Research: Popular Diabetes Medications Associated with Increase in Bone Fractures

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 http://www.medcohealth.com.

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.

Ann Smith of Medco Health Solutions, Inc., +1-201-269-5984,
ann_smith@medco.com; or Janet Schiller or Bill Borden of Coyne Public
Relations, +1-973-316-1665, for Medco Health Solutions, Inc.