Miriam E. Tucker

ST. LOUIS – Sleep apnea assessment and treatment should be considered an integral part of diabetes management, Susan M. LaRue, R.D., said at the annual meeting of the American Association of Diabetes Educators.

“Sleep apnea is highly prevalent in people with diabetes, people with hypertension and obesity, all of which we see in huge numbers in our patient population,” said Ms. LaRue, a certified diabetes educator with Amylin Pharmaceuticals.

Because sleep apnea is so common among people with diabetes–concomitant with obesity and hypertension–the Scripps' Whittier Institute for Diabetes, La Jolla, Calif., has instituted a “best practice” in which every patient is screened for OSA.

In a study published by Whittier's Dr. Daniel Einhorn and his associates, 72% of 279 adults with type 2 diabetes were found to have some degree of sleep apnea, defined as an apnea-hypopnea index (AHI) of five events or more per hour. Over a third of the patients (36%) had an AHI of at least 15 events per hour, which was associated with a doubling of the risk for the development of hypertension after adjustment for comorbidities (Endocrine Practice 2007;13:355-62).

That study and the symposium in which Ms. LaRue spoke were both sponsored by the ResMed Corp., which manufactures continuous positive airway pressure (CPAP) devices for treatment of OSA.

Diabetes is among several cardiovascular-related conditions that are strongly associated with OSA. Data suggest that OSA is present in about 80% of individuals with drug-resistant hypertension (35% of all hypertension) and in 50% of those with atrial fibrillation.

The mechanism for the association is not known, but theories focus on the increased sympathetic nervous activity resulting from repeated apneas, said Ms. LaRue, formerly with the Whittier Institute.

Treatment with CPAP not only reduces apneic episodes and improves sleep quality, but also appears to improve the cardiovascular and metabolic abnormalities. In a German study of 60 patients with moderate to severe OSA, those given “therapeutic” levels of CPAP for an average of 9 weeks had a 95% reduction in apneas and hypopneas and a decrease in mean arterial blood pressure of 9.9 mm Hg.

That level of decline would be predicted to reduce coronary heart disease event risk by 37% and stroke risk by 56%, the investigators said (Circulation 2003;107:68-73).

ST. LOUIS – Sleep apnea assessment and treatment should be considered an integral part of diabetes management, Susan M. LaRue, R.D., said at the annual meeting of the American Association of Diabetes Educators.

“Sleep apnea is highly prevalent in people with diabetes, people with hypertension and obesity, all of which we see in huge numbers in our patient population,” said Ms. LaRue, a certified diabetes educator with Amylin Pharmaceuticals.

Because sleep apnea is so common among people with diabetes–concomitant with obesity and hypertension–the Scripps' Whittier Institute for Diabetes, La Jolla, Calif., has instituted a “best practice” in which every patient is screened for OSA.

In a study published by Whittier's Dr. Daniel Einhorn and his associates, 72% of 279 adults with type 2 diabetes were found to have some degree of sleep apnea, defined as an apnea-hypopnea index (AHI) of five events or more per hour. Over a third of the patients (36%) had an AHI of at least 15 events per hour, which was associated with a doubling of the risk for the development of hypertension after adjustment for comorbidities (Endocrine Practice 2007;13:355-62).

That study and the symposium in which Ms. LaRue spoke were both sponsored by the ResMed Corp., which manufactures continuous positive airway pressure (CPAP) devices for treatment of OSA.

Diabetes is among several cardiovascular-related conditions that are strongly associated with OSA. Data suggest that OSA is present in about 80% of individuals with drug-resistant hypertension (35% of all hypertension) and in 50% of those with atrial fibrillation.

The mechanism for the association is not known, but theories focus on the increased sympathetic nervous activity resulting from repeated apneas, said Ms. LaRue, formerly with the Whittier Institute.

Treatment with CPAP not only reduces apneic episodes and improves sleep quality, but also appears to improve the cardiovascular and metabolic abnormalities. In a German study of 60 patients with moderate to severe OSA, those given “therapeutic” levels of CPAP for an average of 9 weeks had a 95% reduction in apneas and hypopneas and a decrease in mean arterial blood pressure of 9.9 mm Hg.

That level of decline would be predicted to reduce coronary heart disease event risk by 37% and stroke risk by 56%, the investigators said (Circulation 2003;107:68-73).

ST. LOUIS – Sleep apnea assessment and treatment should be considered an integral part of diabetes management, Susan M. LaRue, R.D., said at the annual meeting of the American Association of Diabetes Educators.

“Sleep apnea is highly prevalent in people with diabetes, people with hypertension and obesity, all of which we see in huge numbers in our patient population,” said Ms. LaRue, a certified diabetes educator with Amylin Pharmaceuticals.

Because sleep apnea is so common among people with diabetes–concomitant with obesity and hypertension–the Scripps' Whittier Institute for Diabetes, La Jolla, Calif., has instituted a “best practice” in which every patient is screened for OSA.

In a study published by Whittier's Dr. Daniel Einhorn and his associates, 72% of 279 adults with type 2 diabetes were found to have some degree of sleep apnea, defined as an apnea-hypopnea index (AHI) of five events or more per hour. Over a third of the patients (36%) had an AHI of at least 15 events per hour, which was associated with a doubling of the risk for the development of hypertension after adjustment for comorbidities (Endocrine Practice 2007;13:355-62).

That study and the symposium in which Ms. LaRue spoke were both sponsored by the ResMed Corp., which manufactures continuous positive airway pressure (CPAP) devices for treatment of OSA.

Diabetes is among several cardiovascular-related conditions that are strongly associated with OSA. Data suggest that OSA is present in about 80% of individuals with drug-resistant hypertension (35% of all hypertension) and in 50% of those with atrial fibrillation.

The mechanism for the association is not known, but theories focus on the increased sympathetic nervous activity resulting from repeated apneas, said Ms. LaRue, formerly with the Whittier Institute.

Treatment with CPAP not only reduces apneic episodes and improves sleep quality, but also appears to improve the cardiovascular and metabolic abnormalities. In a German study of 60 patients with moderate to severe OSA, those given “therapeutic” levels of CPAP for an average of 9 weeks had a 95% reduction in apneas and hypopneas and a decrease in mean arterial blood pressure of 9.9 mm Hg.

That level of decline would be predicted to reduce coronary heart disease event risk by 37% and stroke risk by 56%, the investigators said (Circulation 2003;107:68-73).

PITTSBURGH – Financial incentives for smoking cessation offered by employers in large workplace settings succeed in getting employees to quit, the findings from a government-funded study suggest.

The subject is controversial. Two 2005 Cochrane reviews concluded that the evidence did not support the efficacy of incentives–including financial ones–in persuading people to quit smoking in workplace settings or elsewhere (Cochrane Database Syst. Rev. 2005; [doi:10.1002/14651858.CD004307 and doi:10.1002/14651858.CD003440]).

But according to Dr. Kevin G. Volpp, most of the studies examined were underpowered and/or offered insufficient incentives–in some cases as little as $10. “The Cochrane review should have concluded that the things that have been tried to date haven't worked, not that this can't work if properly tested,” Dr. Volpp of the University of Pennsylvania, Philadelphia, said at the annual meeting of the Society of General Internal Medicine.

He is the principal investigator for a randomized, controlled study funded by the Centers for Disease Control and Prevention in which 878 regular smokers (five or more cigarettes/day) employed by General Electric Co. received information about local community-based smoking cessation resources and coverage of prescription drugs and physician visits for smoking cessation. Of those, 436 were randomized also to be offered the incentives of $100 for completing a smoking cessation program, another $250 for quitting smoking by either the 3rd or 6th month after study enrollment, and another $400 for continuous abstinence between the 6- and 12-month follow-up visits. Cotinine tests were done at each visit to verify abstinence.

During the first 6 months, 9% of the incentive group completed smoking cessation programs, compared with just 1% of the controls, a highly significant difference. Quit rates in the first 6 months also were significantly higher for those offered incentives, 23% vs. 13%. The proportions of the two groups that had quit by 12 months, the study's primary end point, were 15% and 6.5%, respectively, again a highly significant difference. Moreover, the relapse rate between 6 and 12 months was significantly lower for the incentive group than for the controls, most likely because the largest dollar amount was offered for the 12-month end point, Dr. Volpp said.

The success of the intervention appeared to be influenced partly by the incentive to enroll in a smoking cessation program. Among all study participants who completed such programs, quit rates at 12 months were 47% for the incentive group and 15% for the controls. Among those who did not participate in a program, 9.5% and 6%, respectively, remained abstinent at 12 months. However, though getting people to enroll in programs did appear to help, most of the subjects who quit did not participate in them, Dr. Volpp said.

The incentives appeared effective regardless of the number of times the employee had tried to quit in the past. The incentives also were at least somewhat effective in those who smoked two packs or more per day, although those numbers–2 of 22 such smokers who received incentives had quit at 12 months, compared with 0 of 20 controls–were too small to be of significance.

The next step in the study is to visit the employees again at 15 and 18 months to see what proportion remains abstinent in the absence of financial reward. The investigators also plan to evaluate the cost-effectiveness of undertaking such an initiative in employer-based settings.

During the question-and-answer period, Dr. Volpp noted that employers might derive even more benefit than would insurance companies from inducing employees to quit: The benefit to insurers would come strictly from lowered health care costs, but employers also could see gains in productivity because employees wouldn't be leaving the building to take smoking breaks during working hours.

ELSEVIER GLOBAL MEDICAL NEWS

PITTSBURGH – Financial incentives for smoking cessation offered by employers in large workplace settings succeed in getting employees to quit, the findings from a government-funded study suggest.

The subject is controversial. Two 2005 Cochrane reviews concluded that the evidence did not support the efficacy of incentives–including financial ones–in persuading people to quit smoking in workplace settings or elsewhere (Cochrane Database Syst. Rev. 2005; [doi:10.1002/14651858.CD004307 and doi:10.1002/14651858.CD003440]).

But according to Dr. Kevin G. Volpp, most of the studies examined were underpowered and/or offered insufficient incentives–in some cases as little as $10. “The Cochrane review should have concluded that the things that have been tried to date haven't worked, not that this can't work if properly tested,” Dr. Volpp of the University of Pennsylvania, Philadelphia, said at the annual meeting of the Society of General Internal Medicine.

He is the principal investigator for a randomized, controlled study funded by the Centers for Disease Control and Prevention in which 878 regular smokers (five or more cigarettes/day) employed by General Electric Co. received information about local community-based smoking cessation resources and coverage of prescription drugs and physician visits for smoking cessation. Of those, 436 were randomized also to be offered the incentives of $100 for completing a smoking cessation program, another $250 for quitting smoking by either the 3rd or 6th month after study enrollment, and another $400 for continuous abstinence between the 6- and 12-month follow-up visits. Cotinine tests were done at each visit to verify abstinence.

