Efficacy of Single-Pill Combination of Telmisartan 80 mg and Hydrochlorothiazide 25 mg in Patients with Cardiovascular Disease Risk Factors: A Prospective Subgroup Analysis of a Randomized, Double-Blind, and Controlled Trial

Abstract

Objective. Report of prespecified and post hoc subgroup analyses of a randomized, controlled trial comparing telmisartan 80 mg/hydrochlorothiazide 25 mg (T80/H25) combination therapy with T80 monotherapy, according to the presence of cardiovascular disease (CVD) risk factors. Methods. Hypertensive patients were randomized (2 : 1) to receive T80/H25 or T80 for 6 weeks, following a 1-week, low-dose, and run-in period. Systolic blood pressure (SBP) and diastolic BP reductions and BP goal achievement were evaluated in patients with CVD risk factors: presence of diabetes mellitus (DM), renal impairment, increased body mass index (BMI), and 10-year estimated risk for coronary heart disease (CHD). Results. In total, 888 patients received treatment. Overall, T80/H25 therapy significantly reduced SBP more than T80 monotherapy, irrespective of patient subgroup. In patients with DM, renal impairment, high BMI, and high CHD risk, BP goal achievement rates (<140/90 mm Hg) at Week 7, among those treated with T80/H25, were 52.8%, 52.8%, 50.6%, and 38.5%, respectively. More patients with DM reached a guideline-based BP goal (<130/80 mm Hg) at 7 weeks with T80/H25 than with T80 monotherapy (16.7% versus 8.8%). Rates of treatment-related adverse events were low and comparable across patient subgroups. Conclusions. Antihypertensive treatment with T80/H25 single-pill combination is effective and generally well tolerated, irrespective of the presence of CVD risk factors.

10 powodów, dla których warto stosować telmisartan i telmisartan z hydrochlorotiazydem w terapii nadciśnienia tętniczego

“…dodatkową korzyścią stosowania telmisartanu i hydrochlorotiazydu jest rzadsze występowanie epizodów hipokaliemii niż podczas monoterapii hydrochlorotiazydem [15]. połączenie t/h wydaje się korzystne u pacjentów z nadciśnieniem tętniczym i dodatkowymi czynnikami ryzyka: otyłością, wysokim ryzykiem choroby wieńcowej, upośledzeniem czynności nerek [16][17][18]. podsuMoWAnIE telmisartan może być stosowany zarówno u pacjentów z niepowikłanym nadciśnieniem tętniczym, jak i u chorych z wysokim ryzykiem sercowo-naczyniowym, z nadciśnieniem tętniczym i uszkodzeniami narządowymi, ze współistniejącą chorobą nerek, z cukrzycą, z jawną chorobą miażdżycową, w tym tętnic obwodowych i po przebytym udarze mózgu.…”

A review of the benefits of early treatment initiation with single-pill combinations of telmisartan with amlodipine or hydrochlorothiazide

“…Furthermore, a retrospective analysis showed that in black patients with hypertension and hypertensive patients with concomitant type 2 diabetes mellitus or moderate or severe renal impairment, T80/H25 resulted in greater reductions in SBP and DBP than telmisartan monotherapy, irrespective of baseline BP 27. A prespecified subgroup analysis of data from patients with stage 2 or 3 hypertension and CV disease risk factors, such as diabetes mellitus, low estimated glomerular filtration rate, high body mass index, and high coronary heart disease risk, reported that 6 weeks’ treatment with T80/H25 consistently provided greater BP reductions and increased BP goal-attainment rates compared with T80 monotherapy 56. A pooled analysis of data from seven studies showed that the efficacy and tolerability of the T/H SPC was similar between younger patients and patients older than 65 years (who may have added CV risk factors and are generally difficult to treat to goal) 57…”