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Tapentadol ER®: effectief en veilig bij diabetische neuropathische pijn

De titel van de presentatie tijdens de 26th vergadering van de 'American Academy of Pain Medicine' (AAPM) was.: Efficacy and Tolerability of Tapentadol Extended Release® for Diabetic Peripheral Neuropathic Pain: Results of a Randomized-Withdrawal, Double-Blind, Placebo-Controlled Phase 3 Study. Het was Abstract 113. De resultaten werden aldus weergegeven:

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.

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.

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).

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.

Bron: http://www.docguide.com/news/content.nsf/News/852576140048867C852576C4007D0E2F?OpenDocument&id=48dde4a73e09a969852568880078c249

Maart 2010, prof.dr. Jan M. Keppel Hesselink