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Extended Commentary from the American Diabetes Association

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Extended Commentary from the American Diabetes Association MEETING REPORT Extended commentary from the American Diabetes Association 2015 meeting Dr Mike Gwilt1 and Dr Caroline Day2 take a closer look at the 75th Annual Scientific Sessions of the American Diabetes Association, Boston, MA, June 4–9, 2015 Introduction ........................................... 1 Table 1 Awards at ADA 2015 Cardiovascular safety............................. 1 Award Recipient PDE5 inhibitors and myocardial National Scientific & Health Care Achievement Awards infarction ................................................ 2 Banting Medal for Scientific Achievement Award Philipp E Scherer, Texas, USA Outstanding Scientific Achievement Award Pere Puigserver, Massachusetts, USA PCSK9 inhibitors..................................... 2 Albert Renold Award Richard N Bergman, California, USA DPP4 inhibitors....................................... 2 Outstanding Achievement in Clinical Diabetes GLP-1 receptor agonists ........................ 2 Research Award David M Nathan, Massachusetts, USA Outstanding Physician in Clinical Diabetes Novel insulins ......................................... 3 Research Award Lori Lafel, Massachusetts, USA Devices .................................................... 4 Outstanding Educator in Diabetes Award Linda M Delahanty, Massachusetts, USA SGLT2 inhibitors –the newest class ....... 5 Harold Rifkin Award for Distinguished International Service in the Care of Diabetes Karl Eric Morgensen, Denmark Novel antidiabetic mechanisms ............ 5 Kelly West Award for Outstanding Achievement Looking back…and looking ahead ...... 6 in Epidemiology K M Venkat Narayan, Georgia, USA Professional Interest Group Award Lectures Introduction Edwin Bierman Award (Complications) George L King, Massachusetts, USA The world’s largest diabetes congress Norbert Freinkel Award (Pregnancy) Elisabeth R Mathiesen, Denmark The 75th Annual Scientific Sessions of the Roger Pecorara Award (Foot care) Karel Bakker, The Netherlands American Diabetes Association was held in Richard R Rubin Award (Behavioural Medicine the Boston Convention and Exhibition Center, & Psychology) Robert Anderson, Michigan, USA close to the city’s harbour. The meeting, at- tended by some 18,000 delegates and ac- Association Officers Leadership and Service Recognition claimed as the world’s largest diabetes Charles H Best Medal Janel L Wright congress, opened with 17 ‘Meet The Expert’ Rachmiel Levine Medal for Service David G Marrero sessions, followed by a multiplicity of sym- Banting Medal Samuel Dagogo-Jack posia, oral sessions, and major award lectures Charles Kopke Medal Richard Farber (Table 1). There were also presentations and displays of posters and more than 3000 Administration (FDA) – have been conducted with dulaglutide also offers reassurance abstracts were published in association with over a relatively short time period with regard (1127-P), as do sub-analyses from the meeting.1,2 The abstracts themselves are to opportunity to observe potential cardiovas- SAVOR/TIMI-53 and EXAMINE. available at www.abstractsonline.com/ cular benefit (in the UKPDS it took 6 years for But how representative are these trials for pp8/#!/3699 and most posters can be viewed the cardiovascular benefit of metformin to people with diabetes seen in routine practice? at www.ada.apprisor.org. become apparent). Thus, it is no surprise that An analysis of the eligibility of the general US Check out the data all the cardiovascular outcomes trials pre- population for cardiovascular outcomes trials In the following commentary the references sented to date have shown non-inferiority (as with incretin agents showed that only 28% cited refer to the numbers of the abstracts, opposed to superiority) for major adverse of the current US population with diabetes which also denotes presentation format: for cardiovascular events (MACE). ELIXA and would have qualified for any of the trials example, 1-OR was an oral presentation, 386- TECOS, which were granted an afternoon of (1201-P). In the routine care setting the pro- P was a poster and 2374-PO shows that the back-to-back symposia, also reassuringly portion of patients who would have been material was in published-only format1 whilst showed non-inferiority for MACE. Neither eligible are: 21% for SAVOR (saxagliptin), 9% 1-LB describes a Late Breaking poster.2 For trial demonstrated any suggestion of adverse for CARMELINA (linagliptin), 5% for CAR- ease of reading we have not spelt out trial cardiovascular outcomes, either on their pre- OLINA (also linagliptin), 4% for TECOS acronyms in the text and you can find these specified