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By William T. Elliott, MD, FACP
Controversy surrounding hormone replacement therapy (HRT) continues with the publication of more data from the Nurses’ Health Study. The focus of this arm of the ongoing study of more than 70,000 women is on primary prevention of cardiovascular disease in postmenopausal women. When all cardiovascular risk factors were considered, major coronary events were significantly lower in current users of HRT compared with never users. A low-dose regimen (conjugated estrogen 0.3 mg/d) was as effective as high dose (conjugated estrogen 0.625 mg/d) in preventing heart disease. However, the higher dose was associated with an increased risk of stroke (Ann Intern Med 2000;133:933-941). Recent data have suggested that HRT is ineffective in a secondary prevention role and may actually increase the risk of coronary events in the first year of therapy in women with known heart disease (JAMA 1998;280:605-613).
A male contraceptive may be nearing reality with the results of a study that show efficacy of continuous release testosterone implants. Researchers in Australia evaluated testosterone implants of 800 or 1200 mg, given every three months for 3-16 months in healthy white males. The implants resulted in long-term suppression of sperm counts below 1 million/mL (the level felt adequate to prevent pregnancy) in 70% of test subjects without significant side effects. The addition of finasteride (Proscar), a 5-alpha-reductase inhibitor, given in a double-blind wing of the study, did not add to the efficacy of the testosterone implants (Contraception 2000;621:73-78).
The FDA has approved a topical form of the immunomodulator tacrolimus for the treatment of eczema. The ointment, which is currently available in Japan, will be marketed by Fujisawa Pharmaceuticals under the name Protropic. Tacrolimus is a nonsteroid preparation that has been shown to be effective in two-thirds of patients with eczema. It may cause local burning and patients need to avoid sunlight or other sources of UV light during treatment. An FDA advisory committee also recently recommended approval of the drug for the treatment of atopic dermatitis in children and adults, but the FDA is yet to rule on that indication.
Could an effective HIV vaccine be a reality in the next few years? Two groups are claiming progress, and one, a joint project between Kenyan and British researchers, plans to start clinical trials later this year. The trial will target HIV strain A, most common in Sub-Saharan Africa. Meanwhile, Merck & Co, the second leading pharmaceutical company in the world, is claiming progress in early human trials of their own HIV vaccine. Merck, which is notoriously conservative in claims about their pipeline drugs, is confident that their vaccine will "ultimately prove effective."
The FDA has approved a new oral agent for the treatment of type 2 diabetes. Nateglinide is indicated for use alone, or in combination with metformin. The drug, which is similar in action to repaglinide (Prandin), increases the release of endogenous insulin, especially first-phase insulin secretion that prevents mealtime hyperglycemia. It may also be less likely than other oral agents to cause late hypoglycemia. Nateglinide will be marketed as Starlix by Novartis Pharmaceuticals.
Nearly a quarter of pneumococcal isolates in the United States in 1998 were resistant to penicillin, and more than half of those isolates were resistant to at least two other antibiotics. This represents a significant increase since 1995. Resistance has been spread across a spectrum of commonly used antibiotics other than penicillin including cefotaxime, meropenem, erythromycin, and trimethoprim-sulfamethoxazole. Multiresistant pneumococci was most common in Georgia, Tennessee, and in children younger than 5 years old. The data, from the CDC in Atlanta and other medical centers across the country, again point out the need to curb the indiscriminant use of antibiotics. The researchers also point out that most resistant pneumococcal isolates are serotypes that are covered by the adult and pediatric pneumococcal vaccines (N Engl J Med 2000;343:1917-1924).