|
April 30, 2009
Sleep disturbances are common in patients with fibromyalgia (FM). The objective of
this analysis was to evaluate the effects of pregabalin on sleep in patients with FM.
Methods
Analyses were based on two randomized, double-blind, placebo-controlled trials
of pregabalin - Lyrica® - (300 mg, 450 mg, and 600 mg daily) in adult FM
patients. Sleep outcomes included the Medical Outcomes Study (MOS) Sleep Scale and a
daily diary assessment of sleep quality. Treatment effects were evaluated using analysis
of covariance. Clinically important differences (CID) in the Sleep Quality Diary and
MOS Sleep Disturbance scores were estimated using mixed-effects models of changes in
scores as a function of patients' global impressions of change. Mediation modeling was
used to quantify the direct treatment effects on sleep in contrast to indirect influence
of the treatment on sleep via pain.
Results
A total of 748 and 745 patients were randomized in the respective studies. Patients
were predominantly Caucasian females, average age 48–50 years, on average had FM for
9–10 years, and experienced moderate to severe baseline pain. Pregabalin
significantly improved the Sleep Quality Diary (P < 0.001), MOS Sleep Disturbance
(P < 0.01), MOS Quantity of Sleep (P < 0.003), and MOS Sleep Problems Index scores
(P < 0.02) relative to placebo. Treatment effects for the 450 mg and 600 mg groups
exceeded the estimated CID thresholds of 0.83 and 7.9 for the Sleep Quality Diary and
MOS Sleep Disturbance scores, respectively. Mediation models indicated that 43–80% of
the benefits on sleep (versus placebo) were direct effects of pregabalin, with
the remainder resulting from an indirect effect of treatment via pain relief.
Conclusions
These data demonstrate improvement in FM-related sleep dysfunction with pregabalin
therapy. The majority of this benefit was a direct effect of pregabalin on the
patients' insomnia, while the remainder occurred through the drug's analgesic activity.
You may also like...
|
