Special Topics in Pain: Opioids

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Efficacy and Safety of Tapentadol Immediate Release Assessment in Treatment of Moderate to Severe Pain: A Systematic Review and Meta-Analysis.

Author(s): Xiao JP, et al.
Journal: Pain Med. 2016; Aug 11. 28 references.
Reprint: Guo-Jun Wang, PhD, Department of Pharmacy, The Affiliated Hospital of Luzhou Medical College, Luzhou 646000, Sichuan Province, People's Republic of China. Email: renren333@126.com
Faculty Disclosure: Abstracted by N Walea, who has nothing to disclose.
Objective: Review and evaluate the latest advances and newest information in the area of Opioids


Editor’s Note: Tapentadol is a unique analgesgic combining opioid and norepinephrine re-uptake inhibition. In this review, it fared well against placebo, was equal to oxycodone ir and had fewer side effects. As the dose increased from 50mg to 75mg to 100mg, the side effects went up but the efficacy stayed the same indicating that 75mg may be the best dose.

Class: Pharmacology: Tapentadol

Presently, opioids such as oxycodone, morphine, and pethidine are considered to be the standard of care to relieve moderate to severe pain. Their utility is often limited by a number of gastrointestinal and central nervous system adverse effects (AEs) including nausea, vomiting, constipation, dizziness, somnolence, and headache. Tapentadol is an analgesic with dual mechanisms that combines µ-opioid receptor agonism with norepinephrine reuptake inhibition. There are some studies in which a new oral agent immediate release (IR) tapentadol (50, 75, and 100mg) is effective in providing pain relief from moderate to severe pain with similar efficacy to oxycodone HCL IR 10mg and had significantly better gastrointestinal tolerance.

For this review and meta-analysis, a database search was done from inception to July 2015 on Medline, Pubmed, and the Cochrane Collaboration Library. Nine randomized controlled trials (RCTs) were found for inclusion.

Trials ranged from three to 10 days. Mean age of patients was 48.3 + 13.1 years, and 22.2% were men. Of the participants, 68.6% had baseline pain intensity of severe pain. Mean body mass index was 28.2 + 5.7; all studies included a placebo group. Tapentadol IR was administered orally, in a dose of 50, 75, or 100mg once every four to six hours in all trials. Causes of moderate to severe pain included bunionectomy, hysterectomy, end-stage joint disease, and joint replacement surgery.

Efficacy was assessed by the sum of pain intensity difference (SPID) over 48 hours, total pain relief (TOTPAR) over 48 hours and the patient global impression of change (PGIC). SPID was calculated as the sum of the differences between the pain scores over a period of time (48 hours). TOTPAR was calculated as the sum of pain relief scores over a period of time (48 hours). Safety was assessed by incidence of frequency and severity of AEs.

This systematic review, mainly assessed the efficacy and safety of tapentadol IR 50, 75, 100mg for patients with moderate to severe pain and tried to find the optimal dosage of tapentadol IR to control moderate to severe. Pain relief was significantly more efficient in all three doses of tapentadol IR compared with placebo based on SIPD48, TOPAR48, and PGIC. Compared with oxycodone HCL IR 10mg, all three doses of tapentadol IR showed similar efficacy in most results based on SIPD48 and TOPAR48, but there was one result that tapentadol IR 100mg was more ameliorative than oxycodone HCL IR 10 mg in TOPAR48. Meanwhile, tapentadol IR 50 and 75mg were compared based on SIPD48 and TOPAR48; the latter dose showed a significant efficacy of analgesia than the former dose. There was no statistical difference between 75 and 100mg dose of tapentadol IR based on SIPD48 and TOPAR48.

In the percentage of patients who rated their status as 'much improved' or 'very much improved’ on the PGIC, tapentadol IR 50 and 75 mg showed similar 'improvement' efficacy as oxycodone HCL IR 10mg. Meanwhile, there was no statistical difference between tapentadol IR 50 and 75mg in PGIC. For AEs, this review evaluated gastrointestinal (nausea, vomiting, constipation) and nervous system (dizziness, somnolence, and headache) tolerability. Tapentadol IR 50 and 75mg were associated with better gastrointestinal tolerance compared with oxycodone HCL IR 10mg. However, the tapentadol IR 100mg showed similar incidence of gastrointestinal AEs as oxycodone HCL IR 10mg. Still, all three dose of tapentadol IR showed numerically lower incidence of gastrointestinal AEs than oxycodone HCL IR 10mg.

Comparison of nervous system AEs showed tapentadol IR 50mg had significantly lower incidence of dizziness than oxycodone HCL IR 10mg. and tapentadol IR 100mg showed significantly higher incidence of somnolence than oxycodone HCL IR 10mg. In terms of other nervous system AEs, all three tapentadol IR doses showed similar incidences compared with oxycodone HCL IR 10mg.

Tapentadol IR 50 and 75mg showed a lower incidence of total AEs than oxycodone HCL IR 10mg, while tapentadol IR 100mg showed a similar incidence as oxycodone HCL IR 10mg.

Important Points:
Treatment with all three doses of tapentadol IR can provide significant relief for moderate to severe pain with similar efficacy to oxycodone HCLO IR 10 mg. Tapentadol 75mg showed more analgesic efficacy than 50mg. Tapentadol IR 50mg and 75mg had better gastrointestinal tolerability than oxycodone HCL IR 10mg; but tapentadol 100mg showed a similar incidence of gastrointestinal AEs and higher nervous system AEs than oxycodone HCL IR 10mg. Furthermore, tapentadol IR 75mg might be the best dosage to control moderate to severe pain.

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