[Efficacy and safety of inhaled insulin in diabetes mellitus treatment].
OBJECTIVE
To evaluate the efficacy and safety of inhaled insulin.


METHODS
Systematic review.


METHODS
Reference data bases, MEDLINE (1999 to November 2005) and EMBASE (2000 to November 2005), the CENTRAL base (Cochrane Library), the European Drug Agency, the Food and Drug Administration, the International Network of Technology Evaluation Agencies, the European Network for Early Detection (EuroScan), and various research registers.


METHODS
Eight clinical trials were recovered. Studies not comparing inhaled with subcutaneous insulin and those that did not measure metabolic control or satisfaction and quality of life were excluded.


METHODS
Critical reading using the methods proposed by the CASPe programme.


RESULTS
The difference between the 2 groups in mean values of descent of glycosylated haemoglobin was -0.07% (95% CI, -0.32 to 0.17) for type-2 diabetics; and between 0.16% (95% CI, -0.01 to 0.32) and -0.16% (95% CI, -0.34 to 0.01) in type-1 diabetics. Hypoglucaemias per subject-month were similar (between 0.83 and 1.57 in type-2 diabetics and between 8.6 and 9.9 in type-1 diabetics). Quality of life and satisfaction were favourable to the intervention group (P< .05). Secondary effects were comparable except in the appearance of cough (21%-27% in inhaled and 2%-7% in subcutaneous insulin).


CONCLUSIONS
Inhaled insulin is comparable to subcutaneous insulin in metabolic control, the number of hypoglucaemias and side-effects. However, the trials reviewed showed certain problems of internal and external validity. Studies with longer follow-up are needed, in order to evaluate possible lung disorders.
Llanos Méndez
Aurora
A
Agencia de Evaluación de Tecnologías Sanitarias de Andalucía, Sevilla, España. aurora.llanos.ext@juntadeandalucia.es
Villegas-Portero
Román
R
D000280:Administration, Inhalation; D002986:Clinical Trials as Topic; D003920:Diabetes Mellitus / Q000188:drug therapy*; D006801:Humans; D007328:Insulin / Q000008:administration & dosage*
D007328:Insulin