Efficacy and safety of amlodipine/valsartan/hydrochlorothiazide single pill combination in Egyptian patients with hypertension uncontrolled on any dual therapy: an observational study

Abstract

Objective

Hypertension is a serious health problem in Egypt, with prevalence rate of 17% as reported in 2015. Despite receiving treatment, many do not achieve blood pressure (BP) control. The current study aimed to evaluate the efficacy and tolerability of amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) single pill combination (SPC) in patients with hypertension from Egypt, who were uncontrolled on any dual therapy.

Methods

In this prospective, open label, multicenter, 12-week observational, cohort study, two doses of Aml/Val/HCTZ (5/160/12.5 mg or 10/160/25 mg) SPC were used to evaluate mean change in BP after 12 weeks (primary endpoint). Safety assessments included presence and intensity of ankle edema and other adverse events (AEs).

Results

Data were collected from 1080 patients who were treated according to the routine medical practice across 47 centers in Egypt. Significant reduction in systolic and diastolic BP (SBP/DBP) was observed from 165.5 ± 12.83/100.8 ± 7.03 mmHg at baseline to 129.7 ± 8.35/80.6 ± 5.25 mmHg after 12 weeks of treatment (p < .0001). Majority of patients (76.85%) reached the BP goal of <140/90 mmHg. The most commonly reported AE was ankle edema (10.92%).

Conclusions

Aml/Val/HCT SPC significantly reduced BP and was well tolerated in Egyptian patients with hypertension not controlled on any previous dual therapy.

Keywords:

• Compliance
• efficacy
• Egypt
• hypertension
• safety
• triple therapy

Transparency

Declaration of funding

Novartis Pharma, Egypt has funded and provided oversight on the conduct of the study, including design, collection and compilation of data.

Declaration of financial/other relationships

AMKE has no conflicts of interest to disclose. SR is a former employee of Novartis Pharma SAE. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Both the authors contributed to the design and execution of the study, data analysis and interpretation, and manuscript preparation and have read, revised, and approved the final manuscript for publication.

Acknowledgements

The authors thank all clinical investigators and study coordinators at the participating centers, all study participants, local laboratory and health facility staff, and Karmic life sciences for statistical analysis. We also thank Meha Mayuri and Dr. Krishna Swetha Gummuluri, Novartis of Healthcare Pvt. Ltd., India, for medical writing support, collating comments from all authors, and editing the final manuscript.