Treatment Patterns of Menopausal Hormone Therapy in South Korea: a Nationwide Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,036,294
- 试验地点
- 1
- 主要终点
- Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year
研究概览
简要总结
The purpose of this study is to learn about how the commonly used menopausal hormone therapies were prescribed and taken in practice. This is done by using healthcare database, to study the overall dangers and benefits of menopausal hormone therapies in real-world practice.
This study will include subjects who were newly diagnosed menopausal symptoms between 2012 and 2019. They were all followed up for 12 months at least.
The study included the below subjects who:
- were aged 40-59 years
- were diagnosed to have menopausal symptoms through some medical check-ups
The data collected will be used to understand:
- how the commonly used menopausal hormone therapies were prescribed and taken in practice
- how patients took medication as prescribed by their doctors This might help to understand treatment trends of these therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40-59 years at cohort entry date
- •Patients who had at least one inpatient or outpatient diagnosis of menopausal symptoms between 01 Jan 2012 and 31 Dec 2019 with any of following diagnosis codes: N95.1, N95.2, N95.3, N95.8, N95.9, M80.0, M81.0, M81.99, M85.99
排除标准
- •Patients diagnosed with breast cancer (C50, D05), endometrial cancer (C54.1), and granulosa cell tumor (C56) within 1 year prior to the index date.
- •Patients diagnosed with coronary heart disease (I20-I25, I51.6), stroke (I60-64), and VTE (I80.2, I80.3 I26) within 1 year prior to the index date.
- •Patients diagnosed with viral hepatitis (B16-B19), cirrhosis (K70.2-K70.4, K71.7, K72.0-K72.1, K72.9, K74.0-K74.6, K76.1, K76.6-K76.7, R18, I85.0, I85.9, I86.4, I86.8, I98.2-I98.3), and hepatic cancer (C22) within 1 year prior to the index date.
- •Patients diagnosed with gallbladder disease (K80, K81, K82, K83, K85.1), gallbladder cancer (C23), extrahepatic bile duct cancer (C24) within 1 year prior to the index date.
结局指标
主要结局
Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year
时间窗: Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 months
Menopausal symptoms: at least one inpatient or outpatient claim with any of diagnosis codes based on Korean standard classification of disease, 8th revision(KCD-8):Korean version of ICD-10(International statistical classification of diseases and related health problems,10th revision), per protocol. N95.1: Menopausal, female climacteric states; N95.2:Postmenopausal atrophic vaginitis; N95.3:States associated with artificial menopause; N95.8 Other specified menopausal, perimenopausal disorders; N95.9: Menopausal, perimenopausal disorder, unspecified; M80.0: Postmenopausal osteoporosis with pathological fracture;M81.0: Postmenopausal osteoporosis; M81.99:Osteoporosis, unspecified, site unspecified; Osteopenia; M85.99: Disorder of bone density, structure, unspecified, site unspecified; Osteopenia, mild; Osteopenia, moderate; Osteopenia, severe. One participant could have visited hospital for \>=1 time for different menopausal symptom. Index date: date of first prescription for MHT.
Number of Women With MHT Use Distributed Per Year
时间窗: Index Date; retrospective data observed in this study for approximately 6 months
Number of Women with MHT use distributed per year was reported in this outcome measure. One participant could have taken more than 1 type of MHT hence participants are not fully exclusive. Three types of MHT included ET (estrogen therapy), EPT (estrogen-progestin therapy), and tibolone. Index date was defined as the date of the first prescription for MHT.
Number of Participants According to Each Type of Menopausal Symptoms Distributed Per Year
时间窗: Date of diagnosis of menopausal symptom during inpatient/outpatient hospital visit; retrospective data observed in this study for approximately 6 months
Menopausal symptoms included vasomotor, bone and joint, genitourinary and psychosomatic. One participant could have more than 1 type of menopausal symptoms. Index date was defined as the date of the first prescription for MHT.
Percentage of Participants With Change in Treatment Regimen Change at Month 6
时间窗: Month 6 post-index date; retrospective data observed in this study for approximately 6 months
Percentage of participants with change in treatment regimen at Month 6 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.
