Drug Utilisation and Safety Study of Mysimba in Europe and Contrave in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43,324
- 试验地点
- 1
- 主要终点
- Demographic characteristics of patients initiating use of Mysimba/Contrave (Smoking Status)
研究概览
简要总结
This study will assess a retrospective cohort of users of Mysimba/Contrave with up to 548 days (~18 months) after initiation with treatment with Mysimba/Contrave. This study will describe Mysimba/Contrave utilisation and incidence of AESIs for users compliant and non-compliant with the SmPC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one prescription of Mysimba/Contrave in his/her medical records any time during the study period (US) OR at least one dispensing of Mysimba/Contrave in his/her registry any time during the study period (Nordic);
- •At least 365 days of computerized records prior to first Mysimba/Contrave prescription or dispensing date; and3Patient is active (i.e., alive and registered/accruing data) at the time of the first Mysimba/Contrave prescription or dispensing date.
排除标准
- •All patients meeting inclusion criteria will be included in the study; no exclusion criteria will be applied.
结局指标
主要结局
Demographic characteristics of patients initiating use of Mysimba/Contrave (Smoking Status)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Smoking status (i.e., current or ever)
Baseline characteristics of patients initiating use of Mysimba/Contrave (Height)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Height (meters) (most recent value on or before the index date)
Demographic characteristics of patients initiating use of Mysimba/Contrave (Comorbidities)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Existing comorbidities: * Metabolic comorbidities (i.e., diabetes or dyslipidemia); * Hypertension; * Seizure disorder; * Hepatic impairment; * Central nervous system tumor
Demographic characteristics of patients initiating use of Mysimba/Contrave (Breastfeeding)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Breastfeeding status.
Baseline characteristics of patients initiating use of Mysimba/Contrave (Weight)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Weight (kg) (most recent value on or before the index date)
Baseline characteristics of patients initiating use of Mysimba/Contrave (BMI)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
BMI (kg/m2) (most recent value on or before the index date) (obtained directly from data sources; BMI may be calculated if height and weight available)
Demographic characteristics of patients initiating use of Mysimba/Contrave (Age)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Patient demographics (years of age on index date)
Demographic characteristics of patients initiating use of Mysimba/Contrave (Substance Abuse/Dependencies)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
History of substance abuse/dependencies; including acute opioid withdrawal
Demographic characteristics of patients initiating use of Mysimba/Contrave (Medical Conditions)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
History of the following medical conditions: * Seizures; * Bipolar disorder; * Major depressive disorder (MDD); * Anorexia nervosa; * Bulimia; * Prior use of naltrexone, bupropion, opioid, or MAOI
Patterns of Mysimba/Contrave initiation (Rx)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave initiation includes number of prescriptions
Patterns of Mysimba/Contrave initiation (Episodes)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave initiation includes number of treatment episodes
Patterns of Mysimba/Contrave use (Compliance)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave use includes the number and percentage of patients compliant with the SmPC.
Demographic characteristics of patients initiating use of Mysimba/Contrave (Race)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Clinically recorded race (i.e., White, Black or African American, Asian, or other/unknown) and ethnicity (i.e., Hispanic or Latino, Non-Hispanic or Latino, or unknown)
Patterns of Mysimba/Contrave use (Non-compliance)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave use includes the number and percentage of patients non-compliant with the SmPC.
Demographic characteristics of patients initiating use of Mysimba/Contrave (Sex)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Patient demographics (sex \[male/female\] on index date)
Demographic characteristics of patients initiating use of Mysimba/Contrave (Pregnancy)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Pregnancy status.
Patterns of Mysimba/Contrave initiation (Duration)
时间窗: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave initiation includes duration between prescriptions
次要结局
未报告次要终点