Sharon Worcester

Major Finding: Of 325 children enrolled in the Research Registry for Neonatal Lupus before October 2010, 57 (18%) died; 30% died in utero, 30% died during the neonatal period, 14% died between 1 and 6 months of age, and 26% died after 6 months of age.

Data Source: A retrospective analysis of data from a large U.S.-based cohort.

Disclosures: No disclosures.

ATLANTA — The overall case fatality rate in cardiac neonatal lupus is nearly 18%, according to a review of data from the Research Registry for Neonatal Lupus.

Of 325 children enrolled in the large U.S.-based registry before October 2010, 57 (18%) died; 30% died in utero, 30% died during the neonatal period, 14% died between 1 and 6 months of age, and 26% died after 6 months of age, said Dr. Peter M. Izmirly.

Of the deaths, 42 were cardiac related – most often a result of complications from cardiomyopathy, 6 were due to infectious complications, and 8 were a result of unknown causes. One pregnancy was terminated electively, said Dr. Izmirly of New York University, New York.

Of white children with cardiac neonatal lupus, 14% died, compared with 28% of minority children.

The study, which was conducted in an effort to update mortality data on cardiac neonatal lupus and to thereby improve evidence-based counseling of anti-Ro/La positive mothers whose babies are at increased risk of cardiac neonatal lupus, identified fetal and maternal risk factors for death in affected babies.

Significant fetal risk factors for death were associated hematologic hepatic neonatal lupus (present in 27% vs. 7% of deceased vs. living babies), earlier gestational age at detection (detection occurred at 21.8 vs. 23.4 weeks in deceased vs. living babies), delivery prior to 37 weeks' gestation (delivery occurred prior to 37 weeks in 69% vs. 42% of deceased vs. living babies), and earlier gestational week of delivery (delivery occurred at 34.2 weeks vs. 36.9 weeks in deceased vs. living babies), Dr. Izmirly said.

Fetal echocardiographic risk factors associated with mortality were lower ventricular rate nadir (rate was 50.2 vs. 53.6 in deceased vs. living babies), and the presence of endocardial fibroelastosis (which occurred in 30.25% vs. 4.3% of deceased vs. living babies), dilated cardiomyopathy (which occurred in 32.6% vs. 8.6% of deceased vs. living babies), hydrops (which occurred in 57.4% vs. 3.4% of deceased vs. living babies), and valvular disease (which occurred in18.2% vs. 4.8% of deceased vs. living babies).

Fetal echocardiographic factors not associated with mortality were ventricular rate detection, atrial septal defect, ventricular septal defect, and patent ductus arteriosus.

Only one maternal risk factor – a maternal diagnosis of systemic lupus erythematosus or Sjögren's syndrome – showed a trend toward significance in terms of risk for fetal death. Diagnosis occurred in 56% of women whose babies died, vs. 43% of those whose babies were living.

Major Finding: Of 325 children enrolled in the Research Registry for Neonatal Lupus before October 2010, 57 (18%) died; 30% died in utero, 30% died during the neonatal period, 14% died between 1 and 6 months of age, and 26% died after 6 months of age.

Data Source: A retrospective analysis of data from a large U.S.-based cohort.

Disclosures: No disclosures.

ATLANTA — The overall case fatality rate in cardiac neonatal lupus is nearly 18%, according to a review of data from the Research Registry for Neonatal Lupus.

Of 325 children enrolled in the large U.S.-based registry before October 2010, 57 (18%) died; 30% died in utero, 30% died during the neonatal period, 14% died between 1 and 6 months of age, and 26% died after 6 months of age, said Dr. Peter M. Izmirly.

Of the deaths, 42 were cardiac related – most often a result of complications from cardiomyopathy, 6 were due to infectious complications, and 8 were a result of unknown causes. One pregnancy was terminated electively, said Dr. Izmirly of New York University, New York.

Of white children with cardiac neonatal lupus, 14% died, compared with 28% of minority children.

The study, which was conducted in an effort to update mortality data on cardiac neonatal lupus and to thereby improve evidence-based counseling of anti-Ro/La positive mothers whose babies are at increased risk of cardiac neonatal lupus, identified fetal and maternal risk factors for death in affected babies.

Significant fetal risk factors for death were associated hematologic hepatic neonatal lupus (present in 27% vs. 7% of deceased vs. living babies), earlier gestational age at detection (detection occurred at 21.8 vs. 23.4 weeks in deceased vs. living babies), delivery prior to 37 weeks' gestation (delivery occurred prior to 37 weeks in 69% vs. 42% of deceased vs. living babies), and earlier gestational week of delivery (delivery occurred at 34.2 weeks vs. 36.9 weeks in deceased vs. living babies), Dr. Izmirly said.

Fetal echocardiographic risk factors associated with mortality were lower ventricular rate nadir (rate was 50.2 vs. 53.6 in deceased vs. living babies), and the presence of endocardial fibroelastosis (which occurred in 30.25% vs. 4.3% of deceased vs. living babies), dilated cardiomyopathy (which occurred in 32.6% vs. 8.6% of deceased vs. living babies), hydrops (which occurred in 57.4% vs. 3.4% of deceased vs. living babies), and valvular disease (which occurred in18.2% vs. 4.8% of deceased vs. living babies).

Fetal echocardiographic factors not associated with mortality were ventricular rate detection, atrial septal defect, ventricular septal defect, and patent ductus arteriosus.

Only one maternal risk factor – a maternal diagnosis of systemic lupus erythematosus or Sjögren's syndrome – showed a trend toward significance in terms of risk for fetal death. Diagnosis occurred in 56% of women whose babies died, vs. 43% of those whose babies were living.

Major Finding: Of 325 children enrolled in the Research Registry for Neonatal Lupus before October 2010, 57 (18%) died; 30% died in utero, 30% died during the neonatal period, 14% died between 1 and 6 months of age, and 26% died after 6 months of age.

Data Source: A retrospective analysis of data from a large U.S.-based cohort.

Disclosures: No disclosures.

ATLANTA — The overall case fatality rate in cardiac neonatal lupus is nearly 18%, according to a review of data from the Research Registry for Neonatal Lupus.

Of 325 children enrolled in the large U.S.-based registry before October 2010, 57 (18%) died; 30% died in utero, 30% died during the neonatal period, 14% died between 1 and 6 months of age, and 26% died after 6 months of age, said Dr. Peter M. Izmirly.

Of the deaths, 42 were cardiac related – most often a result of complications from cardiomyopathy, 6 were due to infectious complications, and 8 were a result of unknown causes. One pregnancy was terminated electively, said Dr. Izmirly of New York University, New York.

Of white children with cardiac neonatal lupus, 14% died, compared with 28% of minority children.

The study, which was conducted in an effort to update mortality data on cardiac neonatal lupus and to thereby improve evidence-based counseling of anti-Ro/La positive mothers whose babies are at increased risk of cardiac neonatal lupus, identified fetal and maternal risk factors for death in affected babies.

Significant fetal risk factors for death were associated hematologic hepatic neonatal lupus (present in 27% vs. 7% of deceased vs. living babies), earlier gestational age at detection (detection occurred at 21.8 vs. 23.4 weeks in deceased vs. living babies), delivery prior to 37 weeks' gestation (delivery occurred prior to 37 weeks in 69% vs. 42% of deceased vs. living babies), and earlier gestational week of delivery (delivery occurred at 34.2 weeks vs. 36.9 weeks in deceased vs. living babies), Dr. Izmirly said.

Fetal echocardiographic risk factors associated with mortality were lower ventricular rate nadir (rate was 50.2 vs. 53.6 in deceased vs. living babies), and the presence of endocardial fibroelastosis (which occurred in 30.25% vs. 4.3% of deceased vs. living babies), dilated cardiomyopathy (which occurred in 32.6% vs. 8.6% of deceased vs. living babies), hydrops (which occurred in 57.4% vs. 3.4% of deceased vs. living babies), and valvular disease (which occurred in18.2% vs. 4.8% of deceased vs. living babies).

Fetal echocardiographic factors not associated with mortality were ventricular rate detection, atrial septal defect, ventricular septal defect, and patent ductus arteriosus.

Only one maternal risk factor – a maternal diagnosis of systemic lupus erythematosus or Sjögren's syndrome – showed a trend toward significance in terms of risk for fetal death. Diagnosis occurred in 56% of women whose babies died, vs. 43% of those whose babies were living.

Major Finding: At 40 months' follow-up, 60% of the adalimumab patients who achieved remission remained in remission, compared with only 18.8% of those in the infliximab group.

Data Source: An open-label prospective cohort study.

Disclosures: Dr. Simonini reported no relevant financial disclosures.

ATLANTA — Adalimumab was more effective than infliximab for the prevention of recurrence of chronic childhood uveitis in a small open-label prospective study.

Remission was achieved within 10-12 weeks in 31 of the 33 children, including 15 of 16 recruited for the adalimumab group, and 16 of 17 recruited for the infliximab group. All were able to discontinue steroid treatment, and no significant differences were seen between the groups in time to remission or time to steroid discontinuation, Dr. Gabriele Simonini reported at the meeting.

At 40 months' follow-up, 60% of the adalimumab patients who achieved remission remained in remission, compared with only 18.8% of those in the infliximab group, said Dr. Simonini of the University of Florence (Italy).

Among those who relapsed, the median number of relapses was 1 (range, 1-3) in the adalimumab group, and 3 (range, 1-5) in the infliximab group.

The difference was statistically significant, Dr. Simonini said.

Major Finding: At 40 months' follow-up, 60% of the adalimumab patients who achieved remission remained in remission, compared with only 18.8% of those in the infliximab group.

Data Source: An open-label prospective cohort study.

Disclosures: Dr. Simonini reported no relevant financial disclosures.

