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By William T. Elliott, MD, FACP
Two recent studies are creating more controversy regarding estrogen replacement therapy (ERT). The first from the American Cancer Society looked at the rate of ovarian cancer in more than 200,000 postmenopausal women. Over the 14-year study period, women who used ERT had a significantly higher mortality rate from ovarian cancer (risk ratio, 1.51) than women who never used ERT. The duration of therapy increased the risk, with women on ERT for more than 10 years at the highest risk (risk ratio, 2.20). However, the overall incidence of fatal ovarian cancer was low, with 944 deaths out of 200,000 women over the 14 years, and Rodriguez and colleagues point out that this has to be weighed against any possible benefit from reduced rates of heart disease or osteoporosis associated with ERT (JAMA. 2001;285:1460-1465). A second small study refutes earlier data suggesting that ERT may protect against Alzheimer’s disease (AD). In a review of 59 women with AD and 221 matched women without the disease, no difference was found in the rate of ERT use among cases or controls. Women who used ERT for more than 5 years were no different than women who used it for less than 5 years. The findings suggest that ERT does not confer protection against AD (Arch Neurol. 2001;58:435-440).
The last 12 months have marked a year in which there have been an unprecedented number of drug shortages. Amid drug company mergers, shortages of raw materials, and production problems, there have also been charges of foul play and price gouging. Two of the most critical shortages have involved the flu vaccine and the tetanus vaccine, both due to production problems. The short-acting narcotic fentanyl has also been in short supply as has succinylcholine, a neuromuscular blocker, and naloxone, a narcotic antagonist. These drugs are commonly used in the operating rooms and emergency departments, and their shortages have created near crisis situations in some US hospitals. Some manufacturers are simply discontinuing the production of certain drugs because they are no longer profitable. This is the case with hyaluronidase, an eye drop commonly used to disperse anesthetics in eye surgery. Some common antibiotics are also running into supply problems. There are no easy answers for most of these issues, and shortages of many commonly used drugs are expected to continue.
Tamoxifen may be safely discontinued after 5 years in women with operable breast cancer according to data from the Scottish Adjuvant Tamoxifen Trial (SATT). At 15 years after surgery, benefit was still seen from tamoxifen treatment, but the benefit was the same whether women were randomized to continue tamoxifen or take placebo after an initial 5 years of therapy. The SATT study, which started in April 1978, has followed more than 1300 women with breast cancer who were initially treated with surgery or surgery and radiation therapy. This study is in accord with other research that indicates that 5 years of tamoxifen therapy is optimum (J Natl Cancer Inst. 2001;93:456-462).
ViroPharma is announcing success with its antiviral drug pleconaril in treating cold viruses. Although the data are yet to be published, the company is reporting that the drug is effective against picornaviruses, the family of viruses responsible for about half of the common colds. The drug is reported to reduce the duration of the illness and to reduce viral shedding. The company is hoping that the oral medication, which is taken 3 times a day, will be on the market within a year.
The National Cholesterol Education Program (NCEP) is expected to release updated recommendations by the Adult Treatment Panel this spring. In the 8 years since the last guidelines were published, there has been considerable research into issues such as primary prevention of coronary artery disease (CAD), treatment of triglycerides, differing risk factors between men and women, and cumulative risk factors such as smoking, diabetes, and hypertension. The guidelines will include wider screening recommendations and will generally recommend more aggressive therapy, up to and including drug therapy, especially for those with multiple risk factors. The guidelines are also expected to clarify treatment goals, including specific LDL goals. The NCEP guidelines are expected in May.
Coronary Artery Disease
There is much speculation about low HDL as an independent risk factor for CAD. A new study indicates that treating low HDL in men who have a history of CAD with gemfibrozil reduces the risk of future coronary events. The data come from the VA High-Density Lipoprotein Intervention Trial of more than 2500 men with a history of coronary artery disease and low levels of HDL as well as low LDL. The subjects were randomized to 1200 mg of gemfibrozil a day or placebo. Only increases in HDL were shown to reduce the risk of future events, with an 11% reduction in events for every 5 mg/dL increase in HDL. However, there is also evidence that gemfibrozil reduces inflammatory markers, including C-reactive protein, which may account for some of the benefit (JAMA. 2001;1585-1591).