ORLANDO (FRONTLINE MEDICAL NEWS) – Cardiovascular outcomes were significantly more favorable with sodium glucose cotransporter-2 inhibitors compared with other glucose-lowering drugs, according to data from more than 400,000 type 2 diabetes patients in the Middle East, Asia Pacific, and North America.

Data on cardiovascular outcomes from diabetes treatments in patients outside the United States and Europe are limited, said Mikhail Kosiborod, MD , of Saint Luke’s Mid-America Heart Institute and University of Missouri–Kansas City.

In fact, most patients with type 2 diabetes reside in the Asia-Pacific and the Middle East, he said in a presentation at the annual meeting of the American College of Cardiology.

Dr. Kosiborod was involved in a previous large pharmaco-epidemiologic study known as the Comparative Effectiveness of Cardiovascular Outcomes in New Users of Sodium-Glucose Cotransporter-2 Inhibitors ( CVD-REAL ), that showed SGLT2 inhibitor effects in a broad population of type 2 diabetes patients, but that study included only patients from Europe and North America, and focused on just two outcomes: all-cause mortality and hospitalization for heart failure.

In this study, CVD-REAL 2, Dr. Kosiborod and his colleagues compared multiple outcomes data for patients treated with other glucose lowering drugs (GLDs) and those treated with SGLT2 inhibitors in three world regions: the Middle East, Asia-Pacific, and North America.

The study population included adults aged 18 years and older diagnosed with type 2 diabetes; a total of 235,064 treated with SGLT2 inhibitors and 235,064 treated with other GLDs. The participants were selected from national databases in Australia, Canada, Israel, Japan, Singapore, and South Korea. Individuals with type 1 diabetes or gestational diabetes were excluded from the study.

Outcomes comparing SGLT2 inhibitors and other GLDs included all-cause death, all-cause death or hospitalization for heart failure, hospitalization for heart failure, myocardial infarction, and stroke. Baseline patient characteristics were similar between the two treatment groups. Exposure time for patients in the SGLT2-inhibitor group was highest by far for dapagliflozin (75%), followed by empagliflozin, ipragliflozin, canagliflozin, tofogliflozin, and luseogliflozin at 9%, 8%, 4%, 3%, and 1%, respectively. (Ipragliflozin, tofogliflozin, and luseogliflozin are approved only in Japan.)

The researchers identified 5,216 deaths from any cause. Overall, treatment with an SGLT2 inhibitor was associated with significantly lower risks of death (hazard ratio, 0.51), hospitalization for heart failure (HR, 0.64), death or hospitalization for heart failure (HR, 0.60), myocardial infarction (HR, 0.81), and stroke (HR, 0.68).

The findings remained consistent across countries and patient subgroups, and in patients with and without cardiovascular disease, Dr. Kosiborod noted.

The results were limited by several factors, including the observational nature of the study and incomplete mortality data, Dr. Kosiborod said. However, the results suggest that the SGLT2 inhibitors’ impacts on cardiovascular outcomes persist across categories of ethnicity, geography, and cardiovascular disease.

AstraZeneca supported the study. Dr. Kosiborod disclosed relationships with multiple companies including AstraZeneca, Boehringer Ingelheim, Janssen, Merck, Novartis, Novo Nordisk, Glytec, and ZS Pharma. The findings were simultaneously published online (J Am Coll Cardiol. 2018 Mar 11. doi: 10.1016/j.jacc.2018.03.009 ).

SOURCE: Kosiborod M. ACC 2018.


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