ATLANTA — Adalimumab was more effective than infliximab for the prevention of recurrence of chronic childhood uveitis in a small open-label prospective study.

Remission was achieved within 10-12 weeks in 31 of the 33 children, including 15 of 16 recruited for the adalimumab group, and 16 of 17 recruited for the infliximab group. All were able to discontinue steroid treatment, and no significant differences were seen between the groups in time to remission or time to steroid discontinuation, Dr. Gabriele Simonini reported at the meeting.

At 40 months' follow-up, 60% of the adalimumab patients who achieved remission remained in remission, compared with only 18.8% of those in the infliximab group, said Dr. Simonini of the University of Florence (Italy).

Among those who relapsed, the median number of relapses was 1 (range, 1-3) in the adalimumab group, and 3 (range, 1-5) in the infliximab group.

The difference was statistically significant, Dr. Simonini said.

Major Finding: At 40 months' follow-up, 60% of the adalimumab patients who achieved remission remained in remission, compared with only 18.8% of those in the infliximab group.

Data Source: An open-label prospective cohort study.

Disclosures: Dr. Simonini reported no relevant financial disclosures.

ATLANTA — Adalimumab was more effective than infliximab for the prevention of recurrence of chronic childhood uveitis in a small open-label prospective study.

Remission was achieved within 10-12 weeks in 31 of the 33 children, including 15 of 16 recruited for the adalimumab group, and 16 of 17 recruited for the infliximab group. All were able to discontinue steroid treatment, and no significant differences were seen between the groups in time to remission or time to steroid discontinuation, Dr. Gabriele Simonini reported at the meeting.

At 40 months' follow-up, 60% of the adalimumab patients who achieved remission remained in remission, compared with only 18.8% of those in the infliximab group, said Dr. Simonini of the University of Florence (Italy).

Among those who relapsed, the median number of relapses was 1 (range, 1-3) in the adalimumab group, and 3 (range, 1-5) in the infliximab group.

The difference was statistically significant, Dr. Simonini said.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its “ambitious, yet achievable” 10-year agenda for improving the nation's health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders lead to improvements in health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

“Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days,” the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a “well-coordinated strategy to improve sleep-related health.”

Objectives are to:

▸ Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

▸ Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

▸ Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

▸ Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to “promote respiratory health through better prevention, detection, treatment, and education efforts,” according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to “provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation.”

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

▸ Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

▸ Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

▸ Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion.

The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its “ambitious, yet achievable” 10-year agenda for improving the nation's health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders lead to improvements in health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

“Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days,” the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a “well-coordinated strategy to improve sleep-related health.”

Objectives are to:

▸ Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

▸ Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

▸ Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

▸ Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to “promote respiratory health through better prevention, detection, treatment, and education efforts,” according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to “provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation.”

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

▸ Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

▸ Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

▸ Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion.

The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its “ambitious, yet achievable” 10-year agenda for improving the nation's health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders lead to improvements in health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

“Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days,” the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a “well-coordinated strategy to improve sleep-related health.”

Objectives are to:

▸ Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

▸ Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

▸ Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

▸ Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to “promote respiratory health through better prevention, detection, treatment, and education efforts,” according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to “provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation.”

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

▸ Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

▸ Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

▸ Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion.

The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

ATLANTA – The best available evidence suggests that exercise should be recommended as a nonpharmacologic treatment option for hip and knee osteoarthritis.

So says a technical panel of experts convened by the American College of Rheumatology to revise existing treatment recommendations on the nonpharmacologic treatment of hand, hip, and knee OA. The panel began work in 2008; the proposed consensus revisions are now under review by the ACR.

The panel found “strong” evidence that aerobic land-based exercise, resistance land-based exercise, aquatic exercise, and weight loss for overweight patients can be helpful for reducing pain and improving physical function in hip and knee osteoarthritis, and the panel plans to recommend them, reported Carol Oatis, Ph.D., professor of physical therapy at Arcadia University in Glenside, Pa., and a panel member.

This was the only time the panel deemed supporting evidence to be “strong,” based on the GRADE (grades of recommendations, assessment, development, and evaluation) methodology used in developing the revised recommendations. GRADE rates the available evidence as “strong,” “weak,” or “none.”

Strong evidence is of high quality with a large gradient between benefits and risks, and little uncertainty or variability in values and preferences; weak evidence has moderate quality with a small gradient between benefits and risks, and moderate uncertainty or variability in values and preferences; and “none” means the evidence was of low or very low quality with no difference between benefits and risks.

Weak evidence of benefit in hip OA was found for manual therapy in combination with supervised exercise programs; the panel suggests – but does not recommend – that this modality be considered for patients with hip OA, Dr. Oatis said.

No evidence was found either in support of or against balance exercises or tai chi, so the panel provided no guidance for these approaches, Dr. Oatis said.

The panel also considered the evidence for hand OA, and for various specific nonpharmacologic approaches to treating OA.

For hand OA, weak evidence was found for the following:

▸ Evaluating patients regarding activities of daily living.

▸ Providing instruction on joint protection techniques.

▸ Providing assistive devices as needed.

▸ Instructing patients regarding the use of thermal modalities.

▸ Using splints for the trapezio-metacarpal joint (carpal metacarpal joint at the base of the thumb).

Thus, the panel “suggests” use of these modalities, said Catherine Backman, Ph.D., an occupational therapist at the University of British Columbia, Vancouver, and a panel member.

When it comes to suggestions based on weak evidence, patient preference comes into play, because this generally means there is no evidence against – and there is some evidence in favor of – use of these modalities, Dr. Backman said.

“Clinicians may want to discuss [these modalities] with patients,” she said.

No other recommendations or suggestions were made for hand OA.

As for specific treatment modalities, weak evidence was found for the following:

▸ Medial wedge shoe insoles for lateral compartment knee OA.

▸ Subtalar strapping and lateral wedge insoles for medial compartment knee OA.

▸ Medial patellar femoral taping.

▸ Transcutaneous electrical nerve stimulation (TENS) for knee OA with chronic moderate to severe pain.

▸ Traditional Chinese acupuncture for knee OA with moderate to severe pain.

▸ Thermal modalities.

▸ Walking aids.

No evidence was found for or against valgus bracing for knee OA, or for lateral patellar-femoral taping; therefore, the panel chose not to provide guidance on these, said G. Kelley Fitzgerald, Ph.D., a physical therapist at the University of Pittsburgh, and a panel member.

The panel, which reviewed existing English-language studies and existing guidelines from the ACR and other organizations, based its evidence-strength determinations on the quality of the evidence and the extent to which the evidence demonstrated pain relief and improved physical functionality.

The panel did not determine that any of the reviewed modalities should not be used.

“The lack of 'do not do' recommendations or suggestions means that there was no definitive evidence of harm or lack of efficacy for the interventions examined, Dr. Oatis explained.

These proposed revisions to the current ACR recommendations, which were last revised in 2000 with an update in 2005 following the withdrawal of rofecoxib from the market, are currently under review by the journal Arthritis Care and Research, and have been submitted to the ACR Committee on Quality of Care for review before they are sent the ACR board of directors for final approval, said Dr. Marc C. Hochberg, head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore.

The ACR awarded the contract for the project to the University of Maryland with Dr. Hochberg as the principal investigator. He is also a member of the project steering committee.

“Hopefully, these will come to the point where the ACR board of directors will be satisfied, and we'll have a publication in 2011,” he said.

Dr. Hochberg disclosed that he has received research support from the National Institutes of Health, and has served as a consultant or on an advisory board or data safety monitoring board for numerous pharmaceutical companies. The other presenters had no disclosures.

Water aerobics can help reduce OA pain and improve physical function, and will be recommended by the panel.

Source ©Sarto/Lund/Getty Images

ATLANTA – The best available evidence suggests that exercise should be recommended as a nonpharmacologic treatment option for hip and knee osteoarthritis.

So says a technical panel of experts convened by the American College of Rheumatology to revise existing treatment recommendations on the nonpharmacologic treatment of hand, hip, and knee OA. The panel began work in 2008; the proposed consensus revisions are now under review by the ACR.

The panel found “strong” evidence that aerobic land-based exercise, resistance land-based exercise, aquatic exercise, and weight loss for overweight patients can be helpful for reducing pain and improving physical function in hip and knee osteoarthritis, and the panel plans to recommend them, reported Carol Oatis, Ph.D., professor of physical therapy at Arcadia University in Glenside, Pa., and a panel member.

This was the only time the panel deemed supporting evidence to be “strong,” based on the GRADE (grades of recommendations, assessment, development, and evaluation) methodology used in developing the revised recommendations. GRADE rates the available evidence as “strong,” “weak,” or “none.”

Strong evidence is of high quality with a large gradient between benefits and risks, and little uncertainty or variability in values and preferences; weak evidence has moderate quality with a small gradient between benefits and risks, and moderate uncertainty or variability in values and preferences; and “none” means the evidence was of low or very low quality with no difference between benefits and risks.

Weak evidence of benefit in hip OA was found for manual therapy in combination with supervised exercise programs; the panel suggests – but does not recommend – that this modality be considered for patients with hip OA, Dr. Oatis said.

No evidence was found either in support of or against balance exercises or tai chi, so the panel provided no guidance for these approaches, Dr. Oatis said.

The panel also considered the evidence for hand OA, and for various specific nonpharmacologic approaches to treating OA.

For hand OA, weak evidence was found for the following:

▸ Evaluating patients regarding activities of daily living.

▸ Providing instruction on joint protection techniques.

▸ Providing assistive devices as needed.

▸ Instructing patients regarding the use of thermal modalities.

▸ Using splints for the trapezio-metacarpal joint (carpal metacarpal joint at the base of the thumb).

Thus, the panel “suggests” use of these modalities, said Catherine Backman, Ph.D., an occupational therapist at the University of British Columbia, Vancouver, and a panel member.

