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| |  Tapentadol Extended Release Effective, Safe for Diabetic Peripheral Neuropathic Pain: Presented at AAPM By Jennifer Reising SAN ANTONIO, Tex -- February 8, 2010 -- Tapentadol extended release (ER) is effective and safe in managing moderate to severe chronic pain in patients with diabetic peripheral neuropathy, compared with placebo, according to a study presented here at the 26th annual meeting of the American Academy of Pain Medicine (AAPM). The immediate release formulation of tapentadol was approved in 2009 by the US Food and Drug Administration (FDA) for the treatment of acute pain, but the ER formulation is still under development and is not FDA approved. This randomised-withdrawal, double-blind, phase 3 study involved patients aged 18 years or older with type 1 or type 2 diabetes with a diagnosis of painful diabetic peripheral neuropathy and symptoms for a minimum of 6 months. Patients had analgesic treatment for painful diabetic peripheral neuropathy for at least 3 months and were not satisfied with their current treatment. A 3-day pain intensity evaluation was administered and patients with average value >=5 (on an 11-point numerical rating scale [NRS]) met the criteria for the open-label phase of the trial. During the 3-week open-label period, 588 patients were titrated to an optimal dose of tapentadol ER 100 to 250 mg twice daily. The majority of these patients (79.4%) had a pain intensity rating >=6 on the 11-point NRS. The double-blind phase consisted of a 12-week maintenance period, during which patients received >=1 dose of study medication. A total of 395 patients had a >=1 point improvement in pain intensity and were then randomised in a 1:1 ratio to tapentadol ER or placebo. The primary efficacy endpoint was the improvement in pain intensity during the double-blind treatment phase. Patients who effectively received an optimal dose of tapentadol ER in the open-label period and began the double-blind phase of treatment had a mean (standard deviation) decrease in pain intensity from 7.3 (1.43), or severe pain, to 3.5 (1.89), or mild pain, during open-label treatment. During the double-blind period, the tapentadol ER group had an average pain intensity that remained relatively constant, while the placebo group had a pain intensity that increased in severity (P < .001). During the open-label treatment phase, 20.1% of patients experienced the onset of 1 or more adverse events and discontinued the study. Of those patients involved in the double-blind phase of the study, 11.2% of patients in the tapentadol ER group and 5.7% of patients in the placebo group discontinued due to adverse events. The most common adverse events were gastrointestinal related and led to discontinuation in 10% of patients. “The most important point coming out of our study is that tapentadol ER has no loss in analgesic emphasis, compared with other drugs, yet it has better side effects,” said Douglas Y. Shapiro, MD, PhD, Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, New Jersey, on February 4. “The side effects that patients find particularly bothersome, such as constipation, are those side effects that are reduced the most with tapentadol ER.” Funding for this study was provided by Johnson & Johnson Pharmaceutical Research & Development, LLC and Grünenthal GmbH. [Presentation title: Efficacy and Tolerability of Tapentadol Extended Release for Diabetic Peripheral Neuropathic Pain: Results of a Randomized-Withdrawal, Double-Blind, Placebo-Controlled Phase 3 Study. Abstract 113]
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