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SEAS: Prostate, skin cancers most common among treatment group
The cancer incidence reported is not likely related to simvastatin and ezetimibe combination.
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MUNICH — Although he presented no new data at the European Society of Cardiology’s annual Congress on the SEAS trial, Terje R. Pedersen, MD, released today specific incidents of cancer that patients developed during the four-year trial.
The trial results, comparing simvastatin and ezetimibe (Vytorin, Merck) in aortic stenosis with placebo, were first announced in July during a press conference.
Pedersen, professor at the Preventive Medicine Clinic, Ulleval University Hospital, Oslo, Norway, said the drug showed no benefit in patients with aortic valve disease in preventing further development and progression of disease.
“None of the aortic valve-specific endpoint components showed even a trend of benefit while there was a significant improvement in the prognosis in regard to ischemic events,” Pedersen said. “Only the bypass surgery reached statistical significance.”
Cancer results defined
There were a total of 108 cancers that developed in the treatment population and 75 in the placebo population. The most common cancer that patients developed in the treatment group (n=943) was prostate (21 patients), any skin cancer (18) and other/unspecified cancer (12). The most common cancer developed by the control group (n=929) was prostate (13) and lung cancer (10). Fatal cancers occurred in 39 people in the treated group and 23 in the placebo group, which Pedersen said was on the border of statistical significance.
“I hardly know of anything that does that,” Pedersen said regarding onset of cancer within about three years of taking a drug.
Results
There were 1,873 patients in the SEAS trial who randomly received either 40 mg/day simvastatin and 10 mg/day ezetimibe or placebo. The combination reduced LDL an average of 76 mg/dL (61%) across the study. The researchers also reported that 688 patients had one or more of the primary endpoint events, which were major adverse events associated with aortic stenosis and atherosclerosis. There was no difference between the placebo group and the treatment group for the combined primary endpoint (333 vs. 355, HR=0.96; 95% CI, 0.83-1.12). – by Judith Rusk
For more information:
- Pedersen, TR. Simvastatin plus ezetimibe in aortic stenosis. Hotline III; Presented at: The European Society of Cardiology Congress 2008; August 30-Sept. 3; Munich.