Transdermal buprenorphine in the treatment of chronic pain: Resultsof a phase III, multicenter, randomized, double-blind, placebo-controlled study

Managing severe cancer pain: the role of transdermal buprenorphine: a systematic review

“…The 19 published articles described 16 different studies: Radbruch 29 presented the aggregated data from Bohme, 28 Sittl, 31 and Sorge; 32 Evans reported efficacy and safety data by pooling the 3 placebo-controlled RCTs; 25 and Radbruch 30 and Apolone 35 reported the preliminary information later published by Griessinger 33 and Apolone, 46 respectively. Nine were clinical trials 28,31,32,37,[39][40][41][42]44 and 7 were observational (non-intervention) studies. 33,34,36,38,43,45,46 Most of the papers reported data from a mixed population including both cancer and non-cancer patients (12/19).…”

“…37 The characteristics of the remaining 6 studies, 28,31,32,40,42,44 involving 499 cancer patients (range 9 to 189) are reported in Table 2A.…”

“…The main characteristics of the remaining 19 papers [28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46] are reported in Table 1. The 19 published articles described 16 different studies: Radbruch 29 presented the aggregated data from Bohme, 28 Sittl, 31 and Sorge; 32 Evans reported efficacy and safety data by pooling the 3 placebo-controlled RCTs; 25 and Radbruch 30 and Apolone 35 reported the preliminary information later published by Griessinger 33 and Apolone, 46 respectively.…”

“…The first Phase III studies were 3 multicenter, randomized, double-blind clinical trials vs placebo (Bohme, 28 Sittl, 31 Sorge) 32 in patients with chronic cancer and non-cancer pain, initiated and sponsored by the industry marketing in Europe the drug under evaluation. In the first and the third study, only patients whose pain was satisfactorily relieved after a run-in phase with buprenorphine SL were randomized.…”

Buprenorphine in Postoperative Pain Management

“…The onset of action of transdermal buprenorphine is 12 to 24 hours and the duration of action of each patch transdermal buprenorphine is 3 days. 39 …”