Twice Daily Versus Once Nightly Dosing of Pregabalin for Fibromyalgia: A Double-Blind Randomized Clinical Trial of Efficacy and Safety

Authors

  • Keaton Nasser,

    1. Osteoporosis Medical Center, Beverly Hills, California
    Search for more papers by this author
  • Alan J. Kivitz,

    1. Altoona Research, Duncansville, Pennsylvania
    Search for more papers by this author
    • Dr. Kivitz has received consultant fees, speaking fees, and/or honoraria (less than $10,000) and research grants from Pfizer.

  • Michael J. Maricic,

    1. Catalina Pointe, Tucson, Arizona
    Search for more papers by this author
    • Dr. Maricic has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) and research grants from Novartis, Eli Lilly, Pfizer, Roche, and Genentech.

  • David S. Silver,

    1. Osteoporosis Medical Center, Beverly Hills, and Targeted Medical Pharma and University of California, Los Angeles
    Search for more papers by this author
    • Dr. Silver serves on the Board of Directors for and holds stock or stock options in Targeted Medical Pharma.

  • Stuart L. Silverman

    Corresponding author
    1. Osteoporosis Medical Center, Beverly Hills, Cedars-Sinai Medical Center, West Hollywood, and University of California, Los Angeles
    Search for more papers by this author
    • Dr. Silverman has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Eli Lilly, Amgen, Warner-Chilcott, Pfizer/Wyeth, Merck, Roche Diagnostics, Genentech, and Novartis and has received research grants from Amgen, Eli Lilly, Merck, Novartis, Pfizer/Wyeth, Medtronics, and the Alliance for Better Bone Health.


  • ClinicalTrials.gov identifier: NCT01226667.

Abstract

Objective

To compare the efficacy, discontinuation rates, and safety of once nightly versus twice daily dosing of pregabalin in a community-based trial.

Methods

This multicenter, double-blind, 8-week randomized clinical trial compared the effects of 300-mg daily doses of pregabalin given either twice daily or once nightly for the treatment of fibromyalgia in 177 patients. The primary outcome was the comparison of end point mean pain scores derived from a daily diary.

Results

Both twice daily (88 patients randomized) and once nightly (89 patients) pregabalin significantly reduced the average severity of pain experienced by patients (P < 0.001 for both). Treatment-emergent adverse events were reported by significantly more patients in the twice daily group than those in the once nightly group (P = 0.023). There were no significant differences between the groups for the frequencies of individual adverse events (P > 0.05 for all). There was no significant difference in adverse events or efficacy in patients taking both pregabalin and a selective serotonin and norepinephrine reuptake inhibitor or selective serotonin uptake inhibitor.

Conclusion

While a nightly dosing schedule of pregabalin has been used by clinicians hoping to improve treatment, this study showed no significant difference (either beneficial or detrimental) between either treatment option. While there was a decrease in total patient-reported adverse events in the once nightly arm, the lack of specificity in relation to a particular adverse event suggested no real difference in adverse events.

Ancillary