Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia

Summary

A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks.It is proposed that use of flexible dosing combined with nightly dosing would have similar pain relief to fixed dosing, would improve adherence, would have less side effects and would be more likely to improve sleep.

Timeline

Start

2010-07

Primary completion

2012-07

Completion

2012-07

Publications

• Nasser K, Kivitz AJ, Maricic MJ, Silver DS, Silverman SL. Twice daily versus once nightly dosing of pregabalin for fibromyalgia: a double-blind randomized clinical trial of efficacy and safety. Arthritis Care Res (Hoboken). 2014 Feb;66(2):293-300. doi: 10.1002/acr.22111.

Drugs

Indications