Single-Pill Combination of Telmisartan and Hydrochlorothiazide: Studies and Pooled Analyses of Earlier Hypertension Treatment

Abstract

Lowering blood pressure (BP) in patients with high blood pressure reduces cardiovascular risk. Studies support health benefits when BP goals are achieved earlier in the course of treatment. Many patients require combination therapy to achieve BP goals; initial use of combination therapy may improve earlier BP goal attainment. This analysis reports the results of a search of the Boehringer Ingelheim clinical trial database for randomized, double-blind studies of telmisartan/hydrochlorothiazide (T/H) combination therapy compared with blood pressure monotherapies. Nine studies were identified. This report examined six separate analyses of these nine studies (three analyses of individual trials; three analyses for which two trials each were pooled). The focus of this report is the BP effects of combination T/H therapy compared with respective monotherapies at the earliest available time points (Weeks 1, 2, 3 and/or 4). These analyses included a total of 5,358 patients. During these earlier time periods, combination T/H reduced systolic BP (SBP) and diastolic BP (DBP) significantly more than placebo or respective monotherapies in most treatment comparisons for patients initiated on monotherapy. Combination T/H also allowed significantly more patients to achieve BP (<140/90 mmHg), SBP (<140 mmHg), and DBP (<90 mmHg) goal attainment rates compared with placebo (p < 0.0002), and numerically higher compared with T or H monotherapy. In patients uncontrolled by monotherapy, combination T/H significantly reduced SBP/DBP more than monotherapy (p < 0.0001). Similarly, BP, SBP and DBP goal attainment rates were significantly higher with combination T/H therapy (p < 0.0022). Reported adverse events with T/H therapy were generally similar to monotherapy, and placebo. In summary, the six separate analyses of nine different trials demonstrated that T/H significantly lowered BP as early as 1-4 weeks after initiation of therapy, with greater BP lowering, and greater BP goal attainment than with monotherapies or placebo.