Inhaled corticosteroids and bone loss

We identified seven randomised trials (5997 participants) of good quality with a duration of six months to three years. All of the trials compared ICS/LABA combination inhalers with LABA and ICS as individual components. Four of these trials included fluticasone and salmeterol monocomponents and the remaining three included budesonide and formoterol monocomponents. There was no statistically significant difference in our primary outcome , the number of patients experiencing exacerbations ( odds ratio ( OR ) ; 95% CI to ), or the rate of exacerbations per patient year (rate ratio ( RR ) ; 95% CI to ) between inhaled corticosteroids and long-acting beta 2 -agonists. The incidence of pneumonia, our co-primary outcome , was significantly higher among patients on inhaled corticosteroids than on long-acting beta 2 -agonists whether classified as an adverse event ( OR ; 95% CI to ) or serious adverse event (Peto OR ; 95% CI to ). Results of the secondary outcomes analysis were as follows. Mortality was higher in patients on inhaled corticosteroids compared to patients on long-acting beta 2 -agonists (Peto OR ; 95% CI to ), although the difference was not statistically significant . Patients treated with beta 2 -agonists showed greater improvements in pre-bronchodilator FEV 1 compared to those treated with inhaled corticosteroids ( mean difference ( MD ) mL; 95% CI to ), whilst greater improvements in health-related quality of life were observed in patients receiving inhaled corticosteroids compared to those receiving long-acting beta 2 -agonists (St George's Respiratory Questionnaire (SGRQ) MD -; 95% CI - to -). In both cases the differences were statistically significant but rather small in magnitude. There were no statistically significant differences between ICS and LABA in the number of hospitalisations due to exacerbations, number of mild exacerbations, peak expiratory flow, dyspnoea , symptoms scores, use of rescue medication, adverse events, all cause hospitalisations, or withdrawals from studies.

The aim of this article is to bring less well recognised adverse effects of inhaled corticosteroids to the attention of prescribers. Whilst inhaled steroids have a more favourable side effect profile than systemic steroids, they are not free from adverse effects. The dose of inhaled steroids used should be carefully monitored, and kept at the lowest dose necessary to maintain adequate control of the patient’s disease process. Be particularly aware of the cumulative effect of co-prescribing various dose forms of corticosteroids (inhaled, intranasal, oral and topical preparations).

The review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations. The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States.

Inhaled corticosteroids and bone loss

inhaled corticosteroids and bone loss


inhaled corticosteroids and bone lossinhaled corticosteroids and bone lossinhaled corticosteroids and bone lossinhaled corticosteroids and bone lossinhaled corticosteroids and bone loss