schwamm, vice chairman of neurology and director of acute stroke services at Massachusetts General Hospital in Boston. The diagnosis of diabetes is dependent on measurement of HbA1c levels, he said, and many hospitals do not routinely screen stroke patients.

“What is really startling is that [66%] of the patients who were known to be diabetic had no measure of [HbA1c] while in the hospital, which tells you that diabetes was not being addressed in the inpatient setting,” he said during an interview at the conference, which was sponsored by the American Stroke Association.

LDL cholesterol levels, he added, were not found in charts for 42% of the stroke patients who were known to have diabetes.

Despite making up a much smaller proportion of the study population, patients who were newly diagnosed with diabetes had significantly worse control of risk factors than did those who had been treated previously, Dr. Schwamm and his colleagues reported.

The researchers said the average age of participants was 70.5 for 46,436 patients known to have diabetes when admitted and 68.67 for 2,630 patients who were newly diagnosed. The difference was statistically significant with a P value of less than .0001.

The mean LDL cholesterol for newly diagnosed patients was 117.6 mg/dL, compared with 106.1 mg/dL in known diabetics; their average total cholesterol was 192.5 mg/dL, compared with 178.2 mg/dL in the stroke patients previously treated for diabetes. The average HbA1c was 7.87% in the previously diagnosed diabetics and 8.18% in patients who were diagnosed while they were hospitalized for stroke.

Compared with the known diabetics, the newly diagnosed were less likely to be obese (27.2% vs. 31.2%) or have high blood pressure (65.5% vs. 82.5%) but more likely to smoke (19.9% vs. 13.7%). They also had fewer vascular risk factors documented in their records before hospitalization.

Ischemic stroke was more common in the patients who had not previously been diagnosed with diabetes (89% vs. 78%).

Dr. Schwamm said the investigators had no way of knowing why diabetes had not been spotted before hospitalization for stroke in the newly diagnosed group. “If you are recognized as a diabetic, lipid control becomes a very important intervention. So the failure to detect diabetes means you are less likely to have lipid control introduced.”

The patients were drawn from a database of 659 hospitals participating in the American Stroke Association's “Get With the Guidelines” stroke initiative, a quality improvement program aimed at increasing adherence to evidence-based guidelines for treatment of acute stroke and prevention of ischemic stroke.

'The failure to detect diabetes means you are less likely to have lipid control introduced.' DR. SCHWAMM

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