Objective: To assess the relationship between chronic intake of nonsteroidal anti-inflammatory drugs (NSAID) and outcome, in particular (gastrointestinal) bleeding and to investigate whether the effect of chronic NSAID intake was similar in untreated and treated elderly hypertensives. Methods: Eligible patients (у60 years, with systolic blood pressure 160-219 mm Hg and diastolic blood pressure Ͻ95 mm Hg) were randomised to active treatment or placebo. Active treatment consisted of nitrendipine, with the possible addition of enalapril, hydrochlorothiazide, or both, titrated or combined to reduce the sitting systolic blood pressure by at least 20 mm Hg to below 150 mm Hg. Patients never taking NSAIDs (n ؍ 2882) were compared with patients on chronic NSAID intake (n ؍ 861), defined as reporting NSAID intake on at least 50% of the patient forms.