Pain relief and tolerability balance of immediate release tapentadol or oxycodone treatment for patients with moderate to severe osteoarthritis or low back pain.

PURPOSE: Opioid treatment effectiveness may be best compared using definitions of treatment response, which combine measures assessing pain reduction and the occurrence of adverse events (AEs). This analysis of data from two phase III clinical trials was conducted to examine the pain relief and tolerability (PRT) balance of immediate release (IR) tapentadol and oxycodone in patients with moderate to severe osteoarthritis (OA) or low back pain. METHODS: This was a post hoc analysis of two multicenter, randomized, double-blind studies (10-day and 90-day) that evaluated the efficacy and safety of tapentadol IR in patients with moderate-severe OA pain. PRT was defined as adequate pain reduction (30% or 50% pain intensity improvement from baseline) and no gastrointestinal AE or other type of treatment-emergent AE. The percentage of patients and mean number of days per patient meeting the PRT criteria were summarized. RESULTS: In the 10-day trial, the percentages of patients meeting PRT criteria (30% reduction) for both tapentadol groups were consistently above that for oxycodone 10 mg, although only significantly different for the 50 mg formulation. The mean number of days per patient meeting the PRT criteria was 3.7, 3.2, and 2.3 days for tapentadol 50 mg, 75 mg and oxycodone 10 mg, respectively. No significant difference between the groups was observed using the 50% pain reduction criterion. For the 90-day trial, using multiple definitions, tapentadol IR showed a significantly higher proportion of days meeting PRT criteria. CONCLUSION: Pain reduction and tolerability are both important attributes of an effective analgesic treatment. Based on data from two trials, tapentadol IR produced an improved PRT balance compared with oxycodone IR.

Cost-effectiveness of edoxaban versus rivaroxaban for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in the US.

BACKGROUND: Understanding the value of new anticoagulation therapies compared with existing therapies is of paramount importance in today's cost-conscious and efficiency-driven health care environment. Edoxaban and rivaroxaban for stroke prevention in nonvalvular atrial fibrillation (NVAF) patients with CHADS2 scores ≥2 have been evaluated in pivotal trials versus warfarin. The relative value of edoxaban versus rivaroxaban would be of interest to health care stakeholders and patients who prefer a once-daily treatment option for long-term stroke prevention in NVAF. OBJECTIVE: To evaluate the relative cost-effectiveness of two once-daily regimens of novel oral anticoagulation therapy - edoxaban (60 mg/30 mg dose-reduced) versus rivaroxaban (20 mg/15 mg dose-reduced) - for stroke prevention in NVAF patients from a US health-plan perspective. MATERIALS AND METHODS: A Markov model simulated lifetime risk and treatment of stroke, systemic embolism, major bleeding, clinically relevant nonmajor bleeding, myocardial infarction, and death in NVAF patients treated with edoxaban or rivaroxaban. Efficacy and safety data were derived from a network meta-analysis that utilized data from patients enrolled in ENGAGE AF-TIMI 48 and ROCKET-AF. Health care cost and utility data were obtained from published sources. Incremental cost-effectiveness ratios of $150,000 per quality-adjusted life year (QALY) gained were used as thresholds for "highly cost-effective", "cost-effective", and "not cost-effective" treatment options, respectively, as per American Heart Association/American College of Cardiology guidelines. RESULTS: Edoxaban was dominant relative to rivaroxaban, such that it was associated with lower total health care costs and better effectiveness in terms of QALYs in the base-case analysis. Results were supported by probabilistic sensitivity analyses that showed edoxaban as either dominant or a highly cost-effective alternative (incremental cost-effectiveness ratio <$50,000) to rivaroxaban in 88.4% of 10,000 simulations. CONCLUSION: Results of this study showed that the once-daily edoxaban (60 mg/30 mg dose-reduced) regimen is a cost-saving or highly cost-effective treatment relative to rivaroxaban (20 mg/15 mg dose-reduced) for stroke prevention in NVAF patients with CHADS2 ≥2.