Laparoscopic Cervicoisthmic Cerclage in Pregnancy

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UNIVERSAL CITY, CALIF. — A significant number of successful deliveries have occurred, and one patient has delivered two babies, following laparoscopic cervicoisthmic cerclage performed during pregnancy at the University of Illinois, Chicago.

Andrew I. Brill, M.D., professor of ob.gyn. and director of gynecologic endoscopy at the university, reported on more than a dozen cases at the annual meeting of the Obstetrical and Gynecological Assembly of Southern California.

The innovative laparoscopic procedure could offer hope of a minimally invasive alternative to a technically demanding and often complicated abdominal surgery during pregnancy, in patients for whom conventional vaginal cerclage has failed or is not possible.

“These are patients who are quite desperate, with a history of multiple losses despite repeated conventional procedures,” Dr. Brill said.

All the patients in his series had experienced failure of conventional vaginal cerclages for cervical incompetence, and many had suffered repeated second-trimester losses. In some patients, previous cervical procedures precluded placement of a vaginal cerclage.

If such patients desire children, “There really is no salvation but abdominal cervicoisthmic cerclage,” he explained.

Conventional abdominal cerclage typically requires an extended midline abdominal incision and a considerable hospital stay. Complications can include hemorrhage and pregnancy loss. Laparoscopic cervicoisthmic cerclage during pregnancy is a novel and technically challenging procedure. Ideally, it should be performed by 12 weeks' gestation, at a point when the risk of spontaneous first trimester loss is minimal but there is still enough space to safely manipulate and work around the gravid uterus, according to Dr. Brill.

Besides the threat of fetal loss, the risk of bleeding is considerable, so the surgical team must be prepared to quickly convert to conventional surgery. Morbid obesity and the risk of significant abdominal adhesions should be viewed with caution, according to Dr. Brill.

“This is a surgery where you know that if you make a mistake, it's over, and it's a very rapid over,” he said.

Nonetheless, the University of Illinois experience has been largely successful. Dr. Brill noted that the exact numbers are being compiled for publication but that at least 10 healthy babies have been born following the procedure.

Some patients have undergone the procedure as outpatients, while perinatologists have opted to observe others overnight. Some pregnancies are ongoing.

Fetal viability is carefully assessed before and after the procedure, which initially took about 4 hours but, with experience, has been reduced to about 90 minutes.

Two losses have occurred, one the day following the procedure and one at about 20 weeks' gestation in a patient with recurrent previous losses. In one early case, the laparoscopic procedure was converted to laparotomy to control bleeding when the underside of a harmonic scalpel abrupted a uterine vein. The procedure is performed under general anesthetic.

A cervical cup is placed into the vagina and up to the fornices to aid in lifting the uterus for skeletonization of the uterine vessels and placement of a Mersiline ligature between the uterine vessels and the lower segment at the isthmus.

A port is placed at the umbilicus for the laparoscope. Two right and two left paraumbilical ports are placed high and lateral, and one is placed at the midline suprapubic abutting the mons pubis. Bipolar dissection and sharp dissection are used to mobilize the uterine arteries well off the lower uterine segment.

Using a right-angle dissector placed through the suprapubic port, a Mersilene stitch is pulled from back to front through windows created in the broad ligament and tied snugly around the isthmus of the uterus, insuring the suture remains flat against the posterior lower segment.

Throughout the procedure, precautions are taken against over-manipulating the uterus or causing vascular injury. Cutting is performed with monopolar energy or blunt-tipped mechanical scissors.

The uterine vessels are skeletonized and isolated from the lower uterine segment.

The knotted Mersilene stitch has been placed, and the procedure is completed. Photos courtesy Dr. Andrew I. Brill

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UNIVERSAL CITY, CALIF. — A significant number of successful deliveries have occurred, and one patient has delivered two babies, following laparoscopic cervicoisthmic cerclage performed during pregnancy at the University of Illinois, Chicago.

Andrew I. Brill, M.D., professor of ob.gyn. and director of gynecologic endoscopy at the university, reported on more than a dozen cases at the annual meeting of the Obstetrical and Gynecological Assembly of Southern California.

The innovative laparoscopic procedure could offer hope of a minimally invasive alternative to a technically demanding and often complicated abdominal surgery during pregnancy, in patients for whom conventional vaginal cerclage has failed or is not possible.

“These are patients who are quite desperate, with a history of multiple losses despite repeated conventional procedures,” Dr. Brill said.

All the patients in his series had experienced failure of conventional vaginal cerclages for cervical incompetence, and many had suffered repeated second-trimester losses. In some patients, previous cervical procedures precluded placement of a vaginal cerclage.

If such patients desire children, “There really is no salvation but abdominal cervicoisthmic cerclage,” he explained.

Conventional abdominal cerclage typically requires an extended midline abdominal incision and a considerable hospital stay. Complications can include hemorrhage and pregnancy loss. Laparoscopic cervicoisthmic cerclage during pregnancy is a novel and technically challenging procedure. Ideally, it should be performed by 12 weeks' gestation, at a point when the risk of spontaneous first trimester loss is minimal but there is still enough space to safely manipulate and work around the gravid uterus, according to Dr. Brill.

Besides the threat of fetal loss, the risk of bleeding is considerable, so the surgical team must be prepared to quickly convert to conventional surgery. Morbid obesity and the risk of significant abdominal adhesions should be viewed with caution, according to Dr. Brill.

“This is a surgery where you know that if you make a mistake, it's over, and it's a very rapid over,” he said.

Nonetheless, the University of Illinois experience has been largely successful. Dr. Brill noted that the exact numbers are being compiled for publication but that at least 10 healthy babies have been born following the procedure.

Some patients have undergone the procedure as outpatients, while perinatologists have opted to observe others overnight. Some pregnancies are ongoing.

Fetal viability is carefully assessed before and after the procedure, which initially took about 4 hours but, with experience, has been reduced to about 90 minutes.

Two losses have occurred, one the day following the procedure and one at about 20 weeks' gestation in a patient with recurrent previous losses. In one early case, the laparoscopic procedure was converted to laparotomy to control bleeding when the underside of a harmonic scalpel abrupted a uterine vein. The procedure is performed under general anesthetic.

A cervical cup is placed into the vagina and up to the fornices to aid in lifting the uterus for skeletonization of the uterine vessels and placement of a Mersiline ligature between the uterine vessels and the lower segment at the isthmus.

A port is placed at the umbilicus for the laparoscope. Two right and two left paraumbilical ports are placed high and lateral, and one is placed at the midline suprapubic abutting the mons pubis. Bipolar dissection and sharp dissection are used to mobilize the uterine arteries well off the lower uterine segment.

Using a right-angle dissector placed through the suprapubic port, a Mersilene stitch is pulled from back to front through windows created in the broad ligament and tied snugly around the isthmus of the uterus, insuring the suture remains flat against the posterior lower segment.

Throughout the procedure, precautions are taken against over-manipulating the uterus or causing vascular injury. Cutting is performed with monopolar energy or blunt-tipped mechanical scissors.

The uterine vessels are skeletonized and isolated from the lower uterine segment.

The knotted Mersilene stitch has been placed, and the procedure is completed. Photos courtesy Dr. Andrew I. Brill

UNIVERSAL CITY, CALIF. — A significant number of successful deliveries have occurred, and one patient has delivered two babies, following laparoscopic cervicoisthmic cerclage performed during pregnancy at the University of Illinois, Chicago.

Andrew I. Brill, M.D., professor of ob.gyn. and director of gynecologic endoscopy at the university, reported on more than a dozen cases at the annual meeting of the Obstetrical and Gynecological Assembly of Southern California.

The innovative laparoscopic procedure could offer hope of a minimally invasive alternative to a technically demanding and often complicated abdominal surgery during pregnancy, in patients for whom conventional vaginal cerclage has failed or is not possible.

“These are patients who are quite desperate, with a history of multiple losses despite repeated conventional procedures,” Dr. Brill said.

All the patients in his series had experienced failure of conventional vaginal cerclages for cervical incompetence, and many had suffered repeated second-trimester losses. In some patients, previous cervical procedures precluded placement of a vaginal cerclage.

If such patients desire children, “There really is no salvation but abdominal cervicoisthmic cerclage,” he explained.

Conventional abdominal cerclage typically requires an extended midline abdominal incision and a considerable hospital stay. Complications can include hemorrhage and pregnancy loss. Laparoscopic cervicoisthmic cerclage during pregnancy is a novel and technically challenging procedure. Ideally, it should be performed by 12 weeks' gestation, at a point when the risk of spontaneous first trimester loss is minimal but there is still enough space to safely manipulate and work around the gravid uterus, according to Dr. Brill.

Besides the threat of fetal loss, the risk of bleeding is considerable, so the surgical team must be prepared to quickly convert to conventional surgery. Morbid obesity and the risk of significant abdominal adhesions should be viewed with caution, according to Dr. Brill.

“This is a surgery where you know that if you make a mistake, it's over, and it's a very rapid over,” he said.

Nonetheless, the University of Illinois experience has been largely successful. Dr. Brill noted that the exact numbers are being compiled for publication but that at least 10 healthy babies have been born following the procedure.

Some patients have undergone the procedure as outpatients, while perinatologists have opted to observe others overnight. Some pregnancies are ongoing.

Fetal viability is carefully assessed before and after the procedure, which initially took about 4 hours but, with experience, has been reduced to about 90 minutes.

Two losses have occurred, one the day following the procedure and one at about 20 weeks' gestation in a patient with recurrent previous losses. In one early case, the laparoscopic procedure was converted to laparotomy to control bleeding when the underside of a harmonic scalpel abrupted a uterine vein. The procedure is performed under general anesthetic.

A cervical cup is placed into the vagina and up to the fornices to aid in lifting the uterus for skeletonization of the uterine vessels and placement of a Mersiline ligature between the uterine vessels and the lower segment at the isthmus.

A port is placed at the umbilicus for the laparoscope. Two right and two left paraumbilical ports are placed high and lateral, and one is placed at the midline suprapubic abutting the mons pubis. Bipolar dissection and sharp dissection are used to mobilize the uterine arteries well off the lower uterine segment.

Using a right-angle dissector placed through the suprapubic port, a Mersilene stitch is pulled from back to front through windows created in the broad ligament and tied snugly around the isthmus of the uterus, insuring the suture remains flat against the posterior lower segment.

Throughout the procedure, precautions are taken against over-manipulating the uterus or causing vascular injury. Cutting is performed with monopolar energy or blunt-tipped mechanical scissors.

The uterine vessels are skeletonized and isolated from the lower uterine segment.

The knotted Mersilene stitch has been placed, and the procedure is completed. Photos courtesy Dr. Andrew I. Brill

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Wash Your Hands After Using Computers

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LOS ANGELES — Computer keyboards and keyboard covers harbored vancomycin-resistant Enterococcus faecium and methicillin-resistant Staphylococcus aureus for more than 24 hours, during which time the bacteria easily spread to bare, and in some cases, gloved hands, a Northwestern University study has found.

