Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Other

If ‘other’, further details on the scope of the study

Adverse event reporting
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

MYSIMBA

Study drug International non-proprietary name (INN) or common name

BUPROPION HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE

Anatomical Therapeutic Chemical (ATC) code

(A08AA62) bupropion and naltrexone
bupropion and naltrexone

Medical condition to be studied

Overweight
Obesity
Population studied

Age groups

Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Hepatic impaired
Pregnant women
Renal impaired

Estimated number of subjects

15000
Study design details

Main study objective

(1) To describe demographic and baseline characteristics of patients initiating use of Mysimba.
(2) To evaluate patterns of Mysimba initiation and use, including estimating the number and percentage of patients compliant and non-compliant with the SmPC.

Outcomes

Among Mysimba initiators, we will describe the population, treatment patterns, and assess (a) use inconsistent with labelled indication (e.g. age <18 years, no obesity/overweight indication, alternat doses), and (b) use incompatible with contradictions set out in the SmPC (e.g. uncontrolled hypertension, seizure disorders, renal failure, hepatic impairment, dependence/withdrawal of opioid). For Mysimba initiators, we will describe (a) incidence of adverse events of special interest overall, based on compliant use, and among subgroups (e.g. comorbidities, pregnant, history of substance abuse/dependencies). We will also describe (b) real-world drug use, e.g. titration schemes, dose adjustments, treatment discontinuations and reasons surrounding discontinuation, if available.

Data analysis plan

Data will be described for each country sample separately and on country samples with ≥750 patients (Sweden, Norway, Finland, Denmark, US). Descriptive statistics will describe demographic and baseline variables and Mysimba treatment duration. Patient subgroups (e.g. comorbidities of interest, pregnant or lactating) and treatment pattern groups (e.g. compliant or non-compliant with the SmPC) will be described with counts and proportions. The incidence of adverse events of special interest (AESI) will be described overall and for subgroups using rates and person-time of exposure. For each type of AESI, we will estimate crude incidence rates and 95% confidence intervals. Treatment modifications (i.e. titration scheme changes, alternative maintenance doses to Mysimba 32mg/360mg, discontinuations) will be described using counts and proportions. Reasons for treatment discontinuations will be described based on data captured before the end of defined treatment discontinuation.