Therapeutics and Drugs Briefs
May 1, 1999 4 minutes read
Therapeutics and Drugs Briefs
Sustained Release Bupropion, a Nicotine Patch, or Both for Smoking Cessation
Source: Jorenby DE, et al. N Engl J Med 1999;340:685-691.
Among the 20 million smokers who attempt cessation each year, more than 90% fail to maintain abstinence for longer than one year. Even in patients who use nicotine patches or gum, only 20-30% will remain nonsmokers long term. Seven-week courses of bupropion have demonstrated as much as 23% efficacy at 12 months for smoking cessation. In this placebo-controlled study, Jorenby and colleagues compared sustained release bupropion (n = 244), nicotine patch (n = 244), and the combination of the two (n = 245).
Bupropion was dosed at 150 mg for the first three days, followed by 150 mg bid for nine weeks; nicotine patches were dosed as 21 mg daily for six weeks, followed by 14 mg daily for one week, then 7 mg daily for one week.
Successful abstinence at one year was achieved by 35.5% of the combination therapy group, compared with 30.3% in the bupropion alone group, and 16.4% in the nicotine patch alone group.
Weight gain, a daunting deterrent to cessation for many smokers, occurred in all groups but was least in the combination treatment group (1.1 kg over 7 weeks). Adverse events caused medication discontinuation in less than 10% of subjects.
In this trial, the combination of bupropion with nicotine patches demonstrated a trend toward greater efficacy than bupropion alone, with less weight gain at seven weeks.
Echinate Purpurea on the Incidence and Severity of Colds and Respiratory Infections
Source: Grimm W, Muller H. Am J Med 1999;106:138-143.
Up until the advent of antibiotics, echinate was the most prominently sold American medical plant in the United States. Echinate-related products remain extremely popular in Europe, particularly in Germany. Echinate products have been used to treat chronic arthritis, cancer, Candida infection, chronic fatigue syndrome, and chronic pelvic infections. The current study examined the efficacy of Echinate purpurea fluid extract on colds and respiratory infections.
Adults (n = 109) were enrolled for an eight-week, placebo-controlled treatment period during which they received either 4 mL placebo juice twice daily or fluid extract of Echinate purpurea. Each subject had a history of at least four respiratory infections in the previous year. Primary outcome measures were the incidence and severity of colds and respiratory infections.
During the eight-week study period, there were no significant differences in incidence, severity, or duration of respiratory infections. Adverse events trended toward greater frequency in the Echinate group, as did treatment dropouts, but adversities were mild and reversible. So, the drug commission of German physicians recommends against the use of Echinate as an immunostimulator pending further data.
Long-term Efficacy and Tolerability of Sibutramine
Source: Apfelbaum M, et al. Am J Med 1999;106:179-184.
Although low-calorie diets (< 800 calories daily) have proven beneficial over the short term, maintenance of weight loss remains problematic. There have been few trials of pharmacotherapy combined with a low-calorie diet. The current study is a 12-month, double-blind trial of sibutramine in addition to a very low calorie diet for obesity.
Study subjects (n = 160) were required to have a baseline body mass index greater than 30. After a four-week, low-calorie diet, subjects were given sibutramine 10 mg daily, and their diet was changed to a reduced calorie intake calculated to be 20-30% less than their pre-study diet. Subjects were followed monthly for one year.
The placebo recipients gained an average of 0.5 kg over 12 months, compared with a 5.2 kg loss in recipients of sibutramine. Also, sibutramine treatment was associated with favorable changes in triglyceride and HDL levels when compared with placebo. Sibutramine treatment was associated with greater likelihood of maintaining more than 50% of initial weight loss than placebo. Withdrawal from treatment was infrequent (4%) but twice as common among placebo recipients. Apfelbaum and colleagues conclude that sibutramine is effective in maintaining, and even enhancing, weight loss after a low-calorie diet.
Weight Control in Obese Subjects Treated with Orlistat
Source: Davidson MH, et al. JAMA 1999;281:235-242.
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.
The Therapeutics and Drugs Briefs were written by Louis Kuritzky, MD, Courtesy Clinical Assistant Professor, University of Florida, Gainesville.
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