title: Drug utilization, safety, and effectiveness of exenatide, sitagliptin, and vildagliptin for type 2 diabetes in the real world: data from the Italian AIFA Anti-diabetics Monitoring Registry.
abstract: OBJECTIVE
  In Italy, the reimbursed use of incretin mimetics and incretin enhancers was subject to enrollment of patients into a web-based system recording the general demographic and clinical data of patients. We report the utilization data of glucagon-like peptide 1 (GLP1) receptor agonists and dipeptidylpeptidase-4 (DPP4) inhibitors in clinical practice as recorded by the Italian Medicines Agency (AIFA) Monitoring Registry.
  
  
  RESULTS
  From February 2008 to August 2010, 75,283 patients with type 2 diabetes were entered into the registry and treated with exenatide, sitagliptin, or vildagliptin. The treatment was administered to patients in a wide range of ages (≥75 years, n = 6125 cases), body mass index (BMI) (≥35 kg/m(2), n = 22,015), and metabolic control (HbA(1c) ≥ 11% ((96 mmol/mol), n = 3151). Overall, 1116 suspected adverse drug reactions were registered, including 12 cases of acute pancreatitis (six on exenatide). Hypoglycemic episodes mainly occurred in combination with sulfonylureas. Treatment discontinuation for the three drugs (logistic regression analysis) was negatively associated with the male gender and positively with baseline HbA1c, diabetes duration, and, limitedly to DPP-4 inhibitors, with BMI. Treatment discontinuation (including loss to follow-up, accounting for 21-26%) was frequent. Discontinuation for treatment failure occurred in 7.7% of cases (exenatide), 3.8% (sitagliptin), and 4.1% (vildagliptin), respectively, corresponding to 27-40% of all discontinuations, after excluding lost to follow-up. HbA1c decreased on average by 0.9-1.0% (9 mmol/mol). Body weight decreased by 3.5% with exenatide and by 1.0-1.5% with DPP-4 inhibitors.
  
  
  CONCLUSIONS
  In the real world of Italian diabetes centers, prescriptions of incretins have been made in many cases outside the regulatory limits. Nevertheless, when appropriately utilized, incretins may grant results at least in line with pivotal trials.
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy. Electronic address: s.montilla@aifa.gov.it.
authors.forename: S
authors.initials: S
authors.lastname: Montilla
authors.affiliation: Unit of Metabolic Diseases, S. Orsola-Malpighi University Hospital, Bologna, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Marchesini
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Sammarco
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy.
authors.forename: M P
authors.initials: MP
authors.lastname: Trotta
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy.
authors.forename: P D
authors.initials: PD
authors.lastname: Siviero
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Tomino
authors.affiliation: Dept. Physiology and Pharmacology, University of Rome "La Sapienza", Rome, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Melchiorri
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Pani
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology; D004363:Drug Utilization; D064420:Drug-Related Side Effects and Adverse Reactions; D000077270:Exenatide; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007558:Italy / Q000453:epidemiology; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D008991:Monitoring, Physiologic; D009570:Nitriles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010455:Peptides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011719:Pyrazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011759:Pyrrolidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012042:Registries; D012737:Sex Factors; D000068900:Sitagliptin Phosphate; D014230:Triazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014688:Venoms / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D001786:Blood Glucose; D000077270:Exenatide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D009570:Nitriles; D010455:Peptides; D011719:Pyrazines; D011759:Pyrrolidines; D000068900:Sitagliptin Phosphate; D014230:Triazoles; D014688:Venoms; D000077597:Vildagliptin
keywords: DPP4 inhibitors and GLP1 receptor agonists; Incretin-mimetics and incretin-enhancers; Monitoring registry; Real clinical practice; Type 2 diabetes