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Incidence of Cancer and Mortality in Patients from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) Trial.

Green, Anders; Ramey, Dena Rosen; Emneus, Martha; Iachina, Maria; Stavem, Knut; Bolin, Kristian; McNally, Richard; Busch-Sørensen, Michael; Willenheimer, Ronnie LU and Egstrup, Kenneth, et al. (2014) In American Journal of Cardiology 114(10). p.1518-1522
Abstract
The Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) clinical trial, including 1,873 patients found an increased risk for cancer with lipid-lowering therapy with ezetimibe/simvastatin 10/40 mg/day, relative to placebo. In a registry-based follow-up study over 21 months from the conclusion of the SEAS trial, new incident cancer and total mortality were investigated in the SEAS study cohort from Denmark, Finland, Norway, Sweden, and the United Kingdom. Among 1,359 subjects eligible for follow-up (73% of the original total cohort), 1,194 had no history of cancer (primary follow-up cohort). New cancers and deaths were identified in the national cancer and mortality registries and classified by an Expert Review Committee. Data were analyzed... (More)
The Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) clinical trial, including 1,873 patients found an increased risk for cancer with lipid-lowering therapy with ezetimibe/simvastatin 10/40 mg/day, relative to placebo. In a registry-based follow-up study over 21 months from the conclusion of the SEAS trial, new incident cancer and total mortality were investigated in the SEAS study cohort from Denmark, Finland, Norway, Sweden, and the United Kingdom. Among 1,359 subjects eligible for follow-up (73% of the original total cohort), 1,194 had no history of cancer (primary follow-up cohort). New cancers and deaths were identified in the national cancer and mortality registries and classified by an Expert Review Committee. Data were analyzed using Cox proportional-hazards models of new cancers and mortality during follow-up according to treatment group assigned in the SEAS base study and with age, gender, smoking history, and previous cancers as covariates. The primary follow-up cohort had 12 patients with new cancers in the ezetimibe/simvastatin group and 22 in the placebo group (hazard ratio 0.55, 95% confidence interval 0.27 to 1.11), indicating no significant difference between the treatment groups. During follow-up, 43 patients assigned to ezetimibe/simvastatin and 33 assigned to placebo died (hazard ratio 1.29, 95% confidence interval 0.82 to 2.03). In conclusion, in this registry-based observational follow-up study of the original SEAS study patient population, treatment with ezetimibe/simvastatin was not associated with an increased risk for cancer or mortality in the 21-month period after the completion of the original SEAS study. (Less)
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American Journal of Cardiology
volume
114
issue
10
pages
1518 - 1522
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Excerpta Medica
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  • pmid:25267716
  • wos:000344837500009
  • scopus:84908373154
ISSN
1879-1913
DOI
10.1016/j.amjcard.2014.08.016
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English
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b5758794-634a-4c4e-8c78-8172388a72f1 (old id 4738759)
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http://www.ncbi.nlm.nih.gov/pubmed/25267716?dopt=Abstract
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2014-11-04 18:45:58
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@article{b5758794-634a-4c4e-8c78-8172388a72f1,
  abstract     = {The Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) clinical trial, including 1,873 patients found an increased risk for cancer with lipid-lowering therapy with ezetimibe/simvastatin 10/40 mg/day, relative to placebo. In a registry-based follow-up study over 21 months from the conclusion of the SEAS trial, new incident cancer and total mortality were investigated in the SEAS study cohort from Denmark, Finland, Norway, Sweden, and the United Kingdom. Among 1,359 subjects eligible for follow-up (73% of the original total cohort), 1,194 had no history of cancer (primary follow-up cohort). New cancers and deaths were identified in the national cancer and mortality registries and classified by an Expert Review Committee. Data were analyzed using Cox proportional-hazards models of new cancers and mortality during follow-up according to treatment group assigned in the SEAS base study and with age, gender, smoking history, and previous cancers as covariates. The primary follow-up cohort had 12 patients with new cancers in the ezetimibe/simvastatin group and 22 in the placebo group (hazard ratio 0.55, 95% confidence interval 0.27 to 1.11), indicating no significant difference between the treatment groups. During follow-up, 43 patients assigned to ezetimibe/simvastatin and 33 assigned to placebo died (hazard ratio 1.29, 95% confidence interval 0.82 to 2.03). In conclusion, in this registry-based observational follow-up study of the original SEAS study patient population, treatment with ezetimibe/simvastatin was not associated with an increased risk for cancer or mortality in the 21-month period after the completion of the original SEAS study.},
  author       = {Green, Anders and Ramey, Dena Rosen and Emneus, Martha and Iachina, Maria and Stavem, Knut and Bolin, Kristian and McNally, Richard and Busch-Sørensen, Michael and Willenheimer, Ronnie and Egstrup, Kenneth and Kesäniemi, Y Antero and Ray, Simon and Basta, Nermine and Kent, Christi and Pedersen, Terje R},
  issn         = {1879-1913},
  language     = {eng},
  number       = {10},
  pages        = {1518--1522},
  publisher    = {Excerpta Medica},
  series       = {American Journal of Cardiology},
  title        = {Incidence of Cancer and Mortality in Patients from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) Trial.},
  url          = {http://dx.doi.org/10.1016/j.amjcard.2014.08.016},
  volume       = {114},
  year         = {2014},
}