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Weight Gain and Somnolence in Long-term Clinical Trials: A Meta-analysis

This meta-analysis examines the effects of medication on weight gain and somnolence in long-term clinical trials. Data from 38 studies involving 3923 patients were analyzed, showing significant weight gain in patients compared to placebo. Additionally, somnolence/sedation was found to be higher in medication groups compared to placebo.

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Weight Gain and Somnolence in Long-term Clinical Trials: A Meta-analysis

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  1. Potentially relevant CTs identified and screened for retrieval (N=115) RCTs excluded because of: ▪ design (crossover, combination, retrospective, discontinuation) (N=8) ▪ lack of control group unless duration ≥ 13 weeks (N=26) ▪ other interests (young adults, pharmaco/vigilance or kinetics (N=9) ▪ Review or meta-analysis (N=6) ▪ Arm with N < 9 (N=2) Potentially appropriate RCTs to be Included in the analysis (N=64) RCTs excluded from analysis because of data reported elsewhere (N=9) Long term CTs: duration ≥13 weeks (N=16) Incomplete reporting of all variables of interest(N=1) RCTs included in the analysis Short term CTs: duration ≤12 weeks (N=38) 38 studies 89 arms 3923 patients

  2. 29 studies 65 arms - 3204 patients Weight gain : compared to placebo kg

  3. 24 studies 57 arms - 3229 patients Patients with significant weight gain

  4. 12 studies 32 arms - 1511 patients

  5. 10 studies 27 arms - 1784 patients mg/dl

  6. 10 studies 27 arms - 1784 patients mg/dl

  7. 10 studies 27 arms - 1655 patients mg/dl

  8. 29 studies 64 arms - 3305 patients somnolence/sedation : compared to placebo

  9. 26 studies 61 arms - 3209 patients

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