Post by harryx1 on Apr 2, 2019 13:32:06 GMT -5
www.ncbi.nlm.nih.gov/pmc/articles/PMC3440146/
Safety of Technosphere Insulin as an Ultra-Rapid-Acting Prandial Insulin
The safety of TI has been studied extensively, both preclinically and in a clinical program involving more than 5600 subjects. The most common treatment-emergent adverse events were hypoglycemia, cough, and upper respiratory tract infection.17 Cough occurred in approxi-mately 32% of patients administering TI but tended to be mild and transient, occurring within minutes of inhalation.17 Furthermore, cough diminished over time and rarely led to study discontinuation.
A pooled analysis of cardiovascular events from nine clinical studies comprising 4467 patients who administered TI or usual diabetes care showed that the incidence of cardiovascular or cerebrovascular events was similar between the TI and usual diabetes care groups (relative risk, 1.01; 95% CI, 0.84 to 1.20).23
Lung function was examined in a 2-year prospective, multicenter, randomized, open-label study in patients with type 1 or type 2 diabetes administering TI (n = 730) or usual diabetes care (n = 824) and a cohort without diabetes who did not receive any specific therapy (n = 145).24 Lung function declined from baseline in all treatment groups, in line with normal age-related changes and as seen in diabetes in general. Compared with usual diabetes care, TI showed a small reduction in forced expiratory volume in 1 s (FEV1) from baseline to month 24 (-0.037 ± 0.0119 liter; 95% CI, 0.014 to 0.060). After a greater initial decline by month 3 with TI, the rate of change (slope) in FEV1, forced vital capacity, and diffusing capacity of the lung for carbon monoxide over months 3 to 24 was not statistically different between treatment groups. This observed treatment group difference was small, occurred early after therapy initiation, did not progress over 2 years, and resolved after discontinuation of therapy.
Two cases of cancer involving the lung have been reported during clinical trials, both in ex-smokers. The incidence does not exceed what would be expected in a similar, nontreated population.25 A 2-year carcinogenicity study in rats26 and a 6-month study in transgenic mice (data on file, MannKind Corporation) did not indicate a carcinogenic potential.
Safety of Technosphere Insulin as an Ultra-Rapid-Acting Prandial Insulin
The safety of TI has been studied extensively, both preclinically and in a clinical program involving more than 5600 subjects. The most common treatment-emergent adverse events were hypoglycemia, cough, and upper respiratory tract infection.17 Cough occurred in approxi-mately 32% of patients administering TI but tended to be mild and transient, occurring within minutes of inhalation.17 Furthermore, cough diminished over time and rarely led to study discontinuation.
A pooled analysis of cardiovascular events from nine clinical studies comprising 4467 patients who administered TI or usual diabetes care showed that the incidence of cardiovascular or cerebrovascular events was similar between the TI and usual diabetes care groups (relative risk, 1.01; 95% CI, 0.84 to 1.20).23
Lung function was examined in a 2-year prospective, multicenter, randomized, open-label study in patients with type 1 or type 2 diabetes administering TI (n = 730) or usual diabetes care (n = 824) and a cohort without diabetes who did not receive any specific therapy (n = 145).24 Lung function declined from baseline in all treatment groups, in line with normal age-related changes and as seen in diabetes in general. Compared with usual diabetes care, TI showed a small reduction in forced expiratory volume in 1 s (FEV1) from baseline to month 24 (-0.037 ± 0.0119 liter; 95% CI, 0.014 to 0.060). After a greater initial decline by month 3 with TI, the rate of change (slope) in FEV1, forced vital capacity, and diffusing capacity of the lung for carbon monoxide over months 3 to 24 was not statistically different between treatment groups. This observed treatment group difference was small, occurred early after therapy initiation, did not progress over 2 years, and resolved after discontinuation of therapy.
Two cases of cancer involving the lung have been reported during clinical trials, both in ex-smokers. The incidence does not exceed what would be expected in a similar, nontreated population.25 A 2-year carcinogenicity study in rats26 and a 6-month study in transgenic mice (data on file, MannKind Corporation) did not indicate a carcinogenic potential.