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奥利司他在超重/肥胖合并高尿酸血症男性患者中的疗效与安全性:一项随机、双盲、安慰剂对照试验的结果

Efficacy and safety of orlistat in male patients with overweight/obesity and hyperuricemia: results of a randomized, double-blind, placebo-controlled trial.

作者信息

Liu Shuang, Lin Xiaojing, Tao Minghao, Chen Qi, Sun Hang, Han Yali, Yang Shaoling, Gao Yining, Qu Shen, Chen Haibing

机构信息

Department of Endocrinology and Metabolism, Shanghai Tenth People's Hospital, Tongji University School of Medicine, 301 Middle Yanchang Road, Shanghai, 200072, China.

Shanghai Center for Thyroid Disease, Shanghai Tenth People's Hospital, Shanghai, 200072, China.

出版信息

Lipids Health Dis. 2024 Mar 11;23(1):77. doi: 10.1186/s12944-024-02047-7.

DOI:10.1186/s12944-024-02047-7
PMID:38468241
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10926609/
Abstract

BACKGROUND

Obesity is associated with elevated serum uric acid (SUA) levels and frequent gout flares. Losing weight can reduce the SUA level and gout flares. The effect of orlistat on SUA levels and gout flares in patients with overweight/obesity and hyperuricemia (HUA) has not been extensively studied. This study investigated the effects of orlistat on SUA levels and gout flares compared to placebo in overweight and obese patients with HUA.

METHODS

A total of 72 Chinese patients with overweight/obesity and HUA were randomly divided into a placebo group (35, 48.6%) and an orlistat group (37, 51.4%); the trial lasted 12 weeks. The primary endpoints were the relative changes in body weight, the SUA level, and gout flares in the per-protocol population.

RESULTS

Orlistat reduced the proportion of patients with gout flares (log-rank P = 0.023, hazard ratio = 0.31, 95% confidence interval 0.11-0.85). There was no significant difference in SUA level between the two groups. The average weight loss of the orlistat group was 2.85 kg, and the average weight loss of the placebo group was 0.76 kg. The weight loss in the orlistat group was significantly greater than that in the control group (P < 0.05).

CONCLUSIONS

This study is the first to demonstrate that orlistat has no significant effect on SUA levels in patients with overweight/obesity and HUA. The utility of orlistat as an adjunct therapy to prevent gout flares during weight loss in patients with HUA was emphasized.

TRIAL REGISTRATION

Clinicaltrials.gov NCT05496075.

摘要

背景

肥胖与血清尿酸(SUA)水平升高及痛风频繁发作相关。减重可降低SUA水平及痛风发作频率。奥利司他对超重/肥胖合并高尿酸血症(HUA)患者的SUA水平及痛风发作的影响尚未得到广泛研究。本研究比较了奥利司他与安慰剂对超重和肥胖HUA患者SUA水平及痛风发作的影响。

方法

共72例中国超重/肥胖合并HUA患者被随机分为安慰剂组(35例,48.6%)和奥利司他组(37例,51.4%);试验持续12周。主要终点为符合方案人群的体重、SUA水平及痛风发作的相对变化。

结果

奥利司他降低了痛风发作患者的比例(对数秩检验P = 0.023,风险比 = 0.31,95%置信区间0.11 - 0.85)。两组间SUA水平无显著差异。奥利司他组平均体重减轻2.85 kg,安慰剂组平均体重减轻0.76 kg。奥利司他组的体重减轻显著大于对照组(P < 0.05)。

结论

本研究首次表明,奥利司他对超重/肥胖合并HUA患者的SUA水平无显著影响。强调了奥利司他作为辅助治疗在预防HUA患者减重期间痛风发作方面的作用。

试验注册

Clinicaltrials.gov NCT05496075。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/250a/10926609/021743f10d28/12944_2024_2047_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/250a/10926609/d0cc7ef56d45/12944_2024_2047_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/250a/10926609/8a035aaf4344/12944_2024_2047_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/250a/10926609/aae287632625/12944_2024_2047_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/250a/10926609/021743f10d28/12944_2024_2047_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/250a/10926609/d0cc7ef56d45/12944_2024_2047_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/250a/10926609/8a035aaf4344/12944_2024_2047_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/250a/10926609/aae287632625/12944_2024_2047_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/250a/10926609/021743f10d28/12944_2024_2047_Fig4_HTML.jpg

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