Long-term tolerability and efficacy of the combination of amlodipine/valsartan in hypertensive patients: a 54-week, open-label extension study^*

ABSTRACT

Objective: To evaluate the long-term tolerability and efficacy of the amlodipine/valsartan 5/320 mg once daily (o.d.) combination in hypertensive patients.

Methods: This was a 54-week, multicenter, open-label extension study in patients with mild-to-moderate essential hypertension selected after successfully completing a core study during which they received either placebo, amlodipine, valsartan or combination therapy. Eligible patients (mean sitting diastolic blood pressure [MSDBP] ≤ 95 mmHg and mean sitting systolic blood pressure [MSSBP] ≤ 150 mmHg; n = 403) were started with amlodipine/valsartan 2.5/160 mg o.d. Following the initial 2-week treatment period, patients were force titrated to amlodipine/valsartan 5/320 mg o.d. for the remainder of the trial. Only the first 150 patients who successfully completed 28 weeks of the extension study were eligible to continue further treatment for 12 months. Efficacy variables were change from core study baseline in MSDBP and MSSBP at study (extension) endpoint. Safety assessments consisted of monitoring and recording all adverse events and serious adverse events.

Results: Reductions in MSDBP and MSSBP were achieved at each extension visit. At endpoint, the reductions in MSDBP and MSSBP were 17.0 and 24.2 mmHg. Summary statistics by subgroup indicate that the combination of amlodipine/valsartan 5/320 mg was effective regardless of age, gender, or stage of hypertension. Peripheral edema occurred in 1.2% of the patients. No case of edema was classified as serious or severe, and no patient was discontinued due to edema. No deaths or clinically significant laboratory findings were observed during this extension study.

Conclusions: Long-term treatment with the amlodipine/valsartan 5/320 mg combination was well-tolerated. Clinically significant and persistent reductions in blood pressure were achieved. Limitations included an open-label design and inclusion of only those patients at or near goal blood pressure after the preceding core trial.

Key words: :

• Amlodipine
• Hypertension
• Peripheral edema
• Valsartan

Acknowledgments

Declaration of interest: This study was supported by Novartis Pharma AG, Basel, Switzerland. Robert D. Glazer and Yanxing Zhao are employees of Novartis Pharmaceuticals Corporation. None of the other authors has any conflicts of interest with respect to the contents of this article. The authors thank Ashish Agarwal, PhD and Sunita Nair, PhD from Novartis, India for writing support.

The authors also acknowledge all investigators and study coordinators at the participating centers, and all patients for their commitment to the study.

Notes

* Abstract presented at the 18th Hypertension 2008 joint congress of the European Society of Hypertension; poster presented at the 22nd meeting of the International Society of Hypertension, Jun 14–19, 2008, Berlin, Germany [Poster number: PS32/WED/19]