Study results leave search for new diabetes and heart disease treatments unresolved -

Home > Health Library > News > Study Results Leave Search for New Diabetes and Heart Disease Treatments Unresolved
Study Results Leave Search for New Diabetes and Heart Disease About This Article
Article Details
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.
For Journalists
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.
Related Content
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.
Health Articles
“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 On Other Web Sites
Additional Resources
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.



DS-9415C Allegra X-22 pdf only.qxp:DS-9415A_B2002-5437_X-22.qxp 6/25/08 9:18 AM Page 1 The Medium Capacity, Compact Multipurpose Benchtop Centrifuge ALLEGRA® X-22 SERIES BENCHTOP CENTRIFUGES With its compact size and library of rotors, the Allegra X-22 Series is the solution for yourmedium capacity, multipurpose centrifuge UP TO 25 CM/10 INCHES THINNER THAN OTHER BENCHTOP CENTRIF

Microsoft word - biotechnology pharmaceuticals and their implications.doc

Medical Director Illumination Medical, Inc. It is imperative that health plans today identify and quantify their existing and projected future liability for the biotechnology derived pharmaceuticals. These agents are becoming the standard for care in most organ system diseases. Not to understand this looming liability could prove fatal for unprepared health plans. Within health care, the ep

Copyright © 2008-2018 All About Drugs