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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Demographic characteristics of patients initiating use of Mysimba/Contrave (Age) | Patient demographics (years of age on index date) | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Demographic characteristics of patients initiating use of Mysimba/Contrave (Sex) | Patient demographics (sex [male/female] on index date) | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Demographic characteristics of patients initiating use of Mysimba/Contrave (Race) | 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) | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Demographic characteristics of patients initiating use of Mysimba/Contrave (Smoking Status) | Smoking status (i.e., current or ever) | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Demographic characteristics of patients initiating use of Mysimba/Contrave (Comorbidities) | Existing comorbidities:
| All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Demographic characteristics of patients initiating use of Mysimba/Contrave (Substance Abuse/Dependencies) |
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Inclusion Criteria:
Exclusion Criteria:
- All patients meeting inclusion criteria will be included in the study; no exclusion criteria will be applied.
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Users of Mysimba/Contrave with at least 365 days of computerized records prior to first use in Denmark Finland, Norway and Sweden, and other countries (if meeting the threshold for patients and agreed upon between EMA and MAH) with sufficient uptake of Mysimba/Contrave in the respective national health systems. Additionally, U.S. data will be included.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Currax Pharmaceuticals | Nashville | Tennessee | 37208 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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History of substance abuse/dependencies; including acute opioid withdrawal |
| All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Demographic characteristics of patients initiating use of Mysimba/Contrave (Medical Conditions) | History of the following medical conditions:
| All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Demographic characteristics of patients initiating use of Mysimba/Contrave (Pregnancy) | Pregnancy status. | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Demographic characteristics of patients initiating use of Mysimba/Contrave (Breastfeeding) | Breastfeeding status. | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Patterns of Mysimba/Contrave initiation (Rx) | Mysimba/Contrave initiation includes number of prescriptions | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Patterns of Mysimba/Contrave initiation (Episodes) | Mysimba/Contrave initiation includes number of treatment episodes | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Patterns of Mysimba/Contrave initiation (Duration) | Mysimba/Contrave initiation includes duration between prescriptions | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Baseline characteristics of patients initiating use of Mysimba/Contrave (Height) | Height (meters) (most recent value on or before the index date) | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Baseline characteristics of patients initiating use of Mysimba/Contrave (Weight) | Weight (kg) (most recent value on or before the index date) | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Baseline characteristics of patients initiating use of Mysimba/Contrave (BMI) | 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) | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Patterns of Mysimba/Contrave use (Compliance) | Mysimba/Contrave use includes the number and percentage of patients compliant with the SmPC. | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| Patterns of Mysimba/Contrave use (Non-compliance) | Mysimba/Contrave use includes the number and percentage of patients non-compliant with the SmPC. | All available follow-up data up to 548 days after the index date will be included for each patient or end of study period |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |