Speaker's Remarks

December 17, 2002

Press Conference Remarks

Release of the Results of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial: What Makes ALLHAT Special?

Good morning.

Before we get to the detailed results, we feel it is important to highlight several ways in which ALLHAT is a special--and highly relevant--clinical trial. I'll start by emphasizing a few key aspects of the hypertensive component of ALLHAT.

First, ALLHAT was designed to provide much needed scientific evidence concerning the appropriate selection of blood pressure medications.

• Today, there are well over 100 antihypertensive drugs representing 7 major drug classes on the U.S. market. All of these agents were approved by the FDA based on their ability to lower high blood pressure.
• There are few large clinical trials that have actually compared the health effects of different blood pressure drugs on the cardiovascular risks of hypertension--namely, heart attacks, stroke and heart failure. Without a trial such as ALLHAT to compare the effects of different drugs, we could not answer the important question, "Does it matter which drug is used to control elevated blood pressure?"
• ALLHAT looked at the treatment effects of these drugs on all major cardiovascular complications of high blood pressure, not just on high blood pressure per se. Recognizing that all drugs studied in ALLHAT have many mechanisms of action over and above blood pressure lowering, we examined these "non-blood pressure" effects so we could weigh them against the benefit conveyed by blood pressure lowering.
• The focus of ALLHAT was on the initial drug selection - the first-line drug.

Second, as designed, the ALLHAT findings have very broad applicability.

• ALLHAT is the largest hypertension clinical trial ever conducted--more than 42,000 patients enrolled.
• ALLHAT was specifically seeking representation from population groups that are often underrepresented in clinical trials. Nearly one-half were women; about 35 percent were black; and about 20 percent were Hispanic.
• Other groups of individuals who are at high risk of cardiovascular disease, such as older patients and those who have diabetes, were also specifically recruited.
• The results of ALLHAT can be broadly applied to the general population also because the study was done in settings that reflect "real-life" situations and with medications that are commonly prescribed in general practice. More than 600 sites across the United States, as well as in Puerto Rico, the U.S. Virgin Islands, and eastern Canada participated. These sites were largely in community-based physician practices; they also represented V.A. hospitals, academic centers, military clinics and community health centers, HMOs and other managed care organizations--nearly every conceivable, appropriate health setting in the United States, and beyond.
• Similarly, the ALLHAT investigators were clinicians who routinely treat patients with hypertension and other cardiovascular conditions.

Finally, ALLHAT's results have far-reaching implications and applications.

• The findings have the potential of improving individual care for patients with high blood pressure, and, ultimately, to improve the health of the U.S. population.
• ALLHAT's results could help lower the treatment cost for patients and for insurers. The trial compared lower cost diuretics, which are available in generic form, with more recently developed drugs that are more costly. A core question posed by ALLHAT was "Do the more expensive drugs add value?"
• Payors of health care will also benefit from valuable information about optimal care, resource utilization, and scientific evidence regarding the most effective and the most cost-effective blood pressure prescription drugs.

Large clinical trials like ALLHAT that compare different treatments are essential to our society. They provide reliable evidence concerning how best to treat different health conditions and how to curtail escalating costs of health care, including prescription drugs. These issues are particularly relevant in ALLHAT, which combined two trials--the study of hypertension drugs and the study of statins versus "usual care" to treat high blood cholesterol--to address the disease area that kills more men and women than any other condition. ALLHAT represents a major contribution by the NHLBI to the Nation's health and to science.

Dr. Wright...