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Median follow-up results from the ALTITUDE study, stopped prematurely in December 2011

Hotline I - Late Breaking Trials on Prevention of Heart Failure

Munich, Germany – 26 August 2012: Preliminary results from the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE) do not support administration of aliskiren on top of standard therapy with renin-angiotensin-aldosterone system (RAAS) blockade in type 2 diabetics at high risk of cardiovascular and renal events, according to Professor Hans-Henrik Parving from Rigshospitalet, University of Copenhagen, Denmark. Presenting results from the study today, he said the treatment "may even be harmful".
Heart Failure (HF)

 

The ALTITUDE trial was stopped prematurely in December 2011 on recommendation of the data monitoring committee after it found an increased occurrence of side effects and continuation of the study was deemed  "futile". The study had been investigator initiated to determine whether use of the direct renin inhibitor aliskiren would improve prognosis by reducing fatal and non-fatal cardiovascular and renal events in type 2 diabetics at high risk of these complications. Macro- and microvascular complications of type 2 diabetes are augmented in those with concomitant kidney and/or cardiovascular disease.

ALTITUDE was an international double-blind study in 8561 subjects randomised to aliskiren 300 mg once daily or placebo on top of single RAAS blockade. The primary outcome measure was time to first event for the composite endpoint of cardiovascular death, resuscitated death, myocardial infarction, stroke, unplanned hospitalisation for heart failure, onset of end-stage renal disease or doubling of baseline creatinine.

At a median follow-up of 32 months the primary composite endpoint had occurred in 767 patients (17.9%) assigned to aliskiren and 721 (16.8%) assigned to placebo, HR for aliskiren vs. placebo 1.08 (95% CI 0.98-1.20, p=0.14). Stroke occurred in 146 (3.4%) of the aliskiren and 118 (2.7%) in placebo, HR 1.25 (95% CI 0.98-1.60, p=0.070).

Doubling of serum creatinine or end-stage renal disease was similar in the two groups and the mean reduction in albuminuria was 14% (95% CI 11-17) lower in aliskiren treated patients.

Patients in the aliskiren group experienced significantly increased serum potassium =6 mmol/L (8.8% vs. 5.6%), and reported hypotension (12.1% vs. 8.0%).

References

This press release accompanies both a presentation and an ESC press conference at the ESC Congress 2012. Edited by the ESC from material supplied by the investigator himself/herself, this press release does not necessarily reflect the opinion of the European Society of Cardiology. The content of the press release has been approved by the investigator.
Refers to session: Hot Line I: Late Breaking Trials on Prevention to Heart Failure

Refers to press conference:  Hotline I - Late Breaking Trials on Prevention of Heart Failure

Notes to editor

About the European Society of Cardiology
The European Society of Cardiology (ESC) represents more than 75,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.

About ESC Congress 2012
ESC Congress 2012 will take place from 25 to 29 August at the Messe München centre in Munich, Germany. Information on the scientific programme is available here. More information on ESC Congress 2012 is available from the ESC Press Office or contact us at press@escardio.org


 

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