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The aim was to assess the long-term hypertension management in Chinese hypertensive patients who were already treated with valsartan/amlodipine FDC in a real-world observational setting. BP control rate and the proportion of patients who were still taking the medication after one year follow-up were assessed.
This was a one-year, observational, multicenter, prospective registry. The patients who were enrolled in this registry were already treated with valsartan/amlodipine FDC for at least 4 weeks prior to this study. The investigators recorded patients' data every 3 months and were asked to record patient data 5 times during the one-year follow-up period. Effectiveness was assessed as BP control rate and as the average duration on treatment at the end of study. Safety was monitored by the incidence of adverse events (AEs) and serious AEs (SAEs).
Overall, 985 patients from 27 centers across China were enrolled. 87% of patients remained on valsartan/amlodipine FDC at one-year with an average exposure of 311.5 days. At baseline, BP was controlled (<140/90 mmHg) in 64.3% of the patients taking valsartan/amlodipine FDC for at least 4 weeks prior to the study. BP control rates increased significantly from baseline with 74.1% (p<0.0001) at 12 month. AEs were reported by 23.3% of patients. The majority of AEs were mild or moderate and none was related to valsartan/amlodipine FDC. The 0.6% of patients discontinued valsartan/amlodipine FDC treatment due to SAEs.
Valsartan/amlodipine FDC provided high BP control rate consistently in a one-year real-world registry with high persistence rates and was well tolerated in Chinese hypertensive patients.