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Atorvastatin Addition to High Blood Pressure Treatment Reduces Heart Events: Presented at ACC

By Ed Susman

CHICAGO, IL -- April 3, 2003 -- Addition of atorvastatin results in marked reductions in heart attacks, strokes, and cardiac events in patients being treated for high blood pressure and high cholesterol, according to results from the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT).

The trial was stopped early -- after 3.3 years of its 5-year schedule -- because the Data Safety Monitoring Board detected that patients in the atorvastatin cohort were having better outcomes than patients receiving placebo, said Dr. Peter Sever, Imperial College, London, England. He presented the findings here April 2^nd at the 55^th Annual Scientific Session of the American College of Cardiology.

The study recruited 18,000 patients to determine which of 2 anti-high blood pressure strategies controlled blood pressure and prevented cardiac events. About half those patients were then entered into the study to determine whether administration of atorvastatin would influence outcomes.

Dr. Sever said that on average, the patients in the study had modestly elevated cholesterol -- 213 mg/dL, a level that is not necessarily treated. The patients had an average age of 63 years and 81% were men. The most common risk factors for heart disease were hypertension (100%), male gender, and age above 55 years (84%).

The lipid part of ASCOT enrolled 5,168 patients to receive atorvastatin and 5,137 to receive placebo. At the end of the trial, 185 of the atorvastatin patients had died compared with 213 placebo patients, said Bjorn Dahlof, MD, of Sahlgrenska University Hospital, Ostra, Sweden, co-chairman of the study. The difference in mortality trended to favor atorvastatin, but did not achieve statistical significance, he said.

On the other hand, Dr. Dahlof noted that atorvastatin prevented cardiac events, even though blood pressure control was well maintained by patients on the initial part of the study. The average blood pressure in the study participants was 138/80 mm Hg. Atorvastatin reduced cholesterol levels from an average of 213 mg/dL to about 170 mg/dL for the patients getting active treatment.

Patients on atorvastatin had a 30% reduced risk of reaching the primary end point of fatal and nonfatal coronary heart disease -- including silent heart disease. Dr. Dahlof said 100 patients on atorvastatin experienced the end point compared with 154 on placebo. That was statistically significant at the P=0.005 level, he said.

Other results on atorvastatin compared with placebo:
- Stroke was reduced by 27%.
- All cardiovascular events were reduced by 21%.
- All coronary events were reduced by 29%.

All those differences reached statistical significance, Dr. Dahlof said.

The number of noncardiovascular deaths was higher in the placebo arm, although the difference did not reach statistical significance.

Bertram Pitt, MD, professor of medicine at the University of Michigan, Ann Arbor, and moderator of the late-breaker session at which Dr. Dahlof presented his study, said the results would be immediately relevant to clinical practice. The addition of atorvastatin to patients that fit the ASCOT cohort profile was justified, he added.

The principal sponsor of ASCOT is Pfizer Inc, New York. Support was also provided by Servier Research Group, Paris, and Leo Laboratories, Copenhagen.


[Study title: The Anglo-Scandinavian Cardiac Outcomes Trial: Morbidity-Mortality Outcome From Lipid-Lowering in a Hypertensive Population. Abstract: 421-3]

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