Background/Purpose:

Fibromyalgia (FM) is a chronic condition characterized by widespread pain and tenderness. Sleep disturbance is common in patients with FM, and both pain and poor sleep quality can have a significant impact on patients’ quality of life. Pregabalin is one of 3 drugs approved for the treatment of FM in the United States. Several placebo-controlled clinical trials have demonstrated that pregabalin treatment results in significant improvements in both pain and sleep in patients with FM.

Methods:

This post-hoc analysis examined the time-to-onset (TTO) of improvement in pain and sleep quality in patients diagnosed with FM from four 8- to 14-week Phase III placebo-controlled trials of pregabalin at 150, 300, 450 or 600 mg/d. Pain scores were recorded in a daily diary on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Daily sleep quality was also reported on an 11-point NRS ranging from 0 (best possible sleep) to 10 (worst possible sleep). Daily pain and sleep quality scores were analyzed using analysis of covariance in the intent-to-treat population. The TTO of improvement in pain and sleep quality scores was calculated for all pregabalin dose arms that showed a statistically significant (p<0.05) reduction in their respective score at endpoint compared with placebo. TTO was defined as the first of 2 consecutive days for which the mean score was statistically significantly lower for pregabalin vs placebo.

Results:

Across the 4 studies included in the analysis, there was a total of 12 pregabalin dose arms, with 2069 patients receiving pregabalin and 689 placebo. Patients had a mean age ranging from 48.0-49.7 years and the majority were women (93.1%). Mean baseline pain scores were similar for the pregabalin (range 6.8-7.0) and placebo groups (6.8). Mean baseline sleep quality scores were also similar for the pregabalin (range 6.3-6.4) and placebo (6.4) groups. Eight of 12 pregabalin dose arms were associated with a significant reduction in pain scores vs placebo at endpoint. TTO of improvement in pain occurred at day 1 of treatment for 7 dose arms (average reduction in mean pain score vs placebo, -0.36 for 300 mg/d, -0.55 for 450 mg/d, and -0.41 for 600 mg/d) and at day 2 for 1 arm (-0.59 for 300 mg/d). Eleven of 12 pregabalin dose arms were associated with a significant improvement in sleep quality score vs placebo at endpoint. TTO of improvement in sleep occurred at day 1 of treatment for these 11 arms (average reduction in mean sleep quality score vs placebo, -0.77 for 300 mg/d, -0.77 for 450 mg/d, and -0.71 for 600 mg/d pregabalin).

Conclusion:

In patients with FM, statistically significant improvement in pain typically occurs within 2 days, and statistically significant improvement of sleep quality within 1 day, of initiating treatment with pregabalin.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/time-to-improvement-of-pain-and-sleep-in-clinical-trials-of-pregabalin-treatment-of-fibromyalgia/