The findings strongly suggest the need for health care providers to wash their hands after using computers, particularly in hospital settings and around immunocompromised patients, said Gary A. Noskin, M.D., an infectious disease specialist at Northwestern University and director of health care epidemiology and quality at Northwestern Memorial Hospital in Chicago.

Electronic patient records have ushered more computers into examining and patient rooms, heightening the importance of their role as a “viable reservoir for pathogenic bacteria,” in the words of the study presented in poster form at the annual meeting of the Society for Healthcare Epidemiology of America.

Investigators inoculated standard computer keyboards and Dell computer keyboard covers with isolates of vancomycin-resistant E. faecium (VRE), methicillin-resistant S. aureus (MRSA), and Pseudomonas aeruginosa (PSAE).

Samples obtained at various time intervals determined that both VRE and MRSA survived 24 hours, while PSAE was less hardy, growing for 5 minutes on keyboard covers and 1 hour on keyboards.

Bacteria transmission to volunteers' hands increased with the number of times they touched the keyboards. For example, MRSA resulted in recovery of bacteria on hands 92% of the time with 5 touches, versus 42% of the time after 1 touch of the keyboard. Rates for VRE were 50% and 22% after 5 touches and 1 touch, and with PSAE, 18% and 9%, respectively. Bare hands were more likely than were gloved hands to acquire VRE and MRSA, 67% versus 7%, and 80% versus 67%, respectively.

Investigators then conducted an experiment to see whether two quaternary ammonium-based germicides commonly used in health care settings could eliminate bacterial contamination on keyboards and keyboard covers. Virex II 256 (Johnson Wax Professional, Sturtevant, Wisc.), when used as directed with a 10-minute dwell time, successfully disinfected both keyboards and keyboard covers. Sani-Wipes (PDI, Upper Saddle River, N.J.), used as directed with a 5-minute dwell time, disinfected keyboards but failed to eliminate VRE and PSAE on keyboard covers.

Dr. Noskin and his associates recommended hand washing after contact with computers. It is unknown how keyboards and keyboard covers should be disinfected, since there's “just no data” on how frequent germicide use might impact their durability, circuitry, and electronics, he said in a telephone interview following the meeting.

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LOS ANGELES — Computer keyboards and keyboard covers harbored vancomycin-resistant Enterococcus faecium and methicillin-resistant Staphylococcus aureus for more than 24 hours, during which time the bacteria easily spread to bare, and in some cases, gloved hands, a Northwestern University study has found.

The findings strongly suggest the need for health care providers to wash their hands after using computers, particularly in hospital settings and around immunocompromised patients, said Gary A. Noskin, M.D., an infectious disease specialist at Northwestern University and director of health care epidemiology and quality at Northwestern Memorial Hospital in Chicago.

Electronic patient records have ushered more computers into examining and patient rooms, heightening the importance of their role as a “viable reservoir for pathogenic bacteria,” in the words of the study presented in poster form at the annual meeting of the Society for Healthcare Epidemiology of America.

Investigators inoculated standard computer keyboards and Dell computer keyboard covers with isolates of vancomycin-resistant E. faecium (VRE), methicillin-resistant S. aureus (MRSA), and Pseudomonas aeruginosa (PSAE).

Samples obtained at various time intervals determined that both VRE and MRSA survived 24 hours, while PSAE was less hardy, growing for 5 minutes on keyboard covers and 1 hour on keyboards.

Bacteria transmission to volunteers' hands increased with the number of times they touched the keyboards. For example, MRSA resulted in recovery of bacteria on hands 92% of the time with 5 touches, versus 42% of the time after 1 touch of the keyboard. Rates for VRE were 50% and 22% after 5 touches and 1 touch, and with PSAE, 18% and 9%, respectively. Bare hands were more likely than were gloved hands to acquire VRE and MRSA, 67% versus 7%, and 80% versus 67%, respectively.

Investigators then conducted an experiment to see whether two quaternary ammonium-based germicides commonly used in health care settings could eliminate bacterial contamination on keyboards and keyboard covers. Virex II 256 (Johnson Wax Professional, Sturtevant, Wisc.), when used as directed with a 10-minute dwell time, successfully disinfected both keyboards and keyboard covers. Sani-Wipes (PDI, Upper Saddle River, N.J.), used as directed with a 5-minute dwell time, disinfected keyboards but failed to eliminate VRE and PSAE on keyboard covers.

Dr. Noskin and his associates recommended hand washing after contact with computers. It is unknown how keyboards and keyboard covers should be disinfected, since there's “just no data” on how frequent germicide use might impact their durability, circuitry, and electronics, he said in a telephone interview following the meeting.

LOS ANGELES — Computer keyboards and keyboard covers harbored vancomycin-resistant Enterococcus faecium and methicillin-resistant Staphylococcus aureus for more than 24 hours, during which time the bacteria easily spread to bare, and in some cases, gloved hands, a Northwestern University study has found.

The findings strongly suggest the need for health care providers to wash their hands after using computers, particularly in hospital settings and around immunocompromised patients, said Gary A. Noskin, M.D., an infectious disease specialist at Northwestern University and director of health care epidemiology and quality at Northwestern Memorial Hospital in Chicago.

Electronic patient records have ushered more computers into examining and patient rooms, heightening the importance of their role as a “viable reservoir for pathogenic bacteria,” in the words of the study presented in poster form at the annual meeting of the Society for Healthcare Epidemiology of America.

Investigators inoculated standard computer keyboards and Dell computer keyboard covers with isolates of vancomycin-resistant E. faecium (VRE), methicillin-resistant S. aureus (MRSA), and Pseudomonas aeruginosa (PSAE).

Samples obtained at various time intervals determined that both VRE and MRSA survived 24 hours, while PSAE was less hardy, growing for 5 minutes on keyboard covers and 1 hour on keyboards.

Bacteria transmission to volunteers' hands increased with the number of times they touched the keyboards. For example, MRSA resulted in recovery of bacteria on hands 92% of the time with 5 touches, versus 42% of the time after 1 touch of the keyboard. Rates for VRE were 50% and 22% after 5 touches and 1 touch, and with PSAE, 18% and 9%, respectively. Bare hands were more likely than were gloved hands to acquire VRE and MRSA, 67% versus 7%, and 80% versus 67%, respectively.

Investigators then conducted an experiment to see whether two quaternary ammonium-based germicides commonly used in health care settings could eliminate bacterial contamination on keyboards and keyboard covers. Virex II 256 (Johnson Wax Professional, Sturtevant, Wisc.), when used as directed with a 10-minute dwell time, successfully disinfected both keyboards and keyboard covers. Sani-Wipes (PDI, Upper Saddle River, N.J.), used as directed with a 5-minute dwell time, disinfected keyboards but failed to eliminate VRE and PSAE on keyboard covers.

Dr. Noskin and his associates recommended hand washing after contact with computers. It is unknown how keyboards and keyboard covers should be disinfected, since there's “just no data” on how frequent germicide use might impact their durability, circuitry, and electronics, he said in a telephone interview following the meeting.

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Super Obese Women Could Boost Cesarean Section Rates

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PALM DESERT, CALIF. — There may be a threshold of morbid obesity associated with a sharply increased risk of nonelective cesarean delivery that is not shared by less obese women, according to results of a preliminary study presented at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

The issue may have clinical implications for management of women at the lower ranges of morbid obesity who may wish to undergo labor without early and aggressive epidural management in anticipation of a probable cesarean section.

In their study, investigators at the University of Michigan, Ann Arbor, looked for a linear increase in cesarean deliveries as obesity increased, but instead found that nonelective cesarean deliveries did not significantly increase until body mass indexes rose above 46.

At the highest ranges of obesity, a very significant increase in nonelective C-sections was seen in the study of 226 parturients: 58% or those with a BMI of 47–88, compared with 39% for women with BMIs between 30 and 46.

Monica Riesner, M.D., of the department of anesthesiology at the University of Michigan, presented the findings on behalf of a colleague, Jill Mhyre, M.D., who could not attend the meeting.

Dr. Mhyre and associates studied the charts of obese parturients who delivered vaginally or by nonelective C-section at their institution between 1999 and 2002. Women undergoing elective C-sections were not included in the analysis.

Among the patients meeting study criteria, 62 had a BMI between 30 and 39.9 (defined as obese by the Institute of Medicine); 116 had a BMI between 40 and 49.9, and 48 had a BMI between 50 and 88.

A BMI greater than 50 has been proposed by some authors to constitute a new category, the “super obese.”

The mean BMI in the cohort was 44.5. The mean age was 28 years.

Fourteen percent of the group had diabetes, 14% had preeclampsia, one-fifth had asthma, and a quarter smoked.

Slightly more than half of the women delivered vaginally.

The nonelective C-section rate was 42% in women with BMIs between 30 and 39, and 45.7% for those with BMIs between 40 and 88, a nonsignificant difference.

In fact, a statistically meaningful difference in C-section rates was not observed in women with BMIs lower than 46, although they were significant at every cut point of BMIs above that level.

The single-institution study was not sufficiently powered to determine an absolute threshold for increased cesarean risk, which investigators hypothesized “may be as high as 50 or even 55,” said Dr. Riesner.

Stepwise logistic regression analyses found that a BMI greater than 46 was independently associated with more than a twofold increase in the risk of C-section.

Parity appeared to be protective in less obese women, but not in women with a BMI of 47 or higher.

A more comprehensive study is underway using a new electronic records system to capture more cases, with the aim of shedding more light on the findings of this preliminary study.

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PALM DESERT, CALIF. — There may be a threshold of morbid obesity associated with a sharply increased risk of nonelective cesarean delivery that is not shared by less obese women, according to results of a preliminary study presented at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

The issue may have clinical implications for management of women at the lower ranges of morbid obesity who may wish to undergo labor without early and aggressive epidural management in anticipation of a probable cesarean section.

In their study, investigators at the University of Michigan, Ann Arbor, looked for a linear increase in cesarean deliveries as obesity increased, but instead found that nonelective cesarean deliveries did not significantly increase until body mass indexes rose above 46.

At the highest ranges of obesity, a very significant increase in nonelective C-sections was seen in the study of 226 parturients: 58% or those with a BMI of 47–88, compared with 39% for women with BMIs between 30 and 46.

Monica Riesner, M.D., of the department of anesthesiology at the University of Michigan, presented the findings on behalf of a colleague, Jill Mhyre, M.D., who could not attend the meeting.

Dr. Mhyre and associates studied the charts of obese parturients who delivered vaginally or by nonelective C-section at their institution between 1999 and 2002. Women undergoing elective C-sections were not included in the analysis.

