Characterizing and understanding body weight patterns in patients treated with pregabalin

We examined patterns of weight change among patients treated with pregabalin for up to 1 year. Patients with ≥1 pre-treatment weight measurement, ≥2 measurements in Period 1 (day 2–56), and ≥2 during Period 2 (day 57–356) were identified from pooled data of 106 studies including 43,525 patients. Seven patterns were developed and used for exploratory ‘change point’ analyses (day on-treatment when weight-change trend changed from initial trajectory) and to assess patterns of weight change by baseline weight/body mass index (BMI). A total of 3187 patients (from 41 studies) were eligible. 98.9% of patients were described by three of the seven patterns. The majority of patients (2607/3187 [81.8%]) remained within ±7% of baseline weight (‘Pattern 4’). Fewer patients (463/3187 [14.5%]) were ‘delayed weight gainers’ (exceeded 7% weight gain in Period 2 but not Period 1 [‘Pattern 6’]), fewer still (82/3187 [2.6%]) were ‘early weight gainers’ (exceeded ≥7% baseline weight in Period 1 and remained above 7% or continued to gain weight in Period 2 [‘Pattern 7’]). Overall weight gainers (Patterns 6, 7) experienced 1-year weight gain (median [% change]) of +6.20 kg [+9.12%] and 5.46 kg [+13.9%] vs. 2.22 kg [+2.10%] for non-weight gainers (Pattern 4). Average baseline weight/BMI was lower for weight gainers (Patterns 6, 7) versus other patterns. Early weight gainers (Pattern 7) had change point day at day 40 versus day 54 for Pattern 4 and day 69 for Pattern 6. Use of concomitant medications and influence of comorbid conditions on weight should be considered as inherent variables when interpreting the study. The majority of patients treated with pregabalin (150–600 mg/day) for 1 year maintained weight within ±7% baseline weight. One in six patients gained ≥7% weight from baseline, and generally exceeded 7%, 2–12 months after treatment onset.

本研究针对接受普瑞巴林（pregabalin）治疗最长达1年的患者群体，分析其体重变化模式。从纳入43525名患者的106项研究的汇总数据中，筛选出满足以下条件的受试者：治疗前至少有1次体重测量值、第1阶段（第2~56天）至少2次测量值、第2阶段（第57~356天）至少2次测量值。本研究构建了7种体重变化模式，用于探索性“变化点”分析（即治疗期间体重变化趋势偏离初始轨迹的时间点），并基于基线体重/体重指数（BMI，Body Mass Index）对体重变化模式进行评估。最终共有来自41项研究的3187名患者符合入组标准，其中98.9%的患者可被归为7种模式中的3种。大多数患者（2607/3187 [81.8%]）的体重维持在基线体重的±7%范围内，即“模式4”。仅有较少患者（463/3187 [14.5%]）属于“迟发性体重增加者”（即在第2阶段出现超过7%的体重增幅，而第1阶段未出现，即“模式6”）；更少的患者（82/3187 [2.6%]）为“早发性体重增加者”（即在第1阶段即出现≥7%的基线体重增幅，并在第2阶段维持该增幅或持续增重，即“模式7”）。整体体重增加者（模式6、7）的1年体重变化中位数为+6.20 kg [+9.12%]和5.46 kg [+13.9%]，而非体重增加者（模式4）的中位数仅为2.22 kg [+2.10%]。体重增加者（模式6、7）的平均基线体重/体重指数低于其他模式的患者。早发性体重增加者（模式7）的变化点位于治疗第40天，而模式4和模式6的变化点分别为第54天和第69天。解读本研究结果时，需将合并用药情况及共病状态对体重的影响作为固有变量纳入考量。绝大多数接受普瑞巴林（150~600 mg/日）治疗1年的患者，其体重维持在基线体重的±7%范围内。每6名患者中即有1名在治疗开始后2~12个月内出现≥7%的基线体重增幅。