title: A comparison of Naprelan and Naprosyn in the treatment of osteoarthritis of the knee.
abstract: This double-blind, double-dummy, placebo-controlled, randomized study compared the safety and efficacy of Naprelan (Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania), a once-daily, controlled-release formulation of naproxen sodium with that of Naprosyn (Syntex Laboratories, Inc., Palo Alto, California), a conventional naproxen formulation. A total of 347 patients with osteoarthritis (OA) of the knee were assigned to receive Naprelan 1,000 mg once daily, Naprosyn 500 mg BID, or placebo for 12 weeks. Two hundred twenty-eight patients who completed the study then entered an open-label extension in which they received Naprelan 1,000 mg daily for as many as 9 additional months. In the double-blind phase, Naprelan and Naprosyn demonstrated comparable efficacy with no significant differences in mean efficacy scores. After 12 weeks, three primary variables significantly favored Naprelan and Naprosyn over placebo, while a fourth approached significance. Statistical analysis confirmed that Naprelan and Naprosyn were equally effective. Significantly more Naprosyn--than placebo-treated patients had at least one drug-related adverse event (AE) and at least one drug-related gastrointestinal (GI) system AE, but there were no significant differences between Naprelan and placebo. During the open-label phase, patients initially treated with Naprelan or Naprosyn maintained the improvement achieved in the double-blind phase, while those initially treated with placebo showed significantly greater improvement after the first month of Naprelan treatment than the other two groups. As assessed by one of two primary efficacy measures, the greater improvement in those initially treated with placebo was maintained until the end of the study. The AE profile for patients treated with Naprelan for up to 1 year was not significantly different than that for the double-blind phase. The results of this study have confirmed the efficacy of Naprelan 1,000 mg once daily in the treatment of OA as superior to placebo and equivalent to Naprosyn 500 mg BID.
authors.affiliation: University of Colorado School of Medicine, Denver, USA.
authors.forename: M H
authors.initials: MH
authors.lastname: Schiff
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D006801:Humans; D007719:Knee Joint; D008875:Middle Aged; D009288:Naproxen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010003:Osteoarthritis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D009288:Naproxen