Real-world Evaluation of GLP-1 Receptor Agonists (GLP-1RA) on Efficacy and Persistence, Adherence and Therapeutic Inertia Among Type 2 Diabetes Adults With Obesity
Condition: Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Type 2 diabetes (T2D) is a progressive chronic condition associated with a high
      morbi-mortality that has a considerable impact on healthcare resources.

      Glucagon-like peptide-1 receptor agonists (GLP-1RA) are incretin mimetics that have been
      shown to improve glycemic control with a low associated risk of hypoglycemia. Additionally,
      previous studies have linked the use of GLP-1RA with a reduction in the risk of
      cardiovascular events and kidney disease progression. Despite these positive results,
      GLP1-RA´s prescription, following the failure of treatment with metformin monotherapy or dual
      therapy, remains low in Spain compared to other countries in our milieu. Furthermore, the use
      of this therapeutic class is not homogeneous across the different autonomous communities in
      Spain, and, no objective justification for these differences seems to exist. Consequently,
      there is a need to understand which are the benefits associated with the use of GLP-1RA,
      versus intensification with other oral agents, in real-life conditions.

      In this study, the impact of the use of GLP-1RA on clinical outcomes such as all-cause
      mortality, cardiovascular and renal outcomes as well as severe hypoglycemia will be evaluated
      based on the analysis of longitudinal databases that collect the variables of interest
      generated in a real-life scenario. In addition, both persistence and adherence to treatment
      in patients treated with GLP-1RA and its impact on the clinical outcomes of interest will be
      studied. Finally, therapeutic inertia will be analyzed.

      All these data will contribute to generating cost-effective strategies aimed at improving
      health outcomes among T2D patients in our setting, reinforcing persistence and adherence to
      the prescribed treatment, and reducing therapeutic inertia in this group of patients.

      Since the use of GLP-1RA versus intensification with other oral agents has been associated
      with better glycemic control, and, when compared to intensification with basal insulin, with
      a lower incidence of severe hypoglycemia, we hypothesized that T2D adults treated with
      GLP-1RA would present a lower incidence of cardiovascular and renal outcomes and fewer
      hospitalizations due to severe hypoglycemia events as well as a decreased all-cause
      mortality. On the other hand, patients on GLP-1RA who would present greater persistence and
      adherence to treatment should experience fewer cardiovascular and renal outcomes and lower
      mortality compared to those with less persistence and adherence. Finally, it is possible that
      the type of GLP-1RA and the mode of administration, weekly versus daily, may influence
      adherence, persistence and therapeutic inertia in this group of patients.
    


Intervention name(s): GLP-1RA; SGLT2i; Insulin; Miscellany
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): All T2D adults treated with Glucagon-like peptide-1 receptor agonists (GLP-1RA) or initiating a GLP-1RA during the study period; SGLT2 inhibitors users with no GLP-1RA prescription: all T2D adults treated with Sodium/glucose cotransporter-2 inhibitors (SGLT2i) or initiating treatment with SGLT2i during the study period and who were not treated with a GLP-1RA; Insulin users with no GLP-1RA and/or SGLT2i prescriptions: all T2D adults treated with insulin or initiating insulin treatment during the study period and who were not treated with GLP-1RA/SGLT2i; Other glucose-lowering agents users: all T2D adults who were not treated with GLP-1RA and/or SGLT2i and/or insulin during the study period and who were treated with other glucose-lowering agents during the study period
Intervention MeSH terms: Insulin
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All identified adults with type 2 diabetes registered in the Population Information System
        (SIP) of the Valencian Community and corresponding to the Valencia Clínico-La Malvarrosa
        Health Department who were diagnosed before the end of the study period were included. Type
        2 diabetes (T2D) diagnosis was defined according to the International Classification of
        Diseases, Ninth and Tenth Revisions, Clinical Modification (ICD-9-CM, ICD-10-CM) codes.

        To exclude temporary treatment effects due to short-term use of the antidiabetic
        treatments, only individuals in the study groups with at least a 6-month prescription were
        included in the analyses.