During the first 6 months, 9% of the incentive group completed smoking cessation programs, compared with just 1% of the controls, a highly significant difference. Quit rates in the first 6 months also were significantly higher for those offered incentives, 23% vs. 13%. The proportions of the two groups that had quit by 12 months, the study's primary end point, were 15% and 6.5%, respectively, again a highly significant difference. Moreover, the relapse rate between 6 and 12 months was significantly lower for the incentive group than for the controls, most likely because the largest dollar amount was offered for the 12-month end point, Dr. Volpp said.

The success of the intervention appeared to be influenced partly by the incentive to enroll in a smoking cessation program. Among all study participants who completed such programs, quit rates at 12 months were 47% for the incentive group and 15% for the controls. Among those who did not participate in a program, 9.5% and 6%, respectively, remained abstinent at 12 months. However, though getting people to enroll in programs did appear to help, most of the subjects who quit did not participate in them, Dr. Volpp said.

The incentives appeared effective regardless of the number of times the employee had tried to quit in the past. The incentives also were at least somewhat effective in those who smoked two packs or more per day, although those numbers–2 of 22 such smokers who received incentives had quit at 12 months, compared with 0 of 20 controls–were too small to be of significance.

The next step in the study is to visit the employees again at 15 and 18 months to see what proportion remains abstinent in the absence of financial reward. The investigators also plan to evaluate the cost-effectiveness of undertaking such an initiative in employer-based settings.

During the question-and-answer period, Dr. Volpp noted that employers might derive even more benefit than would insurance companies from inducing employees to quit: The benefit to insurers would come strictly from lowered health care costs, but employers also could see gains in productivity because employees wouldn't be leaving the building to take smoking breaks during working hours.

ELSEVIER GLOBAL MEDICAL NEWS

PITTSBURGH – Financial incentives for smoking cessation offered by employers in large workplace settings succeed in getting employees to quit, the findings from a government-funded study suggest.

The subject is controversial. Two 2005 Cochrane reviews concluded that the evidence did not support the efficacy of incentives–including financial ones–in persuading people to quit smoking in workplace settings or elsewhere (Cochrane Database Syst. Rev. 2005; [doi:10.1002/14651858.CD004307 and doi:10.1002/14651858.CD003440]).

But according to Dr. Kevin G. Volpp, most of the studies examined were underpowered and/or offered insufficient incentives–in some cases as little as $10. “The Cochrane review should have concluded that the things that have been tried to date haven't worked, not that this can't work if properly tested,” Dr. Volpp of the University of Pennsylvania, Philadelphia, said at the annual meeting of the Society of General Internal Medicine.

He is the principal investigator for a randomized, controlled study funded by the Centers for Disease Control and Prevention in which 878 regular smokers (five or more cigarettes/day) employed by General Electric Co. received information about local community-based smoking cessation resources and coverage of prescription drugs and physician visits for smoking cessation. Of those, 436 were randomized also to be offered the incentives of $100 for completing a smoking cessation program, another $250 for quitting smoking by either the 3rd or 6th month after study enrollment, and another $400 for continuous abstinence between the 6- and 12-month follow-up visits. Cotinine tests were done at each visit to verify abstinence.

During the first 6 months, 9% of the incentive group completed smoking cessation programs, compared with just 1% of the controls, a highly significant difference. Quit rates in the first 6 months also were significantly higher for those offered incentives, 23% vs. 13%. The proportions of the two groups that had quit by 12 months, the study's primary end point, were 15% and 6.5%, respectively, again a highly significant difference. Moreover, the relapse rate between 6 and 12 months was significantly lower for the incentive group than for the controls, most likely because the largest dollar amount was offered for the 12-month end point, Dr. Volpp said.

The success of the intervention appeared to be influenced partly by the incentive to enroll in a smoking cessation program. Among all study participants who completed such programs, quit rates at 12 months were 47% for the incentive group and 15% for the controls. Among those who did not participate in a program, 9.5% and 6%, respectively, remained abstinent at 12 months. However, though getting people to enroll in programs did appear to help, most of the subjects who quit did not participate in them, Dr. Volpp said.

The incentives appeared effective regardless of the number of times the employee had tried to quit in the past. The incentives also were at least somewhat effective in those who smoked two packs or more per day, although those numbers–2 of 22 such smokers who received incentives had quit at 12 months, compared with 0 of 20 controls–were too small to be of significance.

The next step in the study is to visit the employees again at 15 and 18 months to see what proportion remains abstinent in the absence of financial reward. The investigators also plan to evaluate the cost-effectiveness of undertaking such an initiative in employer-based settings.

During the question-and-answer period, Dr. Volpp noted that employers might derive even more benefit than would insurance companies from inducing employees to quit: The benefit to insurers would come strictly from lowered health care costs, but employers also could see gains in productivity because employees wouldn't be leaving the building to take smoking breaks during working hours.

ELSEVIER GLOBAL MEDICAL NEWS

PITTSBURGH – Among medically ill smokers, a combination of the nicotine patch, a nicotine inhaler, and bupropion significantly increased smoking cessation rates at 26 weeks compared with the nicotine patch alone and did not result in serious adverse events.

In a randomized trial of 127 medically ill smokers, 35% of those given the combination therapy and 19% of those given the patch alone continued to be cigarette abstinent at 26 weeks. Participants' diagnoses included cancer, cardiovascular disease, and diabetes.

The combination therapy was associated with more reports of adverse effects, but these were not serious effects nor did they prompt participants to quit therapy at higher rates. Study quit rates were 6% in both groups.

About 50% of medically ill smokers continue to smoke after their diagnosis, said Dr. Michael B. Steinberg, who presented the findings at the annual meeting of the Society of General Internal Medicine. Yet this patient group is typically excluded from clinical trials evaluating smoking cessation medications. Further, there is a perceived but unsubstantiated belief that smoking cessation agents may be harmful to patients with chronic conditions.

Moreover, the labeling of over-the-counter nicotine replacement products advises against combining them with other cessation medications and specifies a standard 8- to 12-week duration of treatment, said Dr. Steinberg of the Robert Wood Johnson Medical School, New Brunswick, N.J. Previous observational data from his group's tobacco dependence program have shown increased abstinence rates with the use of medication combinations for longer durations (Prev. Med. 2006;42:114-9).

The current study is the first-ever randomized trial to evaluate a three-medication combination for extended duration in medically ill smokers, according to Dr. Steinberg.

The study was funded by the Cancer Institute of New Jersey and the Robert Wood Johnson Foundation-Physician Faculty Scholars Program. Dr. Steinberg disclosed that he has received research grant and consultancy funds from Pfizer Inc.

The intervention combined both passive (the 21-mg/day patch) with active (inhaler) nicotine replacement, along with 150 mg/day bupropion sustained release (SR). The 63 patients randomized to the intervention group were instructed to continue using all three medications as long as they needed, until they were able to go 14 days without cravings or withdrawal symptoms.

The 64 controls were randomized to nicotine patch alone, with the usual 10-week taper: 21 mg/day for 6 weeks, then 14 mg/day for 2 weeks, 7 mg/day for another 2 weeks, then discontinuation. Both groups also were given an American Heart Association brochure about smoking cessation, but no other behavioral therapy.

The two groups were similar in mean age (49 years, ranging from 22 to 86 years), percentage of females (65%), and ethnicity (61% white, 32% black, and 6% Hispanic). Medical conditions included cancer in 13%, cardiovascular disease in 24%, chronic obstructive pulmonary disease in 24%, diabetes in 16%, hypertension in 39%, and depression in 36%.

At baseline, participants smoked a mean of 21 cigarettes per day and had tried to quit an average of 12 times.

At 4 weeks, abstinence rates–verified by a measured expired carbon monoxide level less than 10 ppm–were 62% for those given the triple combination and 47% for those on the patch alone.

At 26 weeks, 35% of the combination patients and 19% of the controls were still abstinent. That difference was statistically significant, with an odds ratio of 2.33 (P = .04).

People in the combination therapy group were more likely to stick with their treatment. Mean duration of treatment was 89 days for the combination group and 35 days for the patch only group.

The mean time to relapse was 96 days after the target quit date for the combination group, compared with 59 days for the patch alone, with a hazard ratio of 0.55 (P = .006).

This was an intention-to-treat analysis in which the smokers who were lost to follow-up were counted as continued smokers. Approximately 24% of each group were lost to follow-up by 26 weeks, he noted.

Similar to other studies, time to the first cigarette of the day predicted abstinence rates at 6 months, which were 33% in those who waited longer than 30 minutes and 19% in those who waited less than 5 minutes.

Adverse events that occurred significantly more often in the combination group were insomnia (25% vs. 9%), anxiety (22% vs. 3%), fatigue (22% vs. 3%), and diarrhea (13% vs. 2%). Dream disturbance and rash occurred in about a third of the combination group and a quarter of the patch group. In both groups, 6% of patients discontinued because of adverse events.

PITTSBURGH – Among medically ill smokers, a combination of the nicotine patch, a nicotine inhaler, and bupropion significantly increased smoking cessation rates at 26 weeks compared with the nicotine patch alone and did not result in serious adverse events.

In a randomized trial of 127 medically ill smokers, 35% of those given the combination therapy and 19% of those given the patch alone continued to be cigarette abstinent at 26 weeks. Participants' diagnoses included cancer, cardiovascular disease, and diabetes.

The combination therapy was associated with more reports of adverse effects, but these were not serious effects nor did they prompt participants to quit therapy at higher rates. Study quit rates were 6% in both groups.

About 50% of medically ill smokers continue to smoke after their diagnosis, said Dr. Michael B. Steinberg, who presented the findings at the annual meeting of the Society of General Internal Medicine. Yet this patient group is typically excluded from clinical trials evaluating smoking cessation medications. Further, there is a perceived but unsubstantiated belief that smoking cessation agents may be harmful to patients with chronic conditions.

Moreover, the labeling of over-the-counter nicotine replacement products advises against combining them with other cessation medications and specifies a standard 8- to 12-week duration of treatment, said Dr. Steinberg of the Robert Wood Johnson Medical School, New Brunswick, N.J. Previous observational data from his group's tobacco dependence program have shown increased abstinence rates with the use of medication combinations for longer durations (Prev. Med. 2006;42:114-9).

The current study is the first-ever randomized trial to evaluate a three-medication combination for extended duration in medically ill smokers, according to Dr. Steinberg.

The study was funded by the Cancer Institute of New Jersey and the Robert Wood Johnson Foundation-Physician Faculty Scholars Program. Dr. Steinberg disclosed that he has received research grant and consultancy funds from Pfizer Inc.