Among the patients meeting study criteria, 62 had a BMI between 30 and 39.9 (defined as obese by the Institute of Medicine); 116 had a BMI between 40 and 49.9, and 48 had a BMI between 50 and 88.

A BMI greater than 50 has been proposed by some authors to constitute a new category, the “super obese.”

The mean BMI in the cohort was 44.5. The mean age was 28 years.

Fourteen percent of the group had diabetes, 14% had preeclampsia, one-fifth had asthma, and a quarter smoked.

Slightly more than half of the women delivered vaginally.

The nonelective C-section rate was 42% in women with BMIs between 30 and 39, and 45.7% for those with BMIs between 40 and 88, a nonsignificant difference.

In fact, a statistically meaningful difference in C-section rates was not observed in women with BMIs lower than 46, although they were significant at every cut point of BMIs above that level.

The single-institution study was not sufficiently powered to determine an absolute threshold for increased cesarean risk, which investigators hypothesized “may be as high as 50 or even 55,” said Dr. Riesner.

Stepwise logistic regression analyses found that a BMI greater than 46 was independently associated with more than a twofold increase in the risk of C-section.

Parity appeared to be protective in less obese women, but not in women with a BMI of 47 or higher.

A more comprehensive study is underway using a new electronic records system to capture more cases, with the aim of shedding more light on the findings of this preliminary study.

PALM DESERT, CALIF. — There may be a threshold of morbid obesity associated with a sharply increased risk of nonelective cesarean delivery that is not shared by less obese women, according to results of a preliminary study presented at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

The issue may have clinical implications for management of women at the lower ranges of morbid obesity who may wish to undergo labor without early and aggressive epidural management in anticipation of a probable cesarean section.

In their study, investigators at the University of Michigan, Ann Arbor, looked for a linear increase in cesarean deliveries as obesity increased, but instead found that nonelective cesarean deliveries did not significantly increase until body mass indexes rose above 46.

At the highest ranges of obesity, a very significant increase in nonelective C-sections was seen in the study of 226 parturients: 58% or those with a BMI of 47–88, compared with 39% for women with BMIs between 30 and 46.

Monica Riesner, M.D., of the department of anesthesiology at the University of Michigan, presented the findings on behalf of a colleague, Jill Mhyre, M.D., who could not attend the meeting.

Dr. Mhyre and associates studied the charts of obese parturients who delivered vaginally or by nonelective C-section at their institution between 1999 and 2002. Women undergoing elective C-sections were not included in the analysis.

Among the patients meeting study criteria, 62 had a BMI between 30 and 39.9 (defined as obese by the Institute of Medicine); 116 had a BMI between 40 and 49.9, and 48 had a BMI between 50 and 88.

A BMI greater than 50 has been proposed by some authors to constitute a new category, the “super obese.”

The mean BMI in the cohort was 44.5. The mean age was 28 years.

Fourteen percent of the group had diabetes, 14% had preeclampsia, one-fifth had asthma, and a quarter smoked.

Slightly more than half of the women delivered vaginally.

The nonelective C-section rate was 42% in women with BMIs between 30 and 39, and 45.7% for those with BMIs between 40 and 88, a nonsignificant difference.

In fact, a statistically meaningful difference in C-section rates was not observed in women with BMIs lower than 46, although they were significant at every cut point of BMIs above that level.

The single-institution study was not sufficiently powered to determine an absolute threshold for increased cesarean risk, which investigators hypothesized “may be as high as 50 or even 55,” said Dr. Riesner.

Stepwise logistic regression analyses found that a BMI greater than 46 was independently associated with more than a twofold increase in the risk of C-section.

Parity appeared to be protective in less obese women, but not in women with a BMI of 47 or higher.

A more comprehensive study is underway using a new electronic records system to capture more cases, with the aim of shedding more light on the findings of this preliminary study.

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Mental Illness Flares for Some Patients in Rehab : Symptoms worsened in 13% of patients undergoing substance abuse treatment, a VA study showed.

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SANTA BARBARA, CALIF. — Psychiatric symptoms are common among people with substance abuse disorders, but in most patients those symptoms improve over the course of residential substance abuse treatment.

A recent Veterans Affairs study sheds light on patients whose psychiatric symptoms actually worsen during substance abuse treatment, with the aim of providing insight into which patients are at risk.

Mark Ilgen, Ph.D., and Rudolf Moos, Ph.D., prospectively studied 3,322 men with psychiatric symptoms who underwent treatment for substance use disorders at 1 of 15 residential programs in the VA health care system. (Women were not included in the study because of the small number treated within the system.)

Results were presented in a poster at the annual meeting of the Research Society on Alcoholism.

Symptoms improved during treatment in 85% of patients, as measured by the Brief Symptom Inventory, a self-reported 5-point scale of severity on each of 22 psychiatric symptoms.

Symptoms were unchanged in 2% of patients, and symptoms worsened in 13%, reported Dr. Ilgen and Dr. Moos, both of whom are affiliated with the VA Palo Alto Health Care System and Stanford (Calif.) University.

When they closely compared the patients with worsening symptoms to a matched sample of patients whose conditions did not deteriorate, they could find no differences in baseline psychiatric symptom scores, demographic characteristics, or severity of substance use.

However, those who worsened were more likely to have been treated under court order and to have a diagnosis of psychosis. They were also more likely to use substances during treatment, to express dissatisfaction with the treatment experience, and to drop out early, the investigators said.

A year later, those patients were more likely to be using alcohol and/or drugs than were their counterparts whose psychiatric symptoms improved during treatment.

“Finally, they continued to report elevated psychiatric symptoms relative to nondeteriorated patients despite roughly equivalent scores on the same measure between groups at baseline,” Dr. Ilgen and Dr. Moos noted.

The type or length of substance abuse treatment did not appear to influence the worsening of psychiatric symptoms.

“Given the importance of psychiatric symptoms in influencing the response to substance use disorder treatment … it is important to identify those for whom treatment has been associated with an increase in psychiatric symptoms,” they wrote. “Monitoring patients for psychiatric deterioration in treatment may be a way to identify patients at risk for treatment dropout and for poor prognosis following treatment,” they concluded.

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SANTA BARBARA, CALIF. — Psychiatric symptoms are common among people with substance abuse disorders, but in most patients those symptoms improve over the course of residential substance abuse treatment.

A recent Veterans Affairs study sheds light on patients whose psychiatric symptoms actually worsen during substance abuse treatment, with the aim of providing insight into which patients are at risk.

Mark Ilgen, Ph.D., and Rudolf Moos, Ph.D., prospectively studied 3,322 men with psychiatric symptoms who underwent treatment for substance use disorders at 1 of 15 residential programs in the VA health care system. (Women were not included in the study because of the small number treated within the system.)

Results were presented in a poster at the annual meeting of the Research Society on Alcoholism.

Symptoms improved during treatment in 85% of patients, as measured by the Brief Symptom Inventory, a self-reported 5-point scale of severity on each of 22 psychiatric symptoms.

Symptoms were unchanged in 2% of patients, and symptoms worsened in 13%, reported Dr. Ilgen and Dr. Moos, both of whom are affiliated with the VA Palo Alto Health Care System and Stanford (Calif.) University.

When they closely compared the patients with worsening symptoms to a matched sample of patients whose conditions did not deteriorate, they could find no differences in baseline psychiatric symptom scores, demographic characteristics, or severity of substance use.

However, those who worsened were more likely to have been treated under court order and to have a diagnosis of psychosis. They were also more likely to use substances during treatment, to express dissatisfaction with the treatment experience, and to drop out early, the investigators said.

A year later, those patients were more likely to be using alcohol and/or drugs than were their counterparts whose psychiatric symptoms improved during treatment.

“Finally, they continued to report elevated psychiatric symptoms relative to nondeteriorated patients despite roughly equivalent scores on the same measure between groups at baseline,” Dr. Ilgen and Dr. Moos noted.

The type or length of substance abuse treatment did not appear to influence the worsening of psychiatric symptoms.

“Given the importance of psychiatric symptoms in influencing the response to substance use disorder treatment … it is important to identify those for whom treatment has been associated with an increase in psychiatric symptoms,” they wrote. “Monitoring patients for psychiatric deterioration in treatment may be a way to identify patients at risk for treatment dropout and for poor prognosis following treatment,” they concluded.

SANTA BARBARA, CALIF. — Psychiatric symptoms are common among people with substance abuse disorders, but in most patients those symptoms improve over the course of residential substance abuse treatment.

A recent Veterans Affairs study sheds light on patients whose psychiatric symptoms actually worsen during substance abuse treatment, with the aim of providing insight into which patients are at risk.

Mark Ilgen, Ph.D., and Rudolf Moos, Ph.D., prospectively studied 3,322 men with psychiatric symptoms who underwent treatment for substance use disorders at 1 of 15 residential programs in the VA health care system. (Women were not included in the study because of the small number treated within the system.)

Results were presented in a poster at the annual meeting of the Research Society on Alcoholism.

Symptoms improved during treatment in 85% of patients, as measured by the Brief Symptom Inventory, a self-reported 5-point scale of severity on each of 22 psychiatric symptoms.

Symptoms were unchanged in 2% of patients, and symptoms worsened in 13%, reported Dr. Ilgen and Dr. Moos, both of whom are affiliated with the VA Palo Alto Health Care System and Stanford (Calif.) University.

When they closely compared the patients with worsening symptoms to a matched sample of patients whose conditions did not deteriorate, they could find no differences in baseline psychiatric symptom scores, demographic characteristics, or severity of substance use.

However, those who worsened were more likely to have been treated under court order and to have a diagnosis of psychosis. They were also more likely to use substances during treatment, to express dissatisfaction with the treatment experience, and to drop out early, the investigators said.

A year later, those patients were more likely to be using alcohol and/or drugs than were their counterparts whose psychiatric symptoms improved during treatment.

“Finally, they continued to report elevated psychiatric symptoms relative to nondeteriorated patients despite roughly equivalent scores on the same measure between groups at baseline,” Dr. Ilgen and Dr. Moos noted.

The type or length of substance abuse treatment did not appear to influence the worsening of psychiatric symptoms.

“Given the importance of psychiatric symptoms in influencing the response to substance use disorder treatment … it is important to identify those for whom treatment has been associated with an increase in psychiatric symptoms,” they wrote. “Monitoring patients for psychiatric deterioration in treatment may be a way to identify patients at risk for treatment dropout and for poor prognosis following treatment,” they concluded.

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SANTA BARBARA, CALIF. – Psychiatric symptoms are common among people with substance abuse disorders, but in most patients those symptoms improve over the course of residential substance abuse disorder treatment.

A recent Veterans Affairs study sheds light on patients whose psychiatric symptoms actually worsen during substance abuse treatment, with the aim of providing insight into which patients are at risk.

