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

Daiichi Sankyo

Status

Completed

Conditions

Dyslipidemia

Treatments

Drug: Mevalotin

Study type

Observational

Funder types

Industry

Identifiers

NCT05120895

MVT-OS-21-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

3,060 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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