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

Jorge Sison, De La Salle Medical and Health Sciences Institute
Samir Helmy Assaad-Khalil, Alexandria Medical School
Robert Najem, Université Libanaise
Asad Riaz Kitchlew, Pakistan Institute of Medical Sciences
Belong Cho, Seoul National University College of Medicine
Kwo Chang Ueng, Chung Shan Medical University Hospital
Abhijit Shete, Novartis International AG
Ditte Knap, Novartis International AG


© 2014 Informa UK Ltd. 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.