When it comes to suggestions based on weak evidence, patient preference comes into play, because this generally means there is no evidence against – and there is some evidence in favor of – use of these modalities, Dr. Backman said.

“Clinicians may want to discuss [these modalities] with patients,” she said.

No other recommendations or suggestions were made for hand OA.

As for specific treatment modalities, weak evidence was found for the following:

▸ Medial wedge shoe insoles for lateral compartment knee OA.

▸ Subtalar strapping and lateral wedge insoles for medial compartment knee OA.

▸ Medial patellar femoral taping.

▸ Transcutaneous electrical nerve stimulation (TENS) for knee OA with chronic moderate to severe pain.

▸ Traditional Chinese acupuncture for knee OA with moderate to severe pain.

▸ Thermal modalities.

▸ Walking aids.

No evidence was found for or against valgus bracing for knee OA, or for lateral patellar-femoral taping; therefore, the panel chose not to provide guidance on these, said G. Kelley Fitzgerald, Ph.D., a physical therapist at the University of Pittsburgh, and a panel member.

The panel, which reviewed existing English-language studies and existing guidelines from the ACR and other organizations, based its evidence-strength determinations on the quality of the evidence and the extent to which the evidence demonstrated pain relief and improved physical functionality.

The panel did not determine that any of the reviewed modalities should not be used.

“The lack of 'do not do' recommendations or suggestions means that there was no definitive evidence of harm or lack of efficacy for the interventions examined, Dr. Oatis explained.

These proposed revisions to the current ACR recommendations, which were last revised in 2000 with an update in 2005 following the withdrawal of rofecoxib from the market, are currently under review by the journal Arthritis Care and Research, and have been submitted to the ACR Committee on Quality of Care for review before they are sent the ACR board of directors for final approval, said Dr. Marc C. Hochberg, head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore.

The ACR awarded the contract for the project to the University of Maryland with Dr. Hochberg as the principal investigator. He is also a member of the project steering committee.

“Hopefully, these will come to the point where the ACR board of directors will be satisfied, and we'll have a publication in 2011,” he said.

Dr. Hochberg disclosed that he has received research support from the National Institutes of Health, and has served as a consultant or on an advisory board or data safety monitoring board for numerous pharmaceutical companies. The other presenters had no disclosures.

Water aerobics can help reduce OA pain and improve physical function, and will be recommended by the panel.

Source ©Sarto/Lund/Getty Images

ATLANTA – The best available evidence suggests that exercise should be recommended as a nonpharmacologic treatment option for hip and knee osteoarthritis.

So says a technical panel of experts convened by the American College of Rheumatology to revise existing treatment recommendations on the nonpharmacologic treatment of hand, hip, and knee OA. The panel began work in 2008; the proposed consensus revisions are now under review by the ACR.

The panel found “strong” evidence that aerobic land-based exercise, resistance land-based exercise, aquatic exercise, and weight loss for overweight patients can be helpful for reducing pain and improving physical function in hip and knee osteoarthritis, and the panel plans to recommend them, reported Carol Oatis, Ph.D., professor of physical therapy at Arcadia University in Glenside, Pa., and a panel member.

This was the only time the panel deemed supporting evidence to be “strong,” based on the GRADE (grades of recommendations, assessment, development, and evaluation) methodology used in developing the revised recommendations. GRADE rates the available evidence as “strong,” “weak,” or “none.”

Strong evidence is of high quality with a large gradient between benefits and risks, and little uncertainty or variability in values and preferences; weak evidence has moderate quality with a small gradient between benefits and risks, and moderate uncertainty or variability in values and preferences; and “none” means the evidence was of low or very low quality with no difference between benefits and risks.

Weak evidence of benefit in hip OA was found for manual therapy in combination with supervised exercise programs; the panel suggests – but does not recommend – that this modality be considered for patients with hip OA, Dr. Oatis said.

No evidence was found either in support of or against balance exercises or tai chi, so the panel provided no guidance for these approaches, Dr. Oatis said.

The panel also considered the evidence for hand OA, and for various specific nonpharmacologic approaches to treating OA.

For hand OA, weak evidence was found for the following:

▸ Evaluating patients regarding activities of daily living.

▸ Providing instruction on joint protection techniques.

▸ Providing assistive devices as needed.

▸ Instructing patients regarding the use of thermal modalities.

▸ Using splints for the trapezio-metacarpal joint (carpal metacarpal joint at the base of the thumb).

Thus, the panel “suggests” use of these modalities, said Catherine Backman, Ph.D., an occupational therapist at the University of British Columbia, Vancouver, and a panel member.

When it comes to suggestions based on weak evidence, patient preference comes into play, because this generally means there is no evidence against – and there is some evidence in favor of – use of these modalities, Dr. Backman said.

“Clinicians may want to discuss [these modalities] with patients,” she said.

No other recommendations or suggestions were made for hand OA.

As for specific treatment modalities, weak evidence was found for the following:

▸ Medial wedge shoe insoles for lateral compartment knee OA.

▸ Subtalar strapping and lateral wedge insoles for medial compartment knee OA.

▸ Medial patellar femoral taping.

▸ Transcutaneous electrical nerve stimulation (TENS) for knee OA with chronic moderate to severe pain.

▸ Traditional Chinese acupuncture for knee OA with moderate to severe pain.

▸ Thermal modalities.

▸ Walking aids.

No evidence was found for or against valgus bracing for knee OA, or for lateral patellar-femoral taping; therefore, the panel chose not to provide guidance on these, said G. Kelley Fitzgerald, Ph.D., a physical therapist at the University of Pittsburgh, and a panel member.

The panel, which reviewed existing English-language studies and existing guidelines from the ACR and other organizations, based its evidence-strength determinations on the quality of the evidence and the extent to which the evidence demonstrated pain relief and improved physical functionality.

The panel did not determine that any of the reviewed modalities should not be used.

“The lack of 'do not do' recommendations or suggestions means that there was no definitive evidence of harm or lack of efficacy for the interventions examined, Dr. Oatis explained.

These proposed revisions to the current ACR recommendations, which were last revised in 2000 with an update in 2005 following the withdrawal of rofecoxib from the market, are currently under review by the journal Arthritis Care and Research, and have been submitted to the ACR Committee on Quality of Care for review before they are sent the ACR board of directors for final approval, said Dr. Marc C. Hochberg, head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore.

The ACR awarded the contract for the project to the University of Maryland with Dr. Hochberg as the principal investigator. He is also a member of the project steering committee.

“Hopefully, these will come to the point where the ACR board of directors will be satisfied, and we'll have a publication in 2011,” he said.

Dr. Hochberg disclosed that he has received research support from the National Institutes of Health, and has served as a consultant or on an advisory board or data safety monitoring board for numerous pharmaceutical companies. The other presenters had no disclosures.

Water aerobics can help reduce OA pain and improve physical function, and will be recommended by the panel.

Source ©Sarto/Lund/Getty Images

Pigmentary disorders are more than just a cosmetic concern, according to Dr. Susan C. Taylor.

Studies show that disorders such as melasma and postinflammatory hyperpigmentation (PIH) are particularly common in women with darker skin, and the conditions can have a profound effect on quality of life, Dr. Taylor said at the seminar sponsored by Skin Disease Education Foundation (SDEF).

In one prospective cohort study, 47% of patients with pigmentation disorders said they felt self-conscious about their skin, 33% reported feeling unattractive, and 33% reported putting effort into hiding pigment changes. Nearly 24% said they thought their skin condition affected their activities, and 22% believed others focused on their skin (J. Cosmet. Dermatol. 2008;7:164-8).

“These conditions should be treated aggressively,” said Dr. Taylor, founding director of the Skin of Color Center at St. Luke's–Roosevelt Hospital Center in New York. For both melasma and PIH, that means using treatments that decrease melanin formation, block the transfer of melanosomes, minimize inflammation, and nonselectively suppress melanogenesis, or increase melanin removal through desquamation, she said.

Dr. Taylor said topical therapies are not curative, but they can be effective.

For melasma, triple-combination therapy with a cream containing hydroquinone (4%), retinoic acid (0.05%), and fluocinolone acetonide (0.01%) has been shown to be quite effective in multiple studies, and is Dr. Taylor's preferred treatment.

Data from two 8-week randomized trials showed that significantly more patients treated with the triple-combination cream experienced complete clearing, compared with those on dyad creams (26% vs. 5%). An extension study showed that 80% of patients who were treated with or switched to the triple-combination cream were completely cleared or nearly cleared at 12 months. Only 2.5% of patients discontinued the study because of treatment-related adverse events (J. Drugs Dermatol. 2005;4:592-7).

Other options shown to be of benefit for the topical treatment of melasma include 0.1% tretinoin cream or 20% azelaic acid cream, Dr. Taylor said.

Oral therapy with procyanidin plus vitamins A, C, and E also shows promise. In an 8-week randomized, double-blind, placebo-controlled trial in 60 Filipino women, treatment was associated with significant improvements in the left and right malar regions, and was safe and well tolerated (Int. J. Dermatol. 2009;48:896-901). However, additional studies are needed to confirm these results, she noted.

Chemical peeling agents can serve as good adjuncts to other therapies for melasma, particularly in recalcitrant cases. In one study, Dr. Taylor said, the addition of eight glycolic acid peels to topical therapy with azelaic acid and adapalene gel improved outcomes vs. the topical treatments alone. Priming agents such as 2% hydroquinone and 0.025% retinoic acid can boost the effects of such peels (J. Dermatol. 2007;34:25-30).

Finally, an emerging treatment option for melasma appears to be fractional photothermolysis.

