Long-term Safety and Tolerability of Tapentadol Extended Release for the Management of Chronic Low Back Pain or Osteoarthritis Pain

Abstract

Tapentadol ER (100 to 250 mg bid) was associated with better gastrointestinal tolerability than oxycodone HCl CR (20 to 50 mg bid) and provided sustainable relief of moderate to severe chronic knee or hip osteoarthritis or low back pain for up to 1 year.

Long-Term Treatment of Osteoarthritis Pain: Achieving a Balance Between Efficacy and Tolerability for a Successful Chronic Therapy

“…However, the long-term utility of NSAIDs and opioid analgesics may be limited by safety and tolerability issues (Benyamin et al, 2008;Zhang et al, 2008). Tapentadol ER provides effective pain control with good tolerability and improvements in quality of life (Afilalo et al, 2010;Lange et al, 2010;Wild et al, 2010). The favorable tolerability profile of tapentadol ER compared with oxycodone CR may allow patients to remain on treatment for longer periods of time, resulting in consistent, effective pain relief and long-term improvements in quality of life and health status.…”

“…Tapentadol ER was associated with particularly better gastrointestinal tolerability compared with oxycodone CR. Gastrointestinal TEAEs led to discontinuation in 8.6% (77/894) of patients in the tapentadol ER group compared with 21.5% (48/223) of patients in the oxycodone CR group (Wild et al, 2010). In pooled analyses of data from 3 randomized, placebo-and active-controlled, phase 3 studies with 15 weeks of active treatment in patients with moderate to severe, chronic osteoarthritis knee pain (2 studies) or low back pain (1 study), the efficacy of tapentadol ER (100-250 mg bid) was non-inferior to that of oxycodone HCl CR (20-50 mg bid); however, tapentadol ER had a superior gastrointestinal tolerability profile relative to oxycodone CR .…”

Perioperative considerations for “new” kids on the opioid block

“…Selon certaines données probantes, le tapentadol est un analgésique efficace et possède, sans surprise, un meilleur profil d'effets secondaires que les agents plus anciens. 7,8 À notre connaissance, il n'existe pas d'études comparant directement l'efficacité et les effets secondaires du tramadol et du tapentadol, et il est peu probable que le tapentadol soit moins dispendieux que le tramadol, lequel est actuellement fabriqué sous forme générique. Tout comme cela a été le cas avec la prégabaline, nous prévoyons que le degré d'adoption du tapentadol par les personnes traitant la douleur dépendra tout autant, voire plus, de la façon dont ce médicament sera commercialisé que de ses avantages intrinsèques par rapport à d'autres traitements.…”

“…There is certainly evidence that tapentadol is an effective analgesic and that it has, as one would expect, a better side-effect profile than older agents. 7,8 To our knowledge, there are no trials in which tramadol and tapentadol are compared directly for efficacy and side effects, and tapentadol is unlikely to offer a price advantage over tramadol, which can now be manufactured generically. Like pregabalin, we anticipate that the degree to which tapentadol is embraced by the pain management community will owe as much or more to the way in which the drug is marketed as to its intrinsic advantages over available therapies.…”

Role of tapentadol in pain management

“…A randomized, open-label phase III study assessed the long-term safety and tolerability of tapentadol prolonged release in 1121 patients with chronic knee or hip osteoarthritis pain, or lower back pain 23 .Patients received controlled, adjustable, oral, twice daily doses of tapentadol prolonged release (100-250mg twice daily) or oxycodone HCl controlled release (20-50mg twice daily) for up to 1 year.…”