Drug Utilisation of Mysimba/Contrave

Study Overview
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Brief Summary
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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.

Official Title
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Drug Utilisation and Safety Study of Mysimba in Europe and Contrave in the United States

Conditions
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Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: - All patients meeting inclusion criteria will be included in the study; no exclusion criteria will be applied.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: Metabolic comorbidities (i.e., diabetes or dyslipidemia); Hypertension; Seizure disorder; Hepatic impairment; Central nervous system tumor | 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) | 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: Seizures; Bipolar disorder; Major depressive disorder (MDD); Anorexia nervosa; Bulimia; Prior use of naltrexone, bupropion, opioid, or MAOI | 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 |