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Ranexa™ for Chronic Angina An Unmet Need

Ranexa™ for Chronic Angina An Unmet Need. Eugene Braunwald, MD, FACC Harvard Medical School Brigham and Women’s Hospital.

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Ranexa™ for Chronic Angina An Unmet Need

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  1. Ranexa™ for Chronic Angina An Unmet Need Eugene Braunwald, MD, FACC Harvard Medical School Brigham and Women’s Hospital

  2. There is a strong disorder in the breast. The seat of it, and sense of strangling and anxiety with which it is attended, may make it not improperly be called angina pectoris.… Those who are afflicted with it, are seized, while they are walking with a painful and most disagreeable sensation in the breast, which seems as if it would take their life away, if it were to increase or to continue. CM-2 Heberden. Medical Transaction, Royal College of Physicians of London. 1772;2:59-67.

  3. Epidemiology of Chronic Angina • AHA reports that at least 6.6 million Americans suffer with angina pectoris • Despite therapeutic advances • > 13 million episodes of angina a week in the US • > 1000 episodes of angina every minute • Growing prevalence of chronic angina due to reductions in cardiovascular mortality • Improved treatment of angina is an important goal

  4. Comorbid Conditions Complicate Therapy Studies of VA patients with CAD demonstrate the following comorbidity incidence rates • Diabetes: 26% to 31% • COPD: 13% to 22% • Peripheral vascular disease: 16% to 28% • Congestive heart failure: 20% • Rumsfeld, 1999.

  5. Persistent Angina DespiteCurrent Drug Therapy • Despite use of traditional anti-anginal agents (-blockers, CCBs, and nitrates), patients still reported an average of 2 anginal attacks/week† • A significant percentage of patients have relative intolerance to full doses of -blockers, CCBs, and nitrates • -blockers and many CCBs have similar depressive effects on BP, HR and/or AV nodal conduction • It would be desirable to develop an anti-anginal drug without these limitations • †Pepine, 1994.

  6. 1 yr after PCI for. . . Symptom relief(N = 1403) Treatment of acute myocardial infarction(N = 352) . . . the overall prevalence of angina was 26% Persistent Angina DespitePercutaneous Intervention (PCI) Angina at 1-yr follow-up by events during or after initial PCI Holubkov R, et al. NHLBI Dynamic Registry. Am Heart J. 2002;144:826-833.

  7. Persistent Angina DespiteOptimal Revascularization 1 yr after optimal revascularization by stenting or surgery for relief of ischemia (ie, not to prolong survival) … TABLE 3. STATUS WITH RESPECT TO ANGINA AND MEDICATION USE AND QUALITY OF LIFE AMONG SURVIVING PATIENTS.* ~ 60% to 80% are still taking anti-anginal medications ~ 10% to 20% still have angina Serruys PW, et al. for the ARTS Study Group. N Engl J Med.2001;344:1117-1124.

  8. Vitality General health Self Rating of Health for Angina Patients Angina patients Chen AY, et al. Med Decis Making.1996;16:169-177. 100 Normal US population 90 80 70 60 SF36 scores 50 40 30 20 10 0 Physical function Bodily pain

  9. Angina Frequency and Depression • 1957 patients completed SAQ 7 mo after ACS • History of depression documented in 526 (26.7%) patients following ACS • Strong correlation of angina frequency with depression 50 45 40 35 30 % depression 25 20 15 10 5 0 None Monthly Weekly Daily Angina frequency ACS = acute coronary syndrome SAQ = Seattle Angina Questionnaire Rumsfeld JS, et al. Am Heart J.2003;145:492.

  10. Unmet Need of Chronic Angina • Angina continues in many patients despite medical therapy and mechanical revascularization • The personal burden can deprive many patients of their functional independence, forcing them to downsize their lives • The economic toll of angina places a huge burden on patients, their families, the healthcare system, and society

  11. Unmet Need of Chronic Angina When angina cannot be eliminated by current drugs, it is often their additive effects on BP, HR, AV conduction, and other important side effects (depression, fatigue, sexual/sleep disorders, etc.) that preclude complete relief.

  12. Novel Therapies Needed for a Growing Angina Burden 6 4 Patients, millions 2 0 1900 2000

  13. Ranexa™ PCI CCB CABG  block Nitrates Angina—Evolution of Therapy TREATMENT 1880 1965 1969 1975 1977 2004 • O2 demand + + + • O2 supply + + ? + • ATP/O2 + Likelymechanisms

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