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To the Editor:
Siddall et al. conclude with a bullish statement on the effectiveness of pregabalin. The article, acknowledging that all authors worked for or were supported by Pfizer, obfuscates several problems with pregabalin.1
The first problem is study design; all patients were permitted to remain on existing pain therapies except the individuals taking gabapentin, who were required to discontinue treatment at least a week before the study protocol began. This intentionally produced a gabapentin withdrawal state in 34 clients.1 The study may have been biased because those receiving pregabalin were receiving replacement therapy as a byproduct of pre-study drug manipulation; randomization was completed after gabapentin was withdrawn; and the authors did not report which subjects in gabapentin withdrawal were randomized to which treatment group.
The second problem concerns safety. The pregabalin group manifested significantly more adverse side effects, including more serious ones. Twenty-one percent more of the pregabalin-treated patients reported treatment-emergent adverse events compared to placebo. The group discontinuing treatment due to pregabalin was 62% higher than those discontinuing treatment due to placebo.
In addition, side effects included somnolence, dizziness, euphoria (3 with pregabalin vs 0 with placebo), and edema. Adverse …
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