Abstract 656: Efficacy and Safety of Valsartan/Amlodipine Single-Pill Combination in Chinese Elderly Hypertensive Patients with Chronic Kidney Disease: Subgroup analysis of the CHINA STATUS II study

Objective: To evaluate the efficacy and safety of Valsartan/Amlodipine SPC in a sub-group analysis of elderly hypertensive patients (aged ≥65 years) with Chronic Kidney Disease (CKD) treated for 8 weeks in the CHINA STATUS II study. Methods: This post-hoc analysis was conducted in 3297 hypertensive elderly patients from CHINA STATUS II study(CSII), whose blood pressure (BP) was not controlled by monotherapy . 116 patients had CKD (aged 75.5±6.8 years) while 3181 were without CKD (aged 74.4±6.3 years). All patients in CSII received Valsartan/Amlodipine 80/5 mg SPC for 8 weeks. The patients did not achieve BP control at the end of 4 weeks (BP≥ 130/80 mmHg for patients with diabetes or CKD and≥140/90 mmHg for others), an additional antihypertensive agent added. T -test and chi-square test were used for statistical analysis. Results: After valsartan/amlodipine SPC treatment for 8 weeks, mean sitting systolic blood pressure (MSBP) decreased, 25.4±13.3 mmHg and 28.3±12.5 mmHg from baseline in patients with and without CKD, respectively. Mean sitting diastolic blood pressure (MSDP) was reduced by10.4±9.3 mmHg and 13.5±9.5 mmHg from baseline in patients with and without CKD, respectively. 17.2%patients with CKD achieved their BP target of <130/80 mmHg and 77.8% non-CKD patients achieved their BP goal, <140/90 mmHg. The incidence of adverse events was 0.9% in patients without CKD, while none were reported in patients with CKD. Two serious adverse events (SAEs), which were not drug-related, occurred in non-CKD patients and no SAE was reported in CKD patients. 100% of the patients with CKD and 99.2% of patients without CKD rated the tolerance to therapy as ‘good’ or ‘very good’, respectively. Conclusions: Valsartan/amlodipine SPC showed good safety and tolerance in hypertensive patients aged ≥65 with CKD whose BP was uncontrolled by previous monotherapy. Lower proportion of elderly patients with CKD achieved the strict BP target compared to elderly patients without CKD. In view of the limitation of this being a post-hoc analysis, the reason for the observed low BP control rate in elderly patients with CKD needs further analysis and research.