D-1 Pravastatin-Aspirin Combination The Medical Need Thomas A. Pearson, M.D., Ph.D. Albert D. Kaiser Professor of Community & Preventive Medicine University of Rochester School of Medicine 7asdf

D-2 Consistency of the Efficacy Findings Combination is more effective than aspirin alone –LIPID trial –CARE trial –meta-analyses of all 5 trials Combination is more effective than pravastatin alone –LIPID trial –CARE trial –meta-analyses of all 5 trials

D-3 Pravastatin-Aspirin Patient Population Potentially eligible population –all secondary prevention patients –12.4 million people Exclusions –contraindication to pravastatin (3%) –contraindication to aspirin (16%) Eligible population –10.4 million people Sources: ACC/AHA Guidelines 2001, 2001 Pharmametrics Database, Boston MA

D-4 Sources: ACC/AHA Guidelines 2001, NHLBI Chartbook 2000 and Adapted from Foot et al (JACC 2000) U.S. Heart Disease Prevalence Is Projected to Double in the Next Half Century

D-5 Medication Recommendations as Supplements to Lifestyle Modification: –Lipid-lowering therapy to achieve LDL-C of <100mg/dL –Antiplatelet therapy, principally aspirin –Anti-hypertensive therapy to achieve BP of <140/90 –Hypoglycemic therapy to achieve near normal fasting glucose (HbA 1C <7%) –ACE inhibitor –Beta-blocker Medication Recommendations as Supplements to Lifestyle Modification: –Lipid-lowering therapy to achieve LDL-C of <100mg/dL –Antiplatelet therapy, principally aspirin AHA/ACC Guidelines Update in Patients with Atherosclerotic CV Disease Source: Circulation (2001) 104:

D-6 Components of the Treatment Gap in the Secondary Prevention of Coronary Disease Many patients face a high pill burden Many patients fail to receive statins or aspirin Many patients are not optimally medicated –incorrect doses –incorrect therapy

D-7 A typical secondary prevention patient might be taking: –statin –aspirin –ACE inhibitor –beta-blocker A secondary prevention patient with diabetes might also be taking: –oral anti-diabetic agents Following New AHA/ACC Guidelines Necessitates High Pill Burden

D-8 Improved Compliance with Combination Tablet vs. Dual Therapy Diabetes 1 : –21% improvement in tablet consumption over 6 month period in previously treated patients Hypertension: –13% improvement in tablet consumption over 12 month period 2 –11% improvement in prescription renewal over 12 month period 3 HIV 4 : –9% reduction in missing even one dose over 16 week period 1 White & Hopson (2002) Clin Ther - in press 2 White & Hopson (2002) in press 3 Dezii (2000) Manag. Care 4 Eron et al (2000) AIDS

D-9 Components of the Treatment Gap in the Secondary Prevention of Coronary Disease Many patients face a high pill burden Many patients fail to receive statins or aspirin Many patients are not optimally medicated –incorrect doses –incorrect therapy

D-10 Sub-Optimal Usage at Discharge of CV Therapies with Proven Value Source: National Registry of Myocardial Infarction ,000 patients nationwide, July ’99 to June ’00. Includes CHD patients with no exclusions for contraindications or intolerance to these drugs.

D-11 Components of the Treatment Gap in the Secondary Prevention of Coronary Disease Many patients face a high pill burden Many patients fail to receive statins or aspirin Many patients are not optimally medicated –incorrect doses –incorrect therapy

D-12 Sub-Optimal Use of Efficacious Statin Doses: The LTAP Study Survey of 4888 patients from 619 primary care physicians –1460 patients with diagnosis of CHD All patients had to be receiving “lipid-lowering therapy” –Statins used in 85% of CHD patients Doses proven to be efficacious in secondary prevention trials were seldom used, even in CHD patients Source: Pearson et al: Arch Intern Med (2000)

D-13 Sub-Optimal Use of Aspirin in Secondary Prevention Among those with known cardiovascular disease, only 51% reported they were taking aspirin or an ‘equivalent’ Of those who thought they were taking aspirin correctly for secondary prevention: –15% were on non-aspirin analgesic Cook et al, (1999) Med Gen Med,

D-14 Pravastatin-Aspirin in CHD Patients: One Prescription – Two Proven Therapies Proven Doses Proven Products Conclusions Enhanced implementation of guidelines Appropriate pravastatin dose; no safety concerns More appropriate usage of aspirin Enhanced convenience and reassurance for patients and health care providers