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Rationale and Context: Pravastatin-Aspirin Overview

Rationale and Context: Pravastatin-Aspirin Overview. Fred T. Fiedorek, M.D. Vice President, Clinical Design & Evaluation and Exploratory Development Pharmaceutical Research Institute Bristol-Myers Squibb.

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Rationale and Context: Pravastatin-Aspirin Overview

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  1. Rationale and Context: Pravastatin-Aspirin Overview Fred T. Fiedorek, M.D. Vice President, Clinical Design & Evaluation and Exploratory DevelopmentPharmaceutical Research InstituteBristol-Myers Squibb

  2. Pravastatin-Aspirin Advisory Committee – Jan 18, 2002 and Today: Requisites for a Combination Product • Different mechanisms of action of components • No PK interaction between components • Both components contribute to efficacy, in this case with clinical outcome event reduction • Addresses a medical need • Appropriate dose combinations available • Acceptable safety and tolerability profile

  3. “. . . two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling for the drug.” 21 C.F.R. § 300.50 (a) (Underlined emphasis added) Context: Current FDA Fixed-Dose Combination Regulation Established 1971

  4. Fixed-Dose Combination Goals Cited by FDA in 1971 Regulations Remain Relevant Today • Four Key Components – Still a Valid Framework • Efficacy – Through complementary mechanisms for secondary prevention in CHD patients • Safety – In CHD patients, including in clinical situations surrounding surgery • Contribution – (A + B > both A and B alone) • Medical Need – Demonstrated population at risk

  5. . . . Plus for Pravastatin-Aspirin • Comprised of component drugs at selected doses previously approved by the FDA • Labeled only for secondary prevention, an indication previously approved for each component • Practice patterns and medical guidelines support concurrent use

  6. Risk of a CHD Event Based on Placebo Event Rates DIAGNOSIS 10-year Risk of CHD Event (MI and CHD Death) • History of acute MI • LIPID 31% • CARE 26% • 4S 51% • Revascularization procedure 25-30% • Stable angina pectoris 20% www.nhlbi.nih.gov/guidelines/cholesterol/atp3_rpt.htm

  7. Conclusions • Pravastatin-Aspirin: A rational combination product supported through evidence-based medicine • Three doses of pravastatin to be provided: 40mg, 80mg and 20mg • Safety of aspirin and favorable benefit:risk profile in CHD patients • Possible advantages of prescription aspirin in a clearly labeled combination product relative to OTC preparations

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