The pain medication your doctor should be telling you about.
There is a national opioid crisis and the number of overdoses is unacceptably high. Many people live in chronic pain. People are unique and treatment should be individualized. Studies showing long term benefit from opioids are lacking. Typical pain medicines work like Morphine on a specific type of pain receptor. Tapentadol works in a different way because it works on the same receptors as morphine but it also works on the norepinephrine receptors in the brain. This means that it manages your pain differently. This study demonstrated long term benefit for pain control and safety over a 2 year period.
The Research
Clin Ther. 2015 Nov 1;37(11):2420-38. doi: 10.1016/j.clinthera.2015.08.014. Epub 2015 Oct 1.
Long-term Safety and Efficacy of Tapentadol Extended Release Following up to 2 Years of Treatment in Patients With Moderate to Severe, Chronic Pain: Results of an Open-label Extension Trial.
Buynak R1, Rappaport SA2, Rod K3, Arsenault P4, Heisig F5, Rauschkolb C6, Etropolski M7.
1 Northwest Indiana Center for Clinical Research, Valparaiso, Indiana.
2 Agewell(®) Health, Indianapolis, Indiana.
3 Toronto Poly Clinic, Toronto, Ontario, Canada.
4 Diex Research, Sherbrooke, Quebec, Canada.
5 Global Drug Safety, Grünenthal GmbH, Aachen, Germany.
6 Janssen Research & Development, LLC, Raritan, New Jersey.
7 Janssen Research & Development, LLC, Raritan, New Jersey. Electronic address: metropol@its.jnj.com.
Abstract
PURPOSE:
Tapentadol extended release (ER) has demonstrated efficacy and safety for the management of moderate to severe, chronic pain in adults. This study evaluated the long-term safety and tolerability of tapentadol ER in patients with chronic osteoarthritis or low back pain.
METHODS:
Patients were enrolled in this 1-year, open-label extension study after completing one of two 15-week, placebo-controlled studies of tapentadol ER and oxycodone controlled release (CR) for osteoarthritis knee pain (NCT00421928) or low back pain (NCT00449176), a 7-week crossover study between tapentadol immediate release and tapentadol ER for low back pain (NCT00594516), or a 1-year safety study of tapentadol ER and oxycodone CR for osteoarthritis or low back pain (NCT00361504). After titrating the drug to an optimal dose, patients received tapentadol ER (100-250 mg BID) for up to 1 year (after finishing treatment in the preceding studies); patients who were previously treated with tapentadol ER in the 1-year safety study received tapentadol ER continuously for up to 2 years in total.
FINDINGS:
Of the 1,154 patients in the safety population, 82.7% were aged >65 years and 57.9% were female; 50.1% had mild baseline pain intensity. Mean (SD) pain intensity scores (11-point numerical rating scale) were 3.9 (2.38) at baseline (end of preceding study) and 3.7 (2.42) at end point, indicating that pain relief was maintained during the extension study. Improvements in measures of quality of life (eg, EuroQol-5 Dimension and the 36-item Short Form Health Survey [SF-36]) health status questionnaires) achieved during the preceding studies were maintained during the open-label extension study. Tapentadol ER was associated with a safety and tolerability profile comparable to that observed in the preceding studies. The most common treatment-emergent adverse events (incidence ≥10%; n = 1154) were headache (13.1%), nausea (11.8%), and constipation (11.1%). Similar efficacy and tolerability results were shown for patients who received up to 2 years of tapentadol ER treatment.
IMPLICATIONS:
Pain relief and improvements in quality of life achieved during the preceding studies were maintained throughout this extension study, during which tapentadol ER was well tolerated for the long-term treatment of chronic osteoarthritis or low back pain over up to 2 years of treatment. (ClinicalTrials.gov identifier: NCT00487435.).
