Obesity
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Currax Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patterns of Mysimba/Contrave use (Compliance) | 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 (Age) | 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 (Sex) | 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 (Race) | 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) |
| Demographic characteristics of patients initiating use of Mysimba/Contrave (Smoking 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 | Smoking status (i.e., current or ever) |
| Demographic characteristics of patients initiating use of Mysimba/Contrave (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 | 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 (Substance Abuse/Dependencies) | 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) | 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 |
| Demographic characteristics of patients initiating use of Mysimba/Contrave (Pregnancy) | 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. |
| Demographic characteristics of patients initiating use of Mysimba/Contrave (Breastfeeding) | 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. |
| Patterns of Mysimba/Contrave initiation (Rx) | 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) | 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 initiation (Duration) | 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 |
| Baseline characteristics of patients initiating use of Mysimba/Contrave (Height) | 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) |
| Baseline characteristics of patients initiating use of Mysimba/Contrave (Weight) | 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) | 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) |
| Patterns of Mysimba/Contrave use (Non-compliance) | 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. |
Countries
United States
Outcome results
None listed