Post-marketing surveillance of ATEDIO_® combination tablet - An interim report

Background: ATEDIO_® Combination Tablet, a fixed-dose combination of the drugs cilnidipine (10 mg) and valsartan (80 mg), is a triple-blocker that blocks L- and N-type calcium channels as well as angiotensin II type 1 receptor, and is already used as an antihypertensive medicine. However, no large-scale post-marketing surveillance results have been reported regarding its safety and antihypertensive effect. Method: In the post-marketing surveillance of ATEDIO_® Combination Tablet, 2200 patients were examined starting in October 2014. This is an interim report about the safety and efficacy of the drug over a period of 12 months of use in daily medical practice. Results: In total, 2672 patients were registered, and data were collected for 2095 patients by March 2017. A total of 2045 patients met the criteria of this surveillance protocol. Among these patients, 53.6% were male, 46.4% were female, and the average age was 67.5±12.6 years. Seventy-two cases (3.52%) of side effects were observed. Systolic blood pressure, diastolic blood pressure, and pulse rate, measured either at the clinic or at home, decreased significantly after 3 months, and this effect was maintained for 12 months. Conclusion: This real-world study of more than 2000 patients indicated that ATEDIO_® Combination Tablet can be used to control blood pressure for 12 months without causing any significant side effects or increasing patient pulse rate.