Table 1. Major CVOTs With Glucose Lowering Medications in Patients With T2DM at High Risk of a CV Event
| Trial Name | Agent/ comparator | N | Primary Endpoint | Follow-Up | End of Trial HbA1c (%) | Primary Outcome HR (95% CI) |
|---|---|---|---|---|---|---|
| ORIGIN | Insulin glargine/ conventional | 12,537 | 3-point MACE | 6.2 years | Insulin 6.2 Control 6.5 | Neutral HR 1.02 (0.94 to 1.11) |
| SAVOR- TIMI 53 | Saxa ts?gliptin/ placebo | 16,492 | 3-point MACE | 24 months | Saxagliptin 7.7 Placebo 7.9 | Neutral HR 1.00 (0.89 to 1.12) |
| EXAMINE | Alogliptin/ placebo | 5380 | 3-point MACE | 18 months | Alogliptin 7.7 Placebo 8.0 | Neutral HR 0.96 (-1.16) |
| TECOS | Sitagliptin/ placebo | 14,671 | 4-point MACE | 36 months | Sitagliptin 7.1 Placebo 7.4 | Neutral HR 0.98 (0.99 to 1.08) |
| ELIXA | Lixisenatide/ placebo | 6068 | 4-point MACE | 25 months | Lixisenatide 7.4 Placebo 7.6 | Neutral HR 1.02 (0.89 to 1.17) |
| EMPA-REG OUTCOME | Empagliflozin/ placebo | 7020 | 3-point MACE | 37 months | Empagliflozin 7.8 Placebo 8.2 | Superior to placebo HR 0.86 (0.74 to 0.99) |
| LEADER | Liraglutide/ placebo | 9340 | 3-point MACE | 46 months | Liraglutide 7.7 Placebo 8.1 | Superior to placebo HR 0.87 (0.78 to 0.97) |
3-point MACE = composite of CV death and nonfatal MI or stroke; 4-point MACE = composite of CV death, nonfatal MI or stroke and hospitalization for unstable angina; CI = confidence interval; CVOT = cardiovascular outcomes trial; CV = cardiovascular; HbA1c = glycated hemoglobin; HR = hazard ratio; MI = myocardial infarction; T2DM = type 2 diabetes mellitus
Sources: Ryden L et al[3]; Sattar N, et al[4]; and Marso SP, et al.[15]
http://www.medscape.org/sites/conference/easd-2016?src=mkmcmr_conf_easd16_mscpedu_slides