The intervention combined both passive (the 21-mg/day patch) with active (inhaler) nicotine replacement, along with 150 mg/day bupropion sustained release (SR). The 63 patients randomized to the intervention group were instructed to continue using all three medications as long as they needed, until they were able to go 14 days without cravings or withdrawal symptoms.

The 64 controls were randomized to nicotine patch alone, with the usual 10-week taper: 21 mg/day for 6 weeks, then 14 mg/day for 2 weeks, 7 mg/day for another 2 weeks, then discontinuation. Both groups also were given an American Heart Association brochure about smoking cessation, but no other behavioral therapy.

The two groups were similar in mean age (49 years, ranging from 22 to 86 years), percentage of females (65%), and ethnicity (61% white, 32% black, and 6% Hispanic). Medical conditions included cancer in 13%, cardiovascular disease in 24%, chronic obstructive pulmonary disease in 24%, diabetes in 16%, hypertension in 39%, and depression in 36%.

At baseline, participants smoked a mean of 21 cigarettes per day and had tried to quit an average of 12 times.

At 4 weeks, abstinence rates–verified by a measured expired carbon monoxide level less than 10 ppm–were 62% for those given the triple combination and 47% for those on the patch alone.

At 26 weeks, 35% of the combination patients and 19% of the controls were still abstinent. That difference was statistically significant, with an odds ratio of 2.33 (P = .04).

People in the combination therapy group were more likely to stick with their treatment. Mean duration of treatment was 89 days for the combination group and 35 days for the patch only group.

The mean time to relapse was 96 days after the target quit date for the combination group, compared with 59 days for the patch alone, with a hazard ratio of 0.55 (P = .006).

This was an intention-to-treat analysis in which the smokers who were lost to follow-up were counted as continued smokers. Approximately 24% of each group were lost to follow-up by 26 weeks, he noted.

Similar to other studies, time to the first cigarette of the day predicted abstinence rates at 6 months, which were 33% in those who waited longer than 30 minutes and 19% in those who waited less than 5 minutes.

Adverse events that occurred significantly more often in the combination group were insomnia (25% vs. 9%), anxiety (22% vs. 3%), fatigue (22% vs. 3%), and diarrhea (13% vs. 2%). Dream disturbance and rash occurred in about a third of the combination group and a quarter of the patch group. In both groups, 6% of patients discontinued because of adverse events.

PITTSBURGH – Among medically ill smokers, a combination of the nicotine patch, a nicotine inhaler, and bupropion significantly increased smoking cessation rates at 26 weeks compared with the nicotine patch alone and did not result in serious adverse events.

In a randomized trial of 127 medically ill smokers, 35% of those given the combination therapy and 19% of those given the patch alone continued to be cigarette abstinent at 26 weeks. Participants' diagnoses included cancer, cardiovascular disease, and diabetes.

The combination therapy was associated with more reports of adverse effects, but these were not serious effects nor did they prompt participants to quit therapy at higher rates. Study quit rates were 6% in both groups.

About 50% of medically ill smokers continue to smoke after their diagnosis, said Dr. Michael B. Steinberg, who presented the findings at the annual meeting of the Society of General Internal Medicine. Yet this patient group is typically excluded from clinical trials evaluating smoking cessation medications. Further, there is a perceived but unsubstantiated belief that smoking cessation agents may be harmful to patients with chronic conditions.

Moreover, the labeling of over-the-counter nicotine replacement products advises against combining them with other cessation medications and specifies a standard 8- to 12-week duration of treatment, said Dr. Steinberg of the Robert Wood Johnson Medical School, New Brunswick, N.J. Previous observational data from his group's tobacco dependence program have shown increased abstinence rates with the use of medication combinations for longer durations (Prev. Med. 2006;42:114-9).

The current study is the first-ever randomized trial to evaluate a three-medication combination for extended duration in medically ill smokers, according to Dr. Steinberg.

The study was funded by the Cancer Institute of New Jersey and the Robert Wood Johnson Foundation-Physician Faculty Scholars Program. Dr. Steinberg disclosed that he has received research grant and consultancy funds from Pfizer Inc.

The intervention combined both passive (the 21-mg/day patch) with active (inhaler) nicotine replacement, along with 150 mg/day bupropion sustained release (SR). The 63 patients randomized to the intervention group were instructed to continue using all three medications as long as they needed, until they were able to go 14 days without cravings or withdrawal symptoms.

The 64 controls were randomized to nicotine patch alone, with the usual 10-week taper: 21 mg/day for 6 weeks, then 14 mg/day for 2 weeks, 7 mg/day for another 2 weeks, then discontinuation. Both groups also were given an American Heart Association brochure about smoking cessation, but no other behavioral therapy.

The two groups were similar in mean age (49 years, ranging from 22 to 86 years), percentage of females (65%), and ethnicity (61% white, 32% black, and 6% Hispanic). Medical conditions included cancer in 13%, cardiovascular disease in 24%, chronic obstructive pulmonary disease in 24%, diabetes in 16%, hypertension in 39%, and depression in 36%.

At baseline, participants smoked a mean of 21 cigarettes per day and had tried to quit an average of 12 times.

At 4 weeks, abstinence rates–verified by a measured expired carbon monoxide level less than 10 ppm–were 62% for those given the triple combination and 47% for those on the patch alone.

At 26 weeks, 35% of the combination patients and 19% of the controls were still abstinent. That difference was statistically significant, with an odds ratio of 2.33 (P = .04).

People in the combination therapy group were more likely to stick with their treatment. Mean duration of treatment was 89 days for the combination group and 35 days for the patch only group.

The mean time to relapse was 96 days after the target quit date for the combination group, compared with 59 days for the patch alone, with a hazard ratio of 0.55 (P = .006).

This was an intention-to-treat analysis in which the smokers who were lost to follow-up were counted as continued smokers. Approximately 24% of each group were lost to follow-up by 26 weeks, he noted.

Similar to other studies, time to the first cigarette of the day predicted abstinence rates at 6 months, which were 33% in those who waited longer than 30 minutes and 19% in those who waited less than 5 minutes.

Adverse events that occurred significantly more often in the combination group were insomnia (25% vs. 9%), anxiety (22% vs. 3%), fatigue (22% vs. 3%), and diarrhea (13% vs. 2%). Dream disturbance and rash occurred in about a third of the combination group and a quarter of the patch group. In both groups, 6% of patients discontinued because of adverse events.

PITTSBURGH — The initiation of public reporting and pay-for-performance measures, designed as incentives to improve the quality of care at hospitals, may actually have the opposite effect on those institutions that serve lower-income populations.

That conclusion was based on an analysis of performance data on acute myocardial infarction, heart failure, and pneumonia from approximately 3,600 hospitals in the Web site www.hospitalcompare.com

These so-called safety net hospitals were generally in worse financial condition at baseline, and therefore would have fewer resources to invest in quality improvement. As a result, they could receive lower bonus payments and possibly even incur penalties for not meeting quality improvement standards. "There is concern that reporting and pay for performance could set up a system where rich hospitals become richer and poor hospitals become poorer," said Dr. Werner of the Center for Health Equity Research and Promotion at the Philadelphia Veterans Affairs Medical Center.

After controlling for baseline hospital performance and other variables, investigators found that the percentage point improvements from 2004 through 2006 for the hospitals with the highest quartile of Medicaid population (mean, 40%) were 2.3 for composite measures of acute MI, 6.6 for heart failure, and 8.0 for pneumonia, compared with 3.8, 8.0, and 9.3, respectively, for the hospitals in the lowest quartile (mean, 5%).

As a result of these differences, the safety-net hospitals end up with a far lower probability of ranking among the top two deciles for clinical quality scores, designations that earn hospitals bonus incentive payments in the CMS pay-for-performance demonstration: The top decile of participating hospitals receives 2% of the Diagnosis-Related Group (DRG)-based prospective payment for patients with the measured condition for all Medicare fee-for-service beneficiaries. Hospitals in the second decile receive 1% of the payment amount (www.cms.hhs.gov/Hospital

A nationwide simulation of the CMS demonstration showed that not only would the safety-net hospitals suffer because of lower bonus payments, but they would also be financially penalized to a greater extent. If the CMS demonstration were instituted at all hospitals, the result could be substantially smaller payments for the safety-net hospitals, concluded Dr. Werner, who is also with the division of general internal medicine at the University of Pennsylvania, Philadelphia.

The study was funded by a Career Development Award from the Health Services Research and Development Service of the Department of Veterans Affairs.

PITTSBURGH — The initiation of public reporting and pay-for-performance measures, designed as incentives to improve the quality of care at hospitals, may actually have the opposite effect on those institutions that serve lower-income populations.

That conclusion was based on an analysis of performance data on acute myocardial infarction, heart failure, and pneumonia from approximately 3,600 hospitals in the Web site www.hospitalcompare.com

These so-called safety net hospitals were generally in worse financial condition at baseline, and therefore would have fewer resources to invest in quality improvement. As a result, they could receive lower bonus payments and possibly even incur penalties for not meeting quality improvement standards. "There is concern that reporting and pay for performance could set up a system where rich hospitals become richer and poor hospitals become poorer," said Dr. Werner of the Center for Health Equity Research and Promotion at the Philadelphia Veterans Affairs Medical Center.

After controlling for baseline hospital performance and other variables, investigators found that the percentage point improvements from 2004 through 2006 for the hospitals with the highest quartile of Medicaid population (mean, 40%) were 2.3 for composite measures of acute MI, 6.6 for heart failure, and 8.0 for pneumonia, compared with 3.8, 8.0, and 9.3, respectively, for the hospitals in the lowest quartile (mean, 5%).

As a result of these differences, the safety-net hospitals end up with a far lower probability of ranking among the top two deciles for clinical quality scores, designations that earn hospitals bonus incentive payments in the CMS pay-for-performance demonstration: The top decile of participating hospitals receives 2% of the Diagnosis-Related Group (DRG)-based prospective payment for patients with the measured condition for all Medicare fee-for-service beneficiaries. Hospitals in the second decile receive 1% of the payment amount (www.cms.hhs.gov/Hospital

A nationwide simulation of the CMS demonstration showed that not only would the safety-net hospitals suffer because of lower bonus payments, but they would also be financially penalized to a greater extent. If the CMS demonstration were instituted at all hospitals, the result could be substantially smaller payments for the safety-net hospitals, concluded Dr. Werner, who is also with the division of general internal medicine at the University of Pennsylvania, Philadelphia.

The study was funded by a Career Development Award from the Health Services Research and Development Service of the Department of Veterans Affairs.

