AstraZeneca Korea said Tuesday Forxiga (ingredient: dapagliflozin), its SGLT-2 inhibitor for type 2 diabetes patients, has proved to have sufficient clinical efficacy, citing the results of large-scale trial DECLARE-TIMI58.
|Professor Itamar Raz, head of the Diabetes Unit at Hadassah University Hospital, explains clinical trial results for Forxiga, at the Plaza Seoul on Tuesday.|
The DECLARE-TIMI58 study was among the largest cardiovascular outcome trials for SGLT-2 inhibitors to date, involving 17,000 patients from 33 countries.
According to the company, Forxiga reduced re-hospitalization due to heart failure or deaths due to cardiovascular disease -- one of two primary evaluation indexes for the study -- by 17 percent.
Such tendencies were consistent in patients with cardiovascular risk factors such as hypertension, dyslipidemia, and smoking, and those with previous histories of cardiovascular disease.
However, the research showed that the treatment showed no statistical difference in lowering major adverse cardiovascular events (MACE), it said.
Professor Itamar Raz, head of the Diabetes Unit at Hadassah University Hospital in Jerusalem and one of the leading researchers involved in the trial, noted that the researches did not show a statistical difference regarding MACE because relatively healthy diabetics without cardiovascular disease participated in the test.
“About 60 percent of subjects with DECLARE-TIMI58 were relatively healthy diabetics without cardiovascular disease,” Professor Raz said. “The reason there is no difference in cardiovascular mortality compared to the EMPA-REG clinical trial of empagliflozin, a competitive drug, is due to the difference in the subjects participating in the trials.”
Instead, it is important to note that the treatment reduced the risk of cardiovascular disease in a variety of indicators, whether or not the patient had cardiovascular disease, he stressed.
Raz also stressed that the hospitalization and death of diabetic patients are more likely to happen by heart failure. “Therefore the study result, which showed Forxiga had lowered the hospitalization rate due to heart failure, is meaningful,” he added.