Comprehensive Pulmonary Safety Review of Inhaled Technosphere® Insulin in Patients with Diabetes Mellitus
| Autor: | Frank Pompilio, John B. Buse, David M. Kendall, Susanne Steiner, Anne L. Peters, Tiffany S. Tran, Janet B. McGill |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Blood Glucose Male medicine.medical_specialty medicine.medical_treatment 030204 cardiovascular system & hematology Placebo 030226 pharmacology & pharmacy Gastroenterology Pulmonary function testing 03 medical and health sciences 0302 clinical medicine Diabetes mellitus Internal medicine Administration Inhalation medicine Humans Hypoglycemic Agents Insulin Pharmacology (medical) Original Research Article Adverse effect Lung Retrospective Studies Inhalation business.industry Type 2 Diabetes Mellitus General Medicine Middle Aged medicine.disease Postprandial Period medicine.anatomical_structure Cough Diabetes Mellitus Type 2 Female Powders business |
| Zdroj: | Clinical Drug Investigation |
| ISSN: | 1179-1918 1173-2563 |
| Popis: | Background and Objective Technosphere® Insulin (TI), a human insulin powder for inhalation (Afrezza®; MannKind Corporation, Westlake Village, CA, USA), is an ultra-rapid-acting inhaled insulin indicated to improve postprandial glycemic control in patients with type 1 or type 2 diabetes mellitus (T1DM or T2DM). Because TI is absorbed across the alveolar membrane, the objective of this analysis was to characterize its pulmonary safety. Methods Pooled data from 13 phase 2/3 clinical studies in 5505 patients with T1DM or T2DM treated with TI, Technosphere inhalation powder without insulin (TP; placebo), or active-comparator treatment were analyzed for incidences of respiratory treatment-emergent adverse events (TEAEs), changes in pulmonary function, and lung malignancies. Radiographic changes in the lungs were monitored in a subset of 229 patients. Results Among 3017 patients receiving TI, the median duration of TI exposure was 168 days; median active-comparator and TP exposure durations were 363 and 149 days for 2198 and 290 patients, respectively. Respiratory TEAEs were comparable across treatments, except for a higher incidence of mild cough with TI in active-comparator studies (28.0% vs. 5.2%). Slight reversible declines in pulmonary function from baseline were observed for TI versus TP and active-comparator treatments, including in a subpopulation of patients with retrospectively identified lung dysfunction. Lung malignancies were reported in two patients on active TI therapy with a smoking history. No clinically significant changes from baseline were observed in radiographic images. Conclusions Pulmonary safety assessment of the TI inhalation system did not identify any safety issues in individuals with either T1DM or T2DM. Electronic supplementary material The online version of this article (10.1007/s40261-020-00958-8) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink