Clinical Briefs

By Louis Kuritzky, MD

Weight Control in Obese Subjects Treated with Orlistat

Traditional nonpharmacological methods for weight reduction based upon diet and exercise show poor long-term performance. Since unchecked obesity contributes to consequences of diabetes, cardiovascular disease, and overall mortality, the need for more efficacious tools is substantial.

Orlistat (Xenical) is an agent that blocks activity of pancreatic and gastric lipases, resulting in about a one-third reduction in absorption of ingested fat. This randomized, double-blind, placebo-controlled study (n = 892) prospectively evaluated patients receiving orlistat, 120 mg three times daily for one year; a second year of the study randomized subjects to 60 mg or 120 mg orlistat three times daily. A controlled-energy diet was used for all study subjects.

At the end of the first year, subjects receiving orlistat had lost an average of 8.76 kg, compared to 5.81 kg in the placebo group; during the second year of the trial, persons who continued either dose of orlistat regained less weight than those on placebo, but the higher dose had a significantly better maintenance effect. Blood pressure, lipids, glucose, and insulin were favorably affected in the active treatment group when compared with placebo. Adverse events, the most common of which were gastrointestinal, were similar in placebo and treatment groups. The withdrawal from treatment rate was actually higher in the placebo group than in the active treatment group in the first year, but both groups had equal withdrawal rates in the second year.

Orlistat can produce sustained weight loss, as well as improvements in lipids and insulin, and is well tolerated by most patients.

Davidson MH, et al. JAMA 1999;281: 235-242.

Safety of Revaccination with Pneumococcal Polysaccharide Vaccine

Since post-vaccination antibody levels as well as protective efficacy of pneumococcal vaccine decline over time, revaccination after five years or more is recommended for immunocompromised persons and people older than 65 who were vaccinated before the age of 65. Implementation of these recommendations has been suboptimal, to some degree perhaps because of concern about adverse reactions to revaccination. This report details results from a large prospective trial that enrolled more than 1400 individuals aged 50-74 comparing the adverse event rate for persons revaccinated vs. first-time recipients.

Fever, fatigue, myalgia, headache, arthralgia, and rash in the first two weeks post-vaccination were no more frequent in the revaccination group than the new vaccination group. For local adverse reactions, revaccinees had a larger area of redness or swelling, more tenderness and arm soreness, and more limitation of arm movement than new vaccinnees in the first six days, but this difference disappeared during days 7-13. Fifteen percent of healthy immunocompetent adults (RR = 4.9 compared to new vaccinnee) had a sizable local reaction, defined as more than 4 inches of local redness or swelling. Fortunately, even these reactions are self- limited, resolving in a median of three days. There were no serious adverse reactions in any patient from either vaccination group. Revaccination is associated with a greater frequency of local adverse reactions, including sizeable local reactions, but the self-limited nature and brief duration of such adversities should not preclude implementation of current revaccination recommendations.

Jackson LA, et al. JAMA 1999;281: 243-248.

Is There Gulf War Syndrome?

Military veterans from the United Kingdom who were stationed in the Persian Gulf during the Gulf War from Sept. 1, 1990, until June 30, 1991 (n = 53; 462) have reported impaired physical functioning, psychological morbidity, and perception of poor physical health more frequently than individuals not deployed to this area. A similar picture has been reported for U.S. servicepersons. Using a population-based cross-sectional design, Ismail and colleagues sent a standardized survey about 50 physical symptoms to 12,592 men who had served in either the Gulf War or Bosnia, or servicemen who had not been deployed overseas.

The most commonly reported symptoms were headaches, irritability, sleeping difficulties, feeling jumpy, feeling unrefreshed after sleep, fatigue, feeling cut off from others, forgetfulness, loss of concentration, avoidance behaviors, distressing dreams, difficulty breathing deeply, tachypnea, dyspnea, wheezing, and numbness or tingling in extremities. The structure of correlations between symptoms was similar among Gulf War veterans to Bosnia veterans, or servicemen not deployed abroad.

Ismail et al conclude that, although results from complex modeling procedures must be interpreted with caution, the data do not support a unique Gulf War syndrome.

Ismail K, et al. Lancet 1999;353: 179-182.