Characterizing and understanding body weight patterns in patients treated with pregabalin

Objective: We examined patterns of weight change among patients treated with pregabalin for up to ≥1 year. Methods: 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). Results: 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 6.20kg [9.12] and 5.46kg [13.9] vs. 2.22kg [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. Conclusions: The majority of patients treated with pregabalin (150600mg/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.