EUROPEAN POSTMARKETING SURVEILLANCE OF RAMIPRIL IN HYPERTENSION .1. FEASIBILITY AND STUDY COHORT

A prospective observational cohort study of the angiotensin inhibitor, ramipril, was undertaken in four countries within the European Commun ity-Netherlands, United Kingdom, Germany and Belgium. A total of 10,37 7 consecutive patients with essential hypertension were recruited to t he study with the aim of follow-up for one year. Overall 37% of doctor s who agreed to participate in the study actually enrolled at least on e patient. One third of the doctors who enrolled patients in the study entered two thirds of patients studied. Some 15% of participating mal es and 27% of females were aged over 70 years. Newly diagnosed hyperte nsives comprised 22% of the study cohort, the proportion being highest in UK and Netherlands, whereas 53% were established hypertensives of two or more years' duration, the proportion being highest in Germany a nd Belgium. There were substantial differences among the participating countries in the concurrent treatment these patients were receiving f or hypertension, with two or more co-therapies being most frequent in Germany and Belgium. There were also substantial differences in co-the rapies for concurrent diseases among the participating countries, refl ecting both standard therapeutic practices in local areas and differen ces in marketing of drugs in the different countries. This report desc ribes the initial findings of this multinational study and emphasises the need to consider several major potentially confounding variables i n the analysis of the outcome events both in this study and in other c ollaborative observational international monitoring schemes for advers e drug reactions.