PITTSBURGH — The initiation of public reporting and pay-for-performance measures, designed as incentives to improve the quality of care at hospitals, may actually have the opposite effect on those institutions that serve lower-income populations.

That conclusion was based on an analysis of performance data on acute myocardial infarction, heart failure, and pneumonia from approximately 3,600 hospitals in the Web site www.hospitalcompare.com

These so-called safety net hospitals were generally in worse financial condition at baseline, and therefore would have fewer resources to invest in quality improvement. As a result, they could receive lower bonus payments and possibly even incur penalties for not meeting quality improvement standards. "There is concern that reporting and pay for performance could set up a system where rich hospitals become richer and poor hospitals become poorer," said Dr. Werner of the Center for Health Equity Research and Promotion at the Philadelphia Veterans Affairs Medical Center.

After controlling for baseline hospital performance and other variables, investigators found that the percentage point improvements from 2004 through 2006 for the hospitals with the highest quartile of Medicaid population (mean, 40%) were 2.3 for composite measures of acute MI, 6.6 for heart failure, and 8.0 for pneumonia, compared with 3.8, 8.0, and 9.3, respectively, for the hospitals in the lowest quartile (mean, 5%).

As a result of these differences, the safety-net hospitals end up with a far lower probability of ranking among the top two deciles for clinical quality scores, designations that earn hospitals bonus incentive payments in the CMS pay-for-performance demonstration: The top decile of participating hospitals receives 2% of the Diagnosis-Related Group (DRG)-based prospective payment for patients with the measured condition for all Medicare fee-for-service beneficiaries. Hospitals in the second decile receive 1% of the payment amount (www.cms.hhs.gov/Hospital

A nationwide simulation of the CMS demonstration showed that not only would the safety-net hospitals suffer because of lower bonus payments, but they would also be financially penalized to a greater extent. If the CMS demonstration were instituted at all hospitals, the result could be substantially smaller payments for the safety-net hospitals, concluded Dr. Werner, who is also with the division of general internal medicine at the University of Pennsylvania, Philadelphia.

The study was funded by a Career Development Award from the Health Services Research and Development Service of the Department of Veterans Affairs.

PITTSBURGH — An interdisciplinary medication-reconciliation intervention conducted over 2 months at two Boston-area hospitals was associated with a substantial decrease in the number of unintentional medication discrepancies with potential for causing patient harm.

Unintentional medication discrepancies that occur between preadmission and admission or at patient discharge are a major cause of potential adverse drug events (PADEs). To reduce the risk of PADEs at times of patient transition into and out of hospitals and other care settings, the Joint Commission called for all institutions to implement medication-reconciliation programs beginning in January 2006 as one of its National Patient Safety Goals (www.jcipatientsafety.org/14711

Yet little information is available regarding what programs are most likely to be successful, how best to implement these systems, and which patients are most likely to benefit from them, Dr. Jeffrey L. Schnipper said at the annual meeting of the Society of General Internal Medicine.

Dr. Schnipper of Brigham and Women's Hospital, Boston, and his associates conducted a randomized, controlled trial of one such program on general medical units at two academic medical centers. The intervention consisted of a Web application called a preadmission medication list (PAML) builder, along with a "process redesign," which involved restructuring the way that physicians, nurses, and pharmacists enter patient medication notes into charts.

On admission, the ordering physician took a comprehensive medication history, input the initial PAML, and laid out a plan for the patient's medication during hospitalization. The nurse confirmed the accuracy of the instructions and let the physician know if there were any errors. The pharmacist reconciled the PAML with the physicians' admission orders and also checked for errors.

During the patient's hospital stay, the physician, nurse, and pharmacist worked together as a team to update the orders as needed. At discharge, the physician reviewed the PAML and current medications and created a set of discharge orders, while the nurse and pharmacist again contributed to the process.

Study pharmacists took "gold standard" medication histories using all available resources and those results were compared with the PAML and the admission and discharge orders. If any discrepancies were found, the study pharmacist would seek out the reason for it. Two blinded physician adjudicators then evaluated each error and its potential for harm.

A total of 162 patients were randomized to the intervention floor/team, while 160 patients received the usual care on other floors with other teams. About two-thirds of the patients were judged subjectively by the pharmacist at the time of admission to have low to medium understanding of their own medications, Dr. Schnipper said.

The number of PADEs per patient differed significantly between the two groups, with 1.44 per control patient versus 1.05 per intervention patient. The number of patients needed to treat to prevent one PADE was just 2.6, "not a lot of patients," Dr. Schnipper noted. The intervention was associated with a greater reduction in PADEs at discharge than in PADEs at admission. Despite the intervention's success, there was still an average of one PADE per patient, he said.

PITTSBURGH — An interdisciplinary medication-reconciliation intervention conducted over 2 months at two Boston-area hospitals was associated with a substantial decrease in the number of unintentional medication discrepancies with potential for causing patient harm.

Unintentional medication discrepancies that occur between preadmission and admission or at patient discharge are a major cause of potential adverse drug events (PADEs). To reduce the risk of PADEs at times of patient transition into and out of hospitals and other care settings, the Joint Commission called for all institutions to implement medication-reconciliation programs beginning in January 2006 as one of its National Patient Safety Goals (www.jcipatientsafety.org/14711

Yet little information is available regarding what programs are most likely to be successful, how best to implement these systems, and which patients are most likely to benefit from them, Dr. Jeffrey L. Schnipper said at the annual meeting of the Society of General Internal Medicine.

Dr. Schnipper of Brigham and Women's Hospital, Boston, and his associates conducted a randomized, controlled trial of one such program on general medical units at two academic medical centers. The intervention consisted of a Web application called a preadmission medication list (PAML) builder, along with a "process redesign," which involved restructuring the way that physicians, nurses, and pharmacists enter patient medication notes into charts.

On admission, the ordering physician took a comprehensive medication history, input the initial PAML, and laid out a plan for the patient's medication during hospitalization. The nurse confirmed the accuracy of the instructions and let the physician know if there were any errors. The pharmacist reconciled the PAML with the physicians' admission orders and also checked for errors.

During the patient's hospital stay, the physician, nurse, and pharmacist worked together as a team to update the orders as needed. At discharge, the physician reviewed the PAML and current medications and created a set of discharge orders, while the nurse and pharmacist again contributed to the process.

Study pharmacists took "gold standard" medication histories using all available resources and those results were compared with the PAML and the admission and discharge orders. If any discrepancies were found, the study pharmacist would seek out the reason for it. Two blinded physician adjudicators then evaluated each error and its potential for harm.

A total of 162 patients were randomized to the intervention floor/team, while 160 patients received the usual care on other floors with other teams. About two-thirds of the patients were judged subjectively by the pharmacist at the time of admission to have low to medium understanding of their own medications, Dr. Schnipper said.

The number of PADEs per patient differed significantly between the two groups, with 1.44 per control patient versus 1.05 per intervention patient. The number of patients needed to treat to prevent one PADE was just 2.6, "not a lot of patients," Dr. Schnipper noted. The intervention was associated with a greater reduction in PADEs at discharge than in PADEs at admission. Despite the intervention's success, there was still an average of one PADE per patient, he said.

PITTSBURGH — An interdisciplinary medication-reconciliation intervention conducted over 2 months at two Boston-area hospitals was associated with a substantial decrease in the number of unintentional medication discrepancies with potential for causing patient harm.

Unintentional medication discrepancies that occur between preadmission and admission or at patient discharge are a major cause of potential adverse drug events (PADEs). To reduce the risk of PADEs at times of patient transition into and out of hospitals and other care settings, the Joint Commission called for all institutions to implement medication-reconciliation programs beginning in January 2006 as one of its National Patient Safety Goals (www.jcipatientsafety.org/14711

Yet little information is available regarding what programs are most likely to be successful, how best to implement these systems, and which patients are most likely to benefit from them, Dr. Jeffrey L. Schnipper said at the annual meeting of the Society of General Internal Medicine.

Dr. Schnipper of Brigham and Women's Hospital, Boston, and his associates conducted a randomized, controlled trial of one such program on general medical units at two academic medical centers. The intervention consisted of a Web application called a preadmission medication list (PAML) builder, along with a "process redesign," which involved restructuring the way that physicians, nurses, and pharmacists enter patient medication notes into charts.

On admission, the ordering physician took a comprehensive medication history, input the initial PAML, and laid out a plan for the patient's medication during hospitalization. The nurse confirmed the accuracy of the instructions and let the physician know if there were any errors. The pharmacist reconciled the PAML with the physicians' admission orders and also checked for errors.

During the patient's hospital stay, the physician, nurse, and pharmacist worked together as a team to update the orders as needed. At discharge, the physician reviewed the PAML and current medications and created a set of discharge orders, while the nurse and pharmacist again contributed to the process.

Study pharmacists took "gold standard" medication histories using all available resources and those results were compared with the PAML and the admission and discharge orders. If any discrepancies were found, the study pharmacist would seek out the reason for it. Two blinded physician adjudicators then evaluated each error and its potential for harm.

A total of 162 patients were randomized to the intervention floor/team, while 160 patients received the usual care on other floors with other teams. About two-thirds of the patients were judged subjectively by the pharmacist at the time of admission to have low to medium understanding of their own medications, Dr. Schnipper said.

The number of PADEs per patient differed significantly between the two groups, with 1.44 per control patient versus 1.05 per intervention patient. The number of patients needed to treat to prevent one PADE was just 2.6, "not a lot of patients," Dr. Schnipper noted. The intervention was associated with a greater reduction in PADEs at discharge than in PADEs at admission. Despite the intervention's success, there was still an average of one PADE per patient, he said.

PITTSBURGH — Financial incentives for smoking cessation offered by employers in large workplace settings succeed in getting employees to quit, the findings from a government-funded study suggest.

The subject is controversial. Two 2005 Cochrane reviews concluded that the evidence did not support the efficacy of incentives in convincing people to quit smoking (Cochrane Database Syst. Rev. 2005; [doi:10.1002/14651858.CD004307 and doi:10.1002/14651858.CD003440]).

But, according to Dr. Kevin G. Volpp, most of the studies examined were underpowered and/or offered insufficient incentives—in some cases as little as $10.

Dr. Volpp, of the University of Pennsylvania, Philadelphia, reported on a randomized, controlled study funded by the Centers for Disease Control and Prevention in which 878 regular smokers (five or more cigarettes/day) employed by General Electric Co. received information about community-based smoking cessation resources and coverage of prescription drugs and physician visits for smoking cessation.

Of those, 436 were randomized also to be offered the incentives of $100 for completing a smoking cessation program, another $250 for quitting by either the 3rd or 6th month after study enrollment, and another $400 for continuous abstinence between the 6- and 12-month visits. Cotinine tests were done at each visit to verify abstinence.

