Objective.: To compare the risk of cardiovascular (CV) events between use of tumor necrosis factor-α inhibitors (TNFi) and nonbiologic disease-modifying antirheumatic drugs (DMARD) in patients with early rheumatoid arthritis (RA).Methods.: A nested case-control study was conducted using data from Truven’s MarketScan commercial and Medicare claims database for patients with early RA who started treatment with either a TNFi or a nonbiologic DMARD between January 1, 2008, and December 31, 2010. Date of CV event diagnosis for cases was defined as the event date, and 12 age-matched and sex-matched controls were sampled using incidence density sampling. Drug exposure was defined into the following mutually exclusive categories hierarchically: (1) current use of TNFi (with or without nonbiologics), (2) past use of TNFi (with or without nonbiologics), (3) current use of nonbiologics only, and (4) past use of nonbiologics only. Current use was defined as any use in the period 90 days prior to the event date. Conditional logistic regression models were used to derive incidence rate ratios (IRR).Results.: From the cohort of patients with early RA, 279 cases of incident CV events and 3348 matched controls were identified. The adjusted risk of CV events was not significantly different between current TNFi users and current nonbiologic users (IRR 0.92, 95% CI 0.59–1.44). However, past users of nonbiologics showed significantly higher risk compared to current nonbiologic users (IRR 1.47, 95% CI 1.04–2.08).Conclusion.: No differences in the CV risk were found between current TNFi and current nonbiologic DMARD treatment in patients with early RA.
Many state Medicaid programs are implementing pharmacist-led medication management programs to improve outcomes for high-risk beneficiaries. There are a limited number of studies examining implementation of these programs, making it difficult to assess why program outcomes might vary across organizations. To address this, we tested the applicability of the organizational theory of innovation implementation effectiveness to examine implementation of a community pharmacy Medicaid medication management program. We used a hurdle regression model to examine whether organizational determinants, such as implementation climate and innovation-values fit, were associated with effective implementation. We defined effective implementation in two ways: implementation versus non-implementation and program reach (i.e., the proportion of the target population that received the intervention). Data sources included an implementation survey administered to participating community pharmacies and administrative data. The findings suggest that implementation climate is positively and significantly associated with implementation versus non-implementation (AME = 2.65, p < 0.001) and with program reach (AME = 5.05, p = 0.001). Similarly, the results suggest that innovation-values fit is positively and significantly associated with implementation (AME = 2.17, p = 0.037) and program reach (AME = 11.79, p < 0.001). Some structural characteristics, such as having a clinical pharmacist on staff, were significant predictors of implementation and program reach whereas other characteristics, such as pharmacy type or prescription volume, were not. Our study supported the use of the organizational theory of innovation implementation effectiveness to identify organizational determinants that are associated with effective implementation (e.g., implementation climate and innovation-values fit). Unlike broader environmental factors or structural characteristics (e.g., pharmacy type), implementation climate and innovation-values fit are modifiable factors and can be targeted through intervention—a finding that is important for community pharmacy practice. Additional research is needed to determine what implementation strategies can be used by community pharmacy leaders and practitioners to develop a positive implementation climate and innovation-values fit for medication management programs.
BACKGROUND: Administrative claims data are increasingly used to identify nonadherent patients. This necessitates a comprehensive review and assessment of their accuracy in identifying nonadherent p...
13 December 2022 in Clinical Pharmacology & Therapeutics
Comparative effectiveness evaluation of newer P2Y12 inhibitors (prasugrel and ticagrelor) compared with clopidogrel after acute coronary syndrome (ACS) is limited in real-world US populations. The objective of this study was to evaluate cardiovascular events based on ticagrelor, prasugrel, and clopidogrel use in a real-world patient setting. This retrospective cohort study used the IBM MarketScan database (January 1, 2013, to December 31, 2018) to create three propensity score-matched pairs: ticagrelor vs. clopidogrel (N = 21,719), prasugrel vs. clopidogrel (N = 11,513), and prasugrel vs. ticagrelor = 11.065). The primary outcome was a composite of myocardial ischemia. unstable angina, stroke, and heart failure hospitalization. These groups were compared in a time-to-event analysis for the primary outcome at 30, 90, and 180days following P2Y12 inhibitors initiation after percutaneous coronary intervention. Compared with clopidogrel, ticagrelor use suggested a 10% reduction in the primary outcome at 90days (hazard ratio (HR): 0.90, 95% confidence interval (CI): 0.82-0.99). There were no differences for all other matched pairs or follow-up combinations. In the subgroup analysis of females, the results suggested a risk reduction of 27% for prasugrel at 30days (HR: 0.73. 95% CI: 0.53-1.00) and 17% for ticagrelor at 90days (HR: 0.83. 95% CI: 0.70-0.98) when compared with clopidogrel. Among patients treated with bare-metal stents, the results suggested that prasugrel vs. ticagrelor was associated with a 55% and 33% reduced risk for the primary outcome at 30days and 180days, respectively. With limited evidence in the United States comparing these drugs. this study helps inform clinicians when choosing P2Y12 inhibitors after ACS.