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Tapentadol ER Shows Better GI Tolerability Than Oxycodone CR in Patients With Osteoarthritis of the Knee: Presented at OARSI By Louise Gagnon MONTREAL -- September 15, 2009 -- An extended release (ER) formulation of tapentadol has demonstrated better gastrointestinal (GI) tolerability than controlled release (CR) oxycodone in patients with osteoarthritis of the knee, according to a study presented here at the 2009 World Congress of the Osteoarthritis Research Society International (OARSI). Kathleen Kelly, MD, Johnson and Johnson Pharmaceutical Research and Development, LLC, Titusville, New Jersey, presented the results of a randomised, double-blind, 15-week phase 3 trial during a poster session on September 12. The primary objective of the study was to determine if tapentadol ER was effective in treating pain, but the study also compared the side effect profile of tapentadol and oxycodone. “This study focuses on the improved GI profile when it [tapentadol] is compared with oxycodone,” said Dr. Kelly. The study included an intent-to-treat population of 1,023 patients. Investigators found statistically significant differences, when comparing tapentadol ER to oxycodone CR and placebo, in decreasing pain intensity. The overall incidence of treatment-emergent adverse events (TEAEs) was 61.1% in the placebo arm, 75.9% in the tapentadol arm, and 87.4% in the oxycodone arm. When examining those TEAEs related to the GI system, investigators observed 26.1% in the placebo group, 43.0% in the tapentadol ER group, and 67.3% in the oxycodone CR arm. “There were many fewer gastrointestinal-related side effects [with tapentadol] compared with oxycodone, specifically nausea, vomiting, and constipation,” noted Dr. Kelly. Moreover, the TEAEs that were GI-related amongst patients who received oxycodone CR prompted more patient discontinuations from the study compared with GI-TEAEs amongst tapentadol ER-treated patients. “We saw a high withdrawal rate very early on in our oxycodone group,” said Dr. Kelly. “Many of the dropouts in the oxycodone group were due to adverse events, with a large proportion being GI adverse events. We think that this drug is a good option for patients who are expected to have major problems with GI adverse events with standard oxycodone.” Dr. Kelly explained that the ER formulation of tapentadol differs from the standard formulation of tapentadol in that the ER formulation takes longer to reach peak concentration, so that the absorption of the drug is more evenly spread. Funding for this study was provided by Johnson and Johnson Pharmaceutical Research and Development. [Presentation title: Incidence and Severity of Gastrointestinal Treatment-Emergent Adverse Events in Patients Treated With Tapentadol Extended Release (ER) or Oxycodone Controlled Release (CR) for Relief of Chronic Osteoarthritis Knee Pain. Abstract 334] E-mail this page to a friend or colleague! To print, use this version