In the News for the Week of 7-18-06
Clinical news in the headlines
- Annals: The risks, prevention and treatment of adolescent obesity
- Preemptive surgery reduces cancer risks
- Risks may outweigh preventive benefits of raloxifene
- Type 2 diabetes drug back on the market
- Liability program offers discounts to Members who recertify
Clinical news in the headlines
The following articles appear in the July 18 issue of Annals of Internal Medicine. Two articles and an editorial in this issue focus on adolescent obesity. Full text is available to College members and subscribers online.
Adolescent female obesity can lead to premature death as an adult. A study of 102,400 female nurses found that a higher than normal body mass index (BMI) at age 18 was associated with greater risk for death than a normal BMI, even after statistical adjustment for risk factors such as smoking, alcohol use and physical activity. The participants, who were age 24 to 44 at the start of the 12-year study, recalled their weight at age 18. A total of 710 participants died.
Diet drug plus therapy helped very obese adolescents lose weight. In a 22-center study of 498 severely obese adolescents, those who received the diet drug sibutramine along with behavior therapy lost an average of 14 pounds at the end of one year of treatment, while a group who received a placebo with the therapy gained about four pounds. The sibutramine group also had improved profiles of several heart risk factors, such as triglyceride levels, high-density lipoprotein cholesterol levels, insulin levels, and insulin sensitivity. The participants, who were age 12 to16, weighed on average 215 pounds at the beginning of the study.
Prevention of obesity is best long-term solution. An accompanying editorial noted that the sibutramine study does not show what part of the weight loss came from the drug, increased physical activity or counseling. For long-term success, and to avoid the risk of premature death, people must avoid regaining the excess weight lost during treatment but that does not necessarily mean taking the diet drug for life. Since drug therapy is likely to have higher lifetime risks and costs than behavioral interventions, physicians should aim for sustained behavior change and reserve drug therapy for the most severe cases.
Preventive surgery can dramatically reduce the risk of ovarian and fallopian tube cancer in women with BRCA1 and BRCA2 mutations, according to a recent study.
Of the 1,828 women with the BRCA1 or BRCA2 mutations included in the study, 30% had undergone bilateral prophylactic salpingo-oophorectomy, 27% had surgery during the study period and 43% did not undergo the procedure. Researchers noted an 80% overall reduction in risk for ovarian, fallopian tube and peritoneal cancer among women who underwent oophorectomy.
The researchers also concluded that BRCA carriers have a 4% chance of developing peritoneal cancer following such surgery, but that the risk was not high enough to recommend against the procedure. The study appears in the July 12 Journal of the American Medical Association.
The new study points to the importance of the peritoneum in the development of ovarian cancer, according to the July 12 Philadelphia Inquirer. A study author interviewed in the article said that about 20% of ovarian cancers start in the peritoneum, which cannot be removed surgically.
The study did find, however, that salpingo-oophorectomy can reduce the risk of ovarian cancer from an estimated 18%-62% to 4% in women with BRCA mutations. Without such a mutation, a woman has a 1.4% chance of developing ovarian cancer over her lifetime.
Physicians should continue to suggest preventive surgery to women with the BRCA1 genetic mutation at about age 35, said the authors. They also cautioned that it is important that both the fallopian tubes and ovaries be removed because either site may be the origin of cancer.
The JAMA abstract is online.
The Philadelphia Inquirer is online.
Information about the FDA’s March 2005 seizure of Avandamet shipments is online.
Raloxifene was effective in preventing breast cancer in a recent clinical trial but, for women with heart disease, the drug also increased the risk of blood clots and fatal strokes.
In the study, 10,101 postmenopausal women with coronary heart disease (CHD) or at high risk for CHD took either 60 mg a day of raloxifene or placebo for a mean of 5.6 years. Raloxifene did not affect the risk of coronary events, reduced the risk of invasive breast cancer, and did not affect the rate of death from any cause. However, the raloxifene group had an increased risk of fatal stroke (absolute risk increase of 0.7 per 1,000 woman-years) and venous thromboembolism (1.2 per 1,000 woman-years).
It was hoped that raloxifene might present an alternative to tamoxifen—which has been associated with higher endometrial cancer, stroke and other risks—for women at increased risk for coronary heart disease. However, noted an accompanying editorial, the moderate benefits of raloxifene for breast cancer prophylaxis do not seem to justify the risks for women with or at high risk for CHD.
These recent findings emphasize the need for physicians to consider individual risk profiles in determining whether to recommend raloxifene or other selective estrogen-receptor modulators, said the editorial. For now, there is no "magic bullet" that can mitigate the effects of estrogens and aging without posing other serious health risks.
