Abstract-This study evaluated the effects of initial versus delayed treatment with a drug combination on blood pressure (BP) control and the risk of cardiovascular (CV) events in hypertensive patients. Clinical trials suggest that the time to BP control is an important determinant of long-term outcomes, but real-world evidence is scarce. Using electronic medical charts (2005)(2006)(2007)(2008)(2009), we retrospectively analyzed 1762 adult patients with BP elevation initiating combination therapy matched 1:1 with similar patients initiating monotherapy and later switched to combination therapy. Incidence rate ratios of CV events (myocardial infarction, stroke/transient ischemic attack, or hospitalization for heart failure) or all-cause death and Kaplan-Meier analyses of time to BP control were compared between cohorts. Hazard ratios indicating the effects of initial treatment on CV events and BP control were estimated using time-varying Cox proportional hazard models. Initial combination therapy was associated with a significant reduction in the risk of CV events or death (incidence rate ratio, 0. BP reduction and goal attainment, as well as the impact on healthcare resource use in a real-world, practice-based setting.
Methods
Data SourceElectronic medical chart data between January 2005 and November 2009 from a large integrated delivery network of physicians and hospitals, all sharing a single laboratory, were used to conduct the analysis. The database is de-identified and is in compliance with the Health Insurance Portability and Accountability Act of 1996 to preserve patient anonymity and confidentiality. Data elements used in the present analysis included patient demographics, inpatient and outpatient medical services, prescriptions, laboratory results, and clinical measures such as BP, height and weight, and smoking status.
Study DesignAdult patients with uncontrolled BP, newly initiated on antihypertensive therapy including angiotensin-converting enzyme inhibitors, calcium channel blockers, angiotensin II receptor blockers, or diuretics, given as a single agent (monotherapy) or a drug combination, were identified. The study population was stratified into the following mutually exclusive exposure groups: patients initiating combination therapy for ≥60 days (combination therapy cohort) and patients initiating monotherapy for ≥60 days with the subsequent addition of a second agent (add-on cohort). Combination therapy included a single-pill (fixeddose) combination or dual free combination of angiotensin-converting enzyme inhibitor and calcium channel blocker, angiotensin-converting enzyme inhibitor and diuretic, angiotensin II receptor blocker and calcium channel blocker, or angiotensin II receptor blocker and diuretic. A baseline period of 90 days before treatment initiation was imposed to evaluate baseline characteristics and to ascertain that patients had uncontrolled BP, defined as ≥1 BP reading ≥140/90 mm Hg or ≥130/80 mm Hg for patients with diabetes mellitus or CKD. We excluded from the analysis patients...