Quality of Sleep in Patients with Osteoarthritis Treated with Extended-Release and Conventional Etodolac

Abstract

To examine patient-perceived quality of sleep related to osteoarthritis (OA) of the knee before and after treatment with etodolac (Lodine and Lodine XL-Wyeth-Ayerst Laboratories), a nonsteroidal anti-inflammatory drug (NSAID). Data from a 24-week, outpatient clinical trial of two formulations of etodolac. Study protocols specified a parallel group, double-blind, clinical trial conducted at multiple outpatient sites throughout the United States. Patients or Other Participants : 331 patients randomized into three treatment groups. The age range was 36 to 80 years of age; 53% were 64 years of age or older; mean age was 64 years. Women comprised 74% of the patients. Approximately 89% were white, 8% were black, and the remaining 3% reported other racial origins. Patients were assigned to one of three active treatment groups: etodolac ER 800 mg; etodolac ER 1,200 mg; or conventional etodolac 400 mg. A washout period was required to induce arthritic flare prior to therapy. Main Outcome .Mea sures: Quality of sleep during the prior week was assessed at baseline and weeks 1, 2, 4, 8, 12, 16, and 24 of therapy. Other patient outcomes, including pain intensity, night pain, and overall assessment of OA condition, were measured within the same time schedule. Regardless of dosage formulation, the percentage of patients reporting having slept well was greater after etodolac therapy when compared with baseline. Forty-two percent of patients reported having slept well at baseline. After one week of therapy and throughout the remaining assessments, 70% or more reported having slept well. Significant associations were found between quality of sleep and each of the other patient-reported outcomes (night pain, pain intensity, and assessment of condition) at baseline. Use of etodolac to treat OA pain may also result in significant improvement in patient-oriented outcomes, including perceived quality of sleep. The lack of a placebo control may limit this finding.