primary and secondary composite (sitagliptin) and 0.5% for EXAMINE in Table 2. endpoints, the single-outcome components (alogliptin). This is due to the selection of of the composites, or any other exploratory patients at high cardiovascular risk to provide Cardiovascular safety outcomes, including pancreatic cancer, pan- a timely conclusion to an event-driven trial The so-called cardiovascular outcomes trials – creatitis and infection. The cardiovascular and to ensure adequate power to exclude the a requirement of the US Food and Drug outcomes meta-analysis of phase 2/3 trials possibility of adverse cardiovascular outcomes 1 PUBLISHED ONLINE ONLY THE BRITISH JOURNAL OF DIABETES & VASCULAR DISEASE MEETING REPORT lowering efficacy of evolocumab in patients Table 2 Trial acronyms regardless of glycaemic status and recorded CARMELINA Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in no notable changes in glycaemic status, new Patients With Type 2 Diabetes Mellitus onset diabetes (a concern with statin use) or other key safety issues (258-OR). CAROLINA Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes DPP4 inhibitors DECARTES Durable Effect of PCSK9 Antibody Compared with Placebo Study Sub-analyses explored the effects of saxagliptin or alogliptin on outcomes in sub- DECLARE– Dapagliflozin Effect on CardiovascuLAR Events–Thrombolysis in Myocardial populations from SAVOR (cancer [11-OR], TIMI58 Infarction Study group 58 race/ethnicity [15-LB], lymphocyte count [1239-P], liver enzymes [1227-P]) and EXAM- ELIXA Evaluation of LIXasenatide in Acute coronary syndrome INE (ACE inhibitor use [12-OR], ischaemic out- comes and hospitalisations [13-OR]). There EXAMINE EXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome was no cancer signal for DPP4 inhibition and we now know that a lower lymphocyte count SAVOR– Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes is a risk factor for adverse cardiovascular out- TIMI53 mellitus–Thrombolysis in Myocardial Infarction Study group 53 comes. Otherwise, none of these analyses re- vealed a subgroup with outcomes different SCALE Satiety and Clinical Adiposity – Liraglutide Evidence from the main analyses of the trials. Interest- ingly, data from SAVOR suggested that TECOS Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin sulphonylurea treatment did not promote ad- UKPDS UK Prospective Diabetes Study verse cardiovascular outcomes (504-P), which has long been a source of controversy in dia- betes pharmacotherapy. in high-risk patients. Nevertheless, this poster Men receiving testosterone therapy (long- Vildagliptin provided better overall daily raises the question of just how representative acting testosterone undecoanoate) showed a glucose control (as measured by continuous are these trials of the general patient popula- 62% reduction in mortality, despite being at glucose monitoring [CGM]) than sitagliptin tion seen in routine clinics. greater cardiovascular risk at baseline and (942-P) or saxagliptin (1230-P), although DECLARE-TIMI58 is the ongoing cardio- twice as likely to be taking a PDE5 inhibitor vildagliptin and sulphonylureas exerted similar vascular outcomes trial of the SGLT2 inhibitor, (9-LB). Analysis of 42 primary care records effects on glucose variability (1286-P). dapagliflozin. A previously described pooled identified 7,860 men with type 2 diabetes Little was presented this year on analysis (21 phase 2b/3 trials in type 2 dia- diagnosed before 2007. Follow up in 2014 sitagliptin, the first-in-class, but a 12 week betes patients treated with dapagliflozin for showed that PDE5 inhibitor use in men at study showed that this agent given at 50 ≤4 years) demonstrated no excess of MACE high cardiovascular risk was associated with a mg/day reduced circulating CD4+ T cells – with dapagliflozin. New research presented significant reduction in overall mortality and especially the proportion of Th17 and Tregs here showed that there was also no increase the risk of death was reduced by 50% in 432 cells, but numerical data were not provided in cardiovascular events with this agent in a men who had an incident myocardial infarc- (1252-P). With regard to DPP4 inhibition in subgroup of older patients (≥65 years) with tion (7-LB). general, large database studies or meta-analy- cardiovascular disease and hypertension ses provided further evidence of a lack of (15-OR). PCSK9 inhibitors association of DPP4 inhibition with pancreati- A cardiovascular outcome trial with the These drugs represent the next major step for- tis (1703-P). Addition of a DPP4 inhibitor to GPR40 agonist fasiglifam was terminated ward in the management of dyslipidaemia, insulin therapy has again been shown to early due to undue risk of liver toxicity. At reducing in LDL-C in excess
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