Single‐Pill Combination of Telmisartan/Amlodipine in Patients With Severe Hypertension: Results From the TEAMSTA Severe HTN Study

Abstract

6This 8-week, randomized, double-blind, controlled study compared efficacy and tolerability of telmisartan ⁄ amlodipine (T ⁄ A) single-pill combination (SPC) vs the respective monotherapies in 858 patients with severe hypertension (systolic ⁄ diastolic blood pressure [SBP ⁄ DBP] !180 ⁄ 95 mm Hg). At 8 weeks, T ⁄ A provided significantly greater reductions from baseline in seated trough cuff SBP ⁄ DBP ()47.5 mm Hg ⁄ )18.7 mm Hg) vs T (P<.0001) or A (P=.0002) monotherapy; superior reductions were also evident at 1, 2, 4, and 6 weeks. Blood pressure (BP) goal and response rates were consistently higher with T ⁄ A vs T or A. T ⁄ A was well tolerated, with less frequent treatmentrelated adverse events vs A (12.6% vs 16.4%) and a numerically lower incidence of peripheral edema and treatment discontinuation. In conclusion, treatment of patients with substantially elevated BP with T ⁄ A SPCs resulted in high and significantly greater BP reductions and higher BP goal and response rates than the respective monotherapies. T ⁄ A SPCs were well tolerated. J Clin Hypertens (Greenwich). 2012;14:206-215. Ó2012 Wiley Periodicals, Inc.Based on evidence from a number of large antihypertensive trials, 1-9 most guidelines acknowledge that combination therapy is needed to reduce blood pressure (BP) successfully to goal in the majority of patients; only a minority of patients achieve their BP goal with a single agent.10-14 Also, the Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension (ACCOMPLISH) study showed a significant reduction of cardiovascular (CV) events and death in hypertensive patients at high CV risk treated with a combination of an angiotensin-converting enzyme (ACE) inhibitor and a calcium channel blocker (CCB).15 Nevertheless, despite rigorous and comprehensive guidelines, and a trend towards an increase in the use of combination therapy in treatment practice, 16 several studies have demonstrated the persistence of poor BP goal rates in treated patients. [17][18][19] The impact of poor BP control is compounded by the often high prevalence of other CV risk factors in hypertensive patients (eg, hypercholesterolemia, obesity, type 2 diabetes mellitus [T2DM], and smoking).13 Therefore, an urgent need still remains to improve the management of hypertension. One logical approach would be to use 2 drugs from different classes and complementary mechanisms of action in combination. Such combinations may result in additional BP decreases and improved goal rates, compared with either agent used alone. 20-23Furthermore, single-pill combinations (SPCs) are known to increase treatment adherence and reduce health care costs. [24][25][26][27] A combination of a CCB and an angiotensin II receptor blocker (ARB) is a rational approach for managing hypertension and there is increasing evidence that this combination is effective. 11,13,28,29 The aim of the current study was to compare the efficacy and tolerability of the SPC of telmisartan 80 mg ⁄ amlodipine 10 mg (T80 ⁄ A10) with that of...

The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

“…Trials showed that the addition of amlodipine to an ARB resulted in greater BP reductions compared to each component at similar doses. More patients in the combination therapy groups responded to achieve the target BP compared with component monotherapies and with comparable adverse events (72–75). Trials performed in South Korea and Japan have also shown beneficial effects of adding amlodipine to losartan and candesartan but these combinations of losartan/amlodipine and candesartan/amlodipine are not approved in the U.S. (76–77).…”

“…Reported serious adverse events were low in number (0.7% vs 0.9% and 0.9%, respectively). The frequency of peripheral edema was more common with amlodipine monotherapy compared with combination therapy (13.2 versus 9.3%, respectively) (75). …”

Efficacy and Tolerability of Telmisartan Plus Amlodipine in Asian Patients Not Adequately Controlled on Either Monotherapy or on Low-Dose Combination Therapy

“…In international studies, the T/A combination compared with the respective monotherapies has also been shown to provide superior 24-hour BP lowering in patients with mild-to-moderate hypertension [42] and significantly greater BP reductions and higher BP goal and response rates in patients with severe hypertension [43]. Planned and post hoc pooled analysis of data from clinical trials have shown the T/A SPC to be efficacious and well tolerated in hypertensive patients with added risk factors, including obesity, diabetes, metabolic syndrome, renal impairment, and elevated SBP [44–46].…”

Fighting with obesity: the "gold standard" and new horizons

“…при тяжелой, неконтролируемой АГ, со-путствующем СД 2 типа, ожирении, МС. Применение комбинации телмисартана и амлодипина позволяет до-биться снижения уровня АД и поддержания его целе-вых значений у больных высокого риска, включая па-циентов с тяжелой АГ, СД 2 типа и ожирением [24].…”