Real-world effectiveness of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide in high-risk patients and other subgroups.

BACKGROUND: The clinical EXCITE (EXperienCe of amlodIpine and valsarTan in hypErtension) study reported clinically relevant blood pressure (BP) reductions across all doses of amlodipine/valsartan (Aml/Val) and Aml/Val/hydrochlorothiazide (HCT) single-pill combinations. The study prospectively observed a multiethnic population of hypertensive patients for 26 weeks who were treated according to routine clinical practice. Here, we present the results in high-risk subgroups including the elderly, obese patients, and patients with diabetes or isolated systolic hypertension. In addition, we present a post hoc analysis as per prior antihypertensive monotherapy and dual therapy. METHODS: Patients prescribed Aml/Val or Aml/Val/HCT were assessed in this 26±8 week, noninterventional, multicenter study across 13 countries in the Middle East and Asia. Changes in mean sitting systolic BP, mean sitting diastolic BP, and overall safety were assessed. RESULTS: Of a total of 9,794 patients analyzed, 8,603 and 1,191 patients were prescribed Aml/Val and Aml/Val/HCT, respectively. Among these, 15.5% were elderly, 32.5% were obese, 31.3% had diabetes, and 9.8% had isolated systolic hypertension. Both Aml/Val and Aml/Val/HCT single-pill combinations, respectively, were associated with clinically relevant and significant mean sitting systolic/diastolic BP reductions across all subgroups: elderly patients (-32.2/-14.3 mmHg and -38.5/-16.5 mmHg), obese patients (-32.2/-17.9 mmHg and -38.5/-18.4 mmHg), diabetic patients (-30.3/-16.1 mmHg and -34.4/-16.6 mmHg), and patients with isolated systolic hypertension (-25.5/-4.1 mmHg and -30.2/-5.9 mmHg). Incremental BP reductions with Aml/Val or Aml/Val/HCT single-pill combinations were also observed in patients receiving prior monotherapy or dual therapy for hypertension. Overall, both Aml/Val and Aml/Val/HCT were generally well tolerated. CONCLUSION: This large, multiethnic study supports the evidence that Aml/Val and Aml/Val/ HCT single-pill combinations are effective in diverse and clinically important subgroups of patients with hypertension.

Real-world clinical experience of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide in hypertension: the EXCITE study.

OBJECTIVE: The EXCITE (clinical EXperienCe of amlodIpine and valsarTan in hypErtension) study was designed to evaluate the effectiveness, tolerability and adherence of amlodipine/valsartan (Aml/Val) and amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCT) single-pill combination therapies in patients with hypertension from the Middle East and Asia studied in routine clinical practice. RESEARCH DESIGN AND METHODS: This was a prospective, multinational, non-interventional real-world study in which adult patients with hypertension receiving treatment with Aml/Val or Aml/Val/HCT as part of routine clinical practice were observed for a period of 26 ± 8 weeks. Dosages in milligrams (prescribed in accordance with local prescribing information) were Aml/Val: 5/80, 5/160, 10/160, 5/320 or 10/320; Aml/Val/HCT: 5/160/12.5, 10/160/12.5, 5/160/25, 10/160/25 or 10/320/25. MAIN OUTCOME MEASURES: Treatment effectiveness was assessed by change from baseline in mean sitting systolic blood pressure (BP)/diastolic BP (msSBP/msDBP), and the proportion of patients achieving therapeutic goal and BP response. Safety and tolerability were also assessed. RESULTS: Of 9794 patients analyzed (mean age 53.2 years), 8603 received Aml/Val and 1191 Aml/Val/HCT. At study end (26 ± 8 weeks), overall msSBP (95% confidence interval [CI]) reductions from baseline were -31.0 (-31.42, -30.67) mmHg for Aml/Val and -36.6 (-37.61, -35.50) mmHg for Aml/Val/HCT; msDBP reductions from baseline were -16.6 (-16.79, -16.34) mmHg for Aml/Val and -17.8 (-18.41, -17.22) mmHg for Aml/Val/HCT. Meaningful reductions in BP from baseline were also consistently observed across all Aml/Val dosages and severities of hypertension. Adverse events (AEs) were reported in 11.2% and 6.1% of patients in the Aml/Val and Aml/Val/HCT groups, respectively. Most frequently reported AEs in the Aml/Val and Aml/Val/HCT groups were edema and peripheral edema. While the observational design of the study has inherent limitations, it enables collection of real-world data from a more naturalistic clinical setting, and the large size of the study increases the robustness of the study, as indicated by the narrow confidence intervals for the main study outcomes. CONCLUSIONS: The EXCITE study provides evidence that Aml/Val and Aml/Val/HCT provide clinically meaningful BP reductions and are well tolerated in a large multi-ethnic hypertensive population studied in routine clinical practice.