Tapentadol Prolonged Release for Chronic Pain: A Review of Clinical Trials and 5 Years of Routine Clinical Practice Data.
Tapentadol prolonged release (PR) for the treatment of moderate to severe chronic pain combines 2 modes of action. These are μ-opioid receptor agonism and noradrenaline reuptake inhibition in a single molecule that allow higher analgesic potency through modulation of different pharmacological targets within the pain transmitting systems. At the same time, this can also serve as a clue for modulation of different pain-generating mechanisms according to nociceptive, neuropathic, or mixed pain conditions. Tapentadol PR has now been on the market for 5 years, with over 4.6 million people treated worldwide. A panel of pain specialists convened in Germany to review the clinical program and to discuss the role of tapentadol PR in the management of chronic pain. The clinical study program demonstrated effective and generally well-tolerated treatment for up to 2 years in a broad range of chronic pain conditions, including those with neuropathic pain components. This was confirmed in routine clinical practice observations. Head-to-head studies with World Health Organization (WHO) III opioids such as oxycodone controlled release and oxycodone/naloxone PR showed at least comparable pain relief in the treatment of moderate-to-severe musculoskeletal pain. Rotation from poorly tolerated WHO III opioids to tapentadol PR provided effective pain relief and better symptom control for musculoskeletal pain compared to previous medication. Functionality, health status and quality of life also improved under tapentadol PR treatment. The gastrointestinal tolerability profile was more favorable compared to other tested WHO III opioids. Tapentadol PR has a good safety profile and no evidence of acquired tolerance from the long-term data so far collected. Overall, tapentadol PR represents an effective and generally well-tolerated alternative to "classical" opioidergic drugs.
Division of Neurological Pain Research and Therapy, Department of Neurology, University Hospital of Schleswig-Holstein, Kiel, Germany.
Ralf
R
Baron
Department of Anesthesiology and Critical Care Medicine, Philipps-University, Marburg, Germany.
Leopold
L
Eberhart
Institute for Pain Medicine, Wiesbaden, Germany.
Kai-Uwe
KU
Kern
Health Center, Mainz, Germany.
Stefan
S
Regner
Department of Palliative Medicine, Medical Faculty RWTH Aachen University, Aachen, Germany.
Roman
R
Rolke
Department of Trauma, Hand and Foot Surgery, St. Martinus Hospital, Langenfeld, Germany.
Christian
C
Simanski
Department of Neurology, Technische Universität, Munich, Germany.
Thomas
T
Tölle
D000700:Analgesics / Q000627:therapeutic use*; D059350:Chronic Pain / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D003692:Delayed-Action Preparations / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D059408:Pain Management / Q000379:methods*; D010636:Phenols / Q000627:therapeutic use*; D011788:Quality of Life; D000077432:Tapentadol
D000700:Analgesics; D003692:Delayed-Action Preparations; D010636:Phenols; D000077432:Tapentadol
chronic pain; review; tapentadol prolonged release