During the first 6 months, 9% of the incentive group completed smoking cessation programs, compared with just 1% of the controls, a highly significant difference, Dr. Volpp reported at the annual meeting of the Society of General Internal Medicine.

Quit rates in the first 6 months also were significantly higher for those offered incentives, 23% compared with 13%. The proportions of the two groups that had quit by 12 months, the study's primary end point, were 15% and 6.5%, respectively, again a highly significant difference. Moreover, the relapse rate between 6 and 12 months was significantly lower for the incentive group than for the controls, most likely because the largest dollar amount was offered for the 12-month end point.

The success of the intervention appeared to be influenced partially by the incentive to enroll in a smoking cessation program. Among all study participants who completed such programs, quit rates at 12 months were 47% for the incentive group and 15% for the controls. Among those who did not participate in a program, 9.5% and 6%, respectively, remained abstinent at 12 months. However, though getting people to enroll in programs did appear to help, most of the subjects who quit did not participate in them, said Dr. Volpp.

The researchers plan to visit the employees again at 15 and 18 months to see what proportion remains abstinent in the absence of financial reward. They also plan to evaluate the cost-effectiveness of such an initiative in employer-based settings.

Quit rates in the first 6 months were significantly higher for those offered incentives, 23% compared with 13%. DR. VOLPP

Employees who were randomized to receive financial incentives for smoking cessation had higher quit rates and lower relapse rates at 12 months, compared with controls. ©Fotolia VI/

PITTSBURGH — Financial incentives for smoking cessation offered by employers in large workplace settings succeed in getting employees to quit, the findings from a government-funded study suggest.

The subject is controversial. Two 2005 Cochrane reviews concluded that the evidence did not support the efficacy of incentives in convincing people to quit smoking (Cochrane Database Syst. Rev. 2005; [doi:10.1002/14651858.CD004307 and doi:10.1002/14651858.CD003440]).

But, according to Dr. Kevin G. Volpp, most of the studies examined were underpowered and/or offered insufficient incentives—in some cases as little as $10.

Dr. Volpp, of the University of Pennsylvania, Philadelphia, reported on a randomized, controlled study funded by the Centers for Disease Control and Prevention in which 878 regular smokers (five or more cigarettes/day) employed by General Electric Co. received information about community-based smoking cessation resources and coverage of prescription drugs and physician visits for smoking cessation.

Of those, 436 were randomized also to be offered the incentives of $100 for completing a smoking cessation program, another $250 for quitting by either the 3rd or 6th month after study enrollment, and another $400 for continuous abstinence between the 6- and 12-month visits. Cotinine tests were done at each visit to verify abstinence.

During the first 6 months, 9% of the incentive group completed smoking cessation programs, compared with just 1% of the controls, a highly significant difference, Dr. Volpp reported at the annual meeting of the Society of General Internal Medicine.

Quit rates in the first 6 months also were significantly higher for those offered incentives, 23% compared with 13%. The proportions of the two groups that had quit by 12 months, the study's primary end point, were 15% and 6.5%, respectively, again a highly significant difference. Moreover, the relapse rate between 6 and 12 months was significantly lower for the incentive group than for the controls, most likely because the largest dollar amount was offered for the 12-month end point.

The success of the intervention appeared to be influenced partially by the incentive to enroll in a smoking cessation program. Among all study participants who completed such programs, quit rates at 12 months were 47% for the incentive group and 15% for the controls. Among those who did not participate in a program, 9.5% and 6%, respectively, remained abstinent at 12 months. However, though getting people to enroll in programs did appear to help, most of the subjects who quit did not participate in them, said Dr. Volpp.

The researchers plan to visit the employees again at 15 and 18 months to see what proportion remains abstinent in the absence of financial reward. They also plan to evaluate the cost-effectiveness of such an initiative in employer-based settings.

Quit rates in the first 6 months were significantly higher for those offered incentives, 23% compared with 13%. DR. VOLPP

Employees who were randomized to receive financial incentives for smoking cessation had higher quit rates and lower relapse rates at 12 months, compared with controls. ©Fotolia VI/

PITTSBURGH — Financial incentives for smoking cessation offered by employers in large workplace settings succeed in getting employees to quit, the findings from a government-funded study suggest.

The subject is controversial. Two 2005 Cochrane reviews concluded that the evidence did not support the efficacy of incentives in convincing people to quit smoking (Cochrane Database Syst. Rev. 2005; [doi:10.1002/14651858.CD004307 and doi:10.1002/14651858.CD003440]).

But, according to Dr. Kevin G. Volpp, most of the studies examined were underpowered and/or offered insufficient incentives—in some cases as little as $10.

Dr. Volpp, of the University of Pennsylvania, Philadelphia, reported on a randomized, controlled study funded by the Centers for Disease Control and Prevention in which 878 regular smokers (five or more cigarettes/day) employed by General Electric Co. received information about community-based smoking cessation resources and coverage of prescription drugs and physician visits for smoking cessation.

Of those, 436 were randomized also to be offered the incentives of $100 for completing a smoking cessation program, another $250 for quitting by either the 3rd or 6th month after study enrollment, and another $400 for continuous abstinence between the 6- and 12-month visits. Cotinine tests were done at each visit to verify abstinence.

During the first 6 months, 9% of the incentive group completed smoking cessation programs, compared with just 1% of the controls, a highly significant difference, Dr. Volpp reported at the annual meeting of the Society of General Internal Medicine.

Quit rates in the first 6 months also were significantly higher for those offered incentives, 23% compared with 13%. The proportions of the two groups that had quit by 12 months, the study's primary end point, were 15% and 6.5%, respectively, again a highly significant difference. Moreover, the relapse rate between 6 and 12 months was significantly lower for the incentive group than for the controls, most likely because the largest dollar amount was offered for the 12-month end point.

The success of the intervention appeared to be influenced partially by the incentive to enroll in a smoking cessation program. Among all study participants who completed such programs, quit rates at 12 months were 47% for the incentive group and 15% for the controls. Among those who did not participate in a program, 9.5% and 6%, respectively, remained abstinent at 12 months. However, though getting people to enroll in programs did appear to help, most of the subjects who quit did not participate in them, said Dr. Volpp.

The researchers plan to visit the employees again at 15 and 18 months to see what proportion remains abstinent in the absence of financial reward. They also plan to evaluate the cost-effectiveness of such an initiative in employer-based settings.

Quit rates in the first 6 months were significantly higher for those offered incentives, 23% compared with 13%. DR. VOLPP

Employees who were randomized to receive financial incentives for smoking cessation had higher quit rates and lower relapse rates at 12 months, compared with controls. ©Fotolia VI/

PITTSBURGH — The use of antibiotics was associated with a significantly reduced risk of treatment failure for acute exacerbations of chronic obstructive pulmonary disease in the largest-ever study of patients hospitalized for that condition.

Chronic obstructive pulmonary disease (COPD) affects 24 million Americans and is the fourth leading cause of death in the United States. Acute COPD exacerbations are among the top 10 causes of hospitalization of adults in this country. About 50%-60% of acute exacerbations are caused by infections, and current COPD guidelines recommend antibiotic treatment for patients who have severe exacerbations with purulent sputum, even though most of the evidence supporting that practice comes from small, heterogeneous trials that often combined hospitalized and nonhospitalized patients.

Although the routine use of antibiotics does appear beneficial for patients on mechanical ventilation, there is scant published literature that supports their use for other hospitalized patients, Dr. Michael B. Rothberg said at the annual meeting of the Society of General Internal Medicine.

To address the question using a large-enough sample size, Dr. Rothberg and his associates at Baystate Medical Center of Tufts University, Springfield, Mass., conducted a retrospective cohort study of patients hospitalized in 2001 for acute COPD exacerbations at 375 acute care facilities that were part of a large database for measuring quality of care and resource utilization. Included were patients hospitalized for at least 2 days with either a primary diagnosis of COPD or a primary diagnosis of respiratory failure and a secondary diagnosis of COPD; to avoid confusion with asthma, only patients older than 39 years were included.

Patients with direct admission to the intensive care unit also were excluded, as were those who had other bacterial infections for which antibiotics would have been indicated.

Antibiotic treatment was defined as at least 2 consecutive days of an appropriate antibiotic for COPD begun on the first or second day of hospitalization. Treatment failure was defined as either initiation of mechanical ventilation after hospital day 2, in-hospital mortality, or all-cause readmission within 30 days.

Of a total 35,053 patients who met the enrollment criteria, 79% (27,812) had received antibiotics (most commonly quinolones, cephalosporins, or macrolides) and 21% (7,241) had not. Those given antibiotics were significantly younger (median age 70 years vs. 71 years), more likely to be in managed care (20% vs. 19%) and to be white (78% vs. 73%), and less likely to have comorbidities including secondary pulmonary hypertension, sleep apnea, alcohol abuse, renal failure, and heart failure. The proportions with comorbid diabetes and solid tumors did not differ significantly. (Because the database was so large, even seemingly small differences often reached statistical significance, Dr. Rothberg noted.)

Patients who received antibiotics appeared to have more severe disease, based on the tests and other treatments they were given. Significantly more of the patients treated with antibiotics had been given steroids (87% vs. 74%), an arterial blood gas measurement (58% vs. 53%), sputum testing (13% vs. 5%), and short-acting bronchodilators (55% vs. 50%). They also received more methyxanthines, loop diuretics, and morphine. The two groups were equally likely to have been given nutritional supplements and to have been prescribed continuous positive airway pressure or bilevel positive airway pressure.

Unadjusted overall rates of treatment failure were significantly lower in the antibiotic-treated group (20% vs. 22%), mostly accounted for by the significantly lower rates of readmission within 30 days (17% vs. 19%). Although the rates of both mortality (1.5% vs. 1.7%) and mechanical ventilation after day 2 (1.2% vs. 1.4%) also were lower among those receiving antibiotics, those numbers were too small to reach significance, Dr. Rothberg said.

Adverse events, including allergic reactions, diarrhea, and treatment for Clostridium difficile infection after day 3, were not increased in the antibiotic-treated group. Length of stay was significantly greater for the antibiotic group (4.92 days vs. 4.65 days) as was total cost ($4,361 vs. $4,277).

The unadjusted odds of treatment failure were significantly lower for those treated with antibiotics, with an odds ratio (OR) of 0.88. However, because this was not a randomized trial, there was a need to control for selection bias—that is, patients who received antibiotics were likely to have been sicker than those who did not. To control for that, a propensity model was used to predict the likelihood of receiving antibiotics, based on patient factors such as demographics, comorbidities, prior COPD admissions, diagnostic tests and treatments (e.g., arterial blood gas, steroids), physician specialty, and hospital factors such as size and teaching status.

