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5 Jan 2012: Direct Healthcare Professional Communication on potential risks of cardiovascular and renal adverse events in patients with type 2 diabetes and renal impairment and/or cardiovascular disease treated with aliskiren
Novartis would like to update healthcare professionals about important new safety information for aliskiren (Rasilez®) following the early termination of the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE). Analyses of these data are ongoing. In the meantime as a precautionary measure, routine (non-urgent) review is recommended for patients taking aliskiren-containing medicines. Aliskiren or aliskiren-containing fixed combination products should not be used in combination with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) in patients with diabetes. Healthcare professionals are advised to stop aliskiren-containing treatment in patients who are diabetic and also taking an ACE inhibitor or an ARB. Alternative antihypertensive treatment should be considered as necessary. Aliskiren-containing products should not be initiated in diabetic patients who are also taking either an ACE inhibitor or ARB. Patients should be advised not to stop any treatment before discussing with a healthcare professional.
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