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Post-marketing surveillance of Telostop TAB (Telmisartan/Rosuvastatin)
Telostop TAB is fixed-dose combination of telmisartan and rosuvastatin, which was approved in 2015 in the Republic of Korea for the treatment of patients with hypertention and dyslipidemia. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of Telostop TAB in real-world practice.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse event after this drug administration in general medical practice | Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline to week 24 in the LDL cholesterol | LDL cholesterol is measured before administration of the drug and within 24 weeks after administration. | 24 weeks |
| The change from baseline to week 24 in the blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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residents of Korea, in real-world practice
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Blood pressure is measured before administration of the drug and within 24 weeks after administration.
| 24 weeks |
| D009750 | Nutritional and Metabolic Diseases |