Mark Ilgen, Ph.D., and Rudolf Moos, Ph.D., prospectively studied 3,322 men with psychiatric symptoms who underwent treatment for substance use disorders at one of 15 residential programs in the VA health care system. (Women were not included in the study because of the small number treated within the VA system.)

Results were presented in a poster at the annual meeting of the Research Society on Alcoholism.

Symptoms improved during treatment in 85% of patients, as measured by the Brief Symptom Inventory, a self-reported 5-point scale of severity on each of 22 psychiatric symptoms. Symptoms were unchanged in 2% of patients, and symptoms worsened in 13%, reported Dr. Ilgen and Dr. Moos, both of whom are affiliated with the VA Palo Alto Health Care System and Stanford (Calif.) University.

When they closely compared the patients with worsening symptoms to a matched sample of patients whose conditions did not deteriorate, they could find no differences in baseline psychiatric symptom scores, demographic characteristics, or severity of substance use.

However, those who worsened were more likely to have been treated under court order and to have a diagnosis of psychosis. They were also more likely to use substances during treatment, to express dissatisfaction with the treatment experience, and to drop out early, the investigators said.

A year later, those patients were more likely to be using alcohol and/or drugs than were their counterparts whose psychiatric symptoms improved during treatment.

“Finally, they continued to report elevated psychiatric symptoms relative to nondeteriorated patients despite roughly equivalent scores on the same measure between groups at baseline,” Dr. Ilgen and Dr. Moos noted.

The type or length of substance abuse treatment did not appear to influence the worsening of psychiatric symptoms.

“Given the importance of psychiatric symptoms in influencing the response to substance use disorder treatment hellip; it is important to identify those for whom treatment has been associated with an increase in psychiatric symptoms,” they wrote. “Monitoring patients for psychiatric deterioration in treatment may be a way to identify patients at risk for treatment dropout and for poor prognosis following treatment,” they concluded.

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SANTA BARBARA, CALIF. – Psychiatric symptoms are common among people with substance abuse disorders, but in most patients those symptoms improve over the course of residential substance abuse disorder treatment.

A recent Veterans Affairs study sheds light on patients whose psychiatric symptoms actually worsen during substance abuse treatment, with the aim of providing insight into which patients are at risk.

Mark Ilgen, Ph.D., and Rudolf Moos, Ph.D., prospectively studied 3,322 men with psychiatric symptoms who underwent treatment for substance use disorders at one of 15 residential programs in the VA health care system. (Women were not included in the study because of the small number treated within the VA system.)

Results were presented in a poster at the annual meeting of the Research Society on Alcoholism.

Symptoms improved during treatment in 85% of patients, as measured by the Brief Symptom Inventory, a self-reported 5-point scale of severity on each of 22 psychiatric symptoms. Symptoms were unchanged in 2% of patients, and symptoms worsened in 13%, reported Dr. Ilgen and Dr. Moos, both of whom are affiliated with the VA Palo Alto Health Care System and Stanford (Calif.) University.

When they closely compared the patients with worsening symptoms to a matched sample of patients whose conditions did not deteriorate, they could find no differences in baseline psychiatric symptom scores, demographic characteristics, or severity of substance use.

However, those who worsened were more likely to have been treated under court order and to have a diagnosis of psychosis. They were also more likely to use substances during treatment, to express dissatisfaction with the treatment experience, and to drop out early, the investigators said.

A year later, those patients were more likely to be using alcohol and/or drugs than were their counterparts whose psychiatric symptoms improved during treatment.

“Finally, they continued to report elevated psychiatric symptoms relative to nondeteriorated patients despite roughly equivalent scores on the same measure between groups at baseline,” Dr. Ilgen and Dr. Moos noted.

The type or length of substance abuse treatment did not appear to influence the worsening of psychiatric symptoms.

“Given the importance of psychiatric symptoms in influencing the response to substance use disorder treatment hellip; it is important to identify those for whom treatment has been associated with an increase in psychiatric symptoms,” they wrote. “Monitoring patients for psychiatric deterioration in treatment may be a way to identify patients at risk for treatment dropout and for poor prognosis following treatment,” they concluded.

SANTA BARBARA, CALIF. – Psychiatric symptoms are common among people with substance abuse disorders, but in most patients those symptoms improve over the course of residential substance abuse disorder treatment.

A recent Veterans Affairs study sheds light on patients whose psychiatric symptoms actually worsen during substance abuse treatment, with the aim of providing insight into which patients are at risk.

Mark Ilgen, Ph.D., and Rudolf Moos, Ph.D., prospectively studied 3,322 men with psychiatric symptoms who underwent treatment for substance use disorders at one of 15 residential programs in the VA health care system. (Women were not included in the study because of the small number treated within the VA system.)

Results were presented in a poster at the annual meeting of the Research Society on Alcoholism.

Symptoms improved during treatment in 85% of patients, as measured by the Brief Symptom Inventory, a self-reported 5-point scale of severity on each of 22 psychiatric symptoms. Symptoms were unchanged in 2% of patients, and symptoms worsened in 13%, reported Dr. Ilgen and Dr. Moos, both of whom are affiliated with the VA Palo Alto Health Care System and Stanford (Calif.) University.

When they closely compared the patients with worsening symptoms to a matched sample of patients whose conditions did not deteriorate, they could find no differences in baseline psychiatric symptom scores, demographic characteristics, or severity of substance use.

However, those who worsened were more likely to have been treated under court order and to have a diagnosis of psychosis. They were also more likely to use substances during treatment, to express dissatisfaction with the treatment experience, and to drop out early, the investigators said.

A year later, those patients were more likely to be using alcohol and/or drugs than were their counterparts whose psychiatric symptoms improved during treatment.

“Finally, they continued to report elevated psychiatric symptoms relative to nondeteriorated patients despite roughly equivalent scores on the same measure between groups at baseline,” Dr. Ilgen and Dr. Moos noted.

The type or length of substance abuse treatment did not appear to influence the worsening of psychiatric symptoms.

“Given the importance of psychiatric symptoms in influencing the response to substance use disorder treatment hellip; it is important to identify those for whom treatment has been associated with an increase in psychiatric symptoms,” they wrote. “Monitoring patients for psychiatric deterioration in treatment may be a way to identify patients at risk for treatment dropout and for poor prognosis following treatment,” they concluded.

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Watch for the Hallmarks Of 'Pseudoaddiction'

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PALM SPRINGS, CALIF. – Patients suffering severe, inadequately treated chronic pain can closely resemble drug addicts, posing diagnostic and management challenges for addiction and pain specialits, and primary care physicians.

John Femino, M.D., calls them “pseudoaddicts,” a term developed in the past few years to characterize patients whose desperation to obtain relief may look a lot like an addict's drug-seeking behavior.

Like addicts, such patients may have a loss of control over their medication use. They may seek early renewals or report that their medication was “lost” or “stolen.”

Sometimes, as in the case of a patient treated at his recovery center, the unresolved pain will lead to true addiction, said Dr. Femino, who practices addiction medicine in North Kingston, R.I.

This patient had previously unrecognized bone fragments left in his spine after unsuccessful surgery, causing excruciating pain. The patient's addiction and the source of his pain had to be treated in a collaborative, multidisciplinary fashion, Dr. Femino said at the annual meeting of the American Academy of Pain Medicine.

Several tip-offs can help to distinguish addiction from pseudoaddiction.

Importantly, a pseudoaddict is likely to keep appointments and to welcome nonpharmacologic adjuncts to medication.

“If I say, 'I've got a great physical therapist, 8% of our patients who go to him lower the dose of their pain medications,' the pseudoaddict will say, 'Great! Get me an appointment as soon as you can.'”

An addict is much more likely to dismiss the offer out of hand, saying it won't work, Dr. Femino said.

Addicts are also less compliant with psychological and other nondrug interventions and fail to report any pain relief whatsoever from them.

Chronic pain patients' biggest fear is becoming addicted. They may express concern about the possibility, rather than waiting for the physician to bring it up.

Another important element in sorting out addiction and pseudoaddiction is simply the family history, Dr. Femino stressed.

“I believe the single biggest determinant of addiction is genetic,” he said.

Although the DSM-IV does not include a positive family history in the diagnosis of addiction, 100% of the patients in Dr. Femino's recovery center report a family history of alcoholism or drug abuse.

Patients with chronic pain who do have such a history merit special attention, such as more frequent counseling appointments, therapeutic drug monitoring, and stepped-up use of modalities such as physical therapy, he said.

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PALM SPRINGS, CALIF. – Patients suffering severe, inadequately treated chronic pain can closely resemble drug addicts, posing diagnostic and management challenges for addiction and pain specialits, and primary care physicians.

John Femino, M.D., calls them “pseudoaddicts,” a term developed in the past few years to characterize patients whose desperation to obtain relief may look a lot like an addict's drug-seeking behavior.

Like addicts, such patients may have a loss of control over their medication use. They may seek early renewals or report that their medication was “lost” or “stolen.”

Sometimes, as in the case of a patient treated at his recovery center, the unresolved pain will lead to true addiction, said Dr. Femino, who practices addiction medicine in North Kingston, R.I.

This patient had previously unrecognized bone fragments left in his spine after unsuccessful surgery, causing excruciating pain. The patient's addiction and the source of his pain had to be treated in a collaborative, multidisciplinary fashion, Dr. Femino said at the annual meeting of the American Academy of Pain Medicine.

Several tip-offs can help to distinguish addiction from pseudoaddiction.

Importantly, a pseudoaddict is likely to keep appointments and to welcome nonpharmacologic adjuncts to medication.

“If I say, 'I've got a great physical therapist, 8% of our patients who go to him lower the dose of their pain medications,' the pseudoaddict will say, 'Great! Get me an appointment as soon as you can.'”

An addict is much more likely to dismiss the offer out of hand, saying it won't work, Dr. Femino said.

Addicts are also less compliant with psychological and other nondrug interventions and fail to report any pain relief whatsoever from them.

Chronic pain patients' biggest fear is becoming addicted. They may express concern about the possibility, rather than waiting for the physician to bring it up.

Another important element in sorting out addiction and pseudoaddiction is simply the family history, Dr. Femino stressed.

“I believe the single biggest determinant of addiction is genetic,” he said.

Although the DSM-IV does not include a positive family history in the diagnosis of addiction, 100% of the patients in Dr. Femino's recovery center report a family history of alcoholism or drug abuse.

Patients with chronic pain who do have such a history merit special attention, such as more frequent counseling appointments, therapeutic drug monitoring, and stepped-up use of modalities such as physical therapy, he said.

PALM SPRINGS, CALIF. – Patients suffering severe, inadequately treated chronic pain can closely resemble drug addicts, posing diagnostic and management challenges for addiction and pain specialits, and primary care physicians.

