The American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) consensus statement highlights weight management as a consideration when choosing therapy for type-2 diabetes mellitus (T2DM) patients. GLP-1 RAs are a class of medication that had demonstrated significant weight loss in clinical trials. However, the extent to which patients in a real-world setting experience clinically-meaningful weigh loss (a loss of greater than or equal to 5% of their body weight) has not been well described. Furthermore, there are limited real-world data on patient adherence (taking the medication as prescribed) and persistence (continuing to take the medication or not discontinuing the medication) to GLP-1 RAs. This study aims to improve our understanding of patients adherence to and discontinuation of GLP-1 RAs drugs in the real-world. It will also examine demographic and clinical factors associated with adherence and discontinuation.
In order to assess weight change from, adherence to and discontinuation of GLP-1 RA therapy, a retrospective, observational study will be conducted using the Clinical Practice Research Datalink (CPRD) database to identify all Type 2 diabetes (T2DM) patients ? 18 years of age and initiating on GLP-1 RAs as monotherapy or as dual therapy with metformin between January 1, 2010 and December 31, 2016. New users of GLP-1 RA must have one-year of continuous enrolment prior to initiating GLP-1 RA (index date) and for one-year after initiating GLP-1 RA. This study mean weight change as well as the proportion of patients who achieve ?5% weight loss 1 and 2 years post-GLP-1 RA initiation. Adherence will be assessed as proportion of days covered (PDC) ?80% and discontinuation will be defined as a gap >90 days from end of days of supply of a GLP-1 RA prescription; the proportion of patients adherent and the proportion of patients who discontinue will be calculated at 1 and 2 years. Analysis will be descriptive in nature. Statistical tools of mean, median, 95% confidence intervals, standard deviations or standard errors, quartiles (25%, 75%), and range (minimum, maximum) for continuous variables of interest and frequency distributions for categorical variables will be used. Chi square test for categorical variables and one-way ANOVA or t-test, as appropriate, for continuous variables will be performed when comparing proportion of patients who achieved ?5% v. <5% weight loss, adherent v. non-adherent, and discontinued v. non-discontinued. Multiple Logistic Regression will be used to study the strength of association between the independent variables and adherence or discontinuation of index (GLP-1 RA) drug. Kaplan Meier method will be used to estimate the time to discontinuation of index drug.
1) Proportion of patients who attain ?5% weight loss at 1 and 2 years post-GLP-1 RA initiation
2) Mean/median weight change from baseline at 1 and 2 years post-GLP-1 RA initiation
3) Adherence to GLP-RW- mean proportion of days covered (PDC); proportion of patients with PDC ?0.8.
4) Proportion of patients who discontinue GLP-1RA within 1 and 2 years post-GLP-1 RA initiation
Tracey Weiss - Chief Investigator - Merck & Co., Inc.
Tracey Weiss - Corresponding Applicant - Merck & Co., Inc.
Ajay Mishra - Collaborator - CHEORS
Kristy Iglay - Collaborator - Merck & Co., Inc.
Lingfeng Yang - Collaborator - Merck & Co., Inc.
Richard Carr - Collaborator - Merck Sharp & Dohme - UK
Sampriti Pal - Collaborator - CHEORS
Swapnil Rajpathak - Collaborator - Merck & Co., Inc.