In a pilot study, 10 female melasma patients who failed prior treatments received four to six fractional laser treatments at 1- to 2-week intervals using 1,535-nm and 1,550-nm wavelengths and 6- to 12-mJ/microthermal zone. Most patients (60%) had 75%-100% clearing, and 30% had less than 25% improvement, Dr. Taylor said (Dermatol. Surg. 2005;31:1645-50). The investigators used microdermabrasion to improve penetration to the target site, followed by an effective tyrosinase inhibitor to suppress melanocytes and remove melanin from the stratum corneum, she explained, adding that sunscreens and topical vitamin C were also used.

“Fractional resurfacing may hold the key to treatment of dermal melasma,” she said. It also appears to be useful in PIH.

A case report of its use in a patient with PIH on the neck that had failed to respond to topical therapies for 2 years showed that after 3 treatments, the patient had near-complete clearing with no postprocedural complications or recurrence at 7-month follow-up. Treatment was with a 1,550-nm wavelength erbium-doped Fraxel SR1500 laser at a fluence of 15 mJ, level of 6, with 8-10 passes (Dermatol. Surg. 2009;35:1844-8), Dr. Taylor said.

She cautioned, however, that using lasers in patients with skin of color can potentially cause PIH.

Other treatment options for PIH include hydroquinones, which remain the gold standard, and retinoids, mequinol, and azelaic acid, she said, noting that all patients with melasma and PIH should be advised to use sunblock, protective clothing, and sunglasses and to avoid ultraviolet exposure when possible.

Dr. Taylor serves on advisory boards for Beiersdorf, Johnson & Johnson, Medicis, and GlaxoSmithKline. She has been an investigator for Johnson & Johnson, Medicis, Merz, and Palomar, and is on the speakers bureau of Medicis and Stiefel. She owns stock in T2 Skincare.

SDEF and this news organization are owned by Elsevier.

Melasma, seen here on the cheeks, should be treated aggressively.

Source ©2007 Elsevier Inc.

Pigmentary disorders are more than just a cosmetic concern, according to Dr. Susan C. Taylor.

Studies show that disorders such as melasma and postinflammatory hyperpigmentation (PIH) are particularly common in women with darker skin, and the conditions can have a profound effect on quality of life, Dr. Taylor said at the seminar sponsored by Skin Disease Education Foundation (SDEF).

In one prospective cohort study, 47% of patients with pigmentation disorders said they felt self-conscious about their skin, 33% reported feeling unattractive, and 33% reported putting effort into hiding pigment changes. Nearly 24% said they thought their skin condition affected their activities, and 22% believed others focused on their skin (J. Cosmet. Dermatol. 2008;7:164-8).

“These conditions should be treated aggressively,” said Dr. Taylor, founding director of the Skin of Color Center at St. Luke's–Roosevelt Hospital Center in New York. For both melasma and PIH, that means using treatments that decrease melanin formation, block the transfer of melanosomes, minimize inflammation, and nonselectively suppress melanogenesis, or increase melanin removal through desquamation, she said.

Dr. Taylor said topical therapies are not curative, but they can be effective.

For melasma, triple-combination therapy with a cream containing hydroquinone (4%), retinoic acid (0.05%), and fluocinolone acetonide (0.01%) has been shown to be quite effective in multiple studies, and is Dr. Taylor's preferred treatment.

Data from two 8-week randomized trials showed that significantly more patients treated with the triple-combination cream experienced complete clearing, compared with those on dyad creams (26% vs. 5%). An extension study showed that 80% of patients who were treated with or switched to the triple-combination cream were completely cleared or nearly cleared at 12 months. Only 2.5% of patients discontinued the study because of treatment-related adverse events (J. Drugs Dermatol. 2005;4:592-7).

Other options shown to be of benefit for the topical treatment of melasma include 0.1% tretinoin cream or 20% azelaic acid cream, Dr. Taylor said.

Oral therapy with procyanidin plus vitamins A, C, and E also shows promise. In an 8-week randomized, double-blind, placebo-controlled trial in 60 Filipino women, treatment was associated with significant improvements in the left and right malar regions, and was safe and well tolerated (Int. J. Dermatol. 2009;48:896-901). However, additional studies are needed to confirm these results, she noted.

Chemical peeling agents can serve as good adjuncts to other therapies for melasma, particularly in recalcitrant cases. In one study, Dr. Taylor said, the addition of eight glycolic acid peels to topical therapy with azelaic acid and adapalene gel improved outcomes vs. the topical treatments alone. Priming agents such as 2% hydroquinone and 0.025% retinoic acid can boost the effects of such peels (J. Dermatol. 2007;34:25-30).

Finally, an emerging treatment option for melasma appears to be fractional photothermolysis.

In a pilot study, 10 female melasma patients who failed prior treatments received four to six fractional laser treatments at 1- to 2-week intervals using 1,535-nm and 1,550-nm wavelengths and 6- to 12-mJ/microthermal zone. Most patients (60%) had 75%-100% clearing, and 30% had less than 25% improvement, Dr. Taylor said (Dermatol. Surg. 2005;31:1645-50). The investigators used microdermabrasion to improve penetration to the target site, followed by an effective tyrosinase inhibitor to suppress melanocytes and remove melanin from the stratum corneum, she explained, adding that sunscreens and topical vitamin C were also used.

“Fractional resurfacing may hold the key to treatment of dermal melasma,” she said. It also appears to be useful in PIH.

A case report of its use in a patient with PIH on the neck that had failed to respond to topical therapies for 2 years showed that after 3 treatments, the patient had near-complete clearing with no postprocedural complications or recurrence at 7-month follow-up. Treatment was with a 1,550-nm wavelength erbium-doped Fraxel SR1500 laser at a fluence of 15 mJ, level of 6, with 8-10 passes (Dermatol. Surg. 2009;35:1844-8), Dr. Taylor said.

She cautioned, however, that using lasers in patients with skin of color can potentially cause PIH.

Other treatment options for PIH include hydroquinones, which remain the gold standard, and retinoids, mequinol, and azelaic acid, she said, noting that all patients with melasma and PIH should be advised to use sunblock, protective clothing, and sunglasses and to avoid ultraviolet exposure when possible.

Dr. Taylor serves on advisory boards for Beiersdorf, Johnson & Johnson, Medicis, and GlaxoSmithKline. She has been an investigator for Johnson & Johnson, Medicis, Merz, and Palomar, and is on the speakers bureau of Medicis and Stiefel. She owns stock in T2 Skincare.

SDEF and this news organization are owned by Elsevier.

Melasma, seen here on the cheeks, should be treated aggressively.

Source ©2007 Elsevier Inc.

Pigmentary disorders are more than just a cosmetic concern, according to Dr. Susan C. Taylor.

Studies show that disorders such as melasma and postinflammatory hyperpigmentation (PIH) are particularly common in women with darker skin, and the conditions can have a profound effect on quality of life, Dr. Taylor said at the seminar sponsored by Skin Disease Education Foundation (SDEF).

In one prospective cohort study, 47% of patients with pigmentation disorders said they felt self-conscious about their skin, 33% reported feeling unattractive, and 33% reported putting effort into hiding pigment changes. Nearly 24% said they thought their skin condition affected their activities, and 22% believed others focused on their skin (J. Cosmet. Dermatol. 2008;7:164-8).

“These conditions should be treated aggressively,” said Dr. Taylor, founding director of the Skin of Color Center at St. Luke's–Roosevelt Hospital Center in New York. For both melasma and PIH, that means using treatments that decrease melanin formation, block the transfer of melanosomes, minimize inflammation, and nonselectively suppress melanogenesis, or increase melanin removal through desquamation, she said.

Dr. Taylor said topical therapies are not curative, but they can be effective.

For melasma, triple-combination therapy with a cream containing hydroquinone (4%), retinoic acid (0.05%), and fluocinolone acetonide (0.01%) has been shown to be quite effective in multiple studies, and is Dr. Taylor's preferred treatment.

Data from two 8-week randomized trials showed that significantly more patients treated with the triple-combination cream experienced complete clearing, compared with those on dyad creams (26% vs. 5%). An extension study showed that 80% of patients who were treated with or switched to the triple-combination cream were completely cleared or nearly cleared at 12 months. Only 2.5% of patients discontinued the study because of treatment-related adverse events (J. Drugs Dermatol. 2005;4:592-7).

Other options shown to be of benefit for the topical treatment of melasma include 0.1% tretinoin cream or 20% azelaic acid cream, Dr. Taylor said.

Oral therapy with procyanidin plus vitamins A, C, and E also shows promise. In an 8-week randomized, double-blind, placebo-controlled trial in 60 Filipino women, treatment was associated with significant improvements in the left and right malar regions, and was safe and well tolerated (Int. J. Dermatol. 2009;48:896-901). However, additional studies are needed to confirm these results, she noted.

Chemical peeling agents can serve as good adjuncts to other therapies for melasma, particularly in recalcitrant cases. In one study, Dr. Taylor said, the addition of eight glycolic acid peels to topical therapy with azelaic acid and adapalene gel improved outcomes vs. the topical treatments alone. Priming agents such as 2% hydroquinone and 0.025% retinoic acid can boost the effects of such peels (J. Dermatol. 2007;34:25-30).

Finally, an emerging treatment option for melasma appears to be fractional photothermolysis.

In a pilot study, 10 female melasma patients who failed prior treatments received four to six fractional laser treatments at 1- to 2-week intervals using 1,535-nm and 1,550-nm wavelengths and 6- to 12-mJ/microthermal zone. Most patients (60%) had 75%-100% clearing, and 30% had less than 25% improvement, Dr. Taylor said (Dermatol. Surg. 2005;31:1645-50). The investigators used microdermabrasion to improve penetration to the target site, followed by an effective tyrosinase inhibitor to suppress melanocytes and remove melanin from the stratum corneum, she explained, adding that sunscreens and topical vitamin C were also used.

