Patients with Fibromyalgia Improve Rapidly with Pregabalin

VBCR - October 2012, Volume 1, No 5 - Fibromyalgia

First Japanese clinical trial for this condition
By Charles Bankhead

Patients with fibromyalgia had significant improvement in pain, sleep, and quality-of-life mea­sures when treated with pregabalin (Lyrica) versus placebo, according to the results of the first clinical trial of this condition in Japan (Ohta H, et al. Arthritis Res Ther. 2012;14:R217 [Epub ahead of print]). Significant pain relief occurred within the first week of treatment with pregabalin and persisted over the 15-week duration of the trial. Significantly more patients reported being “very much improved” or “much improved” with pregabalin than with placebo (P = .078).

Quality of sleep improved significantly in the pregabalin arm within the first week of treatment and remained significantly improved versus placebo through the end of the study.

“In this, the first clinical trial in fibromyalgia patients in Japan, pregabalin demonstrated significant effi­cacy in pain reduction and also improved measures of sleep and functioning,” Hiroyoshi Ohta, MS, of Pfizer Japan in Tokyo, and colleagues concluded. “The drug was generally well tolerated, and adverse events [AEs] were consistent with prior trials and current product labeling. These data suggest that pregabalin may be an effective treatment option for the relief of pain and sleep problems in Japanese patients with fibromyalgia.”

Approved in the United States for the treatment of fibromyalgia, pregabalin has not been evaluated extensively in controlled trials of Asian patients, and there have not been any clinical trials of patients with fi­bromyalgia in Japan. For this study, investigators at 44 centers in Japan enrolled patients aged ≥18 years who met the 1990 American College of Rheumatology diagnostic criteria for fibromyalgia.

A total of 498 patients (mean age, approximately 47 years) were randomized to placebo or to pregabalin at a starting dose of 150 mg daily, which was titrated over 3 weeks to a maintenance dose of 300 mg or 450 mg daily, and was continued for an additional 12 weeks.

The mean duration of fibromyalgia was 62 months in the placebo group and 69.6 months among those receiving pregabalin.

The primary end point was the mean pain score at the end of the study, as recorded daily by patients, who rated their pain over the previous 24 hours from 0 (no pain) to 10 (worst possible pain). The mean pain score was evaluated weekly during the trial.

Secondary end points consisted of patient assessment of pain by visual analog scale (VAS; 0-100 mm), the Patient Global Impression of Change (PGIC), the Fibromyalgia Impact Questionnaire (FIQ), the 36-Item Short Form Health Survey (SF-36), the Hospital Anxiety and Depression Scale, self-rated sleep quality, and the Medical Outcomes Study (MOS) Sleep Scale.

Encouraging Results
The baseline pain score averaged between 6.4 and 6.5 in the 2 groups. When the trial ended, the pregabalin arm had a mean reduction of 1.48 from baseline compared with a reduction of 1.03 in the placebo group (P = .046).

The proportions of patients with a ≥50% reduction in mean pain score at final assessment were 22.8% in the pregabalin group and 12.1% in the placebo group (P = .017). In addition, 40.4% of the patients treated with pregabalin had a ≥30% reduction in mean pain score compared with 30.6% of patients in the placebo group (P = .023).

The VAS pain score averaged between 67 and 68 at baseline. At final assessment, the mean score was 47.42 with pregabalin, a reduction of 6.19 versus the placebo group (P = .013). PGIC results showed that 38.6% of the pregabalin group was “very much improved” or “much improved” at final assessment compared with 26.7% of the placebo group (P = .078).

There was a significant improvement in FIQ total score, which was 3.33 lower in the pregabalin group versus in the placebo group (P = .014). The FIQ subscales of feeling good, pain, fatigue, and morning tiredness all showed significant differences in favor of the pregabalin arm.

The physical functioning and vitality scales of the SF-36 were significantly improved with pregabalin (P = .006 and P = .052, respectively) versus with placebo.

The mean change in quality-of-sleep score also showed significantly greater improvement with pregabalin at the last assessment (P <.001) and at every time point from week 1 through week 15 (P ≤.001).

Multiple items on the MOS Sleep Scale improved significantly more with pregabalin, such as sleep disturbance (P <.001), sleep adequacy (P <.001), sleep quantity (P = .007), and awakening with shortness of breath or headache (P = .049). In addition, the composite MOS Sleep Scale score was significantly improved in the pregabalin group (P = .013).

Adverse Events
AEs and treatment-emergent AEs occurred more often in the pregabalin arm (90.0% and 82.4%, respectively) than in the placebo group (70.6% and 51.6%, respectively). The most common AEs in the pregabalin arm were somnolence, dizziness, nasopharyngitis, weight gain, and constipation. The authors reported that 9.6% of patients in the pregabalin arm withdrew because of AEs compared with 3.6% in the placebo arm.

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Last modified: May 21, 2015
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