Tekturna fails to show heart attack benefit
pharmafile | March 17, 2010 | News story | Research and Development | Diovan, Novartis, Tekturna, hypertension
Novartis’ hypertension treatment Tekturna has failed to show it helps patients recover from a heart attack when added to standard treatment.
The 36-week ASPIRE study involve 820 patients and was designed to help limit changes to the heart’s shape in patients after a heart attack.
But results showed that adding Tekturna (aliskiren) did not provide the anticipated effect of limiting adverse changes to the heart’s left ventricle, which is the organ’s main pumping chamber.
The study, which was presented at the American College of Cardiology meeting in Atlanta, showed a small numerical reduction in cardiac volume from adding Tekturna to standard therapy, but this was not statistically significant.
The combined rates of cardiovascular death, hospitalisation for heart failure, recurrent heart attack, stroke and resuscitated sudden death were similar in the Tekturna group and the group given standard therapy.
Patients in the Tekturna group also experienced a higher rate of side effects, among them hyperkalaemia and kidney dysfunction, than the group receiving standard therapy alone.
The ASPIRE trial is one of 14 clinical exploratory trial programmes of 35,000 patients designed to evaluate Tekturna’s potential benefit beyond its current indication of blood pressure reduction.
Currently, Novartis’ own Diovan (valsartan), indicated for hypertension and post-myocardial infarction (heart attack), is the biggest selling cardiovascular treatment.
Novartis other hypertension medicines include Exforge, Lotensin, Lotrel and Tekturna, and the three largest – Diovan, Exforge and Tekturna – collectively made Novartis $7 billion last year.
Diovan was the largest contributor to this total, making $6 billion in 2009, but it is approaching patent expiry and Novartis looking to its other hypertension products to help replace the revenue loss this will entail.
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