The primary objective of this study is to evaluate the effectiveness of a combination drug containing fimasartan and statins on the control of hypertension and dyslipidemia, and the secondary objective is to evaluate the drug cost reduction effect, patients' satisfaction level and safety of the combination drug administration.
This study is designed as a non-interventional, multicenter, prospective observational study for patients with hypertension and dyslipidemia. If a patient voluntarily provides written consent to provide information for this study, the enrollment number will be assigned to subjects who meet the inclusion/exclusion criteria, and follow-up will be conducted for approximately 12 weeks. Pre-specified study-related data will be collected in the case report form during the observation period. This is an observational study, and the number or interval of subjects' visits to the hospital is determined by the investigators' clinical judgment under actual medical circumstances in principle. Whether to participate in this study will not affect the patients' treatment (physician's prescription or diagnostic, therapeutic decisions). The follow-up time points specified below indicate the time points of data collection. That is, the schedule of subjects' visits is freely determined by the investigators based on the medical condition of the subjects regardless of the follow-up time points specified in this protocol, but data that are generated during the study period and are deemed necessary in relation to the study may be collected in the case report form.
Study Type
OBSERVATIONAL
Enrollment
10,877
Patients who correspond to one of the following: 1. Patients who are planning to be treated with a combination drug containing fimasartan and statins after being newly diagnosed with essential hypertension and primary hypercholesterolemia 2. Patients who are planning to switch to a combination drug of fimasartan and statins, among those who have been diagnosed with essential hypertension or primary hypercholesterolemia and are receiving hypertension treatment that is containing an ARB or dyslipidemia treatment that is containing a statin 3. Patients who are planning to switch to a combination drug of fimasartan and statins, among those who have been diagnosed with essential hypertension and primary hypercholesterolemia and are receiving hypertension treatment that is containing an ARB and dyslipidemia treatment that is containing a statin
Chonnam National University Hospital
Gwangju, Jebong-ro, Jangseong-eup, Jangseong-gun, South Korea
Blood pressure controlled to the target level
Proportion of patients with blood pressure controlled to the target level (SiSBP, SiDBP) according to '2018 Guidelines for Management of Hypertension2' at Week 12. Site staff will be measuring Systolic and Diastolic Blood Pressure.
Time frame: Week12
LDL-C controlled to the target level
Proportion of patients with LDL-C controlled to the target level according to 'Guidelines for Management of Dyslipidemia 4th Edition1' at Week 12
Time frame: Week 12
Medication Satisfaction Questionnaire
Score (or change in the scores) of Medication Satisfaction Questionnaire (MSQ) assessed by patients at Week 12/ The scale title is MSQ(Medication satisfaction Questionnaire). The minimum score is '1' and maximum score is '7'. Higher score means a better outcome.
Time frame: Week 12
Average cost-effectiveness ratio (ACER)
Average cost-effectiveness ratio (ACER) of the study drug at Week 12
Time frame: Week 12
both blood pressure and LDL-C controlled
Proportion of patients with both blood pressure and LDL-C controlled to the target level simultaneously at Week 12
Time frame: Week 12
non-HDL-C controlled
Proportion of patients with non-HDL-C controlled to the target level at Week 12
Time frame: Week 12
Change in blood pressure
Change in blood pressure at Week 12 from baseline
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Time frame: Week 12
Change in Lipid panel
Lipid panel at Week 12 from baseline * Percent change in TC * Percent change in HDL-C * Percent change in TG * Percent change in LDL-C * Percent change in non-HDL-C
Time frame: Week 12