WEUKBRE5554: IMI PROTECT(Work Package 2): Beta2 Agonists and Acute Myocardial Infarction

The studies described in this protocol are all performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Work Package 2 and Workgroup 1. Primary aim of these studies is to develop, test and disseminate methodological standards for the design, conduct and analysis of Pharmacoepidemiological (PE) studies applicable to different safety issues and using different data sources. To achieve this, results from PE studies on five key adverse events (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the methodological aspects of the studies in this protocol and not on the clinical consequences of the association under investigation . Asthma and chronic obstructive pulmonary disease (COPD) are the most common chronic airway diseases in the western world. For both, a stepwise treatment to reduce symptoms, improve lung function, and prevent risk of exacerbation is recommended using several drug classes according to guidelines published by e.g. the Global Initiative for Asthma \[GINA guideline\] and the Global Initiative for Chronic Obstructive Lung Disease \[GOLD guideline\], respectively. Beta-2-adrenoceptor agonists (B2A) are therapeutic mainstays in treating asthma and COPD due to their bronchodilative effects mediated by B2A. This drug class consists of two types of drugs: short acting B2A (SABA) which are used as a reliever medication and long acting B2A (LABA) which are used as maintenance / controller medication. Formoterol and salmeterol are the most frequently used LABA compounds with a half-life between 5-15 hrs and therefore, these compounds most commonly have labelled indications for use twice a day. . Focussing on cardiac side effects of B2A one must consider that drugs with an opposite mechanism of action (beta-adrenoceptor-antagonists) have well-known cardio protective effects and are widely used in patients suffering from e.g. ischemic heart disease, hy