John Femino, M.D., calls them “pseudoaddicts,” a term developed in the past few years to characterize patients whose desperation to obtain relief may look a lot like an addict's drug-seeking behavior.

Like addicts, such patients may have a loss of control over their medication use. They may seek early renewals or report that their medication was “lost” or “stolen.”

Sometimes, as in the case of a patient treated at his recovery center, the unresolved pain will lead to true addiction, said Dr. Femino, who practices addiction medicine in North Kingston, R.I.

This patient had previously unrecognized bone fragments left in his spine after unsuccessful surgery, causing excruciating pain. The patient's addiction and the source of his pain had to be treated in a collaborative, multidisciplinary fashion, Dr. Femino said at the annual meeting of the American Academy of Pain Medicine.

Several tip-offs can help to distinguish addiction from pseudoaddiction.

Importantly, a pseudoaddict is likely to keep appointments and to welcome nonpharmacologic adjuncts to medication.

“If I say, 'I've got a great physical therapist, 8% of our patients who go to him lower the dose of their pain medications,' the pseudoaddict will say, 'Great! Get me an appointment as soon as you can.'”

An addict is much more likely to dismiss the offer out of hand, saying it won't work, Dr. Femino said.

Addicts are also less compliant with psychological and other nondrug interventions and fail to report any pain relief whatsoever from them.

Chronic pain patients' biggest fear is becoming addicted. They may express concern about the possibility, rather than waiting for the physician to bring it up.

Another important element in sorting out addiction and pseudoaddiction is simply the family history, Dr. Femino stressed.

“I believe the single biggest determinant of addiction is genetic,” he said.

Although the DSM-IV does not include a positive family history in the diagnosis of addiction, 100% of the patients in Dr. Femino's recovery center report a family history of alcoholism or drug abuse.

Patients with chronic pain who do have such a history merit special attention, such as more frequent counseling appointments, therapeutic drug monitoring, and stepped-up use of modalities such as physical therapy, he said.

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Simple Score Predicts Benefit Of Early Revascularization

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LOS ANGELES — Specific findings on adenosine stress myocardial perfusion imaging can be combined with other risk factors to offer precise guidance about whether a patient would obtain a significant survival advantage with early revascularization, Rory Hachamovitch, M.D., said at a meeting sponsored by the American College of Cardiology.

Dr. Hachamovitch outlined the simplest of three new prognostic adenosine scores he validated in a group of 5,873 consecutive patients who underwent adenosine stress, dual-isotope single-photon emission computed tomography (SPECT) scanning, and were followed for a mean 2.2 years.

The simple score uses a patient's age, percent of ischemic myocardium, percent of fixed myocardium, presence or absence of dyspnea, resting ECG results, resting and peak stress heart rates, and scan results following early revascularization to predict a patient's 2-year mortality from cardiac causes.

Because revascularization can be plugged into the equation or left out, the formula can offer specific guidance as to the clinical management of an individual patient, said Dr. Hachamovitch of the clinical cardiovascular medicine unit at the University of Southern California, Los Angeles.

He offered the specific example of an 80-year-old man with atypical angina, assessing points to account for his age, the fact that 30% of his myocardium is ischemic, and other clinical characteristics and scan findings.

His final score was plotted on the x-axis of a graph against the 2-year Kaplan Meier Survival Curve on the y-axis.

The hypothetical patient received a total of 150 points if he underwent medical therapy, for a survival score of 91%, meaning he had a 9% chance of dying of cardiac causes in the ensuing 2 years.

When revascularization was factored into the formula, the patient's score dropped to 85 points, and his 2-year survival estimate rose to 97%.

The derivation of such a formula has been dependent on years of research into risk stratification for cardiac patients based on nuclear scan findings, said Dr. Hachamovitch at the meeting, which was cosponsored by the American Society of Nuclear Cardiology and Cedars-Sinai Medical Center.

This research has determined predictors of both relative and absolute risk reduction based on nuclear perfusion study results. Following Dr. Hachamovitch's talk, his findings were published (J. Am. Coll. Cardiol. 2005;45:722–9).

In general, the relative benefit of revascularization over medical therapy after nuclear imaging depends on the extent and severity of the myocardium at risk.

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LOS ANGELES — Specific findings on adenosine stress myocardial perfusion imaging can be combined with other risk factors to offer precise guidance about whether a patient would obtain a significant survival advantage with early revascularization, Rory Hachamovitch, M.D., said at a meeting sponsored by the American College of Cardiology.

Dr. Hachamovitch outlined the simplest of three new prognostic adenosine scores he validated in a group of 5,873 consecutive patients who underwent adenosine stress, dual-isotope single-photon emission computed tomography (SPECT) scanning, and were followed for a mean 2.2 years.

The simple score uses a patient's age, percent of ischemic myocardium, percent of fixed myocardium, presence or absence of dyspnea, resting ECG results, resting and peak stress heart rates, and scan results following early revascularization to predict a patient's 2-year mortality from cardiac causes.

Because revascularization can be plugged into the equation or left out, the formula can offer specific guidance as to the clinical management of an individual patient, said Dr. Hachamovitch of the clinical cardiovascular medicine unit at the University of Southern California, Los Angeles.

He offered the specific example of an 80-year-old man with atypical angina, assessing points to account for his age, the fact that 30% of his myocardium is ischemic, and other clinical characteristics and scan findings.

His final score was plotted on the x-axis of a graph against the 2-year Kaplan Meier Survival Curve on the y-axis.

The hypothetical patient received a total of 150 points if he underwent medical therapy, for a survival score of 91%, meaning he had a 9% chance of dying of cardiac causes in the ensuing 2 years.

When revascularization was factored into the formula, the patient's score dropped to 85 points, and his 2-year survival estimate rose to 97%.

The derivation of such a formula has been dependent on years of research into risk stratification for cardiac patients based on nuclear scan findings, said Dr. Hachamovitch at the meeting, which was cosponsored by the American Society of Nuclear Cardiology and Cedars-Sinai Medical Center.

This research has determined predictors of both relative and absolute risk reduction based on nuclear perfusion study results. Following Dr. Hachamovitch's talk, his findings were published (J. Am. Coll. Cardiol. 2005;45:722–9).

In general, the relative benefit of revascularization over medical therapy after nuclear imaging depends on the extent and severity of the myocardium at risk.

LOS ANGELES — Specific findings on adenosine stress myocardial perfusion imaging can be combined with other risk factors to offer precise guidance about whether a patient would obtain a significant survival advantage with early revascularization, Rory Hachamovitch, M.D., said at a meeting sponsored by the American College of Cardiology.

Dr. Hachamovitch outlined the simplest of three new prognostic adenosine scores he validated in a group of 5,873 consecutive patients who underwent adenosine stress, dual-isotope single-photon emission computed tomography (SPECT) scanning, and were followed for a mean 2.2 years.

The simple score uses a patient's age, percent of ischemic myocardium, percent of fixed myocardium, presence or absence of dyspnea, resting ECG results, resting and peak stress heart rates, and scan results following early revascularization to predict a patient's 2-year mortality from cardiac causes.

Because revascularization can be plugged into the equation or left out, the formula can offer specific guidance as to the clinical management of an individual patient, said Dr. Hachamovitch of the clinical cardiovascular medicine unit at the University of Southern California, Los Angeles.

He offered the specific example of an 80-year-old man with atypical angina, assessing points to account for his age, the fact that 30% of his myocardium is ischemic, and other clinical characteristics and scan findings.

His final score was plotted on the x-axis of a graph against the 2-year Kaplan Meier Survival Curve on the y-axis.

The hypothetical patient received a total of 150 points if he underwent medical therapy, for a survival score of 91%, meaning he had a 9% chance of dying of cardiac causes in the ensuing 2 years.

When revascularization was factored into the formula, the patient's score dropped to 85 points, and his 2-year survival estimate rose to 97%.

The derivation of such a formula has been dependent on years of research into risk stratification for cardiac patients based on nuclear scan findings, said Dr. Hachamovitch at the meeting, which was cosponsored by the American Society of Nuclear Cardiology and Cedars-Sinai Medical Center.

This research has determined predictors of both relative and absolute risk reduction based on nuclear perfusion study results. Following Dr. Hachamovitch's talk, his findings were published (J. Am. Coll. Cardiol. 2005;45:722–9).

In general, the relative benefit of revascularization over medical therapy after nuclear imaging depends on the extent and severity of the myocardium at risk.

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Examine Patient Motivation for Cosmetic Surgery

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LAS VEGAS — Six simple words stop Rona Z. Silkiss, M.D., in her tracks after she greets a cosmetic surgery patient by asking, "What can I do for you?"

Those words are the response: "I don't know, you're the doctor."

Within this seemingly innocuous exchange lies a warning that the balance of power between doctor and patient is already skewed, setting the scene for an unhappy outcome. In cosmetic procedures, the doctor-patient relationship must be bilateral, with each person coming to the table with a defined role and measurable expectations, Dr. Silkiss said at a facial cosmetic surgery symposium.

Don't bite when a patient says, "Take a look at me and tell me what you can do," Dr. Silkiss advised. The patient is not taking responsibility for the initial objectives of his or her cosmetic surgery, she explained. "The environment is wide open and ill defined. As a result, it is impossible for the surgeon to meet the patient's expectations" because they have not been clearly established, she said.

Maintaining a balance of power was just one of a series of tips offered by Dr. Silkiss, chief of the division of ophthalmic plastic, reconstructive, and orbital surgery at California Pacific Medical Center in Oakland.

Another patient to watch out for is one who presents at a young age with a very minor problem, saying she has read articles advocating early cosmetic surgery.

"This is what I call surgery in search of a problem," Dr. Silkiss said at the meeting, which was sponsored by the Multi-Specialty Foundation for Facial Aesthetic Surgical Excellence. Such a patient may be giving in to media pressure fueled by fashion magazines and reality TV shows such as "Nip and Tuck" and "Extreme Makeover."

Reassuring such a patient that she does not need surgery exemplifies surgical integrity that will be rewarded later, Dr. Silkiss said. She reminded her audience of the "Gucci Phenomenon": What is rare or withheld is valued more highly.

Patients who arrive in the traumatic aftermath of a divorce or job loss might be well advised to come back in a few months, when life has stabilized for them.

"The patient is at a stressful juncture in his or her life. What you do not want to do is give the patient the opportunity to transfer his or her unhappiness to the recent surgery and surgeon," she said.

Dr. Silkiss described a scenario in which a 50-year-old man, recently divorced, came to her because his new girlfriend told him he needed blepharoplasty. "Actually, he didn't notice he had a problem."

This patient, she said, had insufficient motivation to undergo an elective surgical procedure. "The patient is not personally committed to the surgery. This is his body and he has to want the surgery himself."

Such patients often come to a consultation hoping that the surgeon will agree that surgical correction for such an issue is purely optional. "They are trying to reestablish their self-esteem. Reassurance alone may be the best medicine," she said.

