TY - JOUR
T1 - The effects of pregabalin on sleep disturbance symptoms among individuals with fibromyalgia syndrome
AU - Russell, I. Jon
AU - Crofford, Leslie J.
AU - Leon, Teresa
AU - Cappelleri, Joseph C.
AU - Bushmakin, Andrew G.
AU - Whalen, Ed
AU - Barrett, Jeannette A.
AU - Sadosky, Alesia
N1 - Funding Information:
This research was funded and supported by Pfizer Inc. Joseph Cappelleri, Andrew Bushmakin, Teresa Leon, Alesia Sadosky, Ed Whalen, and Jeannette Barrett are all employees and shareholders of Pfizer Inc. Dr. Crofford has received research grant funding from Pfizer, Wyeth, Allergan, and Boehringer Ingelheim. She has also received honoraria for CME lectures from Eli Lilly and from 3rd party CME providers, but does not serve on speaker’s bureaus or perform consulting. Dr. Russell received support from Pfizer Inc. to conduct the 1056 and 1077 studies. He is also a member of the National and Global Medical Advisory Boards for Fibromyalgia and the Pfizer Speaker Panel on Fibromyalgia-related topics. The authors thank Anne McDermott, a paid external consultant, for her assistance in preparing the manuscript.
PY - 2009/6
Y1 - 2009/6
N2 - Objectives: 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 (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.
AB - Objectives: 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 (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.
KW - Clinically important difference
KW - Fibromyalgia syndrome
KW - Insomnia
KW - Mediation analysis
KW - MOS Sleep Scale
KW - Pain
KW - Pregabalin
KW - Sleep disturbance
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U2 - 10.1016/j.sleep.2009.01.009
DO - 10.1016/j.sleep.2009.01.009
M3 - Article
C2 - 19410509
AN - SCOPUS:67349113140
SN - 1389-9457
VL - 10
SP - 604
EP - 610
JO - Sleep Medicine
JF - Sleep Medicine
IS - 6
ER -