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These data are consistent with six clinical trials54 that found no association between exenatide BID or placebo in renal AEs and similar changes in kidney function between patients in both groups. Thyroid cancers are of some interest with the GLP-1-RAs, as sustained GLP-1 agonism has been associated with an increased incidence of C-cell adenomas and carcinomas in rodents;55 however, [https://en.wikipedia.org/wiki/E-64 E-64] the clinical relevance of these animal data is unknown. In particular, there appears to be a species-specific difference in thyroid C-cell response to GLP-1RAs that causes C-cell secretion of calcitonin and hyperplasia in rodents.55 In the present analysis, all occurrences of thyroid neoplasm were benign and very rare, and no C-cell cancers were reported in these clinical trials. Thyroid neoplasm has rarely been reported with liraglutide QD, and studies monitoring calcitonin have indicated similar levels with liraglutide QD and comparators.56�C58 A US insurance claims database showed no significant increased risk of inpatient pancreatic or thyroid cancer between exenatide BID and metformin or glyburide.43 Ongoing postmarketing surveillance of exenatide shows no indication of a safety signal.59 Overall, the incidence of thyroid neoplasm-related events across treatments is consistent with the background rate of thyroid cancers in the general population. FDA guidance requires new treatments for type 2 diabetes to demonstrate that treatment [http://www.selleckchem.com/products/jq1.html JQ1 clinical trial] will not result in an unacceptable cardiovascular risk.60 While cardiovascular safety data for exenatide QW and comparators have been limited by a short follow-up duration, in an evaluation of the change in heart rate over time a small increase in heart rate (+1.3 bpm) was observed upon starting exenatide QW therapy; after 26 weeks of treatment, the mean change was +2.6 bpm. Heart rate returned [http://www.selleckchem.com/products/r428.html R428 purchase] to near baseline levels 10�C12 weeks following discontinuation of exenatide QW.61 These data are consistent with demonstrated heart rate changes as observed in previous reports,62 and no increase in cardiovascular event rates for exenatide QW, exenatide BID, or comparators as observed in previous studies of GLP-1RAs.63 Moreover, diabetes increases the risk of cardiovascular disease in men and women.64 Our analysis of primary and expanded MACE in this combined analysis show that the rate of these events was low (