Even after adjustment for the propensity score and covariates, receiving antibiotics still resulted in a lower risk for treatment failure (OR 0.87). The adjusted risk of mortality was also lower (OR 0.85), but the number of deaths was too small for that value to reach statistical significance.

“Having such a large data set allowed us to adjust for just about everything … No matter how we looked at it, we were still left with a benefit for antibiotics,” said Dr. Rothberg, adding that future studies will address whether there are differences between the antibiotic classes.

This study was funded internally by Baystate Medical Center's Division of Healthcare Quality.

'No matter how we looked at it, we were still left with a benefit for antibiotics.' DR. ROTHBERG

ELSEVIER GLOBAL MEDICAL NEWS

PITTSBURGH — The use of antibiotics was associated with a significantly reduced risk of treatment failure for acute exacerbations of chronic obstructive pulmonary disease in the largest-ever study of patients hospitalized for that condition.

Chronic obstructive pulmonary disease (COPD) affects 24 million Americans and is the fourth leading cause of death in the United States. Acute COPD exacerbations are among the top 10 causes of hospitalization of adults in this country. About 50%-60% of acute exacerbations are caused by infections, and current COPD guidelines recommend antibiotic treatment for patients who have severe exacerbations with purulent sputum, even though most of the evidence supporting that practice comes from small, heterogeneous trials that often combined hospitalized and nonhospitalized patients.

Although the routine use of antibiotics does appear beneficial for patients on mechanical ventilation, there is scant published literature that supports their use for other hospitalized patients, Dr. Michael B. Rothberg said at the annual meeting of the Society of General Internal Medicine.

To address the question using a large-enough sample size, Dr. Rothberg and his associates at Baystate Medical Center of Tufts University, Springfield, Mass., conducted a retrospective cohort study of patients hospitalized in 2001 for acute COPD exacerbations at 375 acute care facilities that were part of a large database for measuring quality of care and resource utilization. Included were patients hospitalized for at least 2 days with either a primary diagnosis of COPD or a primary diagnosis of respiratory failure and a secondary diagnosis of COPD; to avoid confusion with asthma, only patients older than 39 years were included.

Patients with direct admission to the intensive care unit also were excluded, as were those who had other bacterial infections for which antibiotics would have been indicated.

Antibiotic treatment was defined as at least 2 consecutive days of an appropriate antibiotic for COPD begun on the first or second day of hospitalization. Treatment failure was defined as either initiation of mechanical ventilation after hospital day 2, in-hospital mortality, or all-cause readmission within 30 days.

Of a total 35,053 patients who met the enrollment criteria, 79% (27,812) had received antibiotics (most commonly quinolones, cephalosporins, or macrolides) and 21% (7,241) had not. Those given antibiotics were significantly younger (median age 70 years vs. 71 years), more likely to be in managed care (20% vs. 19%) and to be white (78% vs. 73%), and less likely to have comorbidities including secondary pulmonary hypertension, sleep apnea, alcohol abuse, renal failure, and heart failure. The proportions with comorbid diabetes and solid tumors did not differ significantly. (Because the database was so large, even seemingly small differences often reached statistical significance, Dr. Rothberg noted.)

Patients who received antibiotics appeared to have more severe disease, based on the tests and other treatments they were given. Significantly more of the patients treated with antibiotics had been given steroids (87% vs. 74%), an arterial blood gas measurement (58% vs. 53%), sputum testing (13% vs. 5%), and short-acting bronchodilators (55% vs. 50%). They also received more methyxanthines, loop diuretics, and morphine. The two groups were equally likely to have been given nutritional supplements and to have been prescribed continuous positive airway pressure or bilevel positive airway pressure.

Unadjusted overall rates of treatment failure were significantly lower in the antibiotic-treated group (20% vs. 22%), mostly accounted for by the significantly lower rates of readmission within 30 days (17% vs. 19%). Although the rates of both mortality (1.5% vs. 1.7%) and mechanical ventilation after day 2 (1.2% vs. 1.4%) also were lower among those receiving antibiotics, those numbers were too small to reach significance, Dr. Rothberg said.

Adverse events, including allergic reactions, diarrhea, and treatment for Clostridium difficile infection after day 3, were not increased in the antibiotic-treated group. Length of stay was significantly greater for the antibiotic group (4.92 days vs. 4.65 days) as was total cost ($4,361 vs. $4,277).

The unadjusted odds of treatment failure were significantly lower for those treated with antibiotics, with an odds ratio (OR) of 0.88. However, because this was not a randomized trial, there was a need to control for selection bias—that is, patients who received antibiotics were likely to have been sicker than those who did not. To control for that, a propensity model was used to predict the likelihood of receiving antibiotics, based on patient factors such as demographics, comorbidities, prior COPD admissions, diagnostic tests and treatments (e.g., arterial blood gas, steroids), physician specialty, and hospital factors such as size and teaching status.

Even after adjustment for the propensity score and covariates, receiving antibiotics still resulted in a lower risk for treatment failure (OR 0.87). The adjusted risk of mortality was also lower (OR 0.85), but the number of deaths was too small for that value to reach statistical significance.

“Having such a large data set allowed us to adjust for just about everything … No matter how we looked at it, we were still left with a benefit for antibiotics,” said Dr. Rothberg, adding that future studies will address whether there are differences between the antibiotic classes.

This study was funded internally by Baystate Medical Center's Division of Healthcare Quality.

'No matter how we looked at it, we were still left with a benefit for antibiotics.' DR. ROTHBERG

ELSEVIER GLOBAL MEDICAL NEWS

PITTSBURGH — The use of antibiotics was associated with a significantly reduced risk of treatment failure for acute exacerbations of chronic obstructive pulmonary disease in the largest-ever study of patients hospitalized for that condition.

Chronic obstructive pulmonary disease (COPD) affects 24 million Americans and is the fourth leading cause of death in the United States. Acute COPD exacerbations are among the top 10 causes of hospitalization of adults in this country. About 50%-60% of acute exacerbations are caused by infections, and current COPD guidelines recommend antibiotic treatment for patients who have severe exacerbations with purulent sputum, even though most of the evidence supporting that practice comes from small, heterogeneous trials that often combined hospitalized and nonhospitalized patients.

Although the routine use of antibiotics does appear beneficial for patients on mechanical ventilation, there is scant published literature that supports their use for other hospitalized patients, Dr. Michael B. Rothberg said at the annual meeting of the Society of General Internal Medicine.

To address the question using a large-enough sample size, Dr. Rothberg and his associates at Baystate Medical Center of Tufts University, Springfield, Mass., conducted a retrospective cohort study of patients hospitalized in 2001 for acute COPD exacerbations at 375 acute care facilities that were part of a large database for measuring quality of care and resource utilization. Included were patients hospitalized for at least 2 days with either a primary diagnosis of COPD or a primary diagnosis of respiratory failure and a secondary diagnosis of COPD; to avoid confusion with asthma, only patients older than 39 years were included.

Patients with direct admission to the intensive care unit also were excluded, as were those who had other bacterial infections for which antibiotics would have been indicated.

Antibiotic treatment was defined as at least 2 consecutive days of an appropriate antibiotic for COPD begun on the first or second day of hospitalization. Treatment failure was defined as either initiation of mechanical ventilation after hospital day 2, in-hospital mortality, or all-cause readmission within 30 days.

Of a total 35,053 patients who met the enrollment criteria, 79% (27,812) had received antibiotics (most commonly quinolones, cephalosporins, or macrolides) and 21% (7,241) had not. Those given antibiotics were significantly younger (median age 70 years vs. 71 years), more likely to be in managed care (20% vs. 19%) and to be white (78% vs. 73%), and less likely to have comorbidities including secondary pulmonary hypertension, sleep apnea, alcohol abuse, renal failure, and heart failure. The proportions with comorbid diabetes and solid tumors did not differ significantly. (Because the database was so large, even seemingly small differences often reached statistical significance, Dr. Rothberg noted.)

Patients who received antibiotics appeared to have more severe disease, based on the tests and other treatments they were given. Significantly more of the patients treated with antibiotics had been given steroids (87% vs. 74%), an arterial blood gas measurement (58% vs. 53%), sputum testing (13% vs. 5%), and short-acting bronchodilators (55% vs. 50%). They also received more methyxanthines, loop diuretics, and morphine. The two groups were equally likely to have been given nutritional supplements and to have been prescribed continuous positive airway pressure or bilevel positive airway pressure.

Unadjusted overall rates of treatment failure were significantly lower in the antibiotic-treated group (20% vs. 22%), mostly accounted for by the significantly lower rates of readmission within 30 days (17% vs. 19%). Although the rates of both mortality (1.5% vs. 1.7%) and mechanical ventilation after day 2 (1.2% vs. 1.4%) also were lower among those receiving antibiotics, those numbers were too small to reach significance, Dr. Rothberg said.

Adverse events, including allergic reactions, diarrhea, and treatment for Clostridium difficile infection after day 3, were not increased in the antibiotic-treated group. Length of stay was significantly greater for the antibiotic group (4.92 days vs. 4.65 days) as was total cost ($4,361 vs. $4,277).

The unadjusted odds of treatment failure were significantly lower for those treated with antibiotics, with an odds ratio (OR) of 0.88. However, because this was not a randomized trial, there was a need to control for selection bias—that is, patients who received antibiotics were likely to have been sicker than those who did not. To control for that, a propensity model was used to predict the likelihood of receiving antibiotics, based on patient factors such as demographics, comorbidities, prior COPD admissions, diagnostic tests and treatments (e.g., arterial blood gas, steroids), physician specialty, and hospital factors such as size and teaching status.

Even after adjustment for the propensity score and covariates, receiving antibiotics still resulted in a lower risk for treatment failure (OR 0.87). The adjusted risk of mortality was also lower (OR 0.85), but the number of deaths was too small for that value to reach statistical significance.

“Having such a large data set allowed us to adjust for just about everything … No matter how we looked at it, we were still left with a benefit for antibiotics,” said Dr. Rothberg, adding that future studies will address whether there are differences between the antibiotic classes.

This study was funded internally by Baystate Medical Center's Division of Healthcare Quality.

'No matter how we looked at it, we were still left with a benefit for antibiotics.' DR. ROTHBERG

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — When women develop deep vein thrombosis while on oral contraceptives, the lower left side of the body is more likely to be affected than are the upper extremities or the lower right side, according to the results of a single-center, retrospective chart review.

The findings also suggest that a narrow left common iliac vein may predispose to thromboses in this location, and that this anatomical risk factor could be addressed with endovascular stenting, according to Dr. Grace A. Tye, who reported the results of the review at the annual meeting of the Society of Interventional Radiology.

