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Results From Largest Study of Anti-Rejection Therapy for Heart Transplant Patients Will be Released at ISHLT Meeting
Date:4/14/2011

end of one year.  This study included 189 patients:  88 patients randomized to Everolimus at low dose of 1.5 mg/day and 101 randomized to MMF. There was no significant difference between the groups with regard to baseline demographics.

"The fact that data was so robust in all IVUS parameters is very significant and clinically applicable" according to the principal investigator Jon Kobashigawa, MD, Cedars-Sinai Heart Institute, Los Angeles.

The data show that a significantly smaller percentage of patients had a change in intimal thickness greater than 0.5mm during the first year after heart transplant in the Everolimus group versus the MMF group. In addition to a benefit in intimal thickness there was also a significant improvement in three dimensional intimal volume in the Everolimus group.  According to Dr. Kobashigawa, this data is crucial, because previous IVUS studies have shown high morbidity and mortality rates at 5 years in those patients with an increase in intimal thickness greater than .5 mm in the first year after heart transplantation.  

On average, all subgroups in the study showed clinical benefit with Everolimus, including patients over 50 years of age, both males and females, diabetics, and patients with previous disease.  

Everolimus with Reduced CsA

These investigators compared Everolimus given with reduced levels of Cyclosporine (CsA) with MMF using standard levels of CsA, specifically looking at the drugs' efficacy and affect on kidney function.

Researchers found that Everolimus does not appear to be superior to MMF in terms of acute cellular rejection, but that adverse effects on the kidneys can be prevented by using lower doses of CsA.  

According to principal investigator, Howard J. Eisen, MD, Drexel University College of Medicine, Philadelphia, using a lower dose of CsA also showed a significant reduction in transplant coronary disease as described
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SOURCE International Society for Heart & Lung Transplantation
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