Effect of orlistat during individualized comprehensive life-style intervention on visceral fat in overweight or obese PCOS patients

Abstract

Objective

To investigate the effect of orlistat combined with drospirenone/ethinylestradiol tablets (DRSP/EE) on the visceral fat area (VFA) compared to DRSP/EE-alone in overweight or obese patients with polycystic ovary syndrome (PCOS).

Methods

90 PCOS patients [body mass index (BMI) ≥24kg/m²] were recruited for a prospective, open-label, 1:2 paired 3-monthly study. All were included during the per-protocol defined recruitment time and numbered according to the entry-order: group-1: No.1-60, orlistat plus DRSP/EE; group-2: No.61-90, DRSP/EE-alone. Both groups received the same comprehensive intervention in terms of individualized, standardized management and lifestyle monitoring such as diet and exercise. Primary study-endpoint was VFA, secondary endpoints were anthropometric indices, sex hormones and glucolipid metabolism. Within- and between-group analyses were performed.

Results

VFA [cm²] in group-1 after treatment decreased significantly (p = 0.001), and the between-group comparison was highly significant (p = 0.001). Body weight, hip circumference (HC), BMI, body fat (BF), free testosterone (FT) and low-density lipoprotein-cholesterol (LDL-C) significantly decreased in both groups (within-group analysis); the decrease in group-1 was significantly greater than in group-2 (p < 0.05). Systolic and diastolic blood pressure (SBP/DBP) and fasting plasma glucose (FPG) in group-1 were significantly decreased, significantly more in group-1 than in group-2 (p < 0.05).

Conclusion

This study is the first to investigate the effect of orlistat combined with DRSP/EE in overweight or obese PCOS patients compared with using DRSP/EE-alone. Orlistat combined with DRSP/EE was better than using DRSP/EE-alone in reducing VFA, body weight, FT, BP and FPG, which provides evidence for the choice of rational drug use in clinical practice.

摘要

目的

研究联合应用奥利司他和屈螺酮/炔雌醇片 (DRSP/EE) 与单用 DRSP/EE 相比对超重或肥胖多囊卵巢综合征 (PCOS) 患者内脏脂肪面积 (VFA) 的影响。

方法

90名PCOS患者[体重指数（BMI）≥24kg/m2]被招募参加一项前瞻性、非盲、1:2配对的3个月的研究。所有患者都在协议规定的招募时间内被招募, 并按照入组顺序进行编号：第一组：编号1-60, 联合应用奥利司他和DRSP/EE；第二组：编号61-90, 单独应用DRSP/EE。两组都接受相同的综合干预, 即个性化、标准化管理和生活方式监测如饮食和运动。主要研究终点是VFA, 次要研究终点是人体测量指数、性激素和糖脂代谢。进行组内和组间分析。

结果

治疗后第1组的VFA[cm2]明显下降（P=0.001）, 组间比较有明显意义（P=0.001）。两组的体重、臀围（HC）、BMI、体脂（BF）、游离睾酮（FT）和低密度脂蛋白胆固醇（LDL-C）都明显下降（组内分析）；第1组的下降幅度明显大于第2组（p < 0.05）。第1组的收缩压和舒张压（SBP/DBP）以及空腹血糖（FPG）都明显下降, 且下降幅度明显大于第2组（P < 0.05）。

结论

本研究首次研究了奥利司他联合DRSP/EE与单独使用DRSP/EE相比对超重或肥胖的PCOS患者的影响。奥利司他联合DRSP/EE在降低VFA、体重、FT、BP和FPG方面优于单独使用DRSP/EE, 这为临床实践中合理用药的选择提供证据。

Keywords:

• Overweight or obese
• polycystic ovary syndrome
• visceral fat area
• orlistat
• drospirenone/ethinylestradiol tablets (DRSP/EE)

关键词:

• 超重或肥胖
• 多囊卵巢综合征
• 内脏脂肪面积
• 奥利司他
• 屈螺酮/炔雌醇片（DRSP/EE）

Acknowledgment

Especially thank Prof. Xingming Li of Capital Medical University (Beijing, China) for his assistance with the statistical analysis.

Disclosure statement

No potential conflict of interest was reported by the authors.

Table 1. Comparison.

Table 2. Comparison of VFA, anthropometric indices, sex hormone levels, glucose and lipid metabolism, parameters for hepatorenal function before and after treatment.

Table 3. Multiple linear regression analysis.

Additional information

Funding

This work was supported by Beijing Municipal Administration of Hospitals’ Ascent Plan (No. DFL20181401).