Oral contraceptives are a well-described risk factor for lower extremity venous thromboembolic events, but there are few published studies on the anatomical distribution of these events in women taking OCs, Dr. Tye said.

Among 52 women who were younger than age 45 and were diagnosed with DVT at Stanford (Calif.) University Hospital in 2002–2006, 19 were on OCs at the time of their diagnosis, reported Dr. Tye, a radiology resident at Stanford. All 19 women on OCs had lower extremity DVTs; of these, 16 were in the left lower extremity and 3 were in the right lower extremity, a statistically significant difference.

Cross-sectional imaging was available for 11 of the 19 patients, and the findings indicated a left common iliac diameter (at the point of maximal narrowing) of 3.7 mm, compared with a right common iliac diameter of 13.1 mm, a highly significant difference.

Dr. Tye proposed that the lower left side predominance of the DVTs might be related to the “May-Thurner Syndrome,” which also is called iliac vein compression syndrome. Named after the two physicians who first described it more than 50 years ago (Angiology 1957;8:419–27), the syndrome describes the small diameter of the left common iliac vein as typically resulting from compression by the right common iliac artery.

The lower left side predominance of the DVTs suggests that women who develop DVT while on oral contraceptives might benefit from early endovascular stenting to relieve compression of the left common iliac vein, according to Dr. Tye, who said that conventional anticoagulation therapy may not address the risk for recurrent DVTs and postthrombotic syndrome in these women. They may benefit from endovascular stenting of the left common iliac vein to relieve compression at this location, which may subsequently result in a lower risk for recurrent DVTs and postthrombotic syndrome, she concluded.

WASHINGTON — When women develop deep vein thrombosis while on oral contraceptives, the lower left side of the body is more likely to be affected than are the upper extremities or the lower right side, according to the results of a single-center, retrospective chart review.

The findings also suggest that a narrow left common iliac vein may predispose to thromboses in this location, and that this anatomical risk factor could be addressed with endovascular stenting, according to Dr. Grace A. Tye, who reported the results of the review at the annual meeting of the Society of Interventional Radiology.

Oral contraceptives are a well-described risk factor for lower extremity venous thromboembolic events, but there are few published studies on the anatomical distribution of these events in women taking OCs, Dr. Tye said.

Among 52 women who were younger than age 45 and were diagnosed with DVT at Stanford (Calif.) University Hospital in 2002–2006, 19 were on OCs at the time of their diagnosis, reported Dr. Tye, a radiology resident at Stanford. All 19 women on OCs had lower extremity DVTs; of these, 16 were in the left lower extremity and 3 were in the right lower extremity, a statistically significant difference.

Cross-sectional imaging was available for 11 of the 19 patients, and the findings indicated a left common iliac diameter (at the point of maximal narrowing) of 3.7 mm, compared with a right common iliac diameter of 13.1 mm, a highly significant difference.

Dr. Tye proposed that the lower left side predominance of the DVTs might be related to the “May-Thurner Syndrome,” which also is called iliac vein compression syndrome. Named after the two physicians who first described it more than 50 years ago (Angiology 1957;8:419–27), the syndrome describes the small diameter of the left common iliac vein as typically resulting from compression by the right common iliac artery.

The lower left side predominance of the DVTs suggests that women who develop DVT while on oral contraceptives might benefit from early endovascular stenting to relieve compression of the left common iliac vein, according to Dr. Tye, who said that conventional anticoagulation therapy may not address the risk for recurrent DVTs and postthrombotic syndrome in these women. They may benefit from endovascular stenting of the left common iliac vein to relieve compression at this location, which may subsequently result in a lower risk for recurrent DVTs and postthrombotic syndrome, she concluded.

WASHINGTON — When women develop deep vein thrombosis while on oral contraceptives, the lower left side of the body is more likely to be affected than are the upper extremities or the lower right side, according to the results of a single-center, retrospective chart review.

The findings also suggest that a narrow left common iliac vein may predispose to thromboses in this location, and that this anatomical risk factor could be addressed with endovascular stenting, according to Dr. Grace A. Tye, who reported the results of the review at the annual meeting of the Society of Interventional Radiology.

Oral contraceptives are a well-described risk factor for lower extremity venous thromboembolic events, but there are few published studies on the anatomical distribution of these events in women taking OCs, Dr. Tye said.

Among 52 women who were younger than age 45 and were diagnosed with DVT at Stanford (Calif.) University Hospital in 2002–2006, 19 were on OCs at the time of their diagnosis, reported Dr. Tye, a radiology resident at Stanford. All 19 women on OCs had lower extremity DVTs; of these, 16 were in the left lower extremity and 3 were in the right lower extremity, a statistically significant difference.

Cross-sectional imaging was available for 11 of the 19 patients, and the findings indicated a left common iliac diameter (at the point of maximal narrowing) of 3.7 mm, compared with a right common iliac diameter of 13.1 mm, a highly significant difference.

Dr. Tye proposed that the lower left side predominance of the DVTs might be related to the “May-Thurner Syndrome,” which also is called iliac vein compression syndrome. Named after the two physicians who first described it more than 50 years ago (Angiology 1957;8:419–27), the syndrome describes the small diameter of the left common iliac vein as typically resulting from compression by the right common iliac artery.

The lower left side predominance of the DVTs suggests that women who develop DVT while on oral contraceptives might benefit from early endovascular stenting to relieve compression of the left common iliac vein, according to Dr. Tye, who said that conventional anticoagulation therapy may not address the risk for recurrent DVTs and postthrombotic syndrome in these women. They may benefit from endovascular stenting of the left common iliac vein to relieve compression at this location, which may subsequently result in a lower risk for recurrent DVTs and postthrombotic syndrome, she concluded.

WASHINGTON — Thrombolytic therapy resulted in limb salvage among 18 patients with severe frostbite treated at one Minnesota hospital in the last few years.

Thrombolytic therapy has been available for management of frostbite for 10 years and has the potential to reduce the need for some amputations. However, its use has not extended to rural northern areas.

Severe frostbite results in ischemia and blistering with subsequent demarcation and loss of tissue. Arterial thrombosis results from injury to endothelial cells that retract to expose subintimal collagen, subsequently triggering acute thrombosis after rewarming, according to Dr. George R. Edmonson of St. Paul (Minn.) Radiology.

At the annual meeting of the Society of Interventional Radiology, Dr. Edmonson described the patient care process at Regions Hospital, also in St. Paul. Patients are admitted from the emergency department to the burn unit, where surgeons assess the affected limb for severity of injury and blood flow. Diagnostic arteriography is done to assess small vessel occlusion and loss of “distal tuft blush” at the tips of digits. Catheters are positioned for simultaneous infusion of treatment drugs into each affected limb. Blisters and wounds are managed with debridement or amputation.

Since the mid-1990s, Dr. Edmonson and his associates have been treating frostbite of the extremities with a variety of combined antithrombotic, antiplatelet, and vasodilating agents. Initially, they used urokinase along with heparin and papaverine, then switched to reteplase, and now have moved to using tenecteplase (TNK) because of its superior plasma stability and higher fibrin specificity compared with reteplase. Tenecteplase is degraded more slowly in the bloodstream during infusion, and binds more firmly to the clot at the target than do similar agents. Because it also affects the normal clotting proteins to a lesser degree, it may therefore reduce the risk of bleeding, he explained.

Six patients aged 18–65 years with severe frostbite at risk for amputation were treated for up to 72 hours with intra-arterial TNK infusions at 0.25 mg/hour per limb, with coaxial papaverine at 30 mg/hour per limb, and intravenous heparin at 500 mcg/hour. They were managed in the burn unit with arteriography.

Of the 6 patients, 3 who had 16 involved digits responded well and required no amputations. The other 3 (6 limbs, 30 digits) had incomplete angiographic responses. Of those, 2 (with 4 limbs, 20 involved digits) improved noticeably following TNK infusion, but then developed infections and required partial amputations. One patient—who needed intubation for alcohol withdrawal—failed to respond and lost 8 fingers, but his thumbs were saved. There were no major bleeds or other periprocedural complications.

Those results were compared with data from 10 surviving patients (14–77 years) of 12 who were treated with the same protocol using various doses of reteplase and papaverine over a 2-year period. Six of the patients recovered with no amputations, 4 had lost 31 digits at 45 days, and 2 had amputations but more distally than would have been anticipated without treatment.

More recently, six more frostbite patients were treated with TNK. Five of these patients had complete response and one had no response. To date, 8 out of 12 TNK-treated patients have been saved from amputation.

These data are part of an ongoing FDA-approved prospective trial undertaken by Dr. Edmonson. The hope was that more scientific results might encourage others to use this type of treatment.

WASHINGTON — Thrombolytic therapy resulted in limb salvage among 18 patients with severe frostbite treated at one Minnesota hospital in the last few years.

Thrombolytic therapy has been available for management of frostbite for 10 years and has the potential to reduce the need for some amputations. However, its use has not extended to rural northern areas.

Severe frostbite results in ischemia and blistering with subsequent demarcation and loss of tissue. Arterial thrombosis results from injury to endothelial cells that retract to expose subintimal collagen, subsequently triggering acute thrombosis after rewarming, according to Dr. George R. Edmonson of St. Paul (Minn.) Radiology.

At the annual meeting of the Society of Interventional Radiology, Dr. Edmonson described the patient care process at Regions Hospital, also in St. Paul. Patients are admitted from the emergency department to the burn unit, where surgeons assess the affected limb for severity of injury and blood flow. Diagnostic arteriography is done to assess small vessel occlusion and loss of “distal tuft blush” at the tips of digits. Catheters are positioned for simultaneous infusion of treatment drugs into each affected limb. Blisters and wounds are managed with debridement or amputation.

Since the mid-1990s, Dr. Edmonson and his associates have been treating frostbite of the extremities with a variety of combined antithrombotic, antiplatelet, and vasodilating agents. Initially, they used urokinase along with heparin and papaverine, then switched to reteplase, and now have moved to using tenecteplase (TNK) because of its superior plasma stability and higher fibrin specificity compared with reteplase. Tenecteplase is degraded more slowly in the bloodstream during infusion, and binds more firmly to the clot at the target than do similar agents. Because it also affects the normal clotting proteins to a lesser degree, it may therefore reduce the risk of bleeding, he explained.

Six patients aged 18–65 years with severe frostbite at risk for amputation were treated for up to 72 hours with intra-arterial TNK infusions at 0.25 mg/hour per limb, with coaxial papaverine at 30 mg/hour per limb, and intravenous heparin at 500 mcg/hour. They were managed in the burn unit with arteriography.

