The largest clinical trial so far to assess the new class of diabetes pills shows that AstraZeneca's Farxiga can prevent heart failure and reduce the risk of kidney problems in various patients.
REUTERS: The biggest clinical trial so far to assess new classes of diabetes pills shows that AstraZeneca's Farxiga can prevent heart failure and reduce the risk of kidney problems in various patients.
However, drugs – belonging to a treatment class known as SGLT2 inhibitors – fail to show statistically significant benefits in preventing heart attacks or strokes, even in patients with predetermined cardiovascular disease (CV).
Diabetics experience an increased risk of heart problems, making CV profiles of medicines to treat conditions is an important focus for doctors and patients.
Dr Stephen Wiviott of Brigham and Women's Hospital in Boston, senior researcher at the trial, said the findings were important in building a clearer picture of SGLT2 drugs, which to date have been targeted at patients with established heart disease.
AstraZeneca hopes that this new data will help expand Farxiga's use to more patients.
The main results of the 17,000 trial patients known as Declare were first announced in September but full details were only revealed on Saturday at the annual American Heart Association meeting, and were published simultaneously in the New England Journal of Medicine.
This shows Farxiga cut the risk of hospitalization 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 heart disease, Wiviott said a more complete picture of Declare showed that widespread prevention of heart failure was a major advantage.
"When you look at the three trials, it's pretty clear that the main benefits of this class of drugs in the cardiovascular environment are 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 vulnerability of diabetics to other problems such as heart failure – where the five-year survival rate is only 50 percent – means a more holistic approach is needed, Wiviott believes.
"The message now is how we reduce blood sugar may be more important than how much," he said. "We have to choose drugs that improve patient outcomes, not just drugs that are effective in reducing blood sugar."
Farxiga competes with competing SGLT2 drugs including Eli Lilly and Boehringer Ingelheim's Jardiance and Johnson & Johnson Invokana, which have shown better results in patients with known heart problems – known as prevention secondary.
Because AstraZeneca's research also looks at patients without existing CV disease, it has the potential to open up a larger market that also includes so-called primary prevention.
The Declare study did not find an increased risk of amputation, fractures, bladder cancer or gangrene in patients taking Farxiga – a problem sometimes noted with the SGLT drug – even though there was an increase in genital infections.
(Reporting by Ben Hirschler; Editing by Elaine Hardcastle)