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To the Editor:
We read the article by Winkelman et al. with interest.1 We noted that every author in this review works for or receives money from Boehringer Ingelheim Pharmaceuticals, Inc. In their abstract, the authors make the following conclusion: “As rated by patients and by clinicians, pramipexole was efficacious and safe in reducing the symptoms of restless legs syndrome.” While we do not dispute that the data imply that pramipexole may have a role in the treatment of restless legs syndrome (RLS), we have several concerns.
The authors listed adverse events (AEs) in table 2. The “safety” that the authors describe is not affirmed when 50.8% of those receiving pramipexole (all doses; compared to 31.4% for placebo) had AEs, including about 37% more of those rated to be severe in intensity.
Less frequently occurring AEs are not reported. We would be interested to learn of neuropsychiatric AEs (e.g., dyskinesia, hallucinations, mood alterations, psychotic reactions), similar to those reported in the US Food and Drug Administration (FDA)–approved product label for pramipexole (as Mirapex).
Secondly, a concern to both the authors and to us was the exceptionally high placebo rate. In the Results …
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