ISHIB News Release: CAB Trial
FIRST OF ITS KIND STUDY IN AFRICAN AMERICANS SHOWS COMPARABLE EFFICACY AND SAFETY AMONG THREE COMMONLY USED BLOOD PRESSURE DRUGS
-- Results Translate Into Potential Cost-Savings for Patients and Health-care Providers --
ATLANTA - October 12, 1998 - According to a report published in the October 12 issue of Archives of Internal Medicine, a clinical trial focusing on the treatment of high blood pressure, or hypertension, in African Americans found comparable safety and efficacy among three medications commonly used to lower blood pressure in this group. The implications are critical to African Americans, a population known to have a higher incidence of hypertension and less access to health-care resources. If not treated, hypertension can lead to stroke, heart attack, kidney and eye problems, and even death.1
Results of the randomized, double-blind Calcium Antagonists in Blacks (CAB) trial, conducted by the International Society on Hypertension in Blacks, Inc. (ISHIB) and supported by Bayer Corporation, showed the once-daily calcium channel antagonist Adalat CC® (nifedipine CC) to be equivalent to once-daily calcium channel antagonists, Procardia XL® (nifedipine GITS) and Norvasc® (amlodipine) in maintaining blood pressure control over eight weeks. Further, all drugs showed a similar reduction in blood pressure. The incidence and severity of side effects were also equivalent.2
"The CAB trial shows us that all three of these commonly used medications provide comparable 24-hour blood pressure control and can be used safely for the treatment of hypertension in the African-American population," said co-principal CAB investigator Dallas Hall, MD, MACP, and ISHIB founder.
The results of the CAB trial could also mean substantial cost savings for patients and health-care providers since Adalat CC® is less expensive at comparable doses than Norvasc® or Procardia XL® in controlling blood pressure.
"Limited financial resources and access to health care remain particularly significant barriers to the treatment of high blood pressure in the African-American population. It is important to provide an effective, safe and well tolerated therapy at the lowest cost with the hopes of increasing compliance with antihypertensive therapy among these patients," said Kermit Payne, executive director of ISHIB.
Study Examined Population at Greatest Risk
The CAB trial is the first of its kind to directly compare three calcium channel antagonists in African-American patients.
"African Americans are at higher risk of hypertension than any other race or ethnic group, yet few studies have examined treatment effects exclusively in African Americans," said James Reed, MD, CAB lead investigator and president of ISHIB. "There is a great need to increase minority representation in all aspects of clinical research. Bayer and ISHIB collaborated in response to this need with the goal of making an innovative contribution to research in the important field of cardiovascular medicine."
Hypertension affects more than one-third of African-American adults3 compared to one quarter of American adults in the general population. 4 In addition to being more common, hypertension is also more dangerous in African Americans than in whites. In 1995, mortality rates from high blood pressure were 31.0 and 22.2 per 100,000 black males and females respectively vs. 6.8 and 5.0 per 100,000 white males and females respectively. 5
Summary Results: Equivalent Efficacy, Safety6
The CAB trial, conducted at 10 United States sites, evaluated the effects of Adalat CC®, Procardia XL® and Norvasc® in 163 patients with stage 1 or 2 hypertension. The primary endpoint was a comparison of the average reduction in 24-hour ambulatory diastolic blood pressure. Secondary endpoints included a comparison of average 24-hour ambulatory systolic blood pressure, office blood pressure (SBP or DBP) reduction, responder rates, safety and tolerability.
After eight weeks of therapy with Adalat CC®, Procardia XL® or Norvasc®, there was no significant difference in the average 24-hour ambulatory diastolic (-9.0, -8.5 and -6.1 mm Hg, respectively) or systolic (-15.7, -14.3 and -11.8 mm Hg, respectively) blood pressure reduction (P = NS). Discontinuation rates and adverse event frequency were distributed similarly across the three treatment groups. Adverse effects reported in the study included dizziness, cough, edema, flushing and headache.
Preliminary results of the CAB trial were presented in November 1997 at the annual meeting of the American Heart Association.
The International Society on Hypertension in Blacks, Inc. (ISHIB) is a not-for-profit, professional medical membership society devoted to improving the health and life expectancy of ethnic populations. ISHIB was founded in Atlanta, Georgia in 1986 to respond to the problems of high blood pressure among ethnic populations. ISHIB's organizational scope includes diabetes, stroke, lipid disorders, renal disease, and other related cardiovascular diseases.
Bayer Corporation has taken other steps, in addition to providing an educational grant for the CAB study, toward improving health-care in the African-American community, including starting "Take It To Heart," a hypertension, cholesterol and diabetes community screening program specifically for African Americans.
Bayer Corporation is committed to advancements in the cardiovascular area; Adalat CC® (nifedipine CC), for the treatment of hypertension, is one of a number of agents Bayer has developed in this area. Other drugs in the Bayer cardiovascular portfolio include Precose® for the treatment of type 2 diabetes, and most recently Baycol® for the treatment of high cholesterol.
Bayer Corporation is a research-based company with major businesses in health care and life sciences, chemicals and imaging technologies. The company had 1997 sales of $9.3 billion and employs 24,000 people. Bayer Corporation is investing approximately $9 billion in capital expenditures and research and development in its U.S. operations from 1995 through the year 2000. Capital expenditures for 1997 totaled $746 million, and $639 million was spent for R&D. Bayer Corporation, with headquarters in Pittsburgh, is a member of the worldwide Bayer Group, a $32 billion chemical and pharmaceutical company based in Leverkusen, Germany.
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References:
- National Heart, Lung and Blood Institute, Protect Your Heart, Prevent High Blood Pressure, Sept. 1997.
- Hall W D, Reed J W, Flack J M et al. Comparison of the Efficacy of Dihydropyridine Calcium Channel Blockers in African American Patients with Hypertension. Archives of Internal Medicine, October 1998; v158, p. 2029-2034.
- American Heart Association, 1998.
- National Heart, Lung and Blood Institute, 1998.
- American Heart Association, High Blood Pressure Statistics, 1998.
- Hall W D, Reed J W, Flack J M et al. Comparison of the Efficacy of Dihydropyridine Calcium Channel Blockers in African American Patients with Hypertension. Archives of Internal Medicine, October 1998; v158, p. 2029-2034.
Note:
Adalat CC® (nifedipine CC) is a registered trademark of Bayer Corporation
Procardia XL® (nifedipine GITS) and Norvasc® (amlodipine) are registered trademarks of Pfizer Inc
Prescribing information for Adalat CC®, Procardia XL® and Norvasc® is available via fax-on-demand by calling 1-800-753-0352, ext. 715.
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