Dapagliflozin Post Marketing Surveillance in HF and CKD

This is an observational, non-interventional, single-arm multicenter study. The objectives of this study are to assess safety and effectiveness of Forxiga in a real world setting in patients who are prescribed with the study drug according to the newly approved indications in the Republic of Korea

As part of a post-approval commitment, the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (hereinafter “Korea”) requests a study to characterize the safety in patients treated with dapagliflozin by physicians in normal clinical practice settings. In principle, all patients treated (minimum of 900 required) with the product in accordance with the newly updated local prescribing information for HFrEF and/or CKD are eligible for the enrolment in this study. Product prescription and patient enrollment will depend on physicians’ medical decision as per routine clinical practice. Patient follow-up will be 12 weeks or about 24 weeks (for long-term surveillance) and patients will be recruited over a period of 4 years after the new HFrEF indication approval by the local health authorities. This is due to the requirements from the local health authorities. The primary objective of this study is to assess the safety profile of the product in Korean adult patients with heart failure with reduced ejection fraction (HFrEF) and/or chronic kidney disease (CKD) in a real world setting under the approved indication(s) in Korea. The secondary objective of this study is to examine the effectiveness of the product, measured as: 1) no worsening in NYHA class, in Korean patients with HFrEF and/or 2) no worsening in UACR category in Korean CKD patients in a real world setting under the approved indication(s) in Korea. The exploratory objective of this study is to identify patients’ baseline characteristics that might be associated with the safety and effectiveness of the product when prescribed under the approved indication(s) in Korean patients with HFrEF and/or CKD during the 12 weeks or about 24 weeks of follow-up duration