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SAT0087 The effect of meloxicam versus usual care nsaids for the treatment of osteoarthritis in a ususal care setting. the results of the improve trial
  1. P Gagnier1,
  2. G Singh2,
  3. JI Reed3,
  4. M Kobe1,
  5. P Arnold1,
  6. E Hwang4
  1. 1Clinical Research
  2. 2Medicine/Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, CA, USA
  3. 3Rheumatology, Fallon Clinic, Worcester, MA, USA
  4. 4Biometrics and Data Management, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield

Abstract

Background Traditionally, NSAIDs have been the mainstays for managing symptoms of osteoarthritis (OA). While NSAIDs generally are considered to be effective in managing pain and inflammation, they frequently are associated with gastrointestinal side effects or lose their effectiveness leading to discontinuation of therapy or switching to another NSAID. These side effects can add significantly to the direct medical cost of managing the OA patient population. This suggests that there is dissatisfaction with current therapies on the part of the patient, physician or both. The time to discontinuation or change to another NSAID may be used as one measure that can examine the interrelated reasons for discontinuation, mainly efficacy and tolerability. Currently, there are no published randomised prospective studies that have examined the time to NSAID discontinuation; or NSAID switches and

Objectives The objective of this study was to compare the percentage of treatment successes or failures in patients randomised to meloxicam 7.5 mg vs. usual care prescription NSAIDS in a variety of managed care settings (MCOs). A success was defined as a patient who started on their initially prescribed study NSAID and never received a different prescription NSAID during the trial. During the trial, the patient could have temporarily discontinued the new study prescription NSAID, restart the same drug and be considered a treatment success. A treatment failure was defined as a patient who started on an originally prescribed study NSAID and changed to another NSAID at any point during the trial.

Methods This was a multicenter, randomised, parallel-group, open-label trial of meloxicam 7.5 mg versus usual care administration of prescription formulary NSAIDs for the treatment of patients with OA in a variety of MCO models. Patients with OA of the hip, knee, hand or spine were randomised to receive either meloxicam 7.5 mg or any other prescription NSAID that they had not previously been treated with for their OA based on the patients formulary. The study was designed to mirror actual MCO practices and not add costly and unnecessary study-driven procedures at enrolment and throughout the observation period. The treatment/observation period was 6 months in duration and assessments were made to determine the reasons for permanent discontinuation from the initial prescription NSAIDs, number of NSAID therapies, as well as the health care utilisation, efficacy and safety.

Results There were 1,321 patients entered into the trial and approximately 67% of the patients were female and 95% Caucasian. The mean age was approximately 64 years and the mean duration of OA was over 9 years. Rates of NSAID switching and efficacy will be discussed.

Conclusion The study was well accepted by physicians and patients.

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