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

N/ACompletedNCT05120895

Daiichi Sankyo3,060 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

3,060

Conditions

Dyslipidemia

Interventions

MevalotinDRUG

Oral tablets (starting dose 5 mg)

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (58)

Outcomes

Primary Outcomes

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.

Time frame: Week 24 post-dose

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Week 48 post-dose

Data from ClinicalTrials.gov

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Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Bucheon Sejong Hospital

Bucheon-si, South Korea

Inje University Busan Paik Hospital

Busan, South Korea

Inje University Haeundae Paik Hospital - Site 0011

Busan, South Korea

Inje University Haeundae Paik Hospital - Site 0031

Busan, South Korea

Boneseng Memorial Hospital

Busan, South Korea

Pusan National University Hospital - Site 0013

Busan, South Korea

Pusan National University Hospital - Site 0033

Busan, South Korea

Chungbuk National University Hospital

Cheongju-si, South Korea

Hallym University Medical Center - Chuncheon

Chuncheon, South Korea

...and 48 more locations