New diabetes drug seems safe for heart, study finds

September 2, 2013 by E.j. Mundell, Healthday Reporter
New diabetes drug seems safe for heart, study finds
Onglyza study reflects new cautious approach to oversight of diabetes medicines, experts say.

(HealthDay)—The new diabetes drug Onglyza has no effect, good or bad, on a patient's risk for heart attacks, a new study finds. However, the researchers from Brigham and Women's Hospital in Boston did find a surprising rise in hospitalizations for heart failure among those who took the medication compared to those who did not.

The findings should "guide physicians and improve their ability to prescribe different drugs in a more evidence-based and data-driven way," study co-principal investigator Dr. Deepak Bhatt, of Brigham and Women's and Harvard Medical School, said in a hospital news release.

The study was funded by the drug's makers, AstraZeneca and Bristol-Myers Squibb, and is published online Sept. 2 in the New England Journal of Medicine, to coincide with its presentation at the annual meeting of the European Society of Cardiology in Amsterdam.

Issues around the safety profiles of newer diabetes drugs gained prominence recently after one blockbuster medication, Avandia, was all but pulled from the market in 2010 due to safety concerns. In a journal editorial accompanying the new study, experts noted that after Avandia gained U.S. Food and Drug Administration approval in 1999, "a highly publicized meta-analysis in 2007 reported a 43 percent increase in [ attacks] and a 64 percent increase in death from cardiovascular causes" tied to use of the drug.

The editorialists say the Avandia experience led the FDA to be highly cautious in its oversight of new , and in 2008 the agency issued a new Guidance for Industry mandating that "preapproval and postapproval studies for all new antidiabetic drugs rule out excess ."

The new trial into the safety of Onglyza (saxagliptin) is in keeping with the new guidelines. The large, international study involved nearly 16,500 patients with type 2 diabetes from 26 countries.

The participants, who also had , were given either saxagliptin at 5 milligrams per day (or 2.5 mg daily in patients with reduced kidney function), or a dummy pill with no active ingredients. The patients did not know if they were taking the medication or the placebo pill.

Over the course of more than two years, the researchers found the patients who took the diabetes drug were at no greater risk for a heart attack than those who took the dummy pill.

The study showed that cardiovascular death, heart attack, stroke, or hospitalization for unstable angina, coronary revascularization (angioplasty), or heart failure occurred in about 12.8 percent of patients who took the drug, compared to 12.4 percent of those in the placebo group—not a significant difference.

However, "our data also show an increase in hospitalization for heart failure in patients who received saxagliptin, which was not expected and deserves further study," the study chairman, Dr. Eugene Braunwald of the TIMI Study Group, cardiovascular division at Brigham and Women's and Harvard Medical School, said in the hospital news release.

But the drug had real benefits, as well. "Patients who received saxagliptin also had better control of blood sugar levels and a reduced need for insulin therapy," noted the study's co-principal investigator, Dr. Itamar Raz, of Hadassah Medical Center, Israel.

Raz added that the diabetes drug also prevented the progression of microalbuminuria, a condition that occurs when a type of protein called albumin is spilling into the urine due to kidney damage.

Two diabetes experts unconnected to the study said the findings should help ease the minds of patients and physicians.

"The treatment of patients with diabetes has been challenging in recent years," said Dr. Sripal Bangalore, director of research in the cardiac catheterization laboratory at NYU Langone Medical Center, New York City. "It is reassuring to see a mega trial . . . re-assuring the cardiovascular safety of saxagliptin given for a median of two years," he added.

"The pessimistic way of looking at this is that the drug was no better than placebo [in reducing heart risks] and had higher risk of and hypoglycemic events," Bangalore said. "Hopefully, the investigators will publish more data from the trial showing improvement in microvascular events."

Dr. Tara Narula is associate director of the cardiac care unit at Lenox Hill Hospital in New York City. She agreed that "there currently exists a tremendous amount of confusion regarding which diabetes drugs are safe to use in patients at risk for or with established cardiovascular disease."

She said the new trial has it upside and downside. "The results are truly noteworthy in that patients taking saxagliptin had significantly improved rates of blood sugar control, less microalbuminuria and no evidence of increased or decreased rates of ischemic [vessel blockage] events," Narula said. "However, the study median duration was only two years and a longer time of drug therapy or longer follow-up may be required to reveal any real signal of improvement or exacerbation of cardiovascular outcomes."

Another study, also presented Monday at the European heart meeting and published in the New England Journal of Medicine, looked at the safety profile of Nesina (alogliptin), another newly FDA-approved .

The study, which was funded by the drug's maker, Takeda, involved nearly 5,400 with type 2 diabetes and a history of heart events (heart attack or angina requiring hospitalization). Patients received either Nesina or a placebo and were followed for an average of 18 months.

The researchers, led by Dr. William White of the University of Connecticut School of Medicine, said they found no increase in cardiovascular events for those using Nesina compared to those on a placebo.

Explore further: Treatment with the anti-diabetic drug alogliptin does not increase CV risk in patients with ACS

More information: The American Diabetes Association provides more information on diabetes medicine.

Related Stories

Treatment with the anti-diabetic drug alogliptin does not increase CV risk in patients with ACS

September 2, 2013
Patients with type 2 diabetes and high cardiovascular risk due to recent acute coronary syndromes had similar rates of cardiovascular events when treated with the anti-diabetic agent alogliptin compared to placebo according ...

Development of new diabetes drug halted by maker

July 10, 2013
(HealthDay)—The development of what might have become a significant diabetes drug has been halted by its maker amid concerns that the medication raises the risk for fractures, kidney problems and heart failure in those ...

Gout drug shown to benefit diabetes patients at risk of heart disease

August 29, 2013
New research carried out at the University of Dundee has led to the possibility of using an old drug to help prevent the biggest cause of death in Type II diabetes patients.

US experts review heart attack risk of diabetes drug

June 5, 2013
GlaxoSmithKline's controversial diabetes drug Avandia, restricted in the US and banned in Europe over concerns it raises heart attack risk, is getting a second look this week by US medical experts.

FDA reviewing heart risks of Glaxo diabetes pill

April 12, 2013
(AP)—The Food and Drug Administration will hold a meeting in June to reassess the safety of GlaxoSmithKline's former blockbuster diabetes drug Avandia.

Drug may ease angina in people with type 2 diabetes

March 11, 2013
(HealthDay)—The drug Ranexa (ranolazine) may help reduce chest pain in people with type 2 diabetes, a new study finds.

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.