New Analysis Showed Efient(R) Cost-Effective Compared with Clopidogrel for Patients with Acute Coronary Syndromes Underg

TOKYO and INDIANAPOLIS, January 5 /PRNewswire/ --

Results from a health economic substudy of the TRITON-TIMI 38 clinical trial showed that among patients with acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI), including stenting, treatment with Efient(R) (prasugrel) compared with branded clopidogrel (Plavix(R)) was more cost effective, and in most cases cost saving. These results were published in Circulation on January 5, 2010.(1)

In the pre-specified analysis of 6,705 patients, treatment with prasugrel compared with clopidogrel reduced total hospitalisation costs over approximately 15 months, not including the cost of study drugs, by US$530 per patient. This cost offset estimate includes bleeding-related costs that a sensitivity analysis showed were not a major driver of the overall cost difference between the two treatments.

The analysis also found that, including cost of the active study drugs as well as costs associated with the initial and subsequent hospitalisations, treatment with prasugrel compared with clopidogrel decreased cumulative medical costs by US$221 per patient over the 14.7-month study. Study drug costs used in the analysis were the net wholesale price as of August 2009, which was US$5.45 per day for prasugrel and US$4.62 per day for clopidogrel.

"Results of the cost-effectiveness analysis showed that treatment with prasugrel was highly cost effective and an economically dominant option," said David J. Cohen, M.D., M.Sc., director of cardiovascular research, Saint Luke's Mid America Heart Institute and professor of medicine, University of Missouri-Kansas City. "These favourable results were found in an analysis that considered only the first 30 days of treatment, as well as an analysis that considered the time period starting from 31 days through the rest of the follow-up period. These analyses are important because the results provide the healthcare community, including formulary decision makers, with new data regarding the cost-effectiveness of prasugrel for patients with ACS undergoing PCI."

"Dominant" is a health economics term used when a new treatment yields greater clinical effectiveness at lower costs. In TRITON-TIMI 38, prasugrel plus aspirin (ASA) was shown to significantly reduce the rate of a combined endpoint of cardiovascular death, non-fatal heart attack, or non-fatal stroke compared to clopidogrel plus ASA. In addition, patients treated with prasugrel also had significantly fewer stent thromboses (stent-related blood clots) compared to those treated with clopidogrel. These benefits were accompanied by a significantly higher risk of bleeding, which in some cases were life-threatening or even fatal in patients treated with prasugrel compared with clopidogrel.

The analysis also compared prasugrel to generic clopidogrel at a hypothetical cost of US$1 per day. When compared to clopidogrel at this lower cost, treatment with prasugrel in the subpopulation as a whole was economically dominant (e.g., cost saving) during the first 30 days of treatment. After day 31, it continued to be a cost-effective therapy relative to many other accepted medical interventions.

"The hypothetical comparison with generic clopidogrel is important because the patent exclusivity for clopidogrel will expire in the US in 2011 or 2012 and is already facing generic competition in several countries in the EU. Results from this comparison to generic clopidogrel will be useful information for the medical community, especially payers, in the future," said Dr. Cohen, "and suggest that the overall benefit of prasugrel was still favourable relative to its higher cost in this setting."

Study Methodology

TRITON-TIMI 38 was a Phase III, randomised, double-blind, head-to-head clinical trial comparing the effects of prasugrel versus clopidogrel in patients with ACS who were managed with PCI, a procedure to open blockages in heart arteries, including the use of coronary stenting. The study enrolled 13,608 patients at 707 trial sites in 30 countries.

The primary endpoint of the study was the combined incidence of cardiovascular death, non-fatal heart attack or non-fatal stroke during a median period of at least 12 months following PCI. Patients were randomly assigned to one of two treatment groups and given a loading dose of either prasugrel 60 mg or the FDA-approved loading dose of clopidogrel 300 mg, followed by a daily maintenance dose of either prasugrel 10 mg or clopidogrel 75 mg. All patients also received a daily dose of aspirin (75 mg to 325 mg).

The economic analysis was completed using data from 6,705 study patients enrolled in eight pre-specified countries, including the United States, Australia, Canada, France, Germany, Italy, Spain and the United Kingdom. The primary economic measure was total in-trial costs including hospitalisation and medication costs. The approach to estimating costs was to multiply counts of resource use (hospitalisations, physician costs, procedures, medications) by price weights derived from comparable populations of US patients. All costs other than study drug costs were assessed in 2005 US dollars.

About Prasugrel

Daiichi Sankyo Company, Limited, and Eli Lilly and Company co-developed prasugrel, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd. Prasugrel helps keep blood platelets from clumping together and developing a blockage in an artery. The European Commission granted marketing authorisation for prasugrel for the prevention of atherothrombotic events in patients with ACS undergoing PCI.

About Acute Coronary Syndrome

Acute coronary syndrome includes heart attacks and unstable angina (chest pain). Coronary heart disease, which can result in ACS, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.(2) In addition, ACS affects nearly 1.5 million people in the United States annually.(3) Heart attack is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits. In some cases the plaque can rupture, resulting in a blood clot, which may partially or totally block the blood supply to portions of the heart, resulting in ACS. Many ACS patients undergo PCI to re-open the artery, which usually includes a stent placement.

Important Safety Information about Prasugrel

In the EU prasugrel label, the risk of non-coronary artery bypass graft (non-CABG) major bleeding, including fatal bleeding, was higher with prasugrel (2.2 percent incidence) compared with clopidogrel (1.7 percent incidence). Compared with the overall study population, a higher risk of serious bleeding among prasugrel patients was most evident in three distinct patient populations that are readily identifiable: patients who weighed less than 60 kg (132 lbs), patients who were 75 years of age or older and patients who have had a prior transient ischemic attack (TIA) or stroke. Patients who weighed less than 60 kg, or were 75 years of age or older had increased exposure with prasugrel. In the EU prasugrel label, a 5 mg maintenance dose is recommended for patients who weigh less than 60 kg. Prasugrel is generally not recommended for use in patients 75 years or older; if treatment is deemed necessary in this age group, a 5 mg maintenance dose should be prescribed. Patients with prior TIA or stroke should not be treated with prasugrel.

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