Business Editors/Health & Pharmaceutical Writers
BERLIN–(BUSINESS WIRE)–Sept. 2, 2002
Results of a large clinical trial comparing COZAAR(R) (losartan potassium tablets) to captopril, an angiotensin converting enzyme (ACE) inhibitor, in the treatment of patients with acute myocardial infarction (commonly known as a heart attack) were presented today at the Congress of the European Society of Cardiology (ESC).
The 5,477 patient randomized, double-blind study — the Optimal Trial in Myocardial Infarction with Angiotensin II Antagonist Losartan (OPTIMAAL) — was designed to determine if COZAAR would be either superior or non-inferior to an ACE inhibitor, captopril, in decreasing the risk of all-cause death in high-risk patients following an acute myocardial infarction (MI) complicated by, or with an increased risk of heart failure. Patients in the trial were randomized to treatment with COZAAR or captopril within 10 days of experiencing an acute MI. Dosing for COZAAR was started at 12.5 mg once daily and titrated as tolerated to a maximum dose of 50 mg once daily, with a mean dose of 45 mg once daily achieved. The dosing for captopril was started with one initial dose of 6.25 mg, was continued at 12.5 mg three times a day, and then titrated, as tolerated, to a maximum dose of 50 mg three times daily. The mean dose achieved was 44 mg three times daily.
In OPTIMAAL, COZAAR was neither superior nor non-inferior to captopril in reducing all-cause mortality in patients with acute MI, with a non-significant difference in favor of captopril.
“Results of any trial apply only to the cohort studied. viagra. In OPTIMAAL, the study population consisted of high-risk patients following an acute MI, with evidence of heart failure and/or left-ventricular dysfunction,” said Kenneth Dickstein, M.D., Ph.D., coordinator of the OPTIMAAL steering committee and professor of medicine at the University of Bergen, Bergen, Norway. “An acute MI is a potentially life-threatening condition during which blood flow to a region of the heart is abruptly interrupted and cell death occurs. This is certainly a common cause of heart failure.”
Approximately 1 million people in the United States experience an acute MI yearly.
COZAAR is indicated for the treatment of hypertension with the usual starting dose of 50 mg once daily. In the United States, approximately 50 million people, or one in five, have hypertension.
The OPTIMAAL study assessed an investigational use of COZAAR.
Results of OPTIMAAL
The intention to treat analysis of the primary endpoint showed:
— There were 447 deaths in the 2,733 patient captopril group
versus 499 deaths in the 2,744 patient group treated with
COZAAR. The difference between the two groups was not
statistically significant (p=0.069).
For the secondary and tertiary endpoints, the differences between treatment groups were also not statistically significant. Specifically these results were:
– The combined endpoint of sudden cardiac death and/or resuscitated cardiac arrest occurred in 203 patients in the captopril group versus 239 patients in the group treated with COZAAR (p=0.072).

– Fatal or non-fatal MI occurred in 379 patients in the captopril group compared to 384 patients in the group treated with COZAAR (p=0.722).

The study investigators also presented the results of the combined endpoint of all-cause mortality and fatal/nonfatal reinfarction and on the endpoints of cardiovascular death, stroke (fatal and nonfatal), coronary revascularization and first all-cause hospitalization. There was no statistically significant difference between the two groups on these endpoints except for cardiovascular death. Cardiovascular death occurred in 363 patients in the captopril group compared to 420 patients in the group treated with COZAAR (p=0.032).
Tolerability of COZAAR in OPTIMAAL
In the OPTIMAAL trial, COZAAR was significantly better tolerated in study patients. Among the patients treated with captopril, 387 patients discontinued study medication due to adverse experiences during the course of the trial, whereas 202 patients in the group treated with COZAAR discontinued medication due to adverse experiences (p
source