FDA approval is recommended for inhaled insulin, combo drug

Action may expand options for patients with diabetes, but safety questions remain.

By Victoria Stagg Elliott — Posted Oct. 10, 2005

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Physicians are one step closer to being able to prescribe insulin that does not require a needle to be administered and to having a diabetes drug that addresses both blood sugar and cardiovascular risk factors.

The Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee recommended in September that Exubera, an insulin powder for inhalation, be approved by the agency for adults with either type 1 or type 2 diabetes. The panel also gave its nod to the first drug that works on both the alpha and gamma peroxisome proliferator-activated receptors. The drug, muraglitazar (Pargluva) has been shown to reduce blood sugar and increase triglycerides among those with type 2.

"The majority of the committee felt they were safe and effective," said Paul Woolf, MD, a committee member and chair of the Dept. of Medicine at Crozer Chester Medical Center in Upland, Pa.

The FDA is not obligated to follow its advisory committee's recommendations but usually does.

Physicians who treat diabetics praised the panel's decisions.

Some anticipate that approval of an inhaled insulin will give needle-fatigued patients a break and make it easier for them to maintain intensive control. It also could increase the number of type 2 patients who initiate insulin therapy at earlier points in the disease's course.

"It's an exciting development," said Nathaniel Clark, MD, national vice president for clinical affairs for the American Diabetes Assn. "Patients are not receiving insulin because of an issue of taking injections, which is a major barrier."

Despite the committee's recommendation, though, there are still reservations. Experts are concerned about how physicians and other health professionals will be trained to teach patients to use the inhalation device, which can be tricky.

"My concern is whether the training program will be adequate for a busy practitioner to be able to teach patients," said Dr. Woolf, who voted against recommending approval for this reason. "I would have liked to see the teaching program that they're planning to roll out in the community evaluated."

There also are concerns about how this delivery method might affect people with healthy lungs over the long term and its effectiveness for those with impaired lung function. Experts expect the medicine to be approved with a recommendation that it not be prescribed to smokers, those who are significantly exposed to secondhand smoke, asthmatics and others without full lung function. But what to do with people who temporarily have impaired lung function? "What do you do if someone has pneumonia or bronchitis? Do we need to switch them over to the injectable?" asked Jeff Unger, MD, a family physician from Chino, Calif., who treats a significant number of patients with diabetes.

Physicians also question how many shots the inhaled version actually could replace. This delivery system is intended to be a substitute for mealtime insulin injections, which might make it a good alternative for people who already get several shots a day. It is not, however, the long-acting basal insulin that many type 2 diabetics are started on and often are resistant to initiating.

"Inhaled insulin has its place. Some patients might prefer it over injections," said Marc Sandberg, MD, of the diabetes health center at Hunterdon Medical Center in Flemington, N.J. "But it's not going to replace the needle completely."

Treatment for other risk factors

Meanwhile, doctors welcomed the possibility of another option -- muraglitazar -- to tackle both a cardiovascular risk factor and a significant issue associated with diabetes. The panel recommended the drug's approval based on its ability to lower hemoglobin A1C values with triglyceride-lowering as an added benefit.

"This is another exciting development," Dr. Clark said. "As we choose drugs, we do have to consider that most of our patients die from cardiovascular disease. This would have an advantage over a drug that simply lowered blood glucose."

This drug, however, was recommended for approval with caveats. The panel noted that it be allowed to be prescribed alongside metformin but not with a sulfonylurea. Concerns also have been raised by the agency about a possible increased risk of heart failure, although it was unclear whether this concern was a direct result of the drug or due to the fact that those with diabetes are more prone to cardiovascular problems.

The advisory committee's endorsement drew the ire of patient safety advocates. Public Citizen argued that the lower numbers in the studies will not necessarily translate to improved outcomes. This position, combined with possible risks and the fact that there are already drugs on the market designed for similar goals -- though not combined in one pill -- led the organization to lobby against approval.

"It's not clear how clinically meaningful the effect of this drug is," said Peter Lurie, MD, MPH, deputy director of Public Citizen's Health Research Group.

The companies behind both products have promised to monitor for any long-term adverse events that occur once they hit the market. Pfizer Inc. and the Sanofi-Aventis Group manufacture Exubera. Merck & Co. and Bristol-Myers Squibb are the companies behind Pargluva.

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External links

American Medical Association's Minority Affairs Consortium on diabetes (link)

Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee (link)

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