The FDA this week approved the first once-a-day pill combining three highly effective active antiretroviral drugs, a move that is expected to dramatically improve the ability of patients to adhere to treatment.
The new pill, called Atripla, is a combination of Bristol-Myers Squibb's efavirenz (Sustiva) and Gilead Sciences' emtricitabine (Emtriva) and tenofovir disoproxil fumarate (Viread), said a July 12 FDA news release. The pill, which will cost about $1,100 a month in the U.S., will be marketed by Merck in developing countries.
The new treatment cuts the number of pills taken per day by HIV patients from 10 or more to one, said the July 13 Washington Post. That is expected to increase patient compliance, a key factor in preventing the virus from mutating into new, drug-resistant forms. In a 48-week clinical trial involving 244 HIV-1 infected adults, the new treatment was 80% effective in reducing the HIV virus level and substantially increasing the number of healthy CD4 cells.
Atripla can be taken as a single tablet once a day or in combination with other retroviral products. The triple combination is recommended as a first-line regimen for treatment-na´ve patients. The national “Guidelines for the Use of Antiretroviral agents in HIV-1-Infected Adults and Adolescents” is available online.
Since the three drugs that make up Atripla have been in use for some time—Sustiva since 1998, Viread since 2001 and Emtriva since 2003—side effects are well known. Emtriva and Viread have been available in a fixed-dose combination known as Truvada since 2004. Atripla’s label will include a boxed warning that the drug can cause lactic acidosis. Since it can cause severe flare-ups of Hepatitis B infection, the FDA has not approved Atripla’s use in patients with chronic Hepatitis B infection.
The Washington Post is online.
The FDA news release is online.
In related news, the FDA in the past month gave tentative approval for another three-ingredient, fixed-dose pill that will be available in 15 developing countries, many of them in Africa, under President Bush’s 2003 Emergency Plan for AIDS Relief (PEPFAR).
The antiretroviral tablet—a combination of lamivudine (Epivir), zidovudine (Retrovir) and nevirapine (Viramune)—which is manufactured by Aurobindo Pharma Ltd., in Hyderabad, India, meets all FDA manufacturing quality and clinical safety and efficacy standards, said a June 30 FDA news release. However, the pill cannot yet be sold in the U. S. due to patent restrictions.
The recommended regimen for the lamivudine-zidovudine-nevirapine tablet is one pill twice a day following an initial two-week treatment with each medication taken individually.
The FDA news release is online.
GlaxoSmithKline's Type 2 diabetes drug Avandamet is set to go back on the market, a year after the FDA and federal Department of Justice seized shipments of the drug for failing to meet manufacturing standards.
Avandamet (rosiglitazone maleate and metformin HCl) combines the GlaxoSmithKline drug Avandia with metformin, a now-generic medication. According to the company, the FDA last week approved marketing the drug as a first-line treatment for Type 2 diabetes. Before that, it was approved only as a second-line therapy for use in patients who did not benefit from metformin alone. GlaxoSmithKline said it has been able to stockpile enough Avandamet to meet demand following government-ordered repairs to the Puerto Rico plant where the drug is manufactured.
Shipments of Avandamet and GlaxoSmithKline’s antidepressant Paxil CR (paroxetine) were seized in March 2004. Problems at the Cidra, Puerto Rico, plant had caused Avandamet pills to have slightly too much of an active ingredient, rosiglitazone. At the time, the FDA said that it did not believe the products posed a significant health hazard to consumers and did not order any recalls.
For more information, go to GlaxoSmithKline’s Web site.
ACP and The Doctors Company are offering ACP Members credit toward medical liability insurance for completing maintenance of certification (MOC). Physicians who recertify, whether as a requirement or voluntarily, will receive a 5% credit in addition to their 5% program discount when they insure with The Doctors Company.
“ACP is pleased to offer this additional premium discount that recognizes the efforts of internists and internal medicine subspecialists who voluntarily engage in the activities of Maintenance of Certification,” said John Tooker, FACP, the College's executive vice president and chief executive officer.
To qualify for the discount, physicians must complete, or have already completed, the MOC process in either the specialty of general internal medicine or their subspecialty. The maximum discount for maintaining certifications in both general internal medicine and a subspecialty is 10%.
More information on the program is available on The Doctors Company's Web site.
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A 50-year-old man is evaluated in follow-up for a recent diagnosis of cirrhosis secondary to nonalcoholic steatohepatitis. He has a history of asthma, type 2 diabetes mellitus, hyperlipidemia, and obesity. His current medications are inhaled fluticasone, montelukast, insulin glargine, insulin lispro, simvastatin, and lisinopril. Following a physical exam, lab studies, and upper endoscopy, what is the most appropriate treatment?
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