A META-ANALYSIS OF EFFICACY AND SAFETY OF PRESCRIPTION OPIOIDS, INCLUDING FORMULATIONS WITH TAMPER-RESISTANT TECHNOLOGIES, IN NON-CANCER PAIN MANAGEMENT

Author(s)

Michna E1;Cheng W*2;Korves C2;Schaaf D3;Andrews R4;Zhou Z4;Mardekian J3;Joshi AV5;Birnbaum H2, Duh MS2 1Brigham and Women's Hospital, Chestnut Hill, MA, USA, 2Analysis Group, Inc., Boston, MA, USA, 3Pfizer, Inc., New York, NY, USA, 4Analysis Group, Boston, MA, USA, 5Shire Pharmaceuticals, Wayne, PA, USA

OBJECTIVES: This meta-analysis was conducted to compare pain intensity and adverse event (AE) outcomes between opioids formulated with technologies designed to deter or resist tampering (tamper-resistant technologies [TRTs]) and non-TRTs for commonly prescribed long-acting opioids (LAOs) and short-acting opioids (SAOs) for treatment of non-cancer pain in adults.  METHODS: Sixteen journal articles [13 non-TRT vs. placebo, 3 TRT vs. placebo] from a systematic literature review (9/1/2001-8/31/2011) meeting eligibility criteria were included in the meta-analyses.  Summary estimates of standardized pain intensity outcomes [difference in mean change of pain intensity from baseline to end of study (DMCPI), difference in sum of pain intensity difference over the study period (DSPID)] and of odds ratios (OR) of 7 AEs were computed through random effects meta-analyses using DerSimonian-Laird method.  Additional analyses included stratified analyses by treatment duration (<2 months, 2-3 months, ≥3 months) and by LAO/SAO, and indirect comparisons to contrast TRTs vs. non-TRTs.  RESULTS: Summary estimates for standardized DMCPI and for standardized DSPID indicated that TRTs and non-TRTs showed significantly greater efficacy than placebo in reducing pain intensity [(Standardized DMCPI) Non-TRT versus placebo: -0.59(95% CI: -0.94,-0.24), TRF vs. placebo: -0.21(-0.35,-0.07); (Standardized DSPID) Non-TRT versus placebo: 0.73(0.26,1.20), TRF versus placebo: 0.51(0.30,0.72)]. TRTs and non-TRTs had similar safety profiles—both were associated with higher odds of AEs than placebo. ORs from indirect analyses comparing AEs for TRTs vs. non-TRTs were not significant different [nausea: 0.87(0.24,3.12), vomiting: 1.54(0.40,5.97), dizziness/vertigo: 0.61(0.21,1.76), headache: 1.42(0.57,3.53), somnolence/drowsiness: 0.47(0.09,2.58), constipation 0.64(0.28,1.49), pruritus 0.41(0.05,3.51)]. CONCLUSIONS: Pain intensity and ORs of AEs between non-TRTs/TRTs and placebo did not vary by treatment duration and opioid formulation (p-values>0.05). TRTs and non-TRTs had comparable safety profiles and both were more efficacious than placebo in reducing pain intensity.  Since TRTs are designed to reduce misuse/abuse due to tampering, they may be a means to reduce public health burden of opioid abuse.

Conference/Value in Health Info

2013-05, ISPOR 2013, New Orleans, LA, USA

Value in Health, Vol. 16, No. 3 (May 2013)

Code

PSY8

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Systemic Disorders/Conditions

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