(Reuters) - The biggest clinical trial so far to assess a new class of diabetes pills shows that AstraZeneca’s Farxiga can prevent heart failure and cut the risk of kidney problems in a broad range of patients.
However, the medicine - belonging to a class of treatments known as SGLT2 inhibitors - failed to show a statistically significant benefit in preventing heart attacks or strokes, even in patients with established cardiovascular (CV) disease.
Diabetics are at increased risk of heart problems, making the CV profile of drugs to treat the condition an important focus for doctors and patients.
Dr Stephen Wiviott of Brigham and Women’s Hospital in Boston, a senior investigator on the trial, said the findings were important in building up a clearer picture of SGLT2 drugs, which until now have been targeted at patients with established heart disease.
AstraZeneca hopes the new data will help expand the use of Farxiga to a much wider range of patients.
Headline results of the 17,000-patient trial known as Declare were first announced in September but full details were only revealed on Saturday at the American Heart Association annual meeting, and published simultaneously in the New England Journal of Medicine.
These showed Farxiga cut the risk of hospitalisation due to heart failure by 27 percent, while also reducing the risk of kidney disease.
While two smaller studies involving rival SGLT2 drugs focused on people with established heart disease, Wiviott said the fuller picture from Declare showed that the broad prevention of heart failure was the key advantage.
“When you look at all three of the trials, it is pretty clear that the major benefit of this drug class in the cardiovascular realm is related to the reduction of heart failure,” he said in an interview.
For decades, diabetes doctors have focused primarily on lowering blood sugar levels to specific targets. But the susceptibility of diabetics to other problems such as heart failure - where five-year survival rates are only 50 percent - means a more holistic approach is needed, Wiviott believes.
“The message now is that how we lower blood sugar may well be more important than how much,” he said. “We should be choosing drugs that improve the outcomes of patients, not just drugs that are effective in lowering blood sugar.”
Farxiga competes with rival SGLT2 drugs including Eli Lilly and Boehringer Ingelheim’s Jardiance and Johnson & Johnson’s Invokana, which have already shown improved outcomes in patients with established heart problems - known as secondary prevention.
Because AstraZeneca’s study also looked at patients without established CV disease, it potentially opens up a larger market that also covers so-called primary prevention.
The Declare study found no increased risk of amputations, fractures, bladder cancer or gangrene in patients taking Farxiga - issues that have occasionally been noted with SGLT drugs - although there was an increase in genital infections.
Reporting by Ben Hirschler; Editing by Elaine Hardcastle