Difficult Patients Are Easy to Spot

Dr. Silkiss provides the following warning signs for surgeons:

▸ The patient's chief complaint is one concerning prior surgeons.

▸ The patient has already received multiple procedures and is still not satisfied.

▸ The patient has unrealistic expectations concerning the surgical outcome.

▸ The patient displays an inappropriate level of familiarity or flattery.

▸ The patient is inappropriately aggressive and/or hostile during the consultation. Remember, the consultation is the honeymoon!

▸ The consultation takes an unusually lengthy period of time, making the surgeon uncomfortable with the degree of self-absorption and detail demanded.

▸ There is excessive "negotiating" about price, location, and insurance prior to surgery.

▸ The patient repeatedly postpones the surgical date.

▸ The patient insists that his or her friend's cosmetic surgery was covered by insurance.

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LAS VEGAS — Six simple words stop Rona Z. Silkiss, M.D., in her tracks after she greets a cosmetic surgery patient by asking, "What can I do for you?"

Those words are the response: "I don't know, you're the doctor."

Within this seemingly innocuous exchange lies a warning that the balance of power between doctor and patient is already skewed, setting the scene for an unhappy outcome. In cosmetic procedures, the doctor-patient relationship must be bilateral, with each person coming to the table with a defined role and measurable expectations, Dr. Silkiss said at a facial cosmetic surgery symposium.

Don't bite when a patient says, "Take a look at me and tell me what you can do," Dr. Silkiss advised. The patient is not taking responsibility for the initial objectives of his or her cosmetic surgery, she explained. "The environment is wide open and ill defined. As a result, it is impossible for the surgeon to meet the patient's expectations" because they have not been clearly established, she said.

Maintaining a balance of power was just one of a series of tips offered by Dr. Silkiss, chief of the division of ophthalmic plastic, reconstructive, and orbital surgery at California Pacific Medical Center in Oakland.

Another patient to watch out for is one who presents at a young age with a very minor problem, saying she has read articles advocating early cosmetic surgery.

"This is what I call surgery in search of a problem," Dr. Silkiss said at the meeting, which was sponsored by the Multi-Specialty Foundation for Facial Aesthetic Surgical Excellence. Such a patient may be giving in to media pressure fueled by fashion magazines and reality TV shows such as "Nip and Tuck" and "Extreme Makeover."

Reassuring such a patient that she does not need surgery exemplifies surgical integrity that will be rewarded later, Dr. Silkiss said. She reminded her audience of the "Gucci Phenomenon": What is rare or withheld is valued more highly.

Patients who arrive in the traumatic aftermath of a divorce or job loss might be well advised to come back in a few months, when life has stabilized for them.

"The patient is at a stressful juncture in his or her life. What you do not want to do is give the patient the opportunity to transfer his or her unhappiness to the recent surgery and surgeon," she said.

Dr. Silkiss described a scenario in which a 50-year-old man, recently divorced, came to her because his new girlfriend told him he needed blepharoplasty. "Actually, he didn't notice he had a problem."

This patient, she said, had insufficient motivation to undergo an elective surgical procedure. "The patient is not personally committed to the surgery. This is his body and he has to want the surgery himself."

Such patients often come to a consultation hoping that the surgeon will agree that surgical correction for such an issue is purely optional. "They are trying to reestablish their self-esteem. Reassurance alone may be the best medicine," she said.

Difficult Patients Are Easy to Spot

Dr. Silkiss provides the following warning signs for surgeons:

▸ The patient's chief complaint is one concerning prior surgeons.

▸ The patient has already received multiple procedures and is still not satisfied.

▸ The patient has unrealistic expectations concerning the surgical outcome.

▸ The patient displays an inappropriate level of familiarity or flattery.

▸ The patient is inappropriately aggressive and/or hostile during the consultation. Remember, the consultation is the honeymoon!

▸ The consultation takes an unusually lengthy period of time, making the surgeon uncomfortable with the degree of self-absorption and detail demanded.

▸ There is excessive "negotiating" about price, location, and insurance prior to surgery.

▸ The patient repeatedly postpones the surgical date.

▸ The patient insists that his or her friend's cosmetic surgery was covered by insurance.

LAS VEGAS — Six simple words stop Rona Z. Silkiss, M.D., in her tracks after she greets a cosmetic surgery patient by asking, "What can I do for you?"

Those words are the response: "I don't know, you're the doctor."

Within this seemingly innocuous exchange lies a warning that the balance of power between doctor and patient is already skewed, setting the scene for an unhappy outcome. In cosmetic procedures, the doctor-patient relationship must be bilateral, with each person coming to the table with a defined role and measurable expectations, Dr. Silkiss said at a facial cosmetic surgery symposium.

Don't bite when a patient says, "Take a look at me and tell me what you can do," Dr. Silkiss advised. The patient is not taking responsibility for the initial objectives of his or her cosmetic surgery, she explained. "The environment is wide open and ill defined. As a result, it is impossible for the surgeon to meet the patient's expectations" because they have not been clearly established, she said.

Maintaining a balance of power was just one of a series of tips offered by Dr. Silkiss, chief of the division of ophthalmic plastic, reconstructive, and orbital surgery at California Pacific Medical Center in Oakland.

Another patient to watch out for is one who presents at a young age with a very minor problem, saying she has read articles advocating early cosmetic surgery.

"This is what I call surgery in search of a problem," Dr. Silkiss said at the meeting, which was sponsored by the Multi-Specialty Foundation for Facial Aesthetic Surgical Excellence. Such a patient may be giving in to media pressure fueled by fashion magazines and reality TV shows such as "Nip and Tuck" and "Extreme Makeover."

Reassuring such a patient that she does not need surgery exemplifies surgical integrity that will be rewarded later, Dr. Silkiss said. She reminded her audience of the "Gucci Phenomenon": What is rare or withheld is valued more highly.

Patients who arrive in the traumatic aftermath of a divorce or job loss might be well advised to come back in a few months, when life has stabilized for them.

"The patient is at a stressful juncture in his or her life. What you do not want to do is give the patient the opportunity to transfer his or her unhappiness to the recent surgery and surgeon," she said.

Dr. Silkiss described a scenario in which a 50-year-old man, recently divorced, came to her because his new girlfriend told him he needed blepharoplasty. "Actually, he didn't notice he had a problem."

This patient, she said, had insufficient motivation to undergo an elective surgical procedure. "The patient is not personally committed to the surgery. This is his body and he has to want the surgery himself."

Such patients often come to a consultation hoping that the surgeon will agree that surgical correction for such an issue is purely optional. "They are trying to reestablish their self-esteem. Reassurance alone may be the best medicine," she said.

Difficult Patients Are Easy to Spot

Dr. Silkiss provides the following warning signs for surgeons:

▸ The patient's chief complaint is one concerning prior surgeons.

▸ The patient has already received multiple procedures and is still not satisfied.

▸ The patient has unrealistic expectations concerning the surgical outcome.

▸ The patient displays an inappropriate level of familiarity or flattery.

▸ The patient is inappropriately aggressive and/or hostile during the consultation. Remember, the consultation is the honeymoon!

▸ The consultation takes an unusually lengthy period of time, making the surgeon uncomfortable with the degree of self-absorption and detail demanded.

▸ There is excessive "negotiating" about price, location, and insurance prior to surgery.

▸ The patient repeatedly postpones the surgical date.

▸ The patient insists that his or her friend's cosmetic surgery was covered by insurance.

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Physicians Reluctant to Prescribe for Alcoholism

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SANTA BARBARA, CALIF. — Newer pharmacologic treatments for alcohol dependence roughly double abstinence rates and significantly reduce heavy alcohol use among patients who return to drinking, a growing body of evidence suggests.

But skepticism and, to a lesser extent, philosophical objections, may be undermining adoption of medications as part of the treatment regimen for alcohol-dependent patients, speakers agreed at the annual meeting of the Research Society on Alcoholism.

“Why are these medications not more widely prescribed [when metaanalyses show they are clearly efficacious]?” asked Henry Kranzler, M.D., professor of psychiatry and assistant dean of clinical research at the University of Connecticut Health Center, Farmington. “It's an interesting conundrum.”

Dr. Kranzler noted there are nearly 8 million alcohol-dependent people in the United States at any time. “Only a fraction of them are being treated, and a small fraction of those are receiving medications approved for alcoholism treatment.”

In contrast, depression strikes about 20 million adults per year in the United States. However, depressed patients are 100 times more likely to be prescribed an antidepressant than alcoholics are to be prescribed an FDA-approved medication to treat alcoholism.

The reasons are myriad, according to David R. Gastfriend, M.D., of Massachusetts General Hospital and Harvard Medical School, Boston, and vice president of medical affairs for Alkermes Inc.

The reasons include:

▸ Perceived ineffectiveness of medications and a deep concern about noncompliance rates.

▸ A sense among counselors that medications might diminish patients' motivation to help themselves or to participate in 12-step program activities.

▸ Worries about side effects and costs.

▸ A belief among providers that patients “may want to reject any treatment that prevents the relief sought from alcohol.”

In some cases, providers' doubts may be justified. Dropout rates are high—even among highly motivated participants in clinical trials. Strong placebo response rates sometimes muddy final results. Medications add expense to alcohol-dependence treatment regimens that are already costly and often underfunded by the government and private insurers.

Perhaps most importantly, the best use of medications may be in combination with one another and with traditional psychosocial support—in ways only now being assessed, Dr. Gastfriend said.

An immediate boost in acceptance of medications may come from a monthly, injectable formulation of an existing drug—naltrexone. If patients did not have the daily responsibility of taking an oral drug, compliance rates might improve, Dr. Kranzler said.

Robert M. Swift, M.D., professor of psychiatry at Brown University in Providence, R.I., noted that although acamprosate (Campral) doubles the abstinence rate in most studies, “the absolute number of patients who continue to be abstinent [following the study period] is not great. Most effects come even in the placebo group. The average clinician is not going to see that much difference.”

A 2003, three-state survey of physicians and nonphysicians who treat alcohol addiction found that nearly 40% of physicians and 70% of nonphysicians said they “never” or “rarely” used naltrexone to assist in the treatment process, even though the survey was taken 4 years after the drug's approval (J. Subst. Abuse Tr. 2003;24:1–11).

When asked why, physicians cited inconsistent compliance, cost, efficacy issues, and side effects. Nonphysicians cited lack of knowledge as their top reason, followed by cost, the inability to predict which patients would benefit, and insufficient efficacy, said Dr. Swift, who has received research support or consulting fees from Pfizer Inc., Ortho-McNeil Pharmaceutical Inc., Bristol-Myers Squibb Co., Forest Laboratories Inc., and Alkermes.

This year, Food and Drug Administration approval is expected for a long-acting depot formulation of naltrexone, to be called Vivitrex.

