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| |  Tapentadol as Effective as Oxycodone for Management of Osteoarthritic Pain, With Fewer Side Effects: Presented at OARSI By Louise Gagnon MONTREAL -- September 14, 2009 -- Prolonged release (PR) tapentadol is associated with a longer period of dose stability than controlled release (CR) oxycodone in patients who have osteoarthritic pain or chronic low back pain, according to a study presented here at the 2009 World Congress of the Osteoarthritis Research Society International (OARSI). “The dose of tapentadol that was mainly used was stable across 1 year,” said Brigitte Kupperwasser, MD, Johnson and Johnson Pharmaceutical Research and Development, LLC, Titusville, New Jersey, at a poster presentation on September 12. “The dose that was mainly used correlated with a noticeable decrease in pain intensity.” The phase 3 study included men and nonpregnant women aged 18 years and older who had a diagnosis of knee or hip osteoarthritis or nonmalignant, low back pain, with pain present for at least 3 months. Patients were randomised in a 4:1 ratio to receive either tapentadol PR 50 mg twice daily or oxycodone hydrochloride (HCl) CR 10 mg twice daily in the first 3 days of the study. Doses were then titrated to tapentadol PR 100 mg twice daily or oxycodone HCl CR 20 mg twice daily over the next 4 days. Over the next 51 weeks, it was at the discretion of patients to titrate doses, upwards to a maximum of tapentadol 250 mg twice daily or oxycodone CR 50 mg twice daily. Patients were not permitted to use any other analgesics during the study period, and they could reduce their dosage as well. Patients who received tapentadol PR took their most frequently used dose for a median duration of 133.5 days while patients who received oxycodone CR took their most frequently used dose of a median duration of 45.0 consecutive days. The mean value of the average daily dose of tapentadol PR throughout the study was 326.7 mg, and the mean value of the average daily dose of oxycodone HCl CR was 51.5 mg. A smaller percentage of patients who took tapentadol PR ceased therapy because of adverse events (22.7%) compared with patients who took oxycodone CR (36.8%). “Patients who took tapentadol had pain relief along with low side effects,” said Dr. Kupperwasser. “The dropout rate was much less with tapentadol than with oxycodone. Patients who took oxycodone dropped out more frequently.” [Presentation title: Dose Stability of Tapentadol Extended Release and Oxycodone Controlled Release in a One-Year, Randomized, Open-Label, Phase 3 Safety Trial in Patients With Chronic Low Back or Osteoarthritis Pain. Abstract 342]
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