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

Abstract

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.

Keywords::

• Amlodipine/valsartan
• Amlodipine/valsartan/hydrochlorothiazide
• Hypertension
• Single-pill combinations

Transparency

Declaration of funding

The study was funded by Novartis Pharma AG, Basel, Switzerland.

Declaration of financial/other relationships

J.S., S.H.A.-K., R.N., A.R.K., B.C. and K.-C.U. have disclosed that they received investigator fees related to the conduct of the EXCITE study from Novartis and its affiliates. A.S. has disclosed that he is an employee and shareholder of Novartis Pharma AG. D.K. has disclosed that she is an employee of Novartis Pharma AG.

CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no relevant financial or other relationships to disclose.

Acknowledgments

The authors acknowledge all investigators at the participating centers and all patients for their commitment to the study. All authors participated in the development and writing of the paper and take full responsibility for its content. The authors wish to thank Dr Sashka Hristoskova and Dr Mahomed Kadwa from Novartis Pharma AG for their critical review and suggestions to the manuscript. The authors were assisted in the preparation of this text by Sharon Smalley and Isobel Lever of CircleScience, part of KnowledgePoint360, an Ashfield Company; this support was funded by Novartis Pharma AG and its relevant affiliates.

Previous presentation: Abstracts of this work were presented at the 23rd European Meeting on Hypertension and Cardiovascular Protection 2013, Milan, Italy, 14–17 June, 2013 and the 5th International Conference on Fixed Combination in the Treatment of Hypertension, Dyslipidemia and Diabetes Mellitus, Bangkok, Thailand, 21–24 November, 2013.