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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

Ranexa™ for Chronic Angina An Unmet Need

Eugene Braunwald, MD, FACC

Harvard Medical School

Brigham and Women’s Hospital

slide2
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.

epidemiology of chronic angina
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
comorbid conditions complicate therapy
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.
persistent angina despite current drug therapy
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.
persistent angina despite percutaneous intervention pci
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.

persistent angina despite optimal revascularization
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.

self rating of health for angina patients

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

angina frequency and depression
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.

unmet need of chronic angina
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
unmet need of chronic angina11
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.

angina evolution of therapy

Ranexa™

PCI

CCB

CABG

 block

Nitrates

Angina—Evolution of Therapy

TREATMENT

1880 1965 1969 1975 1977 2004

  • O2 demand + + +
  • O2 supply + + ? +
  • ATP/O2 +

Likelymechanisms