Pattern of use of incretin-based medicines in a large sample of the Italian general population

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1 Pattern of use of incretin-based medicines in a large sample of the Italian general population Giuseppe Roberto, PharmD, PhD Regional Agency for Helathcare Services of Tuscany 7th European Congress of Pharmacology - Istanbul, 27 June 2016

2 GLP-1 and incretin-based medicines Glucagon-like peptide 1 (GLP-1) is one of the two endogenous incretin hormones GLP1 exerts an important role in the glycemic homeostasis Incretin-based medicines available for the treatment of type 2 diabetes act by potentiating GLP-1 effect: 1) GLP-1 analogues (GLP-1a) - longer half-life than the endogenous GLP1 - administered subcutaneously 2) Dipeptidyl peptidase-4 inhibitors (DPP-4i) - inhibit the the degradation of the endogenous GLP-1 - admistered orally Lancet 2006; 368:

3 Incretin-based medicines in therapy First marketed in Europe in November 2006 Admitted to reimbursement by the Italian Healthcare System as a second/third line therapy for type 2 diabetes (T2DM) in February 2008 Evidence on the pattern of use of GLP-1a and DPP-4i in real world clinical practice is still scarce

4 Study objective To describe the pattern of use of GLP-1a and DPP-4i in a large sample of the Italian general population

5 Methods (data source) The database of the Regional Agency of Healthcare Services of Tuscany: - population-based data source - collects anonymized information on healthcare services delivered by the National Healthcare Service (NHS) to all inhabitants of Tuscany region (about 3,5 million subjects) - All dispensings of prescription drugs in charge to the NHS and intended for outpatient consumption are tracked at individual level

6 Methods Study population - all subjects registered into the database at 1 January of each year between 2008 and years of age - 1 year of look-back Exposure Patients with 1 dispensings of a incretin-based drug were identified throug ATC (Anatomical Chemical Therapeutic) code and classified as: - Prevalent users: 1 dispensing during the year of interest - Incident users: 1 dispensing during the year of interest and none in the past years

7 Incidence of use in the general population Incidence of use per 1000 inhabitants GLP-1a DDP-4i Total

8 Prevalence of use in the general population 18+ Prevalence of use per 1000 inhabitants 18+ PREVALENCE OF USE GLP-1: from 0.2 to 1 DPP-4i: from 0.2 to 5.8 GLP-1a DDP-4i DPP-4i Total

9 Prevalence of use in antidiabetic users % GLP-1a DDP-4i Total Prevalence of use per 100 antidiabetics users 18+

10 Percentage of GLP-1a and DPP-4i in new users of incretin-based medicines % on the total of incident users GLP-1a DPP-4i

11 Characterization of new users of GLP1 analogues and DPP-4 inhibitors

12 Discussion Incidence of use of incretin-based medicines in Tuscany rose steeply during the first half of the observation period. Incidence vs prevalence of use suggests that the majority of new users remain on treatment over the first year DPP4i, which are administered orally, have rapidly become the drugs of choice for the majority of new incretin users Lower age and preponderance of women among GLP-1a new users could related to the ruote of administration and the effect of reduction of body weight Both GLP-1a and DPP-4i were increasingly initiated in patients at earlier stage of the disease suggesting increased confidence of prescribers following the growing body of evidence on their safety/effectiveness A growing percentage of incident incretin users were naive to any antidiabetic treatment (potentially inappropriate prescribing)

13 Conclusion This study provides evidence on changes over time of the exposure to incretin-based drugs in the general population of Tuscany region as well as of differences in baseline characteristics of new users of GLP-1a and DPP-4i This evidence will inform the design of future pharmacoepi studies on safety and effectiveness of incretin medicines Further investigation on cases of potentially inappropriate use highlighted in this study are needed

14 Thanks for your attention!