![]() ![]() We did not see increases in the rate of amputations, we didn’t see increases in the rate of fractures, we didn’t see increases in the rate volume depletion events, which were things that had been raised in other trials. In terms of the overall safety, it appeared to be quite good with DECLARE. One of the other questions that was asked about about this class of drugs was related to some safety issues that had been raised in previous trials. Also of note, we looked at kidney-related outcomes and with kidney-specific composite, we saw almost a 50 percent reduction in progression of kidney disease associated with the use of dapagliflozin. There was no increase in the rate of these events, but we did not see a significant decrease in these outcomes. In terms of major adverse cardiovascular events, ischemic events, we saw that this was non-inferior. This was 17 percent lower with dapagliflozin driven predominantly by a reduction in hospitalization for heart failure, which was reduced by about 27 percent. From a cardiovascular standpoint, there was a significant reduction in cardiovascular death and hospitalization for heart failure. What we saw in the trial was that there were reductions in blood pressure, reductions in weight, and reductions in blood sugar, as would have been expected. There were more than 10,000 patients in this category. This trial was distinct from some of the other trials in this area in that it included a large proportion of patients who would be considered primary prevention, those patients without established cardiovascular disease. The major outcomes were safety related to cardiovascular events and also efficacy, with duel efficacy endpoints of MACE, which was cardiovascular death, myocardial infarction, or stroke, and also the combination of cardiovascular death and hospitalization for heart failure. They were randomized to treatment with dapagliflozin 10 mg or placebo, and followed forward for a period of about 4.5 years. ![]() With this trial, we enrolled just over 17,000 patients. This leads to reductions in blood volume, blood pressure, and weight, and therefore have a favorable effect on cardiovascular risk factors. The SGL2 inhibitors are a class of drugs that treat diabetes and, in doing so, they result in glucose loss in the urine. The background of this trial was that patients with diabetes are at high risk for cardiovascular events, including myocardial infarction and heart failure. DECLARE-TIMI 58 was a trial looking at the effects of an SGL2 inhibitor, dapagliflozin, on patients with or at high risk for atherosclerotic cardiovascular disease. I’m going to tell you a little bit about the DECLARE-TIMI 58 trial that we presented at the American Heart Association meeting this year. I am a cardiologist here at Brigham and Women’s Hospital in Boston. ![]()
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