Study results leave search for new diabetes and heart disease treatments unresolved - dukehealth.org
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Study Results Leave Search for New Diabetes and Heart Disease
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Treatment with the anti-hypertensive drug valsartan (Diovan) led to a modest
reduction in the development of type 2 diabetes but did not significantly reduce
cardiovascular events in patients with impaired glucose tolerance, according toresearchers at Duke University Medical Center and the University of Oxford.
They jointly reported results at the American College of Cardiology meeting todayfrom the world’s first study designed to find ways to control the progression to
diabetes and cardiovascular disease in people at risk.
The study also showed the blood sugar lowering drug nateglinide (Starlix), used to
treat diabetes, proved ineffective at halting progression to diabetes, and had no
significant impact on reducing cardiovascular events.
“This is a sobering confirmation of the need to continue to focus on lifestyle
improvements while also accelerating the efforts to develop new treatments for the
exploding epidemics of diabetes and cardiovascular disease around the world,” saidRobert M. Califf, MD, Vice Chancellor for Clinical Research at Duke UniversitySchool of Medicine, and Director of the Duke Translational Medicine Institute.
He presented the results of the NAVIGATOR trial today with Rury Holman, MD,Professor of Diabetic Medicine and Director of the Diabetes Trials Unit, Oxford.
Simultaneous publication of the results appears online today in the New EnglandJournal of Medicine
“The diabetes epidemic is a major challenge for all health care systems,” Holman
said. “We have effective treatments for lowering high blood sugar and high bloodpressure, but we urgently need pharmacologic interventions that will minimize the
likelihood of diabetes and heart disease in high risk populations.”
More than 150 million people worldwide have diabetes -- 90 percent of which istype 2. Global forecasts predict an increase in disease incidence of almost 50
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Heart disease incidence will rise too as patients with diabetes are up to 10 times
more likely to have higher rates of coronary artery disease, stroke, and peripheral
arterial disease than people without diabetes.
The NAVIGATOR trial was designed to address whether established treatments for
diabetes and blood pressure could also prevent the onset of diabetes andcardiovascular events in patients aged 50 or more who had impaired glucose
tolerance and cardiovascular risk factors or cardiovascular disease.
Researchers analyzed data from more than 9,300 patients at 806 centers in 40
countries who were randomized to the two study drugs or placebo. All participantsreceived a lifestyle modification program aimed at reducing body weight anddietary fat intake while increasing physical activity.
After about five years of follow-up, the researchers found nateglinide, an insulinsecretion enhancer, did not reduce the incidence of diabetes. The diseasedeveloped in 36 percent (1,674) of the nateglinide group and 34 percent (1,580) ofthe placebo group. Nateglinide also had no significant effect on cardiovascularoutcomes.
The angiotensin receptor blocker valsartan had a moderate effect on diabetesprogression, with a 14 percent relative risk reduction (equating to 38 fewer casesof diabetes per 1000 participants treated for five years), but no significant impacton cardiovascular outcomes.
Califf and Holman say that administration of the oral glucose tolerance test (OGTT)without the study drug created difficulties in interpreting the diabetes outcome fornateglinide.
Regardless, the researchers say the trial confirms the high risk of diabetes in thepopulation studied, and reinforces the need to apply the known benefits of lifestylemodification and to continue the search for successful and safe medications.
“We must continue to develop new therapies while encouraging people to exerciseand pay attention to what they eat,” said John McMurray, MD, Professor of MedicalCardiology at the University of Glasgow, Scotland, and a member of theNAVIGATOR trial’s executive committee. “Losing as little as five percent of bodyweight has been shown to make a dramatic difference in other studies. NAVIGATORparticipants lost weight on average showing that a relatively simple lifestyleprogram can make a difference.”
However, stated, McMurray, “In patients with hypertension in need of drugtherapy, clinicians might consider an agent that demonstrated evidence to delay orprevent progression to diabetes, and not increase this risk, as may be the casewith some antihypertensive treatments.”
“Until just a few years ago, drugs for diabetes were approved each year on thebasis of nothing more than symptomatic relief or effects on putative surrogatemarkers of disease," Califf said. "The new FDA and EMEA requirements are nowforcing studies of new drugs to modulate blood sugar to show whether or not theyhave an impact on cardiovascular disease prevention or development, andNAVIGATOR gives us a lot of information about issues in these long term studies. Icommend the sponsor for having the courage to conduct this study before it wasrequired and hope others will look closely at NAVIGATOR and incorporate thelessons into their trials.”
This research was funded by Novartis Pharmaceuticals.
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