“Fractional resurfacing may hold the key to treatment of dermal melasma,” she said. It also appears to be useful in PIH.

A case report of its use in a patient with PIH on the neck that had failed to respond to topical therapies for 2 years showed that after 3 treatments, the patient had near-complete clearing with no postprocedural complications or recurrence at 7-month follow-up. Treatment was with a 1,550-nm wavelength erbium-doped Fraxel SR1500 laser at a fluence of 15 mJ, level of 6, with 8-10 passes (Dermatol. Surg. 2009;35:1844-8), Dr. Taylor said.

She cautioned, however, that using lasers in patients with skin of color can potentially cause PIH.

Other treatment options for PIH include hydroquinones, which remain the gold standard, and retinoids, mequinol, and azelaic acid, she said, noting that all patients with melasma and PIH should be advised to use sunblock, protective clothing, and sunglasses and to avoid ultraviolet exposure when possible.

Dr. Taylor serves on advisory boards for Beiersdorf, Johnson & Johnson, Medicis, and GlaxoSmithKline. She has been an investigator for Johnson & Johnson, Medicis, Merz, and Palomar, and is on the speakers bureau of Medicis and Stiefel. She owns stock in T2 Skincare.

SDEF and this news organization are owned by Elsevier.

Melasma, seen here on the cheeks, should be treated aggressively.

Source ©2007 Elsevier Inc.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its "ambitious, yet achievable" 10-year agenda for improving the nation’s health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

[Healthy People Launches 2020 Goals]

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders improves health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

"Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days," the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a "well-coordinated strategy to improve sleep-related health."

Objectives are to:

• Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

• Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

• Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

• Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to "promote respiratory health through better prevention, detection, treatment, and education efforts," according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to "provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation."

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

• Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

• Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

• Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion. The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its "ambitious, yet achievable" 10-year agenda for improving the nation’s health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

[Healthy People Launches 2020 Goals]

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders improves health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

"Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days," the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a "well-coordinated strategy to improve sleep-related health."

Objectives are to:

• Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

• Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

• Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

• Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to "promote respiratory health through better prevention, detection, treatment, and education efforts," according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to "provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation."

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

• Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

• Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

• Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion. The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its "ambitious, yet achievable" 10-year agenda for improving the nation’s health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

[Healthy People Launches 2020 Goals]

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders improves health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

"Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days," the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a "well-coordinated strategy to improve sleep-related health."

Objectives are to:

• Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

• Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

• Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

• Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to "promote respiratory health through better prevention, detection, treatment, and education efforts," according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to "provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation."

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

• Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

• Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

• Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion. The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its "ambitious, yet achievable" 10-year agenda for improving the nation’s health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

[Healthy People Launches 2020 Goals]

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders improves health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

"Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days," the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a "well-coordinated strategy to improve sleep-related health."

Objectives are to:

• Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

• Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

• Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

• Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to "promote respiratory health through better prevention, detection, treatment, and education efforts," according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to "provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation."

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

• Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

• Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

• Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion. The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its "ambitious, yet achievable" 10-year agenda for improving the nation’s health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

[Healthy People Launches 2020 Goals]

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders improves health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

"Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days," the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a "well-coordinated strategy to improve sleep-related health."

Objectives are to:

• Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

• Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

• Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

• Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to "promote respiratory health through better prevention, detection, treatment, and education efforts," according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to "provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation."

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

• Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

• Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

• Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion. The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its "ambitious, yet achievable" 10-year agenda for improving the nation’s health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

[Healthy People Launches 2020 Goals]

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders improves health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

"Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days," the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a "well-coordinated strategy to improve sleep-related health."

Objectives are to:

• Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

• Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

• Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

• Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to "promote respiratory health through better prevention, detection, treatment, and education efforts," according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to "provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation."

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

• Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

• Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

• Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion. The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

ATLANTA – Mycophenolate mofetil was superior to azathioprine for lupus nephritis maintenance therapy in the 36-month maintenance phase of the Aspreva Lupus Management Study.

Patients who had a partial or complete response to corticosteroids and either mycophenolate mofetil (MMF) or intravenous cyclophosphamide during the 24-week induction phase of the international, randomized, controlled ALMS trial were re-randomized to a double-blind comparison of oral MMF or azathioprine (AZA) for maintenance. In 227 patients in the maintenance phase, MMF, compared with AZA, was associated with significantly longer time to treatment failure, which was defined as a composite of renal flare, sustained doubling of serum creatinine, initiation of rescue therapy for lupus nephritis, progression to end-stage renal disease, or death, Dr. Ellen M. Ginzler reported at the annual meeting of the American College of Rheumatology.

[Check out our coverage of the American College of Rheumatology's annual meeting.]

The probability of being event free at 36 months was about 0.8 and 0.6 in the MMF- and AZA-treated patients, respectively, said Dr. Ginzler of the State University of New York-Downtown Medical Center, Brooklyn.

Similarly, the probability of freedom from renal flare – which was the most common component of the primary end point composite – was greater in the MMF-treated patients than in the AZA-treated patients (about 0.85 vs. about 0.75 at 36 months, respectively).

"During the 3-year maintenance follow-up, overall, 16% of MMF-treated and 32% of AZA-treated subjects progressed to the primary end point of treatment failure," Dr. Ginzler said, noting that when assessed by the type of induction treatment received, fewer intravenous cyclophosphamide induction subjects than MMF induction subjects were treatment failures in the maintenance phase, but MMF (for maintenance) remained superior to AZA for both induction subsets.

Similarly, failure rates were consistently in favor of MMF for all races (although only statistically significantly for blacks), and for all geographic regions evaluated, she noted.

MMF also was superior to AZA on all secondary end points (end-stage renal disease, renal flare, doubling of creatinine, and need for rescue meds), as well as on a secondary efficacy end point that used a broader definition of time to treatment failure: a composite of development of major extra-renal flares, a need for rescue therapy not permitted in the study protocol for extrarenal flares, and withdrawal from the study for any reason.

"Although not statistically significantly different among the two treatment groups, MMF-treated subjects had a better outcome based on all efficacy end points," Dr. Ginzler said.

She also noted that historically, at the conclusion of induction therapy for lupus nephritis, the percentage of patients who achieve complete remission is disappointing. Often, however, patients with a partial response continue to improve during maintenance therapy.

"This is clearly the case overall in the ALMS trial, which demonstrates no difference between MMF and AZA in rate of development of complete renal remission," she said.

MMF in the maintenance phase was given at a target dose of 1 g twice daily, and AZA was given at a target dose of 2 mg/kg per day. Dose adjustments were allowed (up to 3 g twice daily and 3 mg/kg per day for MMF and AZA, respectively) and prednisone was allowed at a maximum dose of 10 mg/day or equivalent.

Both treatments were well tolerated, with a similar incidence of adverse events in both groups, although lupus-related adverse events and serious adverse events were more frequent in the azathioprine group. The most common adverse events were infections/infestations, and gastrointestinal disorders.

Also, the two treatment groups were similar in regard to demographic and disease characteristics, Dr. Ginzler said.

"In conclusion, the ALMS trial demonstrated improved clinical benefit for MMF over azathioprine as maintenance therapy for lupus nephritis," she said.

Dr. Ginzler is a member of ALMS steering committee, which is sponsored by ViforPharma.

ATLANTA – Mycophenolate mofetil was superior to azathioprine for lupus nephritis maintenance therapy in the 36-month maintenance phase of the Aspreva Lupus Management Study.

Patients who had a partial or complete response to corticosteroids and either mycophenolate mofetil (MMF) or intravenous cyclophosphamide during the 24-week induction phase of the international, randomized, controlled ALMS trial were re-randomized to a double-blind comparison of oral MMF or azathioprine (AZA) for maintenance. In 227 patients in the maintenance phase, MMF, compared with AZA, was associated with significantly longer time to treatment failure, which was defined as a composite of renal flare, sustained doubling of serum creatinine, initiation of rescue therapy for lupus nephritis, progression to end-stage renal disease, or death, Dr. Ellen M. Ginzler reported at the annual meeting of the American College of Rheumatology.

[Check out our coverage of the American College of Rheumatology's annual meeting.]

The probability of being event free at 36 months was about 0.8 and 0.6 in the MMF- and AZA-treated patients, respectively, said Dr. Ginzler of the State University of New York-Downtown Medical Center, Brooklyn.

Similarly, the probability of freedom from renal flare – which was the most common component of the primary end point composite – was greater in the MMF-treated patients than in the AZA-treated patients (about 0.85 vs. about 0.75 at 36 months, respectively).

"During the 3-year maintenance follow-up, overall, 16% of MMF-treated and 32% of AZA-treated subjects progressed to the primary end point of treatment failure," Dr. Ginzler said, noting that when assessed by the type of induction treatment received, fewer intravenous cyclophosphamide induction subjects than MMF induction subjects were treatment failures in the maintenance phase, but MMF (for maintenance) remained superior to AZA for both induction subsets.

Similarly, failure rates were consistently in favor of MMF for all races (although only statistically significantly for blacks), and for all geographic regions evaluated, she noted.

MMF also was superior to AZA on all secondary end points (end-stage renal disease, renal flare, doubling of creatinine, and need for rescue meds), as well as on a secondary efficacy end point that used a broader definition of time to treatment failure: a composite of development of major extra-renal flares, a need for rescue therapy not permitted in the study protocol for extrarenal flares, and withdrawal from the study for any reason.

"Although not statistically significantly different among the two treatment groups, MMF-treated subjects had a better outcome based on all efficacy end points," Dr. Ginzler said.

She also noted that historically, at the conclusion of induction therapy for lupus nephritis, the percentage of patients who achieve complete remission is disappointing. Often, however, patients with a partial response continue to improve during maintenance therapy.