Phase III trials found a 25% reduction in heavy-drinking days among subjects receiving a 380-mg monthly, injected dosage of naltrexone in combination with a low-intensity psychosocial intervention during the 6-month trial (JAMA 2005;293:1617–25).

Follow-up studies presented at the meeting found a much larger effect size (74%, compared with 19%) among subjects who entered the trial having been abstinent (even though abstinence was not a requirement for entry into the study) and also found that mental health-related quality of life scores paralleled the reduction in heavy drinking among subjects.

An open-label extension study directed by Dr. Gastfriend—an employee of Alkermes, maker of long-acting naltrexone—found that the treatment effect persisted for a year among patients who continued to receive injections.

An Internet marketing survey suggests that patients may be amenable to considering injectable long-acting naltrexone.

Among 176 problem drinkers who responded to the survey, 57% expressed positive or at least neutral opinions about whether such a drug would be helpful. Just 14% said they had no expectation that the drug would be helpful, reported Dr. Gastfriend at the meeting.

 

 

Other drugs may be on the horizon as well, said Dr. Kranzler, who disclosed that he has received research support and consulting fees from Ortho-McNeil Pharmaceutical, Bristol-Myers Squibb, Forest Pharmaceuticals, and DrugAbuse Sciences Inc.—all of which are involved in manufacturing and/or developing medications for alcohol-dependence treatment.

Phase III trials are underway to test the efficacy of the anticonvulsant topiramate (Topamax) for treating alcohol dependence. An antipsychotic medication, aripiprazole (Abilify), is also being studied in a multicenter trial.

Dr. Kranzler termed both agents “promising,” although their use in clinical practice may be several years away.

Ups and Downs Of Alcohol Drugs

Pharmacology for alcohol treatment has followed a somewhat rocky path.

The first FDA-approved medication for alcohol treatment, disulfiram (Antabuse), was not a blockbuster drug in terms of efficacy. In the largest study of the drug, a 1-year trial, noncompliance with the medication was 80% and was associated with a lower rate of abstinence, Dr. Kranzler said.

A short-acting naltrexone formulation (Revia) came next, in 1994, initially demonstrating a “pretty robust effect” on abstinence and heavy drinking. But a meager 3-year exclusivity arrangement provided little incentive for the manufacturer to market the drug at that time.

Acamprosate (Campral), approved in 2004, may show a healthier acceptance rate. Studies in the United States and Europe suggest that the oral agent may not only double abstinence rates but also may have a meaningful effect on abstinence for as long as a year after discontinuation. Acamprosate is being heavily marketed to primary care physicians as well as psychiatrists and alcohol-dependency treatment specialists.

The Combining Medications and Behavioral Interventions (COMBINE) trial sponsored by the National Institute on Alcohol Abuse and Alcoholism is nearing completion. The trial will evaluate a multifaceted approach to alcohol-dependency treatment, comparing a placebo with two FDA-approved medications.

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SANTA BARBARA, CALIF. — Newer pharmacologic treatments for alcohol dependence roughly double abstinence rates and significantly reduce heavy alcohol use among patients who return to drinking, a growing body of evidence suggests.

But skepticism and, to a lesser extent, philosophical objections, may be undermining adoption of medications as part of the treatment regimen for alcohol-dependent patients, speakers agreed at the annual meeting of the Research Society on Alcoholism.

“Why are these medications not more widely prescribed [when metaanalyses show they are clearly efficacious]?” asked Henry Kranzler, M.D., professor of psychiatry and assistant dean of clinical research at the University of Connecticut Health Center, Farmington. “It's an interesting conundrum.”

Dr. Kranzler noted there are nearly 8 million alcohol-dependent people in the United States at any time. “Only a fraction of them are being treated, and a small fraction of those are receiving medications approved for alcoholism treatment.”

In contrast, depression strikes about 20 million adults per year in the United States. However, depressed patients are 100 times more likely to be prescribed an antidepressant than alcoholics are to be prescribed an FDA-approved medication to treat alcoholism.

The reasons are myriad, according to David R. Gastfriend, M.D., of Massachusetts General Hospital and Harvard Medical School, Boston, and vice president of medical affairs for Alkermes Inc.

The reasons include:

▸ Perceived ineffectiveness of medications and a deep concern about noncompliance rates.

▸ A sense among counselors that medications might diminish patients' motivation to help themselves or to participate in 12-step program activities.

▸ Worries about side effects and costs.

▸ A belief among providers that patients “may want to reject any treatment that prevents the relief sought from alcohol.”

In some cases, providers' doubts may be justified. Dropout rates are high—even among highly motivated participants in clinical trials. Strong placebo response rates sometimes muddy final results. Medications add expense to alcohol-dependence treatment regimens that are already costly and often underfunded by the government and private insurers.

Perhaps most importantly, the best use of medications may be in combination with one another and with traditional psychosocial support—in ways only now being assessed, Dr. Gastfriend said.

An immediate boost in acceptance of medications may come from a monthly, injectable formulation of an existing drug—naltrexone. If patients did not have the daily responsibility of taking an oral drug, compliance rates might improve, Dr. Kranzler said.

Robert M. Swift, M.D., professor of psychiatry at Brown University in Providence, R.I., noted that although acamprosate (Campral) doubles the abstinence rate in most studies, “the absolute number of patients who continue to be abstinent [following the study period] is not great. Most effects come even in the placebo group. The average clinician is not going to see that much difference.”

A 2003, three-state survey of physicians and nonphysicians who treat alcohol addiction found that nearly 40% of physicians and 70% of nonphysicians said they “never” or “rarely” used naltrexone to assist in the treatment process, even though the survey was taken 4 years after the drug's approval (J. Subst. Abuse Tr. 2003;24:1–11).

When asked why, physicians cited inconsistent compliance, cost, efficacy issues, and side effects. Nonphysicians cited lack of knowledge as their top reason, followed by cost, the inability to predict which patients would benefit, and insufficient efficacy, said Dr. Swift, who has received research support or consulting fees from Pfizer Inc., Ortho-McNeil Pharmaceutical Inc., Bristol-Myers Squibb Co., Forest Laboratories Inc., and Alkermes.

This year, Food and Drug Administration approval is expected for a long-acting depot formulation of naltrexone, to be called Vivitrex.

Phase III trials found a 25% reduction in heavy-drinking days among subjects receiving a 380-mg monthly, injected dosage of naltrexone in combination with a low-intensity psychosocial intervention during the 6-month trial (JAMA 2005;293:1617–25).

Follow-up studies presented at the meeting found a much larger effect size (74%, compared with 19%) among subjects who entered the trial having been abstinent (even though abstinence was not a requirement for entry into the study) and also found that mental health-related quality of life scores paralleled the reduction in heavy drinking among subjects.

An open-label extension study directed by Dr. Gastfriend—an employee of Alkermes, maker of long-acting naltrexone—found that the treatment effect persisted for a year among patients who continued to receive injections.

An Internet marketing survey suggests that patients may be amenable to considering injectable long-acting naltrexone.

Among 176 problem drinkers who responded to the survey, 57% expressed positive or at least neutral opinions about whether such a drug would be helpful. Just 14% said they had no expectation that the drug would be helpful, reported Dr. Gastfriend at the meeting.

 

 

Other drugs may be on the horizon as well, said Dr. Kranzler, who disclosed that he has received research support and consulting fees from Ortho-McNeil Pharmaceutical, Bristol-Myers Squibb, Forest Pharmaceuticals, and DrugAbuse Sciences Inc.—all of which are involved in manufacturing and/or developing medications for alcohol-dependence treatment.

Phase III trials are underway to test the efficacy of the anticonvulsant topiramate (Topamax) for treating alcohol dependence. An antipsychotic medication, aripiprazole (Abilify), is also being studied in a multicenter trial.

Dr. Kranzler termed both agents “promising,” although their use in clinical practice may be several years away.

Ups and Downs Of Alcohol Drugs

Pharmacology for alcohol treatment has followed a somewhat rocky path.

The first FDA-approved medication for alcohol treatment, disulfiram (Antabuse), was not a blockbuster drug in terms of efficacy. In the largest study of the drug, a 1-year trial, noncompliance with the medication was 80% and was associated with a lower rate of abstinence, Dr. Kranzler said.

A short-acting naltrexone formulation (Revia) came next, in 1994, initially demonstrating a “pretty robust effect” on abstinence and heavy drinking. But a meager 3-year exclusivity arrangement provided little incentive for the manufacturer to market the drug at that time.

Acamprosate (Campral), approved in 2004, may show a healthier acceptance rate. Studies in the United States and Europe suggest that the oral agent may not only double abstinence rates but also may have a meaningful effect on abstinence for as long as a year after discontinuation. Acamprosate is being heavily marketed to primary care physicians as well as psychiatrists and alcohol-dependency treatment specialists.

The Combining Medications and Behavioral Interventions (COMBINE) trial sponsored by the National Institute on Alcohol Abuse and Alcoholism is nearing completion. The trial will evaluate a multifaceted approach to alcohol-dependency treatment, comparing a placebo with two FDA-approved medications.

SANTA BARBARA, CALIF. — Newer pharmacologic treatments for alcohol dependence roughly double abstinence rates and significantly reduce heavy alcohol use among patients who return to drinking, a growing body of evidence suggests.

But skepticism and, to a lesser extent, philosophical objections, may be undermining adoption of medications as part of the treatment regimen for alcohol-dependent patients, speakers agreed at the annual meeting of the Research Society on Alcoholism.

“Why are these medications not more widely prescribed [when metaanalyses show they are clearly efficacious]?” asked Henry Kranzler, M.D., professor of psychiatry and assistant dean of clinical research at the University of Connecticut Health Center, Farmington. “It's an interesting conundrum.”

Dr. Kranzler noted there are nearly 8 million alcohol-dependent people in the United States at any time. “Only a fraction of them are being treated, and a small fraction of those are receiving medications approved for alcoholism treatment.”

In contrast, depression strikes about 20 million adults per year in the United States. However, depressed patients are 100 times more likely to be prescribed an antidepressant than alcoholics are to be prescribed an FDA-approved medication to treat alcoholism.

The reasons are myriad, according to David R. Gastfriend, M.D., of Massachusetts General Hospital and Harvard Medical School, Boston, and vice president of medical affairs for Alkermes Inc.

The reasons include:

▸ Perceived ineffectiveness of medications and a deep concern about noncompliance rates.

▸ A sense among counselors that medications might diminish patients' motivation to help themselves or to participate in 12-step program activities.

▸ Worries about side effects and costs.

▸ A belief among providers that patients “may want to reject any treatment that prevents the relief sought from alcohol.”

In some cases, providers' doubts may be justified. Dropout rates are high—even among highly motivated participants in clinical trials. Strong placebo response rates sometimes muddy final results. Medications add expense to alcohol-dependence treatment regimens that are already costly and often underfunded by the government and private insurers.

