PHARMACY

Drug therapy more cost-effective than angioplasty for diabetic patients with heart disease, study suggests

BY Allison Cerra

NEW YORK Many patients with diabetes should forgo angioplasties for heart disease and just take medicine instead, according to a new National Institutes of Health study led by Stanford University School of Medicine researcher Mark Hlatky.

Previous research had shown that patients with Type 2 diabetes and mild-to-moderate heart disease have no reduction in risk for heart attacks, strokes or death if they have an angioplasty compared with simply taking the right medications. The new study shows that there’s substantial cost savings in sticking with drug treatment, with an average savings of $11,000 per patient over four years.

“For patients with relatively mild symptoms of heart disease, angioplasty is clearly more expensive and it’s clearly not more beneficial,” said Hlatky, professor of health research and policy and of cardiovascular medicine, presented the new findings Nov. 17 in Orlando at the annual meeting of the American Heart Association. The report also was published online that same day in the journal Circulation.

The analysis described in the new paper is an example of the sort of comparative effectiveness research that the federal government is now promoting as critical for successful healthcare reform.

The data come from the NIH’s Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes study, called BARI 2D, which tracked the health of more than 2,000 patients for five years. During the trial, the patients all received intensive drug therapy according to accepted clinical guidelines, with use of statins, aspirin, beta-blockers and either ACE inhibitors or angiotensin-receptor blockers. The cost-effectiveness findings are based on the accumulated costs over a four-year period.

The earlier findings, on effectiveness of angioplasty and bypass surgery on death, heart attacks and strokes, were published June 11 in the New England Journal of Medicine.

The study also assessed the cost effectiveness of bypass surgery and two different approaches to treating diabetes.

Bypass surgery is much more costly than drug treatment, running $20,000 more over four years on average, Hlatky noted. But while surgery is much more expensive than drug treatment, for patients with severe heart symptoms it appears to be cost-effective; since people with more severe coronary disease suitable for bypass surgery were significantly less likely to have a heart attack or stroke, or die than patients treated with drugs alone.

The two different approaches to diabetes that were studied — drugs that improve the body’s response to insulin versus drugs that increase the delivery of insulin — had comparable costs over four years. BARI 2D had previously shown that medical effectiveness of these approaches to drug treatment was similar too.

“For the two diabetes treatments, there was no difference in heart attack or death, and no difference in cost. It comes down to preference,” said Hlatky. For example, patients who dislike injections might favor the insulin sensitization treatment, which relies on pills instead of shots.

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Senate opens health-reform debate

BY Jim Frederick

WASHINGTON After months of wrangling in committee meetings and weeks spent rounding up support from his Democratic colleagues, Senate majority leader Harry Reid Monday morning gaveled the opening round of what is expected to be weeks of debate on a massive health-reform bill.

Reid was successful last week in rounding up a 60-vote majority to allow the legislation to come before the full Senate for debate. But the bill faces a tough battle in a bitterly partisan fight that could push any chance of passage into next year.

The Reid bill would overhaul the U.S. health system by providing coverage to millions of uninsured Americans, mandating that all Americans have coverage, creating a publicly funded insurance option to compete with private insurance plans and setting up new incentives and processes to promote healthier lifestyles and disease prevention. To help defray the expected cost of the overhaul — estimated to be $848 billion over 10 years — the Senate bill would levy a tax on the highest-value insurance plans dispensed by employers, and create a review system to seek out the most cost-effective treatments and reduce waste and unneeded medical procedures in government-funded health programs.

Republicans are almost unanimously opposed to many of the health-reform measures proposed in the Reid bill. Debate is likely to center on hot-button issues like federal funding for abortions, the public insurance plan option and the taxation of premium health plans.

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FDA approves expanded use of Cymbalta

BY Alaric DeArment

INDIANAPOLIS The Food and Drug Administration has approved a new use for an Eli Lilly & Co. drug.

Lilly announced Monday that the FDA had approved Cymbalta (duloxetine hydrochloride) as a maintenance treatment for generalized anxiety disorder in adults. The drug already had approval for treating major depressive disorder, generalized anxiety disorder and diabetic peripheral neuropathic pain and fibromyalgia.

“Since generalized anxiety disorder can be a chronic illness, it is important that doctors and their patients find a treatment option that is effective in both the acute and maintenance phase of treatment,” Lilly medical director for Cymbalta in the United States James Martinez said in a statement. “With this additional approval, Cymbalta offers a new option for the maintenance treatment of this often-debilitating condition.”

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