Number of Participants According to Each Type of Menopausal Symptoms Per MHT
时间窗: Index Date; retrospective data observed in this study for approximately 6 months
Menopausal symptoms included vasomotor symptoms, bone and joint symptoms, genitourinary symptoms, psychosomatic symptoms for systemic, Estrogen Therapy (ET), Estrogen-Progestin Therapy (EPT) and Tibolone. One participant could have more than 1 type of menopausal symptoms and have received more than 1 type of therapy. Index date was defined as the date of the first prescription for MHT.
Number of Participants With Use of Any MHT According to Age Group
时间窗: Index Date; retrospective data observed in this study for approximately 6 months
Number of participants with use of any MHT according to age group were reported in this outcome measure. Index date was defined as the date of the first prescription for MHT.
Number of Participants With MHT According to Type of Administration
时间窗: Index Date; retrospective data observed in this study for approximately 6 months
Number of participants with MHT according to type of administration were reported in this outcome measure. Type of administration included systemic hormone therapy (HT) (oral), systemic HT (transdermal), local HT (transvaginal). One participant could have received more than 1 type of therapy. Index date was defined as the date of the first prescription for MHT.
Percentage of Participants With Change in Treatment Regimen Change at Month 3
时间窗: Month 3 post-index date; retrospective data observed in this study for approximately 6 months
Percentage of participants with change in treatment regimen at Month 3 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.
Percentage of Participants With Change in Treatment Regimen Change at Month 9
时间窗: Month 9 post-index date; retrospective data observed in this study for approximately 6 months
Percentage of participants with change in treatment regimen at Month 9 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.
Percentage of Participants With Change in Treatment Regimen Change at Month 12
时间窗: Month 12 post-index date; retrospective data observed in this study for approximately 6 months
Percentage of participants with change in treatment regimen at Month 12 were reported in this outcome measure. Data reported in this outcome measure included participants who received the treatments which included Systemic ET, EPT, Tibolone, Local ET and also participants with no treatment. Index date was defined as the date of the first prescription for MHT.
Time to Discontinuation of MHT
时间窗: During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 months
Time to discontinuation was defined as no subsequent prescriptions within 2 months of last prescription date. MHT included: Systemic MHT: ET, EPT, Tibolone and Local MHT: ET. Index date was defined as the date of the first prescription for MHT.
Time to Switching of MHT
时间窗: During 2 year of follow up from index date; retrospective data observed in this study for approximately 6 months
Time to switching of MHT was reported in this outcome measure. Participants who switched the treatment classes were included. MHT included: Systemic MHT: ET, EPT, Tibolone and Local MHT: ET. Index date was defined as the date of the first prescription for MHT.
Percentage of Participants With Treatment Persistence at Month 3 Post-index According to Treatment Type
时间窗: Month 3 post-index; retrospective data observed in this study for approximately 6 months
Treatment persistence was calculated by the average length of treatment of the drugs prescribed at the index date. Index date was defined as the date of the first prescription for MHT.
Percentage of Participants With Treatment Persistence at Month 12 Post-index According to Treatment Type
时间窗: Month 12 post-index; retrospective data observed in this study for approximately 6 months
Treatment persistence was calculated by the average length of treatment of the drugs prescribed at the index date. Index date was defined as the date of the first prescription for MHT.
Percentage of Participants With Treatment Persistence at Month 6 Post-index According to Treatment Type
时间窗: Month 6 post-index; retrospective data observed in this study for approximately 6 months
Treatment persistence was calculated by the average length of treatment of the drugs prescribed at the index date. Index date was defined as the date of the first prescription for MHT.
Percentage of Participants With Treatment Persistence at Month 9 Post-index According to Treatment Type
时间窗: Month 9 post-index; retrospective data observed in this study for approximately 6 months
Treatment persistence was calculated by the average length of treatment of the drugs prescribed at the index date. Index date was defined as the date of the first prescription for MHT.
Mean Treatment Adherence (%)
时间窗: Index Date; retrospective data observed in this study for approximately 6 months
Treatment adherence was evaluated using medication possession ratio (MPR), calculated as the total number of days of medication supply divided by the number of days in the follow-up period. Data for this outcome is expressed in percentage. Index date was defined as the date of the first prescription for MHT.
次要结局
未报告次要终点