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Aliskiren study terminated early once more: Following the premature termination of the ALTITUDE* study with aliskiren (RASILEZ) on top of high blood pressure treatment including ACE inhibitors or angiotensin II antagonists in diabetes patients at the end of 2011 due to adverse effects of the investigational medicinal product (a-t 2012; 43: 16), another study with the renin inhibitor, the APOLLO* study, is now being terminated by Novartis. According to the study registry, the APOLLO study was to involve 11,000 elderly patients with a minimum age of 65 years and to examine the effect of aliskiren on cardiovascular events such as heart attack or stroke. The manufacturer is not explaining the reasons for the study's termination, which to our knowledge took place against the recommendations of the data safety monitoring board and the steering committee. When asked about this, Novartis was "not prepared to comment". In the ALTITUDE study, which has still not been published in full, there was apparently a worse trend in the aliskiren group for five out of the seven components of the primary composite endpoint, particularly the rate of strokes and sudden death (HUGHES, S.: Heartwire dated 26 Aug. 2012/ati d). Also in the ASPIRE* study in heart attack patients, there has been a significant increase in adverse effects such as raised serum potassium levels and a numerical increase in mortality on aliskiren (SOLOMON, S.C. et al.: Eur. Heart J. 2011; 32: 1227-34). No positive results in relation to clinical endpoints have been published for the renin inhibitor. Despite the lack of proof of benefits and the signal of potential harm, more than 700,000 packs of aliskiren were dispensed through public pharmacies at a cost of about 60 million euros (ex-factory price) in 2011. We strongly advise against its use, - Ed.
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