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The $15 billion dietary supplement industry took a bruising in the last month with reports that some of the most popular over-the-counter treatments are little more than expensive placebo. Ginkgo, the commonly used memory enhancing agent, was evaluated in 230 men and women older than the age of 60 who had normal memory and were in good health. Patients were randomly assigned to receive ginkgo 40 mg 3 times a day or matching placebo for 6 weeks. Neuropsychological tests were administered at the end of the study, which revealed no significant differences between treatment groups on any of the outcome measures including verbal and nonverbal learning and memory, attention and concentration, naming and expressive language, self-reported memory, and companion scoring. The study concluded that ginkgo did not facilitate learning memory tension or concentration in adults older than the age of 60 (JAMA. 2002;288:835-840). In a separate study from The Netherlands, 652 adults older than age 60 were given a multivitamin/mineral supplement, 200 mg of vitamin E, both, or placebo in a study to evaluate whether the supplements would reduce the incidence and severity of acute respiratory tract infections. Patients were followed for nearly 1.5 years. No difference was found among any of the groups with regard to incidence or severity of acute respiratory infections, except for the finding of worsening severity of disease in the vitamin E group (19 days illness with vitamin E vs 14 days illness with placebo; P = 0.2). (JAMA. 2002;288:715-721.)
On the other hand, a homocysteine-lowering therapy with a combination of B vitamins effectively improves clinical outcomes after percutaneous coronary interventions. Folic acid, vitamin B12, and vitamin B6 were tested in a randomized, double-blind, placebo-controlled trial involving more than 550 patients in Switzerland who had undergone successful angioplasty. The participants received a combination of folic acid 1 mg/d, vitamin B12 400 m/d, and vitamin B6 10 mg/d, or placebo. The main outcome measure was the composite outcome of major adverse events including death, nonfatal myocardial infarction, and the need for repeat revascularization evaluated at 6 months and 1 year. The composite end point was significantly lower at 1 year in the vitamin-treated patients (15.4%) compared to the placebo group (22.8%) (RR, 0.68; 95% CI, 0.48-0.96; P = .03) primarily due to reduce rate of revascularization. (JAMA. 2002;288:973-979).
Celebrex OK for Asthma Patients
Celecoxib (CelebrexTM) may be safe to use in patients with a history of aspirin-induced asthma. Patients with known aspirin sensitivity, or aspirin-exacerbated respiratory disease (AERD), are generally unable to take aspirin or any NSAID. In a study from San Diego, 60 patients with AERD were challenged with celecoxib, a COX-2 inhibitor, or placebo over 48 hours. During the study period, none of the 60 patients experienced any symptoms or changes in nasal examinations or declines in FEV1. The following day, all 60 patients were exposed to aspirin and all showed sensitivity. The study concluded that inhibition of COX-1 is the critical initiating event in respiratory reactions in patients with AERD (Arthritis Rheum. 2002;46:2201-2206).
Losartan Not Superior to Captopril
The angiotensin II receptor blocker losartan is not superior to the ace inhibitor captopril after complicated acute myocardial infarction. The large OPTIMAAL trial (Optimal Trial in Myocardial Infarction with the Angiotensin II Antagonist Losartan) looked at 5477 patients in 7 European countries with confirmed acute myocardial infarction and heart failure. Patients were randomly assigned and titrated to target dose of losartan 50 mg once daily or captopril 50 mg 3 times daily. The primary end point was all-cause mortality. During a mean follow-up of 2.7 years, there were 499 (18%) deaths in losartan group and 447 (16%) in the captopril group (RR 1.13; 95% CI, 0.99-1.28; P = 0.07). Because of this nonsignificant trend in total mortality in favor of captopril, the study suggests that losartan cannot be generally recommended in this population. It is noted however that losartan was better tolerated than captopril, and associated with significantly fewer discontinuations (Lancet. 2002;360:752-760).
Alfa-Interferon Could Help Fight West Nile
The number of West Nile virus cases is mounting in the United States, Canada, and Mexico where 37 deaths have been attributed to the virus, now the first case has been reported in California, and other cases are the result of organ donation from infected donor. Researchers are hoping that alfa-interferon may be of help. The drug has been effective against St. Louis encephalitis, a similar virus, and is the drug of choice for treatment of hepatitis C. Researchers are enrolling patients in the New York area where the virus first appeared 3 years ago. Although infection with the mosquito-borne virus rarely causes serious illness (< 1%), the elderly and chronically ill are particularly prone to encephalitis. alfa-interferon will be given for 2 weeks and should be started within the first few days of illness, prior to the onset of encephalitis. Research is also progressing on 3 West Nile virus vaccines, which should be in human trials by 2003.
Sertraline Effective Against Depression
Depression is common in patients with coronary artery disease and represents a significant independent risk factor for both first myocardial infarction and cardiovascular mortality. A new study shows that the selective serotonin reuptake inhibitor sertraline is safe and effective for treating major depression in patients with recent myocardial infarction or unstable angina. A total of 369 patients on 3 continents with major depressive disorder were enrolled and randomized to sertraline 50-200 mg/d or placebo in a double-blind fashion for 24 weeks. The main outcome was change in left ventricular ejection fraction (LVEF) while other outcomes included surrogate cardiac measures and cardiovascular adverse events. Sertraline had no significant effect on LVEF, and also did not increase ventricular premature complex runs, QTc intervals, or other cardiac measures. The incidence of severe cardiovascular adverse events was 14.5% with sertraline and 22.4% with placebo. Depression scores were better in the sertraline group. The authors conclude that sertraline is safe and effective for trading depression in patients with recent MI or unstable angina (JAMA. 2002;288:701-709).
FDA Actions
Procter & Gamble has announced that it expects an over-the-counter form of omeprazole (Prilosec) to be available by early 2003. The company has received an approval letter from the FDA but needs to clarify language on the package label so that consumers will clearly understand how to use the drug. Procter & Gamble is planning a study to make sure consumers understand the drug labeling, a process which will take several months. The FDA has approved fluoxetine (Prozac) for the treatment of panic disorder. The indication was previously only granted to paroxetine (Paxil) and sertraline (Zoloft), and it has been heavily promoted by the manufacturers of these drugs. Fluoxetine is also recently approved for long-term treatment of bulimia. The drug has been been available as a generic for more than a year, and as such represents a lower cost alternative for patients with these conditions.
This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. Telephone: (404) 262-5517. E-mail: robin.mason@ahcpub.com. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.