Characterizing and understanding body weight patterns in patients treated with pregabalin

Abstract

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 +6.20 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.

Conclusions:

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.

Key words::

• Change point modeling
• Data analysis
• Lyrica
• Weight gain

Transparency

Declaration of funding

This study was sponsored by Pfizer Inc.

Declaration of financial/other relationships

J.C. was a paid consultant to Pfizer Inc in connection with the conduct of the study. B.E., D.D., T.K.M, E.W., and A.C. are employees of Pfizer Inc. CMRO peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

Medical writing support was provided by Karen Burrows, MPhil, of UBC Scientific Solutions and funded by Pfizer Inc. The authors would like to thank Dr Leigh Perreault, MD, of the University of Colorado Anschutz Medical Campus for her critical review and input into the manuscript during development.