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Research: Popular Diabetes Medications Associated with Increase in Bone Fractures

FRANKLIN LAKES, N.J., June 8, /PRNewswire-FirstCall/ -- Research presented at the American Diabetes Association's 69th Scientific Sessions points to increased risk for people with diabetes associated with two widely used drug classes; while another study shed new light on a different class of drugs that faced increased scrutiny from the US Food and Drug Administration (FDA).

Researchers from Medco Health Solutions, Inc. (NYSE: MHS) today released the results of a number of studies that will help advance the body of evidence informing the clinical care of diabetes patients.

"Diabetes is one of the greatest clinical challenges impacting the health of our nation," said Dr. Robert S. Epstein, Medco chief medical officer. "Knowing which drugs work for which individuals with diabetes will provide a more personalized approach which can help improve care for people with diabetes and significantly impact the health of Americans, as well as the cost of care for these patients."

Thiazolidinediones Increase Risk of Fracture

A study by researchers from Medco and the University of Texas Health Sciences Center found that patients with type 2 diabetes taking a thiazolidinedione (TZD) to help control their blood sugar experienced a 43 percent higher incidence of bone fracture than type 2 diabetes patients not taking TZDs. TZDs -- a class of drugs used to control blood sugar -- are used by as many as 4 million Americans.

The study examined the effects of pioglitazone (Actos(R)) and rosiglitazone (Avandia(R)), the two drugs that make up the TZD class, and found that both medications equally increase the risk of bone fracture. In addition, the study showed that men, as well as women, are at a higher risk of fracture when taking these drugs. These findings support previous research showing increased fracture risks related to TZDs.

"This is a serious issue for diabetes patients since they are already at higher risk for a bone fracture given the nature of their disease and further increasing their odds of a fracture with these medications can be very problematic," said Merri Pendergrass, MD, PhD, national practice leader of the Medco Therapeutic Resource Center(R) for diabetes and one of the study researchers. "Based on these results, as well as the findings of prior studies, physicians should consider the increased risk of fractures with these agents when weighing treatment options for their patients."

The study analyzed pharmacy and medical claims between January 2006 and July 2008 of 144,399 patients age 43-63 with type 2 diabetes. The study sample consisted of 69,047 patients who were taking TZD, and 75,352 who were not taking a TZD. Among patients taking TZD, there were a total of 3,346 fractures, a 43 percent higher rate than identified in patients not taking TZD. When analyzed by gender, women on a TZD were 55 percent more likely to experience a bone fracture than women not on a TZD; men on a TZD had a 26 percent higher likelihood of suffering a fracture.

The findings support previous assertions that TZDs increase the risk of fractures. In 2007, the US Food and Drug Administration issued a warning for one particular TZD due to risk of fracture. The alert was based upon data from A Diabetes Outcome Progression Trial (ADOPT). Since then, additional studies -- including a recent study published in the Canadian Medical Association Journal -- also found an increased risk in fractures in women taking the drugs.

Researchers posit that TZDs may increase fat in bone marrow, reduce the development of bone cells, and negatively impact estrogen production. The risk of fracture adds to a growing body of evidence on potential risks for the drug class, which has also been associated with cardiovascular issues. Troglitazone, the third of three major drugs in the TZD class, was withdrawn from the market due to increased risk of drug-induced liver failure.

New Findings Contradict Pancreatitis Risk from Incretin Mimetics

New research suggests that the medications known as incretin mimetics -- which include exenatide and sitagliptin -- do not increase the risk of pancreatitis in patients with diabetes, contradicting previous case reports concerning the drug class that led to strong FDA warnings.

Researchers from Medco reviewed the pharmacy and medical claims of 123,621 patients with diabetes between the ages of 18 and 63 who were non-insulin users. Among the 9,260 patients taking exenatide, less than one-half of 1 percent (0.44 percent) experienced an episode of acute pancreatitis. Among the 2,143 patients taking sitagliptin, a drug with a mechanism of action related to that of exenatide, acute pancreatitis was identify in only 6 patients (0.28 percent). The rates of pancreatitis were comparable in the study's control group, which saw a 0.39 percent incidence.

While the study was descriptive, authors state it suggests that there was no increased risk of pancreatitis among patients taking either of the two drugs over patients not taking the drugs.

Diabetes Patients on Clopidogrel and Proton Pump Inhibitors at Greater Risk for Cardiovascular Events

New research from the Clopidogrel Medco Outcomes Study (CMOS) has revealed an increased risk for major cardiovascular events in patients with diabetes who take clopidogrel (the active ingredient in Plavix(R)) and proton pump inhibitors (PPIs) together. A growing body of evidence highlights the risk of taking the two drugs together; however, this latest study is particularly important due to the increased risk of cardiovascular disease in people with diabetes.

According to researchers, patients with diabetes who took a PPI and clopidogrel together experienced a 44 percent higher relative risk for a cardiovascular event than patients taking clopidogrel alone. Of those who took the medications together, nearly 27 percent experienced a major cardiovascular event within the first 12 months of taking the drugs together, compared to only 19.7 percent of patients on clopidogrel alone.

Communications with Doctors Increase Use of Key Medications in Diabetes

Ace Inhibitors (ACE-I) and angiotensin receptor blockers (ARB), two major categories of antihypertensives, appear to have unique clinical benefits compared to other antihypertensive therapies. New Medco research points to a simple fax communication as an important vehicle for increasing the use of these medications among people with diabetes.

The American Diabetes Association recommends ACE-I or ARB in diabetic patients with certain clinical conditions such as nephropathy or hypertension. Unfortunately, these agents are not frequently prescribed to many patients for whom treatment is indicated. In the Medco study, a fax from the pharmacy to the physician doubled the percent of patients who were prescribed one of these medications.

Patients with diabetes that were not receiving one of these medications were divided into two groups. Physicians from one group received a fax from the pharmacy that outlined clinical guidelines from the American Diabetes Association and provided a list of available medications available in the category and a prescription form pre-populated with the patient's information. Twenty-one percent of patients whose physicians received faxes were started on an ACE-I or ARB, vs. only 10 percent of control patients. Researchers concluded that the findings support the value of the pharmacies engaging with physicians when they find patients who are lacking important therapies.

About Medco

Medco Health Solutions, Inc. (NYSE: MHS) is a leading health care company, serving the needs of more than 60 million people. Medco, the world's most advanced pharmacy(R), provides clinically driven pharmacy services designed to improve the quality of care and lower total health care costs for private and public employers, health plans, labor unions and government agencies of all sizes, and for individuals served by Medicare Part D Prescription Drug Plans. Through its unique Medco Therapeutic Resource Centers(R) and the Accredo Health Group, Medco's Specialty Pharmacy, the company is creating innovative models for the care of patients with chronic and complex conditions. Medco is a leader in the emerging field of personalized medicine and in applying evidence-based protocols to elevate the practice of pharmacy -- a key element in reforming America's health care system. Medco is ranked number 45 on the Fortune 500 list, with 2008 revenues of more than $51 billion. For more information about Medco, go to

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the risks and uncertainties that affect our business, particularly those mentioned in the Risk Factors section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.

SOURCE Medco Health Solutions, Inc.
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