An Observational Study Investigating the Change in Blood Cholesterol With Mevalotin® Tablet Administration in Korean Menopausal Women Aged 50 Years or More Who Require Treatment of Dyslipidemia

Study Overview
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Brief Summary
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This study will investigate the efficacy and safety based on the observation of the blood cholesterol change with Mevalotin® Tablet administration in Korean menopausal women aged 50 years or more who require treatment of dyslipidemia.

Detailed Description
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In this prospective, observational study, patient data (eg, clinical outcomes in actual clinical settings, demographic information, medical treatment-related information, Mevalotin® Tablet administration start date [Index date], and the lipid profile results at Week 24 after Mevalotin® Tablet administration start date) will be collected from medical records. No study drug will be administered in this study. Patient data will be used to determine the change in blood cholesterol with Mevalotin® Tablet administration (5 mg, 10 mg, 20 mg, 40 mg as determined by Investigator in clinical practice) in Korean menopausal women aged 50 years or more who require treatment of dyslipidemia.

Official Title
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A Multicenter, Prospective, Non-interventional Observational Study to Investigate the Change in Blood Cholesterol With Mevalotin® Tablet Administration in Korean Menopausal Women Aged 50 Years or More Who Require Treatment of Dyslipidemia

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: Mevalotin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Menopausal women aged 50 years or more diagnosed with dyslipidemia Menopause was defined as the condition of not having menstruation for 1 year with no specific cause or being diagnosed with menopause at the discretion of an investigator (except for the case of being diagnosed with menopause for a surgical reason within 5 years), and the menopausal status is confirmed as of the Mevalotin® Tablet administration start date (Index date). Patients who are determined to be prescribed with Mevalotin® Tablet at the discretion of an investigator or patients who started Mevalotin® Tablet administration within 6 weeks prior to enrollment in this observational study (however, in case of patients switching from statins to Mevalotin® Tablet, only those who receive from low/intermediate intensity statins treatment to low/intermediate intensity statins treatment can be enrolled in this study) Patients who provided voluntary written consent to take part in this observational study Exclusion Criteria: Patients with a history of cancer within 5 years (however, patients with a history of brain tumor, breast cancer, uterine cancer, ovarian cancer, or endometrial cancer are excluded from enrollment regardless of duration.) Patients who received hormone replacement therapy within 1 year of enrollment Patients who are determined to be ineligible for participation in this observational study

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mevalotin<br>Korean menopausal women aged 50 years or more who required treatment of dyslipidemia and received Mevalotin® tablets. | Drug: Mevalotin<br>* Oral tablets (starting dose 5 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in low-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration | The change from baseline (mg/dL) in low-density lipoprotein cholesterol (LDL-C) will be assessed at Week 24 from blood plasma samples. | Week 24 post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration | The change from baseline (mg/dL) in total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoprotein cholesterol will be assessed at Week 24 from blood plasma samples. | Week 24 post-dose | 
| Percent change from baseline in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration | The percent change from baseline (%) in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoprotein cholesterol will be assessed at Week 24 from blood plasma samples. | Week 24 post-dose | 
| Change from baseline in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 48 after Mevalotin® Tablet administration | The change from baseline (mg/dL) in total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoprotein cholesterol will be assessed at Week 48 from blood plasma samples. | Week 48 post-dose | 
| Percent change from baseline in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 48 after Mevalotin® Tablet administration | The percent change from baseline (%) in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoprotein cholesterol will be assessed at Week 48 from blood plasma samples. | Week 48 post-dose | 
| Number of participants with treatment-emergent adverse events after Mevalotin® Tablet administration | Treatment-emergent adverse event (TEAE) is defined as an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. | Week 48 post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, Menopause, Blood cholesterol, Mevalotin®