"This is clearly the case overall in the ALMS trial, which demonstrates no difference between MMF and AZA in rate of development of complete renal remission," she said.

MMF in the maintenance phase was given at a target dose of 1 g twice daily, and AZA was given at a target dose of 2 mg/kg per day. Dose adjustments were allowed (up to 3 g twice daily and 3 mg/kg per day for MMF and AZA, respectively) and prednisone was allowed at a maximum dose of 10 mg/day or equivalent.

Both treatments were well tolerated, with a similar incidence of adverse events in both groups, although lupus-related adverse events and serious adverse events were more frequent in the azathioprine group. The most common adverse events were infections/infestations, and gastrointestinal disorders.

Also, the two treatment groups were similar in regard to demographic and disease characteristics, Dr. Ginzler said.

"In conclusion, the ALMS trial demonstrated improved clinical benefit for MMF over azathioprine as maintenance therapy for lupus nephritis," she said.

Dr. Ginzler is a member of ALMS steering committee, which is sponsored by ViforPharma.

ATLANTA – Mycophenolate mofetil was superior to azathioprine for lupus nephritis maintenance therapy in the 36-month maintenance phase of the Aspreva Lupus Management Study.

Patients who had a partial or complete response to corticosteroids and either mycophenolate mofetil (MMF) or intravenous cyclophosphamide during the 24-week induction phase of the international, randomized, controlled ALMS trial were re-randomized to a double-blind comparison of oral MMF or azathioprine (AZA) for maintenance. In 227 patients in the maintenance phase, MMF, compared with AZA, was associated with significantly longer time to treatment failure, which was defined as a composite of renal flare, sustained doubling of serum creatinine, initiation of rescue therapy for lupus nephritis, progression to end-stage renal disease, or death, Dr. Ellen M. Ginzler reported at the annual meeting of the American College of Rheumatology.

[Check out our coverage of the American College of Rheumatology's annual meeting.]

The probability of being event free at 36 months was about 0.8 and 0.6 in the MMF- and AZA-treated patients, respectively, said Dr. Ginzler of the State University of New York-Downtown Medical Center, Brooklyn.

Similarly, the probability of freedom from renal flare – which was the most common component of the primary end point composite – was greater in the MMF-treated patients than in the AZA-treated patients (about 0.85 vs. about 0.75 at 36 months, respectively).

"During the 3-year maintenance follow-up, overall, 16% of MMF-treated and 32% of AZA-treated subjects progressed to the primary end point of treatment failure," Dr. Ginzler said, noting that when assessed by the type of induction treatment received, fewer intravenous cyclophosphamide induction subjects than MMF induction subjects were treatment failures in the maintenance phase, but MMF (for maintenance) remained superior to AZA for both induction subsets.

Similarly, failure rates were consistently in favor of MMF for all races (although only statistically significantly for blacks), and for all geographic regions evaluated, she noted.

MMF also was superior to AZA on all secondary end points (end-stage renal disease, renal flare, doubling of creatinine, and need for rescue meds), as well as on a secondary efficacy end point that used a broader definition of time to treatment failure: a composite of development of major extra-renal flares, a need for rescue therapy not permitted in the study protocol for extrarenal flares, and withdrawal from the study for any reason.

"Although not statistically significantly different among the two treatment groups, MMF-treated subjects had a better outcome based on all efficacy end points," Dr. Ginzler said.

She also noted that historically, at the conclusion of induction therapy for lupus nephritis, the percentage of patients who achieve complete remission is disappointing. Often, however, patients with a partial response continue to improve during maintenance therapy.

"This is clearly the case overall in the ALMS trial, which demonstrates no difference between MMF and AZA in rate of development of complete renal remission," she said.

MMF in the maintenance phase was given at a target dose of 1 g twice daily, and AZA was given at a target dose of 2 mg/kg per day. Dose adjustments were allowed (up to 3 g twice daily and 3 mg/kg per day for MMF and AZA, respectively) and prednisone was allowed at a maximum dose of 10 mg/day or equivalent.

Both treatments were well tolerated, with a similar incidence of adverse events in both groups, although lupus-related adverse events and serious adverse events were more frequent in the azathioprine group. The most common adverse events were infections/infestations, and gastrointestinal disorders.

Also, the two treatment groups were similar in regard to demographic and disease characteristics, Dr. Ginzler said.

"In conclusion, the ALMS trial demonstrated improved clinical benefit for MMF over azathioprine as maintenance therapy for lupus nephritis," she said.

Dr. Ginzler is a member of ALMS steering committee, which is sponsored by ViforPharma.

ATLANTA – Getting to the place in rheumatoid arthritis therapy where remission is a possibility has been much like the process of conquering a treacherous mountain, according to Dr. Duncan Porter.

Early climbers struggled and failed, but lessons were learned, better equipment was developed, and those who followed in the footsteps of the pioneers achieved what was once thought to be impossible.

"In rheumatology, we have had our own mountain to climb: Twenty years ago we were still puttering around in the foothills with symptom control, through the ’80s and ’90s we were developing increasing evidence that confirmed that conventional disease-modifying drugs ... truly did modify disease activity, but it’s been only recently that we’ve come to focus on the possibility of achieving remission," he said at the annual meeting of the American College of Rheumatology.

Now the top of the mountain is being reached "a good deal more often and a good deal more quickly," he said, citing findings from the Dutch Rheumatoid Arthritis Monitoring (DREAM) cohort study, which were also presented at the meeting, showing that in 64% of 534 patients with newly diagnosed RA, remission was rapidly achieved with a tight control treatment strategy (Arthritis Rheum. 2010;62[supple.]:abstract 662).

"I think the reason we’re getting there is because we’ve got better equipment, so we’ve got more drugs to employ," Dr. Porter said, adding that although the "better equipment" includes biologics, the improvements are primarily due to the new strategies of care.

"It’s how we attack the mountain, it’s how we deploy the drugs that we have, that has yielded the greatest improvements in outcome," said Dr. Porter of the University of Glasgow (Scotland).

The treatment strategies he discussed included intensive management, treatment to target, combination disease-modifying anti-rheumatic drug (DMARD) strategies, and remission induction.

Although intensive management and treatment to target often overlap, they are not the same, he stressed.

Intensive management, using monthly patient visits, liberal intramuscular and intra-articular steroid injections, escalation of therapy for persistent disease, and step-up dosing, has been shown to be highly effective for inducing remission. In the TICORA (Tight Control for Rheumatoid Arthritis) study (Lancet 2004;364:263-9), for example, 65% of patients achieved remission, compared with 16% of patients who did not receive intensive management.

Treatment to target was a component of that study, but treatment to target doesn’t necessarily include intensive management components, Dr. Porter explained, adding, "I think that may be significant."

Nonetheless, a recent literature review concluded that although few studies have used a randomized approach to test the value of treatment to target strategies, there is "unanimous" and "compelling" evidence that targeted approaches are of benefit (Ann. Rheum. Dis. 2010;69:638-43).

When using a treatment to target strategy, it is important to measure progress toward the target and to adjust therapy accordingly based on clinical judgment. Targets can be based on disease activity scores, or they can be based on remission, ultrasound findings, or biomarkers.

"If nothing else, using [the] disease activity score and applying it to treat to target and intensive management strategies has simply been proven to work," Dr. Porter said, adding that "starting [patients] on methotrexate and sending them away for 6 months is no longer acceptable."

Because most studies use a constant dose of the study drug, interpretation in terms of treatment to target strategies can be difficult, as that’s not the way treatment to target works, and it’s not the way most physicians practice, he said.

"Keeping that in mind is critical if we’re to ... come to the best strategy," he added.

One area where it is important to make a distinction between intensive management and treatment to target is with the third strategy Dr. Porter discussed: the combined use of DMARDs. These can include step-up, step-down, and parallel therapy.

In the Bone Estrogen Strength Training (BEST) study, for example, treatment to target, but not intensive management, was used. Four strategies were evaluated, including sequential monotherapy, step-up combination therapy, initial combination therapy plus steroids, and initial biologic therapy.

At 2 years, the groups were identical, and importantly, 39% of patients had sustained low disease activity on monotherapy (Arthritis Rheum. 2005;52:3381-90).

"I think that’s quite important if we’re to avoid overtreating patients with multiple drugs when they will just do fine on one drug alone," he said.

Other studies have compared various combinations, and showed that nothing is lost in waiting to see whether combination therapy versus monotherapy is needed. As for the use of biologics, the decision must be based on the complex synthesis of knowledge about efficacy, toxicity, and cost.

A key factor – and a challenge – is knowing the clinical significance of small numbers of Sharp score changes, particularly when you recognize that there is no evidence at all of a window of opportunity when it comes to biologic therapy and halting radiographic progression, Dr. Porter said.

The final strategy – remission induction – remains largely uncharacterized, he said, noting that there are few good studies, and more definitive research is needed to clarify its role.

"By and large we need to maintain the therapies we’ve started that get our patients into remission, and by and large we cannot plan to withdraw therapies large scale. ... There’s little compelling evidence, as far as I can see, of early aggressive therapy of any form that can substantially and permanently modify disease processes such that therapy can be withdrawn," Dr. Porter said.

That suggests that while we are doing much better than 20 years ago in terms of climbing the RA therapy mountain, the summit has not been reached. And if the RA therapy goals of drug-free remission, cure, and prevention are added to that mountain – which currently has symptom control at its base, followed by disease modification and remission, then half of the mountain remains to be conquered.

In conclusion, Dr. Porter quoted a recent editorial that accompanied another DMARD combination trial (Lancet 2009;374:430-2).

"The most important information to be gathered from clinical trials in RA is not necessarily comparison of agents, but rather the strategy of tight control aiming for remission."

