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Concerned about Avandia? Here are other options

By Sabriya Rice, CNN
Edward Darden became concerned after seeing warnings about the diabetes drug Avandia.
Edward Darden became concerned after seeing warnings about the diabetes drug Avandia.
STORY HIGHLIGHTS
  • A study linked the drug Avandia to a 43 percent increased risk of heart attack in 2007
  • Experts say patients should not do anything drastic, despite concerns about Avandia.
  • 90 percent of the nearly 24 million Americans living with diabetes have type 2
  • Some alternative treatments to lower blood sugar are metformin and pioglitazone (Actos)
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(CNN) -- Edward Darden started taking the diabetes drug Avandia in 2006 to help control his blood sugar and was doing just fine, he said. But he became concerned when he saw warnings linking the drug to a 43 percent increased risk of heart attack, following the 2007 release of a study in the "New England Journal of Medicine."

"I had been tolerating the drug very well," said Darden, "but I had a family history of heart disease and I was also taking blood pressure medications."

His doctor performed several cardiac tests and found Darden's heart was in good shape. But Darden and his doctor decided to err on the side of caution and switch medications anyway.

It's a predicament many people taking Avandia have faced over the past few years, and this week the Food and Drug Administration held hearings evaluating the drug's safety. The panel found Avandia does increase the risk of heart problems compared to other diabetes medications. However the panel was divided over removing the drug from market.

Twelve of the 33 members voted to withdraw Avandia from the market, while 20 voted to let the drug remain on the market with enhanced restrictions and rigorous black box warning labels. Avandia's manufacturer, Glaxo Smith Kline, said the company will continue to work with the FDA as the agency considers Wednesday's recommendations.

"We remain fully committed to maintaining best practice disclosure of clinical data to serve the interests of regulators, physicians and patients," said Dr. Ellen Strahlman, the company's chief medical officer.

Video: Alternatives for Avandia
Video: FDA panel split on Avandia
Video: Patient: I need Avandia to survive

Nearly 24 million Americans, or about 8 percent of the U.S population, live with diabetes. Type 2 diabetes accounts for more than 90 percent of those cases, according to the National Diabetes Information Clearinghouse. Avandia came to market in 1999 to treat type 2 diabetes, and sales of the drug exceeded $3 billion by 2006. Avandia use fell sharply after publication of the NEJM study, with sales down to about $1.2 billion in 2009.

Chuck Keyserling told the advisory panel he had taken Avandia for the past 10 years.

"In making this plea to keep Avandia on the market, I believe I am pleading for my life," he said. For people like himself, he said, pulling Avandia would be a "death sentence."

Dr. David Nathan, director of the diabetes center at Massachusetts General Hospital, is not so sure.

Nathan is the lead author of a 2008 report published in the journal "Diabetes Care" which outlines guidelines for the best treatments for type 2 diabetes.

"I don't have any patients currently taking Avandia," said Nathan. He stopped prescribing the drug because "it just didn't make sense," considering there are alternatives that didn't carry the potential risk, he said.

Experts say patients should not do anything drastic, despite concerns they may have about Avandia. "The most important thing is that patients should not stop taking any of their medications, because that can result in changes in the blood that can be dangerous," said Dr. David Kendall, chief scientific and medical officer for the American Diabetes Association. Anyone concerned about their prescription should talk to his or her doctor about other options, he said.

Here's an explanation of the pros and cons of other treatments to lower blood sugar for people with type 2 diabetes.

Metformin

"This is generally accepted as the initial medical therapy choice for patients with type 2 diabetes," explains Kendall. "It lowers the blood sugar without the risk of it going too low."

Metformin is an oral medication taken twice a day to slow the amount of glucose the liver produces. The medication can be taken alone, but is often combined with other medications such as insulin more effective results.

Pros: Safe and effective in lowering blood sugar without risk of hypoglycemia. Well tolerated by most patients.

Cons: Some patients experience gastrointestinal side effects when starting the drug.

The National Institutes of Health has a comprehensive list of what you need to know about metformin including, how it should be taken, the full list of potential side effects on its website.

Metformin with sulfonylureas

Sulfonylureas work by helping your pancreas to produce extra insulin, said Nathan.

"If your blood control isn't working with metformin alone, this combination is often the next line of defense."

Pros: Powerful when used in combination. Inexpensive. Well tolerated by most patients.

Cons: Risk of extremely low blood sugar (hypoglycemia) and weight gain.

The medical center at the University of Maryland Medical provides this list of common sulfonylurea medications.

Metformin with insulin

The bodies of people with type 2 diabetes do not make enough insulin, the hormone needed to move blood sugar into the cells to be stored for future energy use. Daily insulin injections help the body make up for the deficiency. "It's also worth noting that insulin is the only medicine we treat people with that's naturally occurring in the body," said Nathan.

Pros: Has very few side effects.

Cons: Requires an injection. Risk of hypoglycemia.

According to the American Diabetes Association

There are more than 20 types of insulin sold in the United States, according to the American Diabetes Association. Here's the ADA's list of basics about insulin.

Pioglitazone

If you want to stick to the same class of drug as Avandia, your doctor may suggest, pioglitazone, also known by the brand name Actos.

"With all drugs in this class, there is a risk of fluid retention and weight gain, however Actos has not been implicated to increase the risk of heart attack," said Kendall.

This medication works by decreasing the amount of insulin needed to move glucose from the blood into the cells by increasing the body's sensitivity to the substance.

If Avandia were to be pulled from the market, Actos would be the only drug in its class of medication to treat diabetes patients; a previous drug, troglitazone, was discontinued in 2000 because it was linked to liver failure in some patients.

Pros: Effective in reducing blood sugar levels.

Cons: Not suggested for patients with heart disease. Risk of hypoglycemia. Linked to increased risk of osteoporosis in women.

Here's is more information on pioglitazone from the NIH.

DPP-4 inhibitors

DPP-4 inhibitors are a new class of drug that lower your blood glucose by helping your body produce insulin when needed, and also prevent the liver from depositing stored glucose into the blood. The medication is currently available in pill form, and may soon be available as a weekly injection.

Pros: No major increase in body weight. Reduced risk of hypoglycemia

Cons: More expensive than some other drugs. Fairly new on the market.

The Agency for Healthcare Research and Quality has this comparison of oral diabetes medications -- see Page 4 for a breakdown of the estimated costs of the medications in both generic and name-brand form. Also, if you are taking more than one medication, the National Institutes of Health has this downloadable form to help you keep track of them.

Diet and exercise

It's important to remember, not everyone needs to take medication.

"Anyone who has just developed diabetes, who can control their blood sugar with food intake, can manage with eating healthy and exercising and not taking a medication," said Kendall.

The Centers for Disease Control estimates more than 72 million U.S adults are obese, putting them at increased risk of coronary heart disease, type 2 diabetes, hypertension and other chronic problems.

"The absolute best alternative therapy to treat diabetes is to lose weight," said Nathan. "The problem is that many patients fail, and that's why we turn to medication."

To help reduce your risk of developing type 2 diabetes -- and get your blood sugar under control if you already have the condition -- the National Diabetes Education Program offers this booklet to help you keep track of your food intake and physical activity, as well as a list of the calories in common foods. The American Association of Diabetes Educators offers tips for seven focus areas for managing diabetes.

After Darden spoke to his doctor, he immediately switched to a different treatment, and so far hasn't had any problems.

"I'm happy that I came off of it," he said. "If there's a better alternative, something that doesn't have as much risk I'd rather do that."

CNN's Saundra Young, Caleb Hellerman and Miriam Falco contributed to this report.

 
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