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Systematic Literature Review and Analysis of the Efficacy and Safety of Prescription Opioids, Including Abuse-Deterrent Formulations, in Non-Cancer Pain Management

Michna E M, et al.

Journal: Pain Med. 2014; 15: 79-92. 82 references.
Reprint: Mei Sheng Duh, MPH, ScD, Analysis Group, Inc. 111 Huntington Ave. 10th Floor, Boston, MA 02199, USA
Email: mduh@analysisgroup.com 
Faculty Disclosure: Abstracted by T Newitt, who has nothing to disclose.

Editor's Note:
The need to safeguard the public from the adverse effects of opioids in non cancer pain is overwhelming. Are the abuse-deterrent formulations (ADFs) of the same efficacy and safety as the non-ADFs? This review indicates that ADFs and non-ADFs are similar in efficacy and safety profile findings, and also show that both have an acceptable degree of patient satisfaction and an improvement in quality of life. Unfortunately recently developed ADFs morphine sulfate and naltrexone ER, oxycodone hydrochloride controlled-release, and oxycodone hydrochloride ER were not included, somewhat diminishing the impact of the review.

Class: Pharmacology: Opioids
Subclass: Disaease entity: Non-Cancer Pain

Diversion and abuse of prescribed opioids for chronic non-cancer pain has become more prominent with their use (prescriptions quadrupled from 1990 to 2000). Formulations of addictive opioids have been combined with mechanical and pharmaceutical barriers to reduce or prevent the euphoric effects gained by tampering with these prescriptions. Questions arise as to whether the abuse-deterrent formulations (ADFs) are of the same efficacy and safety as the non-ADFs. This study is a literature review and meta--analysis using PubMed and Cochrane Library databases over the decade from September 1, 2001 to August 31, 2011.The study compared the efficacy and safety outcomes from short-acting opioids (SAOs) and long-acting opioids (LAOs) in ADFs vs. traditional non-ADFs. Opioids selected were the 12 most commonly prescribed LAOs and SAOs. LAOs included oxycodone, fentanyl, morphine, tramatol, methadone, and oxymorphone, while the SAOs included hydrocodone, oxycodone, oxycodone combination, tramadol, codeine, and codeine combination. The authors state that the recently developed ADFs morphine sulfate and naltrexone ER, oxycodone hydrochloride controlled-release, and oxycodone hydrochloride ER, were not included but have a high applicability to the present study.Primary outcomes were efficacy and safety, the mean change of pain intensity from baseline to end of study, and sum of pain intensity differences over study. Pain intensity scales used were the visual analog scale (VAS) 100 mm, the numerical rating scale (NRS 11), patient rating scale (PRS 3), and the brief pain index (BPI 10). A negative number over time indicated a decrease in pain while a positive number indicated an increase of the indicated scale.A meta-analysis was conducted for each of the seven adverse effects (AEs): nausea, vomiting, dizziness/vertigo, headache, somnolence/drowsiness, constipation, and pruritus. Patient satisfaction with the medication was recorded.After exclusions, 16 studies were used, 13 non-ADFs and three ADFs. Outcomes in mean pain intensity changes from baseline were: non-ADFs = -0.59; ADFs = -0.21. Standardized difference in sum of pain intensity differences over the study period were: non--ADFs vs. placebo = 0.73; while ADFs = 0.51.Adverse events show that the most common AE was nausea = 26% in non-ADF patients and 21% in ADF patients.

Important Points:

It is demonstrated in this review that ADFs and non-ADFs are similar in efficacy and safety profile findings, and also show that both have an acceptable degree of patient satisfaction and an improvement in quality of life.

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