title: Need for streamlined use of DPP-4 inhibitors in the treatment of type 2 diabetes.
abstract: Regulatory agencies request an assessment of cardiovascular safety for all "new" oral anti-diabetic drugs in order to avoid possible negative effects on cardiovascular events. Dipeptidyl peptidase 4 inhibitors have emerged as a new therapeutic alternative for the treatment of type 2 diabetes mellitus, but the several large post-marketing clinical trials have shown only a modest effect in glycaemic control and, more importantly, a neutral effect on total and cardiovascular events. Conversely a recent trial with empagliflozin, a sodium-glucose co-transporter 2 inhibitor, has shown significant effect on overall and cardiovascular mortality. Although glycaemic control is an important aspect of diabetes management, the results of the EMPA-REG outcome trial suggest that it is possible to develop anti-diabetic drugs that may exert an overall beneficial effect beyond the mere improvement of glycaemic control. While the regulatory hurdles should not be increased, there is the need for evaluation of the net clinical impact and cost effectiveness of all anti-diabetic agents. Therefore, a better collaboration among all stakeholders is needed in order to develop studies with endpoints that will be both clinically meaningful including appropriate follow-up, and economically relevant in patients with type 2 diabetes mellitus.
authors.affiliation: Centre for Clinical & Basic Research, IRCCS San Raffaele Pisana, via della Pisana, 235, 00163, Rome, Italy. cristiana.vitale@gmail.com.
authors.forename: Cristiana
authors.initials: C
authors.lastname: Vitale
authors.affiliation: Centre for Clinical & Basic Research, IRCCS San Raffaele Pisana, via della Pisana, 235, 00163, Rome, Italy.|St George's University of London, London, UK.
authors.forename: Giuseppe M C
authors.initials: GM
authors.lastname: Rosano
authors.affiliation: St Thomas' Hospital, London, UK.
authors.forename: Krishna
authors.initials: K
authors.lastname: Prasad
mesh_terms: D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D001786:Blood Glucose / Q000187:drug effects; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000191:economics / Q000627:therapeutic use*; D005960:Glucosides / Q000627:therapeutic use*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*
chemical_list: D001559:Benzhydryl Compounds; D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D005960:Glucosides; D007004:Hypoglycemic Agents; C570240:empagliflozin
keywords: Cardiovascular; Clinical trials; Cost-effectiveness; Diabetes mellitus; Dipeptidyl peptidase 4 inhibitors; Empagliflozin; Healthcare; Regulatory