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Drug Reduces Risk of Death, Heart Attack, and Stroke in patients with Diabetes

Study indicates that giving 1,000 patients pioglitazone (Actos) would avoid 21 first heart attacks, strokes or deaths over 3 years.

British scientists said last week that a new study funded by the manufacturers of the diabetes drug Actos indicates the medication reduces the risk of death, heart attack and stroke in patients with type 2 diabetes.

Actos was approved by the Food and Drug Administration for the treatment of type 2 diabetes in 1999. The drug belongs to a class known as thiazolidinediones, which help keep diabetes in check by increasing the body’s sensitivity to insulin, which regulates blood-sugar levels.

The study, known as PROactive — for PROspective pioglitAzone Clinical Trial In macroVascular Events — involved 5,238 patients with type 2 diabetes with macrovascular disease in 19 European countries. Patients were assigned randomly to receive either pioglitazone or placebo along with any medications they already were taking for diabetes or heart disease.

The study demonstrated that pioglitazone significantly reduced the combined risk of heart attacks, strokes and death by 16% in high-risk patients with type 2 diabetes.

At an average follow-up time of about 34 months, there were 803 deaths, heart attacks, strokes, acute coronary syndrome and cardiac or leg interventions in the pioglitazone group, compared to 900 in those receiving the placebo.

The PROactive study shows a 16% RELATIVE reduction in a CV secondary endpoint when Actos is added to usual therapy…ACE inhibitors, beta-blockers, aspirin, statins, and other diabetes meds. The ABSOLUTE reduction is 2.1%. This translates into needing to treat 48 type 2 patients with CV disease, with Actos as add-on therapy, for 3 years, to prevent one MI, stroke, or death. It’s not known if this benefit is due to improved blood glucose. Actos also improves lipids, blood pressure, and C-reactive protein. It’s too soon to tell if this is a class effect. Both Actos and Avandia reduce A1C equally…but Actos seems better for lipids.

It sounds contradictory, but Actos increases the risk of heart failure. Tell patients to report edema or shortness of breath. The patients receiving pioglitazone also were able to delay taking insulin.

In an accompanying commentary, Hannele Yki-Jarvinen of the University of Helsinki in Finland called the findings "important" but said they may leave some key questions unanswered.

"The clinician, of course wants to know who should be treated with pioglitazone," Yki-Jarvinen wrote. "Unfortunately, the study does not provide such answers. It showed that pioglitazone is beneficial in patients with type 2 diabetes and pre-existing macrovascular disease who do not develop heart failure."

Yki-Jarvinen also noted the patients taking pioglitazone had higher rates of heart failure and edema not due to heart failure than the placebo group, and added that the medication appeared to increase body weight, which could increase the risk of heart failure.
The Lancet, Oct. 8, 2006

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FACT:
Elevated Insulin Levels Can Lead to Alzheimer’s – Moderately elevated levels of insulin have been shown to increase levels of inflammatory markers and ß-amyloid in plasma and cerebrospinal fluid, which researchers indicate may contribute to the development of Alzheimer’s disease. Investigators found that moderate peripheral hyperinsulinemia provoked increases in central nervous system inflammatory markers., study authors suggest that insulin-resistant conditions may increase the risk for Alzheimer’s disease partly because of insulin-induced inflammation. The study team concluded: “Moderate hyperinsulinemia can elevate inflammatory markers and Aß42 in the periphery and the brain, thereby potentially increasing the risk of Alzheimer disease.”
August 8, 2005 online edition of Archives of Neurology An abstract of the study is available at http://archneur.ama-assn.org/cgi/content/abstract/62.10.noc50112v1