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ALTITUDEAliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpointswas a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney diseasecardiovascular diseaseor bothThe study was terminated early because of an increased risk of adverse outcomesCardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interesthyperkalaemiahypotension and renal dysfunctionwere more frequently reported in the aliskiren group than in the placebo group.

The dose should be individualised according to patient profile and blood pressure responsesee section 4.4

Fetal toxicity may developdiscontinue if pregnancy is detectedRenal impairmentDialysisesphigh-flux membraneSalt/volume depletionHypertrophic cardiomyopathySevere CHFIschemic heart diseaseCerebrovascular diseaseHyponatremiaRenal artery stenosisSurgeryMonitor BPelectrolytesrenal and liver functionMonitor serum potassium in diabeticsDiscontinue if angioedema or laryngeal edemajaundice or marked elevations of liver enzymes occurBlack patients may have higher rate of angioedema than non-Black patientsElderlyNeonatesPregnancymonitorNursing mothersnot recommended.

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ACE inhibitor and thiazide therapy may impair glucose toleranceDosage adjustment of antidiabetic agentsincluding insulinmay be requiredIn diabetic patients treated with oral antidiabetic agents or insulinglycaemia levels should be closely monitored during the first month of treatment with an ACE inhibitorLatent diabetes mellitus may become manifest during thiazide therapy.

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver diseasesince minor alterations of fluid and electrolyte balance may precipitate hepatic comasee section 4.3RarelyACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant necrosis andsometimesdeathThe mechanism of this syndrome is not understoodPatients receiving lisinopril/hydrochlorothiazide who develop jaundice or marked elevations of hepatic enzymes should discontinue lisinopril/hydrochlorothiazide and receive appropriate medical follow-up.

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