Real-life effectiveness, safety, and tolerability of amlodipine/valsartan or amlodipine/valsartan/hydrochlorothiazide single-pill combination in patients with hypertension from Pakistan

OBJECTIVE: EXCITE (clinical EXperienCe of amlodIpine and valsarTan in hypErtension) evaluated the real-life effectiveness, safety, and tolerability of single-pill combinations (SPCs) of amlodipine/valsartan (Aml/Val) and amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) in patients with hypertension from 13 countries in the Middle East and Asia. Here, we present data from Pakistan. METHODS: This was a 26-week observational, multicenter, prospective, open-label study. At week 26, change from baseline in mean sitting systolic (msSBP) and diastolic blood pressure (msDBP) and the proportion of patients achieving BP goal (SBP/DBP <140/90 mmHg; <130/80 mmHg in patients with diabetes) and response rates (SBP <140 mmHg [130 mmHg for patients with diabetes] or reduction of ≥20 mmHg; DBP <90 mmHg [80 mmHg for patients with diabetes] or reduction of ≥10 mmHg), were evaluated. Incidence of adverse events (AEs) and serious AEs (SAEs) was recorded as safety variables. Subjective assessment of effectiveness, compliance and tolerability was done by the physician. RESULTS: A total of 500 patients with hypertension (mean age of 48 years) were prescribed Aml/Val (n = 471, 94%) or Aml/Val/HCTZ (n = 29, 6%); 439 (87.8%) patients completed the study. At week 26, the mean BP decreased from 153.4/91.1 mmHg at baseline to 128.9/78.4 mmHg in the Aml/Val cohort (-24.5/-12.7 mmHg; p < 0.0001) and from 171.6/99.3 mmHg at baseline to 127.7/77.4 mmHg (-43.9/-21.9 mmHg; p < 0.0001) in the Aml/Val/HCTZ cohort. BP goals were achieved by 57% and 55.2% of patients in the Aml/Val and Aml/Val/HCTZ cohorts, respectively. A total of 40 (8%) patients reported at least one AE during the study period. Most common AEs included nausea (1.6%), headache (1.2%), vomiting (1.2%), and edema (1.2%). Most patients in Aml/Val cohort and all patients in Aml/Val/HCTZ cohort rated the effectiveness, compliance and tolerability as 'good' or 'very good'. CONCLUSIONS: Aml/Val with or without HCTZ in a SPC was effective and well-tolerated for BP reduction in this cohort of patients with hypertension from Pakistan.