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PubMed · 14330621

[THE REDUCING DIET].

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A HENDIKX. 1965-07-15. [THE REDUCING DIET].. https://pubmed.ncbi.nlm.nih.gov/14330621/

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The efficacy and safety of sibutramine for weight loss: a systematic review.

BACKGROUND: The primary goal of weight loss is to prevent or reduce obesity-associated morbidity and mortality by improving cardiovascular and metabolic risk factors. We conducted a systematic review to assess the efficacy and safety of sibutramine hydrochloride for weight loss. METHODS: In April 2002, we searched MEDLINE, EMBASE, the Cochrane Library, and 7 other computerized bibliographic search tools using the keywords "sibutramine," "Meridia," and "Reductil" (in all languages and all available years). The authors and the manufacturer were contacted. We reviewed randomized placebo-controlled trials of sibutramine, 10 to 20 mg/d, in obese adults. Methodological quality was assessed. RESULTS: A total of 29 trials had sufficient data for analysis after including unpublished data from 10 authors. The summary mean differences in weight loss, sibutramine minus placebo, for the 3-month and 1-year trials were -2.78 kg (95% confidence interval, -2.26 to -3.29 kg) and -4.45 kg (95% confidence interval, -3.62 to -5.29 kg), respectively. The 6-month trials were statistically heterogeneous, and evidence of publication bias was found. One trial found that sibutramine maintains weight loss better than placebo at 2 years. Weight loss with sibutramine was associated with modest increases in heart rate and blood pressure, small improvements in high-density lipoprotein cholesterol and triglycerides levels, and, among diabetic patients, small improvements in glycemic control. There was no direct evidence that sibutramine reduces obesity-associated morbidity or mortality. CONCLUSIONS: Sibutramine is effective in promoting weight loss. Weight loss with sibutramine is associated with both positive and negative changes in cardiovascular and metabolic risk factors. There is insufficient evidence to accurately determine the long-term risk-benefit profile for sibutramine.

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[Sustained weight reduction after cessation of obesity treatment with Sibutramine].

BACKGROUND AND AIM OF THE STUDY: Aim of the study was to examine the course of body weight and cardiovascular risk parameters under the everyday life conditions in general practice after obese patients had terminated their sibutramine treatment. PATIENTS AND METHODS: Patients were administered sibutramine (10 mg oder 15 mg, once daily) for at least six months could be included in the post-marketing surveillance (PMS) study. Control visits to document body weight, laboratory parameters and blood pressure took place after 12 weeks and after 24 weeks. RESULTS: In all, 374 patients (77 % women, 20 % men) with an average age of 45.8 +/- 11.8 years terminated the previous sibutramine therapy at the latest with inclusion into the study. On average, they had administered sibutramine for six months. At the end of the 24-week observation period the majority of the patients stated that they had continuously adhered to changed life habits during the last six months. On average, the body weight of the patients did not increase (mean weight reduction of 1 kg between start and end of the observation period). The stable course of the body weight was mirrored by the values of the laboratory parameters: values for total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, serum glucose (fasting), HbA (1c), urea, uric acid and liver parameters remained unchanged compared to the values on entry into the study. Throughout the observation period, blood pressure values remained stable as well. CONCLUSION: Values for body weight, vital signs (blood pressure, heart rate), serum glucose and serum lipids remain constant even after termination of the sibutramine therapy. Possibly, the positive effect on body weight reduction by the treatment with sibutramine support the adherence to a changed life style. Obviously, this action continues after termination of the drug treatment.

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