In the original article, there was a mistake in Table 2 “Key published studies demonstrating the safety and tolerability of DPP-4 inhibitors” as published. Unfortunately, two of the citations were transposed in the table. The correct citation for the SAVOR-TIMI trial is Scirica et al. (2013): Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med 369: 1317–1326 (ref 127), while the correct citation for the TECOS trial is Green et al. (2015): Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med 373: 232–242, 2015 (ref 126). The corrected Table 2 appears below. The authors apologize for this error and state that this does not change the scientific conclusions of the article in any way. The original article has been updated.
Table 2.
Key published studies demonstrating the safety and tolerability of DPP-4 inhibitors.
| Inhibitor | Alogliptin | Linagliptin | Saxagliptin | Sitagliptin | Vildagliptin |
|---|---|---|---|---|---|
| POOLED SAFETY ANALYSES | |||||
| References | Prately et al. (119) | Lehrke et al. (120) | Hirshberg et al. (121) | Engel et al. (122) | Schweizer et al. (123) |
| Study | 6 phase 2 and 3 clinical trials | 22 phase 1, 2 and 3 clinical trials | 20 phase 2 and 3 clinical trials | 25 phase 2 and 3 clinical trials | 38 phase 2 and 3 clinical trials |
| Number | 2,366 | 7,400 | 9,156 | 14,611 | 12,326 |
| Comparator | Placebo | Placebo | Placebo or active comparator | Placebo or active comparator | Placebo or active comparator |
| Duration | 12–26 weeks | < 2–104 weeks | 4–206 weeks | 12–104 weeks | 12–104 weeks |
| CARDIOVASCULAR SAFETY OUTCOME TRIALS | |||||
| References | White et al. (124) | Rosenstock et al. (125) | Scirica et al. (127) | Green et al. (126) | – |
| Trial name | EXAMINE | CARMELINA | SAVOR-TIMI | TECOS | – |
| History of CV disease (%) | !00 (ACS) | 57 | 78 | 100 | – |
| Number | 5,380 | 6,979 | 16,492 | 14,671 | – |
| Comparator | Placebo | Placebo | Placebo | Placebo | – |
| Follow-up (y) | 1.5 | 2.2 | 2.1 | 3.0 | – |
| MACE HR (95% CI) | 0.96 (upper, 1.16) | 1.02 (0.89; 1.17) | 1.00 (0.89; 1.12) | 0.98 (0.88; 1.09) | – |
Pooled safety analyses examined patient-level safety data from phase 1–3 clinical trials in patients with T2DM. Cardiovascular safety outcome trials included patients with T2DM and either established CV disease or multiple CV risk factors (and albuminuria or impaired renal function in CARMELINA). The primary endpoint in the CV safety outcome trials was a composite of CV death, non-fatal myocardial infarct, and non-fatal stroke (and unstable angina requiring hospitalization in TECOS). Note: there is no equivalent large CV safety outcome trial with vildagliptin.
ACS, acute coronary syndrome; CI, confidence interval; CV, cardiovascular; HR, hazard ratio; MACE, major adverse cardiovascular events.