Dr. Porter said he has received research funding, served as a consultant, and/or served on the speakers bureau for Abbott, Pfizer, Roche, Schering Plough, and UCB.

ATLANTA – Getting to the place in rheumatoid arthritis therapy where remission is a possibility has been much like the process of conquering a treacherous mountain, according to Dr. Duncan Porter.

Early climbers struggled and failed, but lessons were learned, better equipment was developed, and those who followed in the footsteps of the pioneers achieved what was once thought to be impossible.

"In rheumatology, we have had our own mountain to climb: Twenty years ago we were still puttering around in the foothills with symptom control, through the ’80s and ’90s we were developing increasing evidence that confirmed that conventional disease-modifying drugs ... truly did modify disease activity, but it’s been only recently that we’ve come to focus on the possibility of achieving remission," he said at the annual meeting of the American College of Rheumatology.

Now the top of the mountain is being reached "a good deal more often and a good deal more quickly," he said, citing findings from the Dutch Rheumatoid Arthritis Monitoring (DREAM) cohort study, which were also presented at the meeting, showing that in 64% of 534 patients with newly diagnosed RA, remission was rapidly achieved with a tight control treatment strategy (Arthritis Rheum. 2010;62[supple.]:abstract 662).

"I think the reason we’re getting there is because we’ve got better equipment, so we’ve got more drugs to employ," Dr. Porter said, adding that although the "better equipment" includes biologics, the improvements are primarily due to the new strategies of care.

"It’s how we attack the mountain, it’s how we deploy the drugs that we have, that has yielded the greatest improvements in outcome," said Dr. Porter of the University of Glasgow (Scotland).

The treatment strategies he discussed included intensive management, treatment to target, combination disease-modifying anti-rheumatic drug (DMARD) strategies, and remission induction.

Although intensive management and treatment to target often overlap, they are not the same, he stressed.

Intensive management, using monthly patient visits, liberal intramuscular and intra-articular steroid injections, escalation of therapy for persistent disease, and step-up dosing, has been shown to be highly effective for inducing remission. In the TICORA (Tight Control for Rheumatoid Arthritis) study (Lancet 2004;364:263-9), for example, 65% of patients achieved remission, compared with 16% of patients who did not receive intensive management.

Treatment to target was a component of that study, but treatment to target doesn’t necessarily include intensive management components, Dr. Porter explained, adding, "I think that may be significant."

Nonetheless, a recent literature review concluded that although few studies have used a randomized approach to test the value of treatment to target strategies, there is "unanimous" and "compelling" evidence that targeted approaches are of benefit (Ann. Rheum. Dis. 2010;69:638-43).

When using a treatment to target strategy, it is important to measure progress toward the target and to adjust therapy accordingly based on clinical judgment. Targets can be based on disease activity scores, or they can be based on remission, ultrasound findings, or biomarkers.

"If nothing else, using [the] disease activity score and applying it to treat to target and intensive management strategies has simply been proven to work," Dr. Porter said, adding that "starting [patients] on methotrexate and sending them away for 6 months is no longer acceptable."

Because most studies use a constant dose of the study drug, interpretation in terms of treatment to target strategies can be difficult, as that’s not the way treatment to target works, and it’s not the way most physicians practice, he said.

"Keeping that in mind is critical if we’re to ... come to the best strategy," he added.

One area where it is important to make a distinction between intensive management and treatment to target is with the third strategy Dr. Porter discussed: the combined use of DMARDs. These can include step-up, step-down, and parallel therapy.

In the Bone Estrogen Strength Training (BEST) study, for example, treatment to target, but not intensive management, was used. Four strategies were evaluated, including sequential monotherapy, step-up combination therapy, initial combination therapy plus steroids, and initial biologic therapy.

At 2 years, the groups were identical, and importantly, 39% of patients had sustained low disease activity on monotherapy (Arthritis Rheum. 2005;52:3381-90).

"I think that’s quite important if we’re to avoid overtreating patients with multiple drugs when they will just do fine on one drug alone," he said.

Other studies have compared various combinations, and showed that nothing is lost in waiting to see whether combination therapy versus monotherapy is needed. As for the use of biologics, the decision must be based on the complex synthesis of knowledge about efficacy, toxicity, and cost.

A key factor – and a challenge – is knowing the clinical significance of small numbers of Sharp score changes, particularly when you recognize that there is no evidence at all of a window of opportunity when it comes to biologic therapy and halting radiographic progression, Dr. Porter said.

The final strategy – remission induction – remains largely uncharacterized, he said, noting that there are few good studies, and more definitive research is needed to clarify its role.

"By and large we need to maintain the therapies we’ve started that get our patients into remission, and by and large we cannot plan to withdraw therapies large scale. ... There’s little compelling evidence, as far as I can see, of early aggressive therapy of any form that can substantially and permanently modify disease processes such that therapy can be withdrawn," Dr. Porter said.

That suggests that while we are doing much better than 20 years ago in terms of climbing the RA therapy mountain, the summit has not been reached. And if the RA therapy goals of drug-free remission, cure, and prevention are added to that mountain – which currently has symptom control at its base, followed by disease modification and remission, then half of the mountain remains to be conquered.

In conclusion, Dr. Porter quoted a recent editorial that accompanied another DMARD combination trial (Lancet 2009;374:430-2).

"The most important information to be gathered from clinical trials in RA is not necessarily comparison of agents, but rather the strategy of tight control aiming for remission."

Dr. Porter said he has received research funding, served as a consultant, and/or served on the speakers bureau for Abbott, Pfizer, Roche, Schering Plough, and UCB.

ATLANTA – Getting to the place in rheumatoid arthritis therapy where remission is a possibility has been much like the process of conquering a treacherous mountain, according to Dr. Duncan Porter.

Early climbers struggled and failed, but lessons were learned, better equipment was developed, and those who followed in the footsteps of the pioneers achieved what was once thought to be impossible.

"In rheumatology, we have had our own mountain to climb: Twenty years ago we were still puttering around in the foothills with symptom control, through the ’80s and ’90s we were developing increasing evidence that confirmed that conventional disease-modifying drugs ... truly did modify disease activity, but it’s been only recently that we’ve come to focus on the possibility of achieving remission," he said at the annual meeting of the American College of Rheumatology.

Now the top of the mountain is being reached "a good deal more often and a good deal more quickly," he said, citing findings from the Dutch Rheumatoid Arthritis Monitoring (DREAM) cohort study, which were also presented at the meeting, showing that in 64% of 534 patients with newly diagnosed RA, remission was rapidly achieved with a tight control treatment strategy (Arthritis Rheum. 2010;62[supple.]:abstract 662).

"I think the reason we’re getting there is because we’ve got better equipment, so we’ve got more drugs to employ," Dr. Porter said, adding that although the "better equipment" includes biologics, the improvements are primarily due to the new strategies of care.

"It’s how we attack the mountain, it’s how we deploy the drugs that we have, that has yielded the greatest improvements in outcome," said Dr. Porter of the University of Glasgow (Scotland).

The treatment strategies he discussed included intensive management, treatment to target, combination disease-modifying anti-rheumatic drug (DMARD) strategies, and remission induction.

Although intensive management and treatment to target often overlap, they are not the same, he stressed.

Intensive management, using monthly patient visits, liberal intramuscular and intra-articular steroid injections, escalation of therapy for persistent disease, and step-up dosing, has been shown to be highly effective for inducing remission. In the TICORA (Tight Control for Rheumatoid Arthritis) study (Lancet 2004;364:263-9), for example, 65% of patients achieved remission, compared with 16% of patients who did not receive intensive management.

Treatment to target was a component of that study, but treatment to target doesn’t necessarily include intensive management components, Dr. Porter explained, adding, "I think that may be significant."

Nonetheless, a recent literature review concluded that although few studies have used a randomized approach to test the value of treatment to target strategies, there is "unanimous" and "compelling" evidence that targeted approaches are of benefit (Ann. Rheum. Dis. 2010;69:638-43).

When using a treatment to target strategy, it is important to measure progress toward the target and to adjust therapy accordingly based on clinical judgment. Targets can be based on disease activity scores, or they can be based on remission, ultrasound findings, or biomarkers.

"If nothing else, using [the] disease activity score and applying it to treat to target and intensive management strategies has simply been proven to work," Dr. Porter said, adding that "starting [patients] on methotrexate and sending them away for 6 months is no longer acceptable."

Because most studies use a constant dose of the study drug, interpretation in terms of treatment to target strategies can be difficult, as that’s not the way treatment to target works, and it’s not the way most physicians practice, he said.

"Keeping that in mind is critical if we’re to ... come to the best strategy," he added.

One area where it is important to make a distinction between intensive management and treatment to target is with the third strategy Dr. Porter discussed: the combined use of DMARDs. These can include step-up, step-down, and parallel therapy.

In the Bone Estrogen Strength Training (BEST) study, for example, treatment to target, but not intensive management, was used. Four strategies were evaluated, including sequential monotherapy, step-up combination therapy, initial combination therapy plus steroids, and initial biologic therapy.

At 2 years, the groups were identical, and importantly, 39% of patients had sustained low disease activity on monotherapy (Arthritis Rheum. 2005;52:3381-90).

"I think that’s quite important if we’re to avoid overtreating patients with multiple drugs when they will just do fine on one drug alone," he said.

Other studies have compared various combinations, and showed that nothing is lost in waiting to see whether combination therapy versus monotherapy is needed. As for the use of biologics, the decision must be based on the complex synthesis of knowledge about efficacy, toxicity, and cost.

A key factor – and a challenge – is knowing the clinical significance of small numbers of Sharp score changes, particularly when you recognize that there is no evidence at all of a window of opportunity when it comes to biologic therapy and halting radiographic progression, Dr. Porter said.

