Crestor hailed as first drug to reverse cardiovascular disease
pharmafile | March 14, 2006 | News story | Research and Development |Â Â Â
Researchers have hailed results from a new study of Crestor which shows it can reverse atherosclerosis, the furring up of the arteries which can trigger a heart attack.
AstraZeneca's Crestor (rosuvastatin) is the first drug shown to unclog the arteries in patients, prompting researchers and experts to hail the results as a breakthrough.
Data from 349 patients involved in the latest arm of the Galaxy trial of the drug showed the build up of plaque in arteries was reduced in 80% of patients.
Dr Howard Hutchinson, AstraZeneca's head of clinical research said: "We designed the Galaxy clinical programme to confirm the hypothesis that Crestor has a positive impact on atherosclerosis and cardiovascular events. The results from Asteroid represent an exciting step towards confirming our hypothesis."
Researchers used coronary angiographies to establish patients had coronary artery disease (CAD) and then gave patients 40mg doses of the drug for two years, with plaque volume measured before and after treatment.
The results showed plaque was reduced by between 7-9% while LDL-C or bad cholesterol levels fell 53% and HDL-C or good cholesterol was raised 15%
AstraZeneca says the results are an important new finding and show the benefits of aggressive management of cholesterol, and will hope the results could eventually translate into a commercial advantage for the drug.
Crestor has struggled to compete with the runaway market leading statin, Pfizer's Lipitor, but the new study could help it close on its rival.
News of the apparent breakthrough has been seized on by the UK media, with no fewer than four national newspapers putting the story on their front page.
Independent experts have also given a cautious welcome to the trial results.
Professor Peter Weissberg, Medical Director of the British Heart Foundation said: "This is an important study as it is one of the first to report on the newest statin, rosuvastatin (Crestor). It uses a very aggressive approach, with the highest dose of what is the most potent statin on the market.
"Previously it was thought that statins saved lives by stabilising plaques – the build up of fatty deposits in the arteries, thereby preventing them from rupturing to cause a heart attack or stroke.
"This study encouragingly seems to demonstrate a small but definite regression of atherosclerotic plaques."
He cautioned that the trial had not been designed to show whether the high-dose regime could help save more lives.
"Whilst the results sound promising and are likely to translate into a better outcome for heart patients, we still need further studies to confirm whether the regression demonstrated translates to fewer heart attacks."
Most patients are not prescribed 40mg of Crestor, with most likely to be started on either 5 or 10mg.
Concerns about the incidence of side-effects in high doses of Crestor led to the drugs starting dose being lowered in 2005, but regulators have indicated they remain confident about its benefit/risk profile.
