| Literature DB >> 31133983 |
Abstract
[This corrects the article DOI: 10.3389/fendo.2019.00080.].Entities:
Keywords: dipeptidyl peptidase-4; glucagon-like peptide-1; incretin; peptide degradation; therapy; type 2 diabetes
Year: 2019 PMID: 31133983 PMCID: PMC6511808 DOI: 10.3389/fendo.2019.00275
Source DB: PubMed Journal: Front Endocrinol (Lausanne) ISSN: 1664-2392 Impact factor: 5.555
Key published studies demonstrating the safety and tolerability of DPP-4 inhibitors.
| 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 |
| 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.