Results from three-year interim analyses of two ongoing long-term clinical trials showed that small mean declines in lung function in diabetes patients who took Exubera (insulin human [rDNA origin]) Inhalation Powder reversed when Exubera was discontinued. Upon re-initiation of Exubera, lung function changes similar to first time users of Exubera were observed.
The studies also showed that patients on an Exubera regimen maintained blood sugar control and generally gained less weight over the three-year period than those on an injected insulin regimen. These data were presented today at the 67th Annual Scientific Sessions of the American Diabetes Association.
In the first two years of these studies, Exubera patients had small and non-progressive mean declines in lung function that reversed one month after discontinuing treatment. Upon re-initiation of Exubera, small changes in lung function re-appeared and were consistent with those shown in previous Exubera studies. These studies are part of the largest database of pulmonary function in patients with diabetes.
"These data further our understanding of the pulmonary profile of Exubera. This highly effective treatment option will help patients control their blood sugar levels, which is critical given the progressive nature of diabetes and the challenges related to treating and managing the disease over time," said Dr. William Cefalu, lead investigator and Chief of the division of nutrition and chronic diseases at the Pennington Biomedical Research Center, a campus of the Louisiana State University System, in Baton Rouge.
The rates of diabetes are high and growing in almost all areas of the globe. By 2030, the World Health Organization predicts that 366 million people worldwide will have diabetes.
The ADA recognizes insulin as the most effective medication to control blood sugar, and despite this, studies have shown that people - even those poorly controlled - delay the initiation of insulin for 5 years or longer. Injection fear and anxiety are often cited as some of the key reasons to delay.
"Patients have stated that Exubera has had a positive impact on their diabetes and some of these patients have been taking Exubera for up to eight years," said Rochelle Chaiken, M.D., vice president cardiovascular medical group leader at Pfizer. "We are committed to educating physicians and patients about the critical role that earlier insulin initiation may play in managing this disease."