U.S. Food And Drug Administration Keeps Rosiglitazone (Avandia) On The Market With Restrictions

Main Category: Cardiovascular / Cardiology
Also Included In: Diabetes;  Regulatory Affairs / Drug Approvals
Article Date: 24 Sep 2010 - 7:00 PST


The U.S. Food and Drug Administration (FDA) has announced that it will significantly restrict the use of the diabetes drug rosiglitazone (brand name, Avandia) to patients with Type 2 diabetes who cannot control their diabetes on other medications.

Their decision is in response to data that suggest an increased risk of cardiovascular events, such as heart attack and stroke, in patients who were treated with rosiglitazone. Rosiglitazone is one in a class of drugs called thiazolidinediones (TZDs), intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in type 2 diabetes patients.

The manufacturer, GlaxoSmithKline, will be required to develop a restricted access program where rosiglitazone will only be available to new patients if they are unable to manage their diabetes on other medications and are unable to take pioglitazone (Actos), the only other drug in this class of medications. Current users of rosiglitazone will be able to continue to use the drug if they want to.

Doctors will have to document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with the drug and acknowledge they understand the risks.

In addition, the FDA stopped the manufacturer's clinical trial known as TIDE, which was a trial that was evaluating patients with type 2 diabetes and a history of or risk for cardiovascular disease, and comparing the cardiovascular effects of long-term treatment with rosiglitazone, pioglitazone or placebo when added to standard care.

The sale of rosiglitazone has been suspended in Europe by the European Medicines Agency, which is the drug regulatory agency in Europe that is similar to the FDA.

For patients with diabetes, the most serious consequences are heart disease and stroke, and the risk of suffering from them is significantly increased when diabetes is present.

"It's important that patients consult with their doctor about the best way to manage their diabetes," said Sacco.

For patients with diabetes, the American Heart Association recommends the following:

- The cornerstone of prevention and treatment should be healthy lifestyle choices, such as not smoking, following a healthy diet and remaining physically active.

- Because of the increased risk of heart disease and stroke, it is very important to achieve optimal control of your blood sugar, blood pressure and lipids (such as cholesterol and triglycerides) with lifestyle and medications when needed. For people with diabetes who are also at increased risk for heart disease, low-dose aspirin therapy is recommended as a reasonable way to prevent a first heart attack or stroke.

-Focus on blood sugar control, keeping your HbA1c level below 7.0, is likely to reduce the risk of the "microvascular" complications of diabetes, such as kidney failure, painful nerve problems and decreased vision or even blindness.

- For healthcare providers, the American Heart Association offers the following guidance on glucose-lowering medications:

- Metformin should generally be the first choice, particularly in obese patients. If it does not produce adequate HbA1c control, other medications can be considered, recognizing that knowledge is limited about the effect of other glucose-lowering agents on cardiovascular risk.

- If a TZD (such as pioglitazone or rosiglitazone) is considered for lowering glucose, patients should not expect it to reduce the occurrence of heart attack or stroke, particularly in relation to today's news from the FDA. The rationale for choosing a TZD should be discussed with a physician. However, patients who have successfully achieved recommended HbA1c control on a TZD may consider remaining on their medication. If the treating physician and/or the patient are uncomfortable with using a TZD, another medication could be substituted.

The American Heart Association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available here.

Related links:

2010 AHA/ACC issue advisory on diabetes drugs and heart risk See here.

2010 Aspirin for Primary Prevention of Cardiovascular Events in People With Diabetes,A Position Statement of the American Diabetes Association, a Scientific Statement of the American Heart Association, and an Expert Consensus Document of the American College of Cardiology Foundation See here

2007 Statement from the American College of Cardiology, American Diabetes Association and American Heart Association Related to NEJM article, "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes" See here

Source:
American Heart Association

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