Bristol, TN and Collegeville, PA – January 11, 2005 – A study published in a recent issue of Circulation, the official journal of the American Heart Association, reports that ALTACE® (ramipril), an ACE inhibitor (ACE-I), shows long-term benefits in reducing the risk of suffering a cardiovascular event in high risk patients age 55 and older. These patients are at high risk for developing a major cardiovascular event, either because of a history of coronary artery disease, stroke, or peripheral vascular disease or because of diabetes that is accompanied by at least one other cardiovascular risk factor.
The study, Heart Outcomes Prevention Evaluation – The Ongoing Outcomes, also known as HOPE-TOO, is a continuation of the original landmark HOPE study, which previously found that ALTACE 10 mg significantly reduced the risk of cardiovascular events in high-risk patients 55 and older. The HOPE-TOO study, a 2.6-year trial extension of HOPE, was conducted to determine whether the cardiovascular benefits of ALTACE 10 mg would continue beyond the 4.5 years originally studied in HOPE. After seven years of treatment, the HOPE and HOPE-TOO studies showed a 17 percent reduction in relative risk in the combined end point of risk of cardiovascular death, MI, or stroke for those patients originally assigned to the ALTACE group.
“The publication of the HOPE-TOO study in Circulation shows the significance of this study,” says Charles L. Pamplin, III, M.D., Vice President Medical Affairs, King Pharmaceuticals. “Men and women age 55 and older are at increasing risk for suffering a cardiovascular event. The important news shown through the additional data from HOPE-TOO is that ALTACE not only reduces this risk of CV events for this age group but also sustains the risk reduction. This is excellent news for high-risk patients age 55 and older taking ALTACE 10 mg who may benefit from its long-term effects.” Patients who remained on ALTACE in HOPE and HOPE – TOO over 7 years showed sustained benefit. The long-term ALTACE group had significant all-cause reductions in heart attacks, strokes, and cardiovascular events compared with the short-term ACE-I group. Sustained ALTACE therapy in high-risk patients can, independently of other treatments, reduce cardiovascular events.
ABOUT THE STUDY During HOPE-TOO, the primary analysis included 6,786 patients from the original 9,297 randomized in HOPE. After the original HOPE study was stopped early due to clear benefits of ramipril in reducing the risk of cardiovascular events, all patients were offered the opportunity to be treated with active, ACE-I therapy. Although these patients were no longer assigned to ALTACE or placebo, approximately 70 percent of patients in HOPE-TOO opted to take an ACE – I. Of these, 90 percent received ALTACE as part of standard care. The effects of ALTACE in the HOPE-TOO trial were evaluated across multiple subgroups defined by risk and among those using other proven drug therapies. In addition, the authors noted that the beneficial effect of ALTACE on the primary composite end point was consistently observed among subgroups analyzed in both the main randomized HOPE trial and the HOPE-TOO extension.
Significant cardiovascular risk reduction benefits were also observed among patients taking ALTACE with other therapies including aspirin, beta-blockers, and lipid-lowering drugs at the beginning of the trial, either in combination or individually, as well as those not taking these medications.
The results of the HOPE-TOO study were released by the Population Health Research Institute at McMaster University in Hamilton, Ontario, Canada. For more information regarding the HOPE-TOO study, see the August 30, 2005, issue of the American Heart Association’s Circulation at www.circ.ahajournals.org. ABOUT ALTACE (ramipril) ALTACE is a product of King Pharmaceuticals, Inc. and is copromoted by King Pharmaceuticals and Wyeth.
ALTACE is indicated in patients 55 years or older at high risk of developing a major cardiovascular event, either because of a history of coronary artery disease, stroke, or peripheral vascular disease or because of diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of stroke, myocardial infarction, or death from cardiovascular causes. ALTACE can be used in addition to other needed treatments (such as antihypertensive, antiplatelet, or lipid-lowering therapies).
IMPORTANT SAFETY INFORMATION
Prescription ALTACE is not for everyone. ALTACE may cause swelling of the mouth, tongue, or throat, which could cause extremely serious risk and requires immediate medical care. There have been rare reports of low blood sugar in patients taking ALTACE with medicine for diabetes. Patients should contact their doctor if they have symptoms of low blood sugar such as sweating or shakiness. Common side effects include persistent dry cough, dizziness, and light-headedness due to low blood pressure.
ALTACE should not be taken during pregnancy, as death or injury to the unborn child may result, or if a person has experienced serious side effects related to previous ACE inhibitors5. For more information about ALTACE and for a copy of the important Product Information, please visit www.ALTACE.com.
ABOUT KING PHARMACEUTICALS King, headquartered in Bristol, Tennessee, is a vertically integrated pharmaceutical company that develops, manufactures, markets and sells branded prescription pharmaceutical products. King, an S&P 500 Index company, seeks to identify promising opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management.
ABOUT WYETH PHARMACEUTICALS Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), has leading products in the areas of women’s health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare, and Fort Dodge Animal Health.
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References Bosch J, Lonn E, Pogue J, et al, for the HOPE/HOPE-TOO Study Investigators. Long-term effects of ramipril on cardiovascular events and on diabetes:, results of the HOPE study extension. Circulation, 2005; 112: 1339-1346.
Gerstein HC, Yusuf s, Mann JFE, et al, for the HOPE Study Investigators. Effects of an angiotensin-converting–enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000;342:145-153.
Anderson RN. Deaths: leading causes for 2000. National Vital Statistics Report. 2002; 50: 1-85.
American Heart Association. Heart Disease and Stroke Statistics-2005 Update, Dallas, TX: American Heart Association; 2005.
