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Drug/intervention combinations offer benefit in severe CVD

Cardiogenic shock is diagnosed when the heart's ability to pump is markedly reduced, causing a "shock-like" state; the condition often occurs as a result of AMI. Studies have shown that overproduction of nitric oxide after a heart attack may play a significant role in the development and persistence of CS, and researchers predicted that Tilarginine Acetate (TAI) may play a role in inhibiting nitric oxide to prevent further damage to the heart muscle, improve blood pressure and improve survival after cardiogenic shock.

Patients with cardiogenic shock due to LV failure (ejection fraction <40 %) and systolic blood pressure (SBP) less than 100mmHg despite vasopressor support for at least one hour post-open artery (coronary angioplasty in the vast majority) were randomized to placebo or TAI 1mg/kg bolus and 1mg/kg/hr for five hours. Researchers compared rates of SBP and 30-day and six-month mortality rates, stratifying patients by age (less than 75 vs. greater than or equal to 75 years). A total of 383 patients received TAI after persistent shock was reconfirmed, prior to drug administration. The Data and Safety Monitoring Board recommended termination of enrollment due to futility based on prespecified stopping rules after review of 317 subjects.

There was a significant rise in blood pressure at two hours in response to Tilarginine compared to placebo (12 vs. 7 mmHg average rise in SBP). However, the primary endpoint at 30 days showed no difference in mortality rates among those treated with TAI versus placebo (48% vs. 42%, risk ratio=1.14).

At six months there were similar outcomes in those in the TAI and placebo groups (58% vs. 59%, hazard ratio=1.04). Rates of adverse events, CS resolution and causes of death were similar. Investigators concluded that while the use of TAI resulted in a significant rise in blood pressure the therapy offered no significant benefit in overall mortality rates in high-risk CS patients. Altho
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Contact: Leslie Humbel
lhumbel@spectrumscience.com
504-613-2418
American College of Cardiology
26-Mar-2007


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