China STudy of valsartan/amlodipine fixed-dose combination-bAsed long-Term blood pressUre management in HypertenSive patients: a one-year registry (China STATUS III)

Abstract

Objective: The present observational study evaluated long-term management of hypertension in patients who received treatment with valsartan and amlodipine in a single-pill combination (Val/Aml SPC) in a real-world setting in China (Chinese Clinical Trial Registry number ChiCTR1900021324).

Methods: This was a prospective, observational, multicenter, real-world registry study wherein patients with hypertension who had already received Val/Aml SPC (80/5 mg) for at least 4 weeks before study enrollment were observed for 1 year. Investigators recorded patient data every 3 months and essentially five times during the 1 year follow-up period. Effectiveness was assessed by the blood pressure (BP) control rate and average duration of treatment at the end of the study. Safety was monitored by the incidence of adverse events (AEs) and serious adverse events (SAEs).

Results: Overall, 985 patients were enrolled (mean ± standard deviation [SD] age: 60.3 ± 11.5 years); of these, 894 were included in the full analysis set, 758 of whom completed the study. At baseline, BP was controlled (<140/90 mmHg) in 64.3% of patients on Val/Aml SPC for at least 4 weeks before enrollment. Office BP control rates significantly improved from baseline in 74.1% of patients at 1 year (p < .0001). Overall, 575 (87.0%) patients remained on Val/Aml SPC at 1 year (average exposure: 311.5 days). AEs were reported in 23.3% of patients. The majority of AEs were mild to moderate, and 0.6% of patients discontinued Val/Aml SPC because of SAEs.

Conclusion: This study provides evidence that Val/Aml SPC effectively reduced BP over the long term among Chinese hypertensive patients, with a good adherence and tolerability profile, and that most hypertensive patients may benefit from this combination.

Trial registration: Chinese Clinical Trial Registry identifier: ChiCTR1900021324.

Keywords:

• Antihypertensive agents
• valsartan/amlodipine
• observational study
• long-term
• hypertension
• single-pill combination

Transparency

Declaration of funding

This study was funded by Novartis Pharmaceuticals, China.

Author contributions

All authors equally contributed to the concept and design of the study, data interpretation and manuscript development. All authors critically revised the article for important intellectual content and approved the final version.

Declaration of financial/other relationships

B.W. has disclosed that she is a full-time employee of Novartis Pharmaceuticals, China, and as such may be eligible for Novartis stock and options. No potential conflict of interest was reported by the remaining authors. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

The authors thank all the clinical investigators and study coordinators at the participating centers, all the patients who participated in the study and the local laboratory and health facility staff. We also thank Rohita Gattoju and Anupama Tamta, Novartis Healthcare Pvt. Ltd., India, for medical writing support, collating comments from all authors and editing the final manuscript.