Efficacy and safety of naproxcinod in the treatment of patients with osteoarthritis of the knee: a 13-week prospective, randomized, multicenter study
| Autor: | B. Duquesroix, H. Frayssinet, A. Kivitz, Thomas J. Schnitzer |
|---|---|
| Jazyk: | angličtina |
| Předmět: |
Male
medicine.medical_specialty Population Biomedical Engineering Pain Blood Pressure Non-steroidal anti-inflammatory drug (NSAIDs) Osteoarthritis Placebo Severity of Illness Index Drug Administration Schedule law.invention chemistry.chemical_compound Naproxen Rheumatology Randomized controlled trial law Heart Rate Internal medicine medicine Clinical endpoint Humans Orthopedics and Sports Medicine Cyclooxygenase Inhibitors Nitric Oxide Donors Prospective Studies Naproxcinod Adverse effect education Prospective cohort study Aged Pain Measurement education.field_of_study Dose-Response Relationship Drug business.industry Anti-Inflammatory Agents Non-Steroidal Middle Aged Osteoarthritis Knee medicine.disease Cyclooxygenase-inhibiting nitric-oxide donator (CINOD) chemistry Physical therapy Female business |
| Zdroj: | Osteoarthritis and Cartilage. (5):629-639 |
| ISSN: | 1063-4584 0054-2555 |
| DOI: | 10.1016/j.joca.2009.12.013 |
| Popis: | Summary Objective To evaluate the efficacy and safety of the cyclooxygenase-inhibiting nitric-oxide donator, naproxcinod, compared with naproxen and placebo in patients with osteoarthritis (OA) of the knee. Method 918 eligible patients were randomly assigned to double-blind treatment with either naproxcinod 375mg, naproxcinod 750mg, naproxen 500mg or placebo, twice daily for 13 weeks. The primary objective was to show superiority of naproxcinod compared to placebo. Main efficacy criteria were assessment of pain and physical function using the Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC™) and patients' overall rating of disease status (Likert scale). The main secondary objectives were to show that naproxcinod was non-inferior to naproxen 500mg and to evaluate overall safety. Results Both doses of naproxcinod were statistically and clinically superior to placebo in relieving signs and symptoms of OA of the knee after 13 weeks of treatment, as demonstrated by all three co-primary endpoints ( P ≤0.0003). The evaluation of the other secondary efficacy measures was consistent with the primary endpoint results. Naproxcinod 750mg was non-inferior to equimolar doses of naproxen 500mg in the Intent-to-Treat (ITT) population. 24.5% of patients discontinued prematurely, with a higher incidence in the placebo group (18.6%) than the active groups (4.3–7.1%) discontinuing due to lack of efficacy. Both doses of naproxcinod were well-tolerated, with most adverse events being mild or moderate. Compared to placebo, naproxcinod 750mg and 375mg showed a similar blood pressure (BP) profile in contrast to naproxen which increased BP. Conclusions These results demonstrated the clinical efficacy and safety of naproxcinod in the management of the signs and symptoms of OA. Naproxcinod was well-tolerated, with BP effects similar to placebo and different from naproxen. Clinical Trials.gov identifier: NCT00542555. |
| Databáze: | OpenAIRE |
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