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Efficacy and Safety of Ketoprofen Patch in Patients With Rheumatoid Arthritis: A Randomized, Double‐Blind, Placebo‐Controlled Study
Author(s) -
Kawai Shinichi,
Uchida Eiji,
Kondo Masakazu,
Ohno Syuji,
Obata Junichi,
Nawata Yasushi,
Sugimoto Kazunori,
Oribe Motohiro,
Nagaya Ikuo
Publication year - 2010
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270009355813
Subject(s) - medicine , ketoprofen , placebo , rheumatoid arthritis , visual analogue scale , wrist , adverse effect , anesthesia , arthritis , surgery , pharmacology , alternative medicine , pathology
This study assessed the efficacy and safety of ketoprofen patch compared with placebo in patients who had rheumatoid arthritis and persistent wrist pain. Patients (N = 676) who had achieved systemic disease control with a disease‐modifying antirheumatic drug and/or systemic corticosteroid, but still had persistent wrist pain, were randomized to a 2‐week course of once‐daily treatment with application of a 20‐mg ketoprofen patch or a placebo patch to the wrist. The primary efficacy end point was the percent change from baseline to the end of treatment in the intensity of wrist pain scored by each patient on a 100‐mm visual analog scale. The mean ± SD percent change on the pain intensity scale was significantly larger in patients treated with ketoprofen than in those receiving placebo (31.2% ± 30.3% [95% confidence interval: 28.0–34.4] vs 25.5% ± 31.2% [95% confidence interval: 22.1–28.8]; P = .020). However, the actual difference of the mean pain intensity scale between the 2 groups was small at the end of treatment. The frequency of adverse events was similar in both groups. The ketoprofen patch was more effective than placebo for relieving persistent local joint pain in patients with rheumatoid arthritis. The patch was also safe and well tolerated during the 2‐week treatment period.