Off-label use of inhaled bronchodilators in hospitalised patients in Spain: a multicentre observational study.

BACKGROUND: Off-label prescription of inhaled bronchodilators (IB) is frequent, despite the fact that they can be ineffective and increase avoidable healthcare costs. OBJECTIVE: To analyse the frequency of off-label prescription of IB in hospitalised patients. Indications and level of evidence, involved drugs, medical specialties prescribing off-label IB and patients' adherence to IBs were also evaluated. METHOD: A descriptive, observational, cross-sectional study was performed in four tertiary hospitals in Spain. The main outcome measure was the number of patients prescribed off-label IBs. Prescriptions were checked against the European Medicines Agency-approved indications. The level of evidence supporting off-label prescription of IBs (according to MICROMEDEX 2.0) was also analysed. Patients were interviewed to test differences (off-label vs on-label) in adherence and knowledge about their inhaled therapy. RESULTS: 217 patients were prescribed IBs, 92 of whom were givend off-label IBs (54.7% men, mean age 73.9±12.9 years). The most common off-label prescriptions for IBs were: unspecified dyspnoea (not related to COPD or asthma) (27.2%), respiratory infections (23.9%) and heart failure (22.8%). 76.8% of patients did not have evidence supporting them. Beta2-agonist+corticosteroids and anticholinergics were most commonly prescribed off-label. Internal Medicine was the main medical specialty involved. There were no differences between off-label and on-label users in terms of patients' knowledge about treatment and adherence. CONCLUSION: Off-label indications for IBs are common in hospitalised patients and are generally indicated without scientific support. Dyspnoea not related to COPD or asthma, respiratory infections and heart failure were the main off-label indications, most frequently treated with anticholinergics and beta2-agonists+corticosteroids, for which their efficacy and safety has not been proved. Our results show that prescribing needs to be improved to follow the evidence that exists. Moreover, further research focused on off-label indications is needed to clarify whether they are effective, safe and cost-effective.

White coat hypertension in patients with obstructive sleep apnea-hypopnea syndrome.

BACKGROUND: The strength of the association between obstructive sleep apnea-hypopnea syndrome (OSAHS) and systemic hypertension could be affected by methodologic problems in the definition of hypertension. STUDY OBJECTIVES: To determine the frequency of white coat hypertension (WCH) in patients with OSAHS, and to analyze the characteristics of patients with OSASH and WCH. PATIENTS AND INTERVENTIONS: Ninety-nine consecutive patients with OSAHS and 20 healthy control subjects were included into the study. Twenty-four-hour ambulatory BP monitoring (ABPM) and urinary catecholamines were determined simultaneously with the polysomnographic study. Arterial blood gases and lung volumes were also measured. RESULTS: Office hypertension was diagnosed in 45 patients, while the control group included 54 normotensive patients with OSAHS. After ABPM, hypertension was confirmed in 30 patients with OSAHS and office hypertension. WCH was diagnosed in the remaining 15 patients (33%). Patients with WCH presented higher values of sleep onset latency and wake after sleep onset than normotensive and sustained hypertensive patients. No other differences in sleep parameters, function tests, or urinary catecholamines were found between the OSAHS groups. CONCLUSION: The results indicate that WCH is a frequent phenomenon in patients with OSAHS, and that it is not predictable by clinical variables.