Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cross-sectional
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

(A08AA) Centrally acting antiobesity products
Centrally acting antiobesity products
Population studied

Age groups

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)

Estimated number of subjects

200
Study design details

Main study objective

The objective of the study is to evaluate physician receipt, knowledge, application and effectiveness in current clinical practice, of the Mysimba PPC.

Outcomes

Primary outcome: 85% of physicians whose correct response rate for the general PPC knowledge and risk-related questions (Questions 2-10) is at least 80%, or a score of 20 out of 25 possible points.

Data analysis plan

Categorical data will be summarised with frequencies and percentages. Continuous data will be summarised with the following descriptive statistics unless otherwise noted: number of observations, mean, standard deviation (SD), median, minimum, and maximum. Descriptive statistics will be performed on each survey question and pooled across all countries. The response rate for each question in the survey will be based on the total number of correct responses out of the total number of responses for that particular question. Responses to survey questions will also be summarised by demographics of respondents (country, medical specialty, years in practice, practice setting, and number of patients prescribed Mysimba). There will be no imputation for incomplete or missing data.