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
• single-pill combinations
• real world
• valsartan

Acknowledgments

The study was funded by Novartis Pharma AG, Basel, Switzerland. The authors thank all clinical investigators and study coordinators at the participating centers and all patients who participated in the study. The authors would like to acknowledge Sashka Hristoskova and Ditte Knap from Novartis Pharma AG, Basel, Switzerland, and Dr Mahomed Kadwa from Novartis South Africa (Pty) Ltd, South Africa, for providing suggestions regarding the content of the manuscript. The authors would like to thank Sreedevi Boggarapu of Novartis Healthcare Pvt Ltd for developing the first draft of the manuscript that was prepared under the guidance of the lead author. The authors also acknowledge the contributions of Madhavi Dokku (Novartis Healthcare Pvt Ltd) and Kanaka Sridharan (Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA) for providing valuable feedback and review during development of the manuscript.

Disclosure

SHA-K, RN, JS, ARK, BC, and K-CU have received investigator fees related to the conduct of the EXCITE study from Novartis and its affiliates. SD is an employee of Novartis Pharma AG. AS is an employee and shareholder of Novartis Pharma AG. The authors report no other conflicts of interest in this work.