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

Abstract

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.

Keywords: amlodipine; hydrochlorothiazide; real world; single-pill combinations; valsartan.

Figure 1

Mean reductions in msSBP and msDBP at 26±8 weeks in subgroups treated with Aml/Val. Note: Overall group includes 8,603 patients who received Aml/Val, subgroups were defined as elderly (≥65 years of age), obesity (BMI ≥30 kg/m²), and ISH (msSBP ≥140 mmHg and msDBP <90 mmHg). Abbreviations: Aml/Val, amlodipine/valsartan; BMI, body mass index; BP, blood pressure; CI, confidence interval; ISH, isolated systolic hypertension; LL, lower limit; msDBP, mean sitting diastolic blood pressure; msSBP, mean sitting systolic blood pressure; UL, upper limit.

Figure 2

Mean reductions in msSBP and msDBP at 26±8 weeks in subgroups treated with Aml/Val/HCT. Note: Overall group includes 8,603 patients who received Aml/Val, subgroups were defined as elderly (≥65 years of age), obesity (BMI ≥30 kg/m²), and ISH (msSBP ≥140 mmHg and msDBP <90 mmHg). Abbreviations: Aml/Val, amlodipine/valsartan; Aml/Val/HCT, amlodipine/valsartan/hydrochlorothiazide; BMI, body mass index; BP, blood pressure; CI, confidence interval; ISH, isolated systolic hypertension; LL, lower limit; msDBP, mean sitting diastolic blood pressure; msSBP, mean sitting systolic blood pressure; UL, upper limit.

Figure 3

Mean reductions in msSBP and msDBP with Aml/Val combination by prior antihypertensive monotherapy class. Notes: Post hoc analysis. Baseline was defined as prior to start of Aml/Val. The end of the study defined as week 26. Patients who did not take any antihypertensive medication during the observational period, in addition to Aml/Val, and did not switch to Aml/Val/HCT were only included. in addition, patients who did not receive additional treatment prior to study entry were included. Only 14 patients received prior diuretic monotherapy and the mean reduction in BP was −30.7/−19.3 mmHg from baseline (162.9/102.9 mmHg) to endpoint. Abbreviations: ACEI, angiotensin-converting enzyme inhibitor; Aml/Val, amlodipine/valsartan; Aml/Val/HCT, amlodipine/valsartan/hydrochlorothiazide; ARB, angiotensin receptor blocker; BB, beta-blocker; BP, blood pressure; CCB, calcium channel blocker; CI, confidence interval; LL, lower limit; msBP, mean sitting blood pressure; msDBP, mean sitting diastolic blood pressure; msSBP, mean sitting systolic blood pressure; UL, upper limit.

Figure 4

Mean reductions in msSBP and msDBP with Aml/Val/HCT combination by prior antihypertensive dual therapy classes. Notes: Post hoc analysis. Baseline was defined as prior to start of Aml/Val/HCT. End of the study defined as week 26. Patients who did not take any antihypertensive medication during the observational period, in addition to Aml/Val/HCT, and did not switch to Aml/Val were only included. in addition, patients who did not receive additional treatment prior to study entry were only included. Only 17 patients received BBs and diuretic combinations and the mean reduction in BP was −35.2/−17.5 mmHg from baseline (161.6/93.7 mmHg). Abbreviations: ACEI, angiotensin-converting enzyme inhibitor; Aml/Val, amlodipine/valsartan; Aml/Val/HCT, amlodipine/valsartan/hydrochlorothiazide; ARB, angiotensin receptor blocker; BBs, beta-blockers; BP, blood pressure; CCB, calcium channel blocker; CI, confidence interval; Diu, diuretic; LL, lower limit; msBP, mean sitting blood pressure; msDBP, mean sitting diastolic blood pressure; msSBP, mean sitting systolic blood pressure; UL, upper limit.