The final strategy – remission induction – remains largely uncharacterized, he said, noting that there are few good studies, and more definitive research is needed to clarify its role.

"By and large we need to maintain the therapies we’ve started that get our patients into remission, and by and large we cannot plan to withdraw therapies large scale. ... There’s little compelling evidence, as far as I can see, of early aggressive therapy of any form that can substantially and permanently modify disease processes such that therapy can be withdrawn," Dr. Porter said.

That suggests that while we are doing much better than 20 years ago in terms of climbing the RA therapy mountain, the summit has not been reached. And if the RA therapy goals of drug-free remission, cure, and prevention are added to that mountain – which currently has symptom control at its base, followed by disease modification and remission, then half of the mountain remains to be conquered.

In conclusion, Dr. Porter quoted a recent editorial that accompanied another DMARD combination trial (Lancet 2009;374:430-2).

"The most important information to be gathered from clinical trials in RA is not necessarily comparison of agents, but rather the strategy of tight control aiming for remission."

Dr. Porter said he has received research funding, served as a consultant, and/or served on the speakers bureau for Abbott, Pfizer, Roche, Schering Plough, and UCB.

Major Finding: In one study of 276 patients who had undergone multiple surgeries for repair and 122 patients undergoing primary repair, success rates using the new transverse repair technique were 91% at 12 months in 150 patients whose surgery involved sutures only, and 92% at 12 months in the remaining patients who were treated with Surgisis Biodesign biologic mesh.

Data Source: Preliminary studies of more than 500 patients.

Disclosures: Dr. Kovac disclosed that the department of gynecology and obstetrics at Emory University, Atlanta, is paid by Cook Medical for teaching activities he performs regarding Surgisis Biodesign for cystocele repair.

ST. LOUIS – A new surgical approach that addresses the anatomical cause of anterior vaginal wall prolapse has much higher success rates than do standard midline and paravaginal repairs that simply reduce the bulge, preliminary results in more than 500 patients suggest.

Success rates with the new procedure, which involves transverse defect repair, have been 91%-95% based on preliminary reports, compared with 40%-60% with traditional colporrhaphy – and even less when the complications associated with the increasing use of synthetic mesh come into play, Dr. S. Robert Kovac reported at the conference, which was sponsored by the Society of Pelvic Reconstructive Surgeons.

The findings regarding the new technique, which have been submitted for publication, need to be confirmed in additional studies. However, it appears that the approach, which does not require plication, trocars, or synthetic mesh, is quite promising for improving outcomes, Dr. Kovac said, adding that the key to successful treatment is finding the cause of the problem, understanding it, and treating it correctly.

“It's not the material you use, it's the technique you use,” he said.

In one study of 276 patients who had undergone multiple surgeries for repair and 122 patients undergoing primary repair, success rates using the new transverse repair technique were 91% at 12 months in 150 patients whose surgery involved sutures only, and 92% at 12 months in the remaining patients who were treated with Surgisis Biodesign (Cook Medical Inc.), said Dr. Kovac, the John D. Thompson Distinguished Professor of Gynecologic Surgery and director of the center for pelvic reconstructive surgery and urogynecology at Emory University, Atlanta.

The success rate was greater than 95% in a separate study involving 122 patients with stage III or IV prolapse who underwent primary repair using Surgisis Biodesign and were followed for 12 months, Dr. Kovac said.

The new transverse defect repair technique involves reattaching the pubocervical fascia to the pericervical ring to correct the transverse defect. This is followed by providing apical support to the iliococcygeal fascia and then to the retroperitoneal uterosacral ligaments at the level of their insertion at S2-S3.

The theory behind this approach to anterior vaginal wall prolapse is based on anatomical childbirth studies that provide “very, very strong evidence” demonstrating that transverse defects, and not midline or paravaginal defects, are the cause of cystocele, he explained.

The reason failure rates are so high with traditional colporrhaphy is because the source of the problem is not treated, Dr. Kovac said.

He noted that despite consistently poor results, 80% of gynecologists are still using “this 100-year-old technique.”

Major Finding: In one study of 276 patients who had undergone multiple surgeries for repair and 122 patients undergoing primary repair, success rates using the new transverse repair technique were 91% at 12 months in 150 patients whose surgery involved sutures only, and 92% at 12 months in the remaining patients who were treated with Surgisis Biodesign biologic mesh.

Data Source: Preliminary studies of more than 500 patients.

Disclosures: Dr. Kovac disclosed that the department of gynecology and obstetrics at Emory University, Atlanta, is paid by Cook Medical for teaching activities he performs regarding Surgisis Biodesign for cystocele repair.

ST. LOUIS – A new surgical approach that addresses the anatomical cause of anterior vaginal wall prolapse has much higher success rates than do standard midline and paravaginal repairs that simply reduce the bulge, preliminary results in more than 500 patients suggest.

Success rates with the new procedure, which involves transverse defect repair, have been 91%-95% based on preliminary reports, compared with 40%-60% with traditional colporrhaphy – and even less when the complications associated with the increasing use of synthetic mesh come into play, Dr. S. Robert Kovac reported at the conference, which was sponsored by the Society of Pelvic Reconstructive Surgeons.

The findings regarding the new technique, which have been submitted for publication, need to be confirmed in additional studies. However, it appears that the approach, which does not require plication, trocars, or synthetic mesh, is quite promising for improving outcomes, Dr. Kovac said, adding that the key to successful treatment is finding the cause of the problem, understanding it, and treating it correctly.

“It's not the material you use, it's the technique you use,” he said.

In one study of 276 patients who had undergone multiple surgeries for repair and 122 patients undergoing primary repair, success rates using the new transverse repair technique were 91% at 12 months in 150 patients whose surgery involved sutures only, and 92% at 12 months in the remaining patients who were treated with Surgisis Biodesign (Cook Medical Inc.), said Dr. Kovac, the John D. Thompson Distinguished Professor of Gynecologic Surgery and director of the center for pelvic reconstructive surgery and urogynecology at Emory University, Atlanta.

The success rate was greater than 95% in a separate study involving 122 patients with stage III or IV prolapse who underwent primary repair using Surgisis Biodesign and were followed for 12 months, Dr. Kovac said.

The new transverse defect repair technique involves reattaching the pubocervical fascia to the pericervical ring to correct the transverse defect. This is followed by providing apical support to the iliococcygeal fascia and then to the retroperitoneal uterosacral ligaments at the level of their insertion at S2-S3.

The theory behind this approach to anterior vaginal wall prolapse is based on anatomical childbirth studies that provide “very, very strong evidence” demonstrating that transverse defects, and not midline or paravaginal defects, are the cause of cystocele, he explained.

The reason failure rates are so high with traditional colporrhaphy is because the source of the problem is not treated, Dr. Kovac said.

He noted that despite consistently poor results, 80% of gynecologists are still using “this 100-year-old technique.”

Major Finding: In one study of 276 patients who had undergone multiple surgeries for repair and 122 patients undergoing primary repair, success rates using the new transverse repair technique were 91% at 12 months in 150 patients whose surgery involved sutures only, and 92% at 12 months in the remaining patients who were treated with Surgisis Biodesign biologic mesh.

Data Source: Preliminary studies of more than 500 patients.

Disclosures: Dr. Kovac disclosed that the department of gynecology and obstetrics at Emory University, Atlanta, is paid by Cook Medical for teaching activities he performs regarding Surgisis Biodesign for cystocele repair.

ST. LOUIS – A new surgical approach that addresses the anatomical cause of anterior vaginal wall prolapse has much higher success rates than do standard midline and paravaginal repairs that simply reduce the bulge, preliminary results in more than 500 patients suggest.

Success rates with the new procedure, which involves transverse defect repair, have been 91%-95% based on preliminary reports, compared with 40%-60% with traditional colporrhaphy – and even less when the complications associated with the increasing use of synthetic mesh come into play, Dr. S. Robert Kovac reported at the conference, which was sponsored by the Society of Pelvic Reconstructive Surgeons.

The findings regarding the new technique, which have been submitted for publication, need to be confirmed in additional studies. However, it appears that the approach, which does not require plication, trocars, or synthetic mesh, is quite promising for improving outcomes, Dr. Kovac said, adding that the key to successful treatment is finding the cause of the problem, understanding it, and treating it correctly.

“It's not the material you use, it's the technique you use,” he said.

In one study of 276 patients who had undergone multiple surgeries for repair and 122 patients undergoing primary repair, success rates using the new transverse repair technique were 91% at 12 months in 150 patients whose surgery involved sutures only, and 92% at 12 months in the remaining patients who were treated with Surgisis Biodesign (Cook Medical Inc.), said Dr. Kovac, the John D. Thompson Distinguished Professor of Gynecologic Surgery and director of the center for pelvic reconstructive surgery and urogynecology at Emory University, Atlanta.

The success rate was greater than 95% in a separate study involving 122 patients with stage III or IV prolapse who underwent primary repair using Surgisis Biodesign and were followed for 12 months, Dr. Kovac said.

The new transverse defect repair technique involves reattaching the pubocervical fascia to the pericervical ring to correct the transverse defect. This is followed by providing apical support to the iliococcygeal fascia and then to the retroperitoneal uterosacral ligaments at the level of their insertion at S2-S3.

The theory behind this approach to anterior vaginal wall prolapse is based on anatomical childbirth studies that provide “very, very strong evidence” demonstrating that transverse defects, and not midline or paravaginal defects, are the cause of cystocele, he explained.

The reason failure rates are so high with traditional colporrhaphy is because the source of the problem is not treated, Dr. Kovac said.

He noted that despite consistently poor results, 80% of gynecologists are still using “this 100-year-old technique.”