PHARMACY

NIH’s ACCORD study: Intensive glucose treatment may not slow diabetes-related damage

BY Allison Cerra

WASHINGTON An intensive glucose treatment may not delay diabetes-related damage in patients with Type 2 diabetes that also are at high risk for heart attack and stroke, according to a National Institutes of Health-funded trial.

The Action to Control Cardiovascular Risk in Diabetes trial stressed that over time, diabetes damages the small blood vessels of the eyes, nerves, kidneys and other organs, leading to pain and disability. Heart disease due to damaged large blood vessels is a major cause of death in people with Type 2 diabetes. The longer a person has diabetes, the greater the chances of serious complications, including vision loss and blindness, foot ulcers and amputations, kidney disease and failure, and heart disease and stroke.

The ACCORD clinical study compared the effect of intensive control of blood sugar, blood pressure and blood lipids with standard, less-intensive treatments on the risk of major cardiovascular events in more than 10,000 adults with established Type 2 diabetes that averaged 62 years of age and were obese. The study’s intensive glycemia arm was halted in February 2008 due to excess deaths in that group. At that time, participants in the intensively treated group were moved to standard glucose control.

In addition to having Type 2 diabetes for an average of 10 years, about one-third had pre-existing heart disease, and the remainder had at least two additional cardiovascular disease risk factors. They also had high blood sugar, as measured by the hemoglobin A1c test, which shows average blood sugar in the preceding two to three months. Half of participants had an A1c more than 8.1% — above the currently recommended target for good control. A1c values in people without diabetes are less than 6%.

In ACCORD, the A1c target for the intensively treated group was less than 6%, a level seen in adults without diabetes and significantly lower than the levels tested in earlier trials. The goal for standard control was an A1c of 7 to 7.9%, an average range achieved by individuals treated for Type 2 diabetes in the United States. Both groups were treated with Food and Drug Administration-approved diabetes medications, as prescribed by their study clinician.

Eye, nerve and kidney complications in the two groups were compared after 3.7 years, when intensive control was halted, and again at the study’s end after 5 years.When intensive glucose treatment was halted in the group receiving such treatment, half those participants had an A1c of 6.4% or lower, which rose to 7.2% at study end. In the standard treatment group, that A1c measure was 7.5%, rising to 7.6% by the end of the study.

The treatment groups did not differ in the rate of progression to kidney failure, major vision loss or advanced peripheral neuropathy, a common nerve problem in diabetes that usually begins as tingling or numbness in the feet. However, people in intensive control had less deterioration in a vision test, and 20% fewer cataract surgeries compared with those in standard control. They also had a 30% lower rate of protein leakage in the urine, a sign of kidney disease and increased risk of heart disease. Testing for vibratory sensation, an indicator of nerve health, showed no difference between the groups, but the intensively controlled group scored better on other nerve tests.

The findings appeared in the June 29 issue of The Lancet, which coincided with a presentation of the study results at the American Diabetes Association’s 70th annual scientific sessions in Orlando, Fla.

“In these ACCORD participants with established Type 2 diabetes and additional risk factors for cardiovascular disease, intensive lowering of blood glucose reduced some markers of eye, nerve and kidney disease compared with standard glucose control, but the groups did not differ in the rate of progression to kidney failure, nerve disease and major vision loss,” said lead author Faramarz Ismail-Beigi of Case Western Reserve University in Cleveland.

“ACCORD provides important data on the risks and benefits of intensive glucose control in people with established Type 2 diabetes,” said Susan B. Shurin, acting director of the NIH’s National Heart, Lung and Blood Institute. “Although increasing treatment to try to achieve near-normal blood sugar provides some benefit, clinicians and patients should note that this treatment strategy also potentially increases the risk of adverse effects in patients with additional risk factors for heart disease, such as those studied in ACCORD.”

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Teva’s generic Effexor XR receives regulatory approval

BY Alaric DeArment

SILVER SPRING, Md. The Food and Drug Administration has approved the first generic version of an extended-release antidepressant pill made by Pfizer, the agency said Tuesday.

The FDA approved Teva Pharmaceutical Industries’ venlafaxine hydrochloride extended-release capsules. The capsules are a generic version of Effexor XR, used to treat major depressive disorder. The capsules will be available in the 37.5 mg, 75 mg and 150 mg strengths.

“The approval of this widely used antidepressant is another example of the FDA’s efforts to increase access to safe and effective generic drugs,” said Keith Webber, FDA Center for Drug Evaluation and Research Office of Pharmaceutical Science deputy director. “Access to treatments for depression is important because depression can interfere with a person’s daily life and routine, which can significantly affect relationships with family and friends.”

Effexor products had sales of $520 million in 2009, according to Pfizer financial data.

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NACDS, NCPA back senatorial MTM bill

BY Antoinette Alexander

ALEXANDRIA, Va. The National Association of Chain Drug Stores and the National Community Pharmacists Association have voiced their support of the Senate medication therapy management bill, authored and introduced Tuesday by Sen. Kay Hagan, D-N.C., as it aims to further pave the way for enhanced pharmacist-provided MTM services.

Hagan’s Medication Therapy Management Expanded Benefits Act of 2010 would enhance pharmacist-provided MTM services for Medicaid and Medicare beneficiaries by opening MTM services to patients suffering from any chronic condition or disease. Sen. Al Franken, D-Minn., is an original co-sponsor of the bill.

"By encouraging MTM services in neighborhood pharmacies, the bill would improve public health and reduce healthcare costs by helping patients to take their medications in the right ways and avoid complications with their drug therapies," stated NACDS president and CEO Steve Anderson. "Patients suffering from chronic disease, be it diabetes, hypertension, asthma or other conditions, will benefit from these pharmacy services, which also strengthen the pharmacist-patient relationship. We thank Senators Hagan and Franken for their commitment to improving health care in a way that stands to reduce costs and improve lives."

Added Douglas Hoey, NCPA acting EVP and CEO, "For many Medicare Part D patients, the challenges of coping with numerous chronic conditions and diseases require an expert’s consultation, and pharmacists are clinically trained in helping ensure their patients are getting the best possible results. The bill offered by Senators Hagan and Franken is the next logical step in broadening the reach of MTM. NCPA urges the Senate to move expeditiously to pass this bill, because true healthcare reform needs to incorporate all the best practices."

The bill is the Senate’s companion to H.R. 3108, the Medication Therapy Management Benefits Act of 2009, introduced by Rep. Mike Ross, D-Ark., last year and endorsed by NACDS and NCPA.

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