CARDIOVASCULAR & RENAL DRUGS ADVISORY COMMITTEE

May 24, 2001

The Antihypersensitive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

Pfizer Pharmaceuticals Group  pdf

Disclaimer

The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Appendix 1A - Davis, Barry R, et al, "Rational and Design for the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)," American Journal of hypertension Ltd, 1996, pp 342-360.*

Appendix 1B - "NHLBI Stops Part of Study - High Blood Pressure Drug Performs No Better Than Standard Treatment," March 8, 2000   pdf

Appendix 1C -Messerli, Frank H, "Implications of discontinuation of doxazosin arm of ALLHAT," The Lancet, Vol 355, March 11, 2000, pp 863-864. *

Appendix 1D - "American College of Cardiology Issues Clinical Alert on the Use of Alpha Blockers for Hypertension," March 15, 2000   pdf

Appendix 1E - "ACC Clarifies Clnical Alert on Alpha Blockers for Hypertension Treatment," March 23, 2000   pdf

Appendix 1F - "Major Cardiovascular Events in Hypertensive Patients Randomized to Doxazosin vs Chlorthalidone: The Antihypertensive and Lipid-Lowering treatment to Prevent Heart Attack Trial (ALLHAT)," JAMA, April 19, 2000, Vol. 283, pp 1967-1975. *

Appendix 1G - Lasagna, Louis, MD, "Diuretics vs a-Blockers for Treatment of Hypertension," JAMA, April 19, 2000, Vol. 283, pp 2013-2014. *

Appendix 1H - Kostis, John B, MD et al, "Prevention of Heart Failure by Antihypertensive Drug Treatment in Older Persons With Isolated Systolic Hypertension," JAMA, July 16, 1997, Vol. 278, pp 212-216. *

Appendix 1I - Staessen, Jan, et al, "Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension," The Lancet, September 13, 1997, Vol. 350, pp 757-764. *

Appendix 2A - Preferred Terms Identified to be Reported in Clinical Trials Tables   pdf

Appendix 2B - List of Doxazosin Protocols with Released Databases (N=271)   pdf

Appendix 2C - Treatment emergent, All Causality Incidence of Selected Cardiovascular Events, By Protocol ID   pdf

Appendix 3 - Review of Pfizer Early Alert Safety Database   pdf

Appendix 4 - Drug Safety Research Unit, DOXAZOSIN, PEM Report Number 17, January 1995*

Appendix 5A - References   pdf

Appendix 5B - References   pdf

Appendix 6 - Statement from the External Advisory Committee, Medical Therapy of Prostatic Systems (MTOPS) Trial Concerning ALLHAT Report on Effect of Alpha-Blocker on Cardiovascular Disease Events Telephone Conference Call of April 25, 2000   pdf

 

 

*Copyrighted material may be viewed at:  Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland  20852.