| Background:Hypertension is a major preventable risk factor for cardiovascular disease and a leading cause of death and disability worldwide, in both developing and developed countries. The risk of hypertension-associated morbidity and mortality may significantly be reduced by lowering BP. To achieve the target blood pressure level with a single drug may often be challenging especially for the high cardiovascular risk patients. Since, the current international treatment guidelines (including the American and the European treatment guidelines) for the management of arterial hypertension have recommended the use of a combination of two or more anti-hypertensive agents as an initial therapy for high or very high cardiovascular risk patients or in patients who require prompt and pronounced reductions in their baseline BP, combination therapy has become an attractive choice for the management of arterial hypertension. This prospective observational study was designed to evaluate the efficacy and safety of Valsartan/Amlodipine (80/5 mg/day) fixed-dose combination therapy in Chinese hypertensive patients who failed to achieve the target blood pressure (< 140/90 mm Hg) level by monotherapy with any CCB in real-world clinical settings.Materials & Methods:This was the first prospective, open label, multicentre, post marketing observational study conducted by China Status II study group. In this observational study,5413 hypertensive patients were enrolled from all over China, who were being treated with calcium channel blockers (CCBs) prior to enrolment. They were prescribed a fixed-dose combination therapy of Val/Aml (80/5 mg/day) for the duration of 8 weeks with a follow-up at every 4 weeks. All patients were required to sign an informed consent. The primary efficacy variables of our study were changes in mean sitting systolic BP (MSSBP) and mean sitting diastolic BP (MSDBP) from base line to week 8 (end point), The secondary efficacy variables of this study were BP control rate and response rate at week 4 and 8. Safety evaluations included recording and measurement of all adverse events (AEs) and vital signs in the safety population.Results:Valsartan/Amlodipine (80/5mg/day) fixed-dose combination therapy has been shown to be associated with a marked reduction of 27.3 mm Hg in MSSBP (160.19 vs.132.88 mm Hg; P<0.0001) and 14.9 mm Hg in MSDBP (95.38 vs.80.42 mm Hg; P<0.0001) from baseline after 8 weeks of treatment. A significant improvements in BP control rates (< 140/90 mmHg) were also observed and approximately 77%(n=4168) of patients were able to achieve BP control after 8 weeks of treatment with Valsartan/Amlodipine (80/5mg/day) fixed-dose combination regimen. In this study, it has been demonstrated that treatment with Val/Aml (80/5 mg/day) combination therapy was well tolerated with a remarkable safety profile regardless of the age, gender, comorbidities, and baseline BP of the patients. The rate of drug associated adverse events was shown to be substantially low at week 4 and week 8. Serious drug-associated adverse events were either not reported during the entire period of study; or none of them was suspected to be attributed to fixed-dose combination therapy. Dizziness (0.2%), headache (0.2%), upper respiratory tract infections (0.2%) and edema (0.2%) were the most frequently reported adverse events.Conclusion:It was the first evidence-based perspective observational study, conducted in Chinese hypertensive patients to evaluate the efficacy and safety of Valsartan/Amlodipine (80/5mg/day) fixed-dose combination in real-world clinical practice. This Val/Aml (80/5mg/) once-daily dosing fixe-dose combination regimen has been associated with significantly greater reductions in MSSBP and MSDBP and substantial improvements in BP control rate, regardless of age, gender and co-morbidities of the patients. Treatment with Val/Aml (80/5mg/) once-daily dosing was shown to be highly efficacious and has an excellent safety and tolerability profile... |
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