Of the 6 patients, 3 who had 16 involved digits responded well and required no amputations. The other 3 (6 limbs, 30 digits) had incomplete angiographic responses. Of those, 2 (with 4 limbs, 20 involved digits) improved noticeably following TNK infusion, but then developed infections and required partial amputations. One patient—who needed intubation for alcohol withdrawal—failed to respond and lost 8 fingers, but his thumbs were saved. There were no major bleeds or other periprocedural complications.

Those results were compared with data from 10 surviving patients (14–77 years) of 12 who were treated with the same protocol using various doses of reteplase and papaverine over a 2-year period. Six of the patients recovered with no amputations, 4 had lost 31 digits at 45 days, and 2 had amputations but more distally than would have been anticipated without treatment.

More recently, six more frostbite patients were treated with TNK. Five of these patients had complete response and one had no response. To date, 8 out of 12 TNK-treated patients have been saved from amputation.

These data are part of an ongoing FDA-approved prospective trial undertaken by Dr. Edmonson. The hope was that more scientific results might encourage others to use this type of treatment.

WASHINGTON — Thrombolytic therapy resulted in limb salvage among 18 patients with severe frostbite treated at one Minnesota hospital in the last few years.

Thrombolytic therapy has been available for management of frostbite for 10 years and has the potential to reduce the need for some amputations. However, its use has not extended to rural northern areas.

Severe frostbite results in ischemia and blistering with subsequent demarcation and loss of tissue. Arterial thrombosis results from injury to endothelial cells that retract to expose subintimal collagen, subsequently triggering acute thrombosis after rewarming, according to Dr. George R. Edmonson of St. Paul (Minn.) Radiology.

At the annual meeting of the Society of Interventional Radiology, Dr. Edmonson described the patient care process at Regions Hospital, also in St. Paul. Patients are admitted from the emergency department to the burn unit, where surgeons assess the affected limb for severity of injury and blood flow. Diagnostic arteriography is done to assess small vessel occlusion and loss of “distal tuft blush” at the tips of digits. Catheters are positioned for simultaneous infusion of treatment drugs into each affected limb. Blisters and wounds are managed with debridement or amputation.

Since the mid-1990s, Dr. Edmonson and his associates have been treating frostbite of the extremities with a variety of combined antithrombotic, antiplatelet, and vasodilating agents. Initially, they used urokinase along with heparin and papaverine, then switched to reteplase, and now have moved to using tenecteplase (TNK) because of its superior plasma stability and higher fibrin specificity compared with reteplase. Tenecteplase is degraded more slowly in the bloodstream during infusion, and binds more firmly to the clot at the target than do similar agents. Because it also affects the normal clotting proteins to a lesser degree, it may therefore reduce the risk of bleeding, he explained.

Six patients aged 18–65 years with severe frostbite at risk for amputation were treated for up to 72 hours with intra-arterial TNK infusions at 0.25 mg/hour per limb, with coaxial papaverine at 30 mg/hour per limb, and intravenous heparin at 500 mcg/hour. They were managed in the burn unit with arteriography.

Of the 6 patients, 3 who had 16 involved digits responded well and required no amputations. The other 3 (6 limbs, 30 digits) had incomplete angiographic responses. Of those, 2 (with 4 limbs, 20 involved digits) improved noticeably following TNK infusion, but then developed infections and required partial amputations. One patient—who needed intubation for alcohol withdrawal—failed to respond and lost 8 fingers, but his thumbs were saved. There were no major bleeds or other periprocedural complications.

Those results were compared with data from 10 surviving patients (14–77 years) of 12 who were treated with the same protocol using various doses of reteplase and papaverine over a 2-year period. Six of the patients recovered with no amputations, 4 had lost 31 digits at 45 days, and 2 had amputations but more distally than would have been anticipated without treatment.

More recently, six more frostbite patients were treated with TNK. Five of these patients had complete response and one had no response. To date, 8 out of 12 TNK-treated patients have been saved from amputation.

These data are part of an ongoing FDA-approved prospective trial undertaken by Dr. Edmonson. The hope was that more scientific results might encourage others to use this type of treatment.

Lipoprotein management in patients with cardiometabolic risk is the focus of a joint consensus statement from the American Diabetes Association and American College of Cardiology Foundation.

The evidence-based statement, written by a seven-member panel, advises assessing global “cardiometabolic risk” (CMR), followed by a multifactorial risk-reduction strategy targeting individual risk factors with lifestyle and pharmacologic therapy. Specific recommendations are given for management of dyslipidemia in patients by risk level (Diabetes Care 2008;31:811–22).

Among the clinical entities considered to increase CMR are type 2 diabetes, familial combined hyperlipidemia, familial hypoalphalipoproteinemia, and polycystic ovary syndrome. All share the characteristics of central obesity, insulin resistance, dyslipoproteinemia, and hypertension. For such patients, the panel recommended statin therapy for the majority of dyslipidemic adult patients with CMR and guiding therapy for patients with CMR on statin therapy, with measurements of apolipoprotein B (apoB) and treatment to apoB goals in addition to LDL-cholesterol and non-HDL-cholesterol assessments.

The panel also recommended treatment goals that address the high lifetime risk of patients with cardiometabolic risk and dyslipidemia:

▸ For patients with either known cardiovascular disease (CVD) or diabetes plus one or more additional major CVD risk factors, LDL cholesterol should be less than 70 mg/dL, non-HDL cholesterol less than 100 mg/dL, and apoB less than 80 mg/dL.

▸ For those with no diabetes or known clinical CVD risk factors but who have two or more additional major CVD risk factors or who have diabetes but no other major CVD risk factors, LDL cholesterol should be less than 100 mg/dL, non-HDL cholesterol less than 130 mg/dL, and apoB less than 90 mg/dL.

The panel also recommended clinical trials to determine whether the pharmacologic therapy for achieving very low levels of atherogenic lipoproteins is safe and cost effective. It also advocated for a public health effort focusing on lifestyle modification for reducing those levels.

Two panelists disclosed no conflicts of interest. The other five each disclosed multiple dualities of interest, including four who accepted consulting fees/honoraria from Merck & Co, and Schering-Plough Corp., three from Abbott Laboratories and Pfizer Inc., and two from Astra-Zeneca Pharmaceuticals, Kos Pharmaceuticals, Sanofi-Aventis, and Daiichi-Sankyo.

Lipoprotein management in patients with cardiometabolic risk is the focus of a joint consensus statement from the American Diabetes Association and American College of Cardiology Foundation.

The evidence-based statement, written by a seven-member panel, advises assessing global “cardiometabolic risk” (CMR), followed by a multifactorial risk-reduction strategy targeting individual risk factors with lifestyle and pharmacologic therapy. Specific recommendations are given for management of dyslipidemia in patients by risk level (Diabetes Care 2008;31:811–22).

Among the clinical entities considered to increase CMR are type 2 diabetes, familial combined hyperlipidemia, familial hypoalphalipoproteinemia, and polycystic ovary syndrome. All share the characteristics of central obesity, insulin resistance, dyslipoproteinemia, and hypertension. For such patients, the panel recommended statin therapy for the majority of dyslipidemic adult patients with CMR and guiding therapy for patients with CMR on statin therapy, with measurements of apolipoprotein B (apoB) and treatment to apoB goals in addition to LDL-cholesterol and non-HDL-cholesterol assessments.

The panel also recommended treatment goals that address the high lifetime risk of patients with cardiometabolic risk and dyslipidemia:

▸ For patients with either known cardiovascular disease (CVD) or diabetes plus one or more additional major CVD risk factors, LDL cholesterol should be less than 70 mg/dL, non-HDL cholesterol less than 100 mg/dL, and apoB less than 80 mg/dL.

▸ For those with no diabetes or known clinical CVD risk factors but who have two or more additional major CVD risk factors or who have diabetes but no other major CVD risk factors, LDL cholesterol should be less than 100 mg/dL, non-HDL cholesterol less than 130 mg/dL, and apoB less than 90 mg/dL.

The panel also recommended clinical trials to determine whether the pharmacologic therapy for achieving very low levels of atherogenic lipoproteins is safe and cost effective. It also advocated for a public health effort focusing on lifestyle modification for reducing those levels.

Two panelists disclosed no conflicts of interest. The other five each disclosed multiple dualities of interest, including four who accepted consulting fees/honoraria from Merck & Co, and Schering-Plough Corp., three from Abbott Laboratories and Pfizer Inc., and two from Astra-Zeneca Pharmaceuticals, Kos Pharmaceuticals, Sanofi-Aventis, and Daiichi-Sankyo.

Lipoprotein management in patients with cardiometabolic risk is the focus of a joint consensus statement from the American Diabetes Association and American College of Cardiology Foundation.

The evidence-based statement, written by a seven-member panel, advises assessing global “cardiometabolic risk” (CMR), followed by a multifactorial risk-reduction strategy targeting individual risk factors with lifestyle and pharmacologic therapy. Specific recommendations are given for management of dyslipidemia in patients by risk level (Diabetes Care 2008;31:811–22).

Among the clinical entities considered to increase CMR are type 2 diabetes, familial combined hyperlipidemia, familial hypoalphalipoproteinemia, and polycystic ovary syndrome. All share the characteristics of central obesity, insulin resistance, dyslipoproteinemia, and hypertension. For such patients, the panel recommended statin therapy for the majority of dyslipidemic adult patients with CMR and guiding therapy for patients with CMR on statin therapy, with measurements of apolipoprotein B (apoB) and treatment to apoB goals in addition to LDL-cholesterol and non-HDL-cholesterol assessments.

The panel also recommended treatment goals that address the high lifetime risk of patients with cardiometabolic risk and dyslipidemia:

▸ For patients with either known cardiovascular disease (CVD) or diabetes plus one or more additional major CVD risk factors, LDL cholesterol should be less than 70 mg/dL, non-HDL cholesterol less than 100 mg/dL, and apoB less than 80 mg/dL.

▸ For those with no diabetes or known clinical CVD risk factors but who have two or more additional major CVD risk factors or who have diabetes but no other major CVD risk factors, LDL cholesterol should be less than 100 mg/dL, non-HDL cholesterol less than 130 mg/dL, and apoB less than 90 mg/dL.

The panel also recommended clinical trials to determine whether the pharmacologic therapy for achieving very low levels of atherogenic lipoproteins is safe and cost effective. It also advocated for a public health effort focusing on lifestyle modification for reducing those levels.

Two panelists disclosed no conflicts of interest. The other five each disclosed multiple dualities of interest, including four who accepted consulting fees/honoraria from Merck & Co, and Schering-Plough Corp., three from Abbott Laboratories and Pfizer Inc., and two from Astra-Zeneca Pharmaceuticals, Kos Pharmaceuticals, Sanofi-Aventis, and Daiichi-Sankyo.