A portion of patients fibromyalgia who took pregabalin in phase 2 and 3 clinical trials showed improved pain symptoms and sleep patterns as early as the first day of treatment, according to a post-hoc study of four similarly designed clinical trials.
Researchers studied four placebo-controlled, parallel, random-control trials of pregablin (150 mg to 600 mg per day) in 2,747 patients who met American College of Rheumatology 1990 criteria for fibromyalgia. All pain medications were discontinued before treatment, with the exception of acetaminophen for rescue pain relief and aspirin for myocardial infarction prophylaxis.
Pregabalin was administered either twice or three times daily in dosages of 150 mg, 300 mg, 450 mg or 600 mg per day during a 2-week period in 12 treatment arms of 2,069 enrollees. Four placebo arms comprised 689 patients.
Lesley H. Arnold
Trial participants rated their pain in the prior 24 hours upon awakening on an 11-point scale, with 0 as no pain and 10 for the worst pain. Sleep quality was self-reported on a similar scale.
The number of patients considered to be responders to treatment in the four trials was 824 (39.8%) vs. 191 (27.7%) of the placebo group. By day 4, at least 25% of the pregabalin group achieved sustained clinical improvement, according to the researchers.
Of those receiving pregabalin, 1,073 (51.9%) were reported to show improved sleep quality vs. 237 (34.4%) in the placebo group. At least 25% of treated patients reported improved sleep by day 2 vs. day 9 in the placebo patients, and 50% achieved sustained clinical improvement in sleep quality by day 11.
Disclosure: Arnold has consulted with Pfizer, Forest Laboratories, Grunenthal, Daiichi Sankyo, Theravance, Purdue, Dainippon Sumitomo Pharma, Johnson & Johnson and Shire; has received research finding from Pfizer, Forest Laboratories, Eli Lilly and Company, AstraZeneca, Theravance, Takeda and Tonix; and was on the speakers bureau for Pfizer. Emir, Pauer, Resnick and Clair are full-time employees of and hold stock in Pfizer.