Perhaps most importantly, the best use of medications may be in combination with one another and with traditional psychosocial support—in ways only now being assessed, Dr. Gastfriend said.

An immediate boost in acceptance of medications may come from a monthly, injectable formulation of an existing drug—naltrexone. If patients did not have the daily responsibility of taking an oral drug, compliance rates might improve, Dr. Kranzler said.

Robert M. Swift, M.D., professor of psychiatry at Brown University in Providence, R.I., noted that although acamprosate (Campral) doubles the abstinence rate in most studies, “the absolute number of patients who continue to be abstinent [following the study period] is not great. Most effects come even in the placebo group. The average clinician is not going to see that much difference.”

A 2003, three-state survey of physicians and nonphysicians who treat alcohol addiction found that nearly 40% of physicians and 70% of nonphysicians said they “never” or “rarely” used naltrexone to assist in the treatment process, even though the survey was taken 4 years after the drug's approval (J. Subst. Abuse Tr. 2003;24:1–11).

When asked why, physicians cited inconsistent compliance, cost, efficacy issues, and side effects. Nonphysicians cited lack of knowledge as their top reason, followed by cost, the inability to predict which patients would benefit, and insufficient efficacy, said Dr. Swift, who has received research support or consulting fees from Pfizer Inc., Ortho-McNeil Pharmaceutical Inc., Bristol-Myers Squibb Co., Forest Laboratories Inc., and Alkermes.

This year, Food and Drug Administration approval is expected for a long-acting depot formulation of naltrexone, to be called Vivitrex.

Phase III trials found a 25% reduction in heavy-drinking days among subjects receiving a 380-mg monthly, injected dosage of naltrexone in combination with a low-intensity psychosocial intervention during the 6-month trial (JAMA 2005;293:1617–25).

Follow-up studies presented at the meeting found a much larger effect size (74%, compared with 19%) among subjects who entered the trial having been abstinent (even though abstinence was not a requirement for entry into the study) and also found that mental health-related quality of life scores paralleled the reduction in heavy drinking among subjects.

An open-label extension study directed by Dr. Gastfriend—an employee of Alkermes, maker of long-acting naltrexone—found that the treatment effect persisted for a year among patients who continued to receive injections.

An Internet marketing survey suggests that patients may be amenable to considering injectable long-acting naltrexone.

Among 176 problem drinkers who responded to the survey, 57% expressed positive or at least neutral opinions about whether such a drug would be helpful. Just 14% said they had no expectation that the drug would be helpful, reported Dr. Gastfriend at the meeting.

 

 

Other drugs may be on the horizon as well, said Dr. Kranzler, who disclosed that he has received research support and consulting fees from Ortho-McNeil Pharmaceutical, Bristol-Myers Squibb, Forest Pharmaceuticals, and DrugAbuse Sciences Inc.—all of which are involved in manufacturing and/or developing medications for alcohol-dependence treatment.

Phase III trials are underway to test the efficacy of the anticonvulsant topiramate (Topamax) for treating alcohol dependence. An antipsychotic medication, aripiprazole (Abilify), is also being studied in a multicenter trial.

Dr. Kranzler termed both agents “promising,” although their use in clinical practice may be several years away.

Ups and Downs Of Alcohol Drugs

Pharmacology for alcohol treatment has followed a somewhat rocky path.

The first FDA-approved medication for alcohol treatment, disulfiram (Antabuse), was not a blockbuster drug in terms of efficacy. In the largest study of the drug, a 1-year trial, noncompliance with the medication was 80% and was associated with a lower rate of abstinence, Dr. Kranzler said.

A short-acting naltrexone formulation (Revia) came next, in 1994, initially demonstrating a “pretty robust effect” on abstinence and heavy drinking. But a meager 3-year exclusivity arrangement provided little incentive for the manufacturer to market the drug at that time.

Acamprosate (Campral), approved in 2004, may show a healthier acceptance rate. Studies in the United States and Europe suggest that the oral agent may not only double abstinence rates but also may have a meaningful effect on abstinence for as long as a year after discontinuation. Acamprosate is being heavily marketed to primary care physicians as well as psychiatrists and alcohol-dependency treatment specialists.

The Combining Medications and Behavioral Interventions (COMBINE) trial sponsored by the National Institute on Alcohol Abuse and Alcoholism is nearing completion. The trial will evaluate a multifaceted approach to alcohol-dependency treatment, comparing a placebo with two FDA-approved medications.

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Fewer Than Half of OxyContin Prescriptions Taken as Directed

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PALM SPRINGS, CALIF. — Just 45% of prescriptions for the opiate OxyContin (oxycodone HCl controlled release) are taken as directed by patients being treated for nonmalignant pain, according to a study of urine samples from approximately 5% of the nation's outpatient pain clinics.

Fully 40% of the drug was recycled among other patients being treated for pain in 264 clinics whose combined caseloads exceeded 33,000 patients, Michael Kell, M.D., of the Labyrinth Institute of Smyrna, Ga., reported at the annual meeting of the American Academy of Pain Medicine.

Another 15% of OxyContin prescriptions were diverted to the black market, said Dr. Kell, who was chosen to present his poster in an oral format at the meeting.

Dr. Kell, a toxicologist, collected his data using software technology that interprets highly specific urinalysis results that control for urine concentration and acidity and patient BMI.

The urine from 55% of approximately 11,000 patients prescribed OxyContin either contained more of the drug, or less, than what would be expected based on the amount prescribed. To allow for time of day and other variations, Dr. Kell considered a patient compliant if the level of OxyContin in his or her urine was within three standard deviations of the mean.

Interestingly, about 15% of patients prescribed OxyContin had none of the drug in their urine. At the same time, many patients being treated with other pain drugs in the clinics had OxyContin in their urine, suggesting that “most of the diversion was patient to patient,” Dr. Kell said.

Funding for Dr. Kell's study was provided by UD Testing Inc., a Marco Island, Fla., company that uses Dr. Kell's software to monitor patient compliance with prescription medicine.

Another study presented at the meeting described very preliminary results from a novel oxycodone drug formulation called Remoxy. The formulation delivers a long-acting dose of the opiate in a gel cap designed to be impervious to efforts to extract the full dose to achieve a “spike” effect by crushing, freezing, heating, or dissolving it in various substances. Current formulations of the drug can be manipulated in this way, adding to abuse and diversion.

Plasma concentrations were markedly lower in 20 subjects who took Remoxy after it had been tampered with, compared with concentrations among people who had taken crushed controlled-release formulations of oxycodone.

The industry-designed study was funded by Pain Therapeutics Inc. of San Francisco.

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PALM SPRINGS, CALIF. — Just 45% of prescriptions for the opiate OxyContin (oxycodone HCl controlled release) are taken as directed by patients being treated for nonmalignant pain, according to a study of urine samples from approximately 5% of the nation's outpatient pain clinics.

Fully 40% of the drug was recycled among other patients being treated for pain in 264 clinics whose combined caseloads exceeded 33,000 patients, Michael Kell, M.D., of the Labyrinth Institute of Smyrna, Ga., reported at the annual meeting of the American Academy of Pain Medicine.

Another 15% of OxyContin prescriptions were diverted to the black market, said Dr. Kell, who was chosen to present his poster in an oral format at the meeting.

Dr. Kell, a toxicologist, collected his data using software technology that interprets highly specific urinalysis results that control for urine concentration and acidity and patient BMI.

The urine from 55% of approximately 11,000 patients prescribed OxyContin either contained more of the drug, or less, than what would be expected based on the amount prescribed. To allow for time of day and other variations, Dr. Kell considered a patient compliant if the level of OxyContin in his or her urine was within three standard deviations of the mean.

Interestingly, about 15% of patients prescribed OxyContin had none of the drug in their urine. At the same time, many patients being treated with other pain drugs in the clinics had OxyContin in their urine, suggesting that “most of the diversion was patient to patient,” Dr. Kell said.

Funding for Dr. Kell's study was provided by UD Testing Inc., a Marco Island, Fla., company that uses Dr. Kell's software to monitor patient compliance with prescription medicine.

Another study presented at the meeting described very preliminary results from a novel oxycodone drug formulation called Remoxy. The formulation delivers a long-acting dose of the opiate in a gel cap designed to be impervious to efforts to extract the full dose to achieve a “spike” effect by crushing, freezing, heating, or dissolving it in various substances. Current formulations of the drug can be manipulated in this way, adding to abuse and diversion.

Plasma concentrations were markedly lower in 20 subjects who took Remoxy after it had been tampered with, compared with concentrations among people who had taken crushed controlled-release formulations of oxycodone.

The industry-designed study was funded by Pain Therapeutics Inc. of San Francisco.

PALM SPRINGS, CALIF. — Just 45% of prescriptions for the opiate OxyContin (oxycodone HCl controlled release) are taken as directed by patients being treated for nonmalignant pain, according to a study of urine samples from approximately 5% of the nation's outpatient pain clinics.

Fully 40% of the drug was recycled among other patients being treated for pain in 264 clinics whose combined caseloads exceeded 33,000 patients, Michael Kell, M.D., of the Labyrinth Institute of Smyrna, Ga., reported at the annual meeting of the American Academy of Pain Medicine.

Another 15% of OxyContin prescriptions were diverted to the black market, said Dr. Kell, who was chosen to present his poster in an oral format at the meeting.

Dr. Kell, a toxicologist, collected his data using software technology that interprets highly specific urinalysis results that control for urine concentration and acidity and patient BMI.

The urine from 55% of approximately 11,000 patients prescribed OxyContin either contained more of the drug, or less, than what would be expected based on the amount prescribed. To allow for time of day and other variations, Dr. Kell considered a patient compliant if the level of OxyContin in his or her urine was within three standard deviations of the mean.

Interestingly, about 15% of patients prescribed OxyContin had none of the drug in their urine. At the same time, many patients being treated with other pain drugs in the clinics had OxyContin in their urine, suggesting that “most of the diversion was patient to patient,” Dr. Kell said.

Funding for Dr. Kell's study was provided by UD Testing Inc., a Marco Island, Fla., company that uses Dr. Kell's software to monitor patient compliance with prescription medicine.

Another study presented at the meeting described very preliminary results from a novel oxycodone drug formulation called Remoxy. The formulation delivers a long-acting dose of the opiate in a gel cap designed to be impervious to efforts to extract the full dose to achieve a “spike” effect by crushing, freezing, heating, or dissolving it in various substances. Current formulations of the drug can be manipulated in this way, adding to abuse and diversion.

Plasma concentrations were markedly lower in 20 subjects who took Remoxy after it had been tampered with, compared with concentrations among people who had taken crushed controlled-release formulations of oxycodone.

The industry-designed study was funded by Pain Therapeutics Inc. of San Francisco.

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