Technosphere inhaled insulin delivery appears safe
By David Douglas
Pooled data indicate that diabetes treatment with insulin powder via the breath-powered Technosphere (Mannkind) inhalation device is safe. But long-term information is lacking.
As Dr. Anastassios G. Pittas told Reuters Health by email, "This newest type of inhaled insulin is an improved version of the prior type in terms of convenience to the patient and ease of use."
However, he added, "Given lack of long-term information on safety, inhaled insulin should be reserved for patients who need insulin treatment but who are unable or unwilling to use injectable insulin."
In a September 2 online paper in The Lancet Diabetes & Endocrinology, Dr. Pittas, of Tufts Medical Center, Boston, and colleagues noted that they came to this conclusion after examining outcomes in trials comparing mealtime Technosphere inhaled insulin with placebo, subcutaneous insulin, or oral antidiabetic drugs.
In all, 13 trials met criteria for review and 12, involving 5273 patients aged 18 to 80, did so for quantitative meta-analysis.
The decrease in hemoglobin A1c (HbA1c) from baseline was greater with subcutaneous insulin than with Technosphere. Inhaled insulin, the researchers wrote, leads to "an atypical dose-response relation whereby increasing doses do not result in proportional glucose-lowering effect."
However, inhaled insulin was associated with less weight gain (as much as 2.1 kg less) and less risk of severe hypoglycemia. In five trials the odds ratio amounted to 0.61.
The incidence of mild transient cough was increased in people allocated to inhaled insulin. There was also a mild and nonprogressive reduction in lung function, but this did not differ significantly between inhaled insulin patients and those given placebo dry powder.
In addition, there was no significant difference between inhaled insulin groups and active comparator groups in quality of life and overall satisfaction.
"Until further data for safety become available," the researchers concluded, "Technosphere inhaled insulin should be reserved for non-pregnant, non-smoking adults with diabetes who do not have pulmonary disease and who would otherwise delay initiating or intensifying insulin therapy."
In an accompanying editorial, Drs. Giuseppe Derosa and Pamela Maffioli of the University of Pavia, Italy, agree that more studies are required, but "if such studies confirm the safety of this new inhaled insulin formulation, its development might come to be considered another milestone in the treatment of diabetes."
The study had no outside funding and the authors declared no competing interests.
SOURCE: http://bit.ly/1NAZvHi and http://bit.ly/1USQAQn
Lancet Diabetes Endocrinol 2015.
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