New Anti Diabetes Drug Trials launched to determine benefits for Cardiovascular Health

Researchers at the University of Dundee have launched a series of projects to determine whether a new class of anti diabetes drug could also be used to treat heart disease.

Diabetes and heart disease are frequently seen together and can be a potentially lethal combination. Past and present anti-diabetic medications that lower blood sugar levels have been shown to improve some markers of cardiovascular disease, however there has yet to be conclusive evidence linking them to a reduction in rates of heart attacks and death.

Recently, research published in the New England Journal of Medicine revealed a new class of anti diabetes drug – called sodium glucose linked cotransporter 2 (SGLT2) inhibitors – reduced the rates of hospitalisation for heart failure and death due to cardiovascular causes among diabetic patients with high cardiovascular risk. (Click here to see the study results in the New England Journal of Medicine.)

SGLT 2 inhibitors, which are already being used to treat diabetes, act to lower blood sugar via the kidneys. Besides that, they have also been shown to increase urinary volume, lower blood pressure and induce weight loss, all of which are potentially beneficial cardiovascular effects.

Now researchers at Dundee, led by Professor Chim Lang (see above image), are simultaneously conducting three clinical trials in a world’s first attempt to study the effects of SGLT2 inhibitors on the cardiovascular system.

“This class of anti-diabetes drugs shows considerable potential to be a treatment for heart disease, with strong indicators of beneficial effects for cardiovascular patients,” said Professor Lang.

“We are uniquely well positioned at Dundee to examine novel approaches like this to simultaneously treating diabetes and heart disease. Our projects involve collaboration across the University between leading experts in cardiovascular disease, diabetes and magnetic imaging, and will place the University of Dundee as the leading authority in this field.”

The three clinical trials that make up this comprehensive research programme include:

• the REFORM trial, looking at the effects of SGLT2 inhibitors on patients with heart failure
• the REGRESS trial, studying the protective effects of SGLT2 inhibitors on thickened heart muscles
• the RECEDE trial, which will be studying the overall cardiovascular and renal effects of SGLT2 inhibitor therapy.

“There has been growing interest in the benefits of this drug in treating diabetes and heart failure and how they work,” said Dr Jagdeep Singh, who is a clinical research fellow working for Professor Lang and the principal investigator of the REFORM trial. “This trial is funded by the European Foundation for the Study of Diabetes and is the first dedicated clinical trial to study the exact mechanisms behind these effects.”

Professor Allan Struthers, chief investigator on the REGRESS study, said it would be surprising if SGLT2 inhibitors were not seen to be protective of the heart in patients at risk of heart disease.

“In diabetes these new drugs reduce the load on the heart by lowering the filling pressure and the emptying pressure. Such effects are usually favourable on the heart and I would be surprised if we did not see this positive effect in the REGRESS study,” said Professor Struthers.

The REGRESS trial is funded by drug-maker Astra Zeneca and is due to begin recruitment imminently.

Professor Lang heads the RECEDE trial, which has been funded by the British Heart Foundation. “This study will help answer some fundamental questions on the action of this drug on the heart and kidneys,” said Professor Lang.

This project also involves collaboration with Dr Ify Mordi, Professors Ewan Pearson, Rory McCrimmon and Graeme Houston, who are experts in the field of experimental diabetes and cardiac magnetic imaging, and is set to position the University of Dundee as the authority in this novel approach of simultaneously treating diabetes and heart disease. The combined funding value of the three trials is over £800,000.

Any patients wishing to volunteer for any of the studies or obtain further information can contact Lynn Rutherford, Senior Clinical Research Nurse/Trial Coordinator, on 01382 383254 or at l.rutherford@dundee.ac.uk

Source: University of Dundee