Landmark UK study shows angina drug ikorel (nicorandil) helps protect the heart in patients with stable angina

LANDMARK UK STUDY SHOWS ANGINA DRUG IKOREL (nicorandil) HELPS PROTECT THE HEART IN PATIENTS WITH STABLE ANGINA IONA Study Findings published in The Lancet The Lancet 13th April 2002: New data from the IONA study published today in The Lancet show that the angina medication Ikorel can actually help to protect the heart from damage in people who suffer from chronic stable angina1. As well as being an effective angina therapy, the new study results show that Ikorel significantly reduced the combined incidence of death, heart attacks and hospital admission associated with coronary heart disease - this could potentially help over 1.5 million people in the UK who experience the distressing and disabling symptoms of angina. The IONA (Impact of Nicorandil in Angina) study1 is the largest study yet reported, into chronic stable angina amongst UK patients. It was designed to test whether Ikorel can protect the heart against life- threatening coronary artery events - like heart attacks - in people who are already being treated for angina. The study was conducted by the University of Glasgow, and recruited 5,126 people with stable angina. Approximately 8,500 patient years of data were collected. Earlier studies2 have suggested that Ikorel may have a 'cardioprotective' effect - that is, it may help to protect the heart from lasting damage after a coronary artery event such as a heart attack. Experts think it may work by mimicking a natural process that protects the heart from damage when there is too little oxygen. This cardioprotective effect has now been proven by the IONA study: researchers found that people taking Ikorel had a combination of fewer heart disease deaths, non-fatal heart attacks and admissions to hospital for chest pain (-17%, p=0.014). Lead Investigator of IONA, Professor Henry Dargie, at Glasgow University, commented: "The IONA trial demonstrates that nicorandil improves outcome in patients with chronic stable angina. This landmark study is the first demonstration of a reduction in major coronary events by specific anti-anginal medication in a trial large enough to address outcomes." These results suggest that Ikorel may play an important role as a potentially life-saving therapy for people with coronary artery disease, in addition to reducing the symptoms of angina. Nicorandil is marketed as Ikorel in the UK, where it was launched in 1994. It is currently licensed for the prevention and treatment of chronic stable angina. -ends- For more information, please contact: Sarah Taylor, Angela Conoley or Hayley Ewa Bird Wood Cohn & Wolfe Aventis Pharma Tel: 020 7331 5300 Tel: 01732 584 000 Fax: 020 7331 9084 Fax: 01732 584 080 E-mail: sarah_taylor@uk.cohnwolfe.com E-mail: ewa.bird@aventis.com angela_conoley@uk.cohnwolfe.com hayley_wood@uk.cohnwolfe.com References: 1. The IONA Study Group. Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in Angina (IONA) randomised trial. The Lancet 13th April 2002 2. Patel DJ, Purcell HJ, Fox KM (1999) Eur Heart J 20: 51-7 Notes to Editors #The IONA study was a multi-centre, double blind controlled study with patients randomised to receive placebo or nicorandil 10mg twice daily, increasing to 20mg twice daily after two weeks. Treatment was given in addition to patients' usual anti-anginal therapy for a duration of between 12 and 36 months. The trial received financial support from Aventis Pharma AG*, Chugai Pharmaceutical Co., Ltd. and Merck KGaA§. Nicorandil is co-promoted by Aventis Pharma and Merck Pharmaceuticals under the brand name Ikorel in the UK. §Merck KGaA Headquartered in Darmstadt/Germany, the Merck Group generated sales of EUR 6,7 billion in 2000 in the fields of Pharmaceuticals, Specialty Chemicals, Lab Products and Lab Distribution. Founded in 1668, the Merck Group is represented today by more than 200 companies in 52 countries and employs 34,300 people worldwide. The company groups its operating activities under Merck KGaA, in which E. Merck, as a general partner, holds the Merck family's 74 percent equity interest in Merck KGaA. The Merck Group strongly believes that promotion of its employees' self-initiative and self-responsibility, application- oriented research and development and close customer relationships in the markets are the keys to long-term corporate success. For more information, please visit www.merck.de. *Aventis (NYSE: AVE) is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes and respiratory disorders as well as on human vaccines. In 2001, Aventis generated sales of E 17.7 billion, invested approx. E 3 billion in research and development and employed approx. 75,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2002/04/11/20020411BIT00340/wkr0001.doc http://www.waymaker.net/bitonline/2002/04/11/20020411BIT00340/wkr0002.pdf