None listed
Conditions
Interventions
None listed
Sponsors
Daiichi-Sankyo Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hypertensive patient with T2DM or pre-DM eligible to receive treatment with Sevikar HCT® tablet at the medical discretion of their treating physician. The diagnostic criteria of T2DM and pre-DM in this study are complied with the criteria of The Korean Diabetes Association (2019) as follows: - T2DM (at least one of the following) 1) HbA1c value is over 6.5% or 2) Fasting glucose concentration (FGC) is greater than or equal to 126 mg/dL after at least 8 hours of fasting or 3) Plasma glucose concentration after 2 hours of 75g oral glucose tolerance test (OGTT) is greater than or equal to 200 mg/dL or 4) Plasma glucose concentration is greater than or equal to 200 mg/dL according to random plasma glucose test with typical symptoms of DM and hyperglycemia (Polyuria, polyphagia, weight loss of unknown cause) - Pre-DM (at least one of the following) 1) Impaired fasting glucose (IFG): fasting plasma glucose concentration is 100~125 mg/dL 2) Impaired glucose tolerance (IGT): Plasma glucose concentration after 2 hours of OGTT is 140~199 mg/dL 3) HbA1c value is 5.7~6.4% 2. Patient or his/her legally authorized representative who agrees and signs a written informed consent on the use of information
Exclusion criteria
Exclusion criteria: 1. Patients who have been prescribed Sevikar HCT® tablet within 3 months of entering the study 2. Patients determined to be ineligible for participation in this study at the discretion of the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Attainment rate of target BP goals* at month 6 after Sevikar HCT® tablet treatment. *Target BP is determined according to the criteria of The Korean society of hypertension (2018). In DM patients, the target BP is decided whether the patients have CVD (defined as coronary artery disease, peripheral vascular disease, aortic disease, heart failure, left ventricular hypertrophy in patients aged 50 years or more) or not. In the absence of CVD, target BP is SBP/DBP<140/85 mmHg whereas the target BP is SBP/DBP<130/80 mmHg in the presence of CVD. For pre-DM or elderly patients, the target BP is SBP/DBP<140/90 mmHg. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in SBP at month 3 and 6 after Sevikar HCT® tablet treatment;Change from baseline in DBP at month 3 and 6 after Sevikar HCT® tablet treatment;Attainment rate of target BP goals* at month 3 after Sevikar HCT® treatment. *Target BP is determined according to the criteria of The Korean society of hypertension (2018). In DM patients, the target BP is decided whether the patients have CVD (defined as coronary artery disease, peripheral vascular disease, aortic disease, heart failure, left ventricular hypertrophy in patients aged 50 years or more) or not. In the absence of CVD, target BP is SBP/DBP<140/85 mmHg whereas the target BP is SBP/DBP<130/80 mmHg in the presence of CVD. For pre-DM or elderly patients, the target BP is SBP/DBP<140/90 mmHg.;Change from baseline in laboratory evaluation of DM (T2DM or pre-diabetes)* and CVD at month 6 after Sevikar HCT® tablet treatment. *Laboratory evaluation of DM and CVD as per routine clinical practice: HbA1c, Serum potassium level, Lipid profile: TC, LDL-C, HDL-C, TG, Liver function test: AST, ALT, LD, ALP, GGT, Renal function test: ACR in urea, SCr, e-GFR;Change from baseline in the lipid profile (?mg/dL) and rate (%) of patients being treated with statin at month 6 after Sevikar HCT® tablet treatment;Rate of withdrawal from Sevikar HCT® treatment due to AE: The percentage of patients who are permanently withdrawn from Sevikar HCT® treatment due to AE prior to 6 months (study end date);Rate of withdrawal from Sevikar HCT® treatment due to any reason: The percentage of patients who are permanently withdrawn from Sevikar HCT® treatment due to any reason prior to 6 months (study end date) | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Rae Kim
The Catholic University of Korea, Bucheon St. Mary's Hospital
Outcome results
None listed