Trial reportObesity facts2018
Body Weight Reduction Associated with the Sibutramine Treatment: Overall Results of the PRIMAVERA Primary Health Care Trial.
Trial report in Obesity facts, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Combination of sibutramine and topiramate for the treatment of obesity: the SIBAMATE retrospective cohort study : Sibutramine and topiramate for the treatment of obesity.Diabetology & metabolic syndrome · 2025Article
- Assessment of redox state and biochemical parameters of salivary glands in rats treated with anti-obesity drug sibutramine hydrochloride.Clinical oral investigations · 2022Article
- The limits and challenges of antiobesity pharmacotherapy.Expert opinion on pharmacotherapy · 2020Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe aim of the study was to assess the effectiveness and safety of long-term sibutramine therapy in routine clinical practice.
methodsIn total, 98,774 patients (82.3% women, 17.7% men) from 142 cities of the Russian Federation were enrolled in the PRIMAVERA program. The mean age of the patients was 39.39 ± 10.38 years, the mean body weight was 99.1 ± 14.28 kg, and the mean BMI was 35.7 ± 4.41 kg/m2. The duration of the sibutramine therapy was determined by physicians: 59.3% of patients took the drug for 6 months, the treatment course of 37.7% of patients was 12 months, and 3% of patients had treatment for 3 months.
resultsThe BMI reduction correlated with the treatment duration: 3.4 ± 1.53 kg/m2 after 3 months of therapy, 5.4 ± 2.22 kg/m2 after 6 months, and 7.2 ± 3.07 kg/m2 after 12 months. The body weight reduction after 3, 6 and 12 months of treatment was 9.5%, 15.1%, and 19.7%, respectively. The body weight loss associated with sibutramine treatment was accompanied by a slight decrease in blood pressure and did not lead to any significant increases of the heart rate.
conclusionsThe results of the PRIMAVERA study confirmed the lack of increased risk of using sibutramine in routine clinical practice in patients without underlying cardiovascular disease and low rate of adverse events.
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