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

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... Full description

Journal Title: The American journal of cardiology 2014, Vol.114 (10), p.1518-1522
Main Author: Green, Anders, MD, PhD, DrMedSci
Other Authors: Ramey, Dena Rosen, BA , Emneus, Martha, MSc , Iachina, Maria, MSc, PhD , Stavem, Knut, MD, MPH, PhD , Bolin, Kristian, PhD , McNally, Richard, PhD , Busch-Sørensen, Michael, MD , Willenheimer, Ronnie, MD, PhD , Egstrup, Kenneth, MD, PhD , Kesäniemi, Y. Antero, MD, PhD , Ray, Simon, MD , Basta, Nermine, MSc , Kent, Christi, RN, BSN , Pedersen, Terje R., MD, PhD
Format: Electronic Article Electronic Article
Language: English
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Publisher: United States: Elsevier Inc
ID: ISSN: 0002-9149
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title: Incidence of Cancer and Mortality in Patients from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) Trial
format: Article
creator:
  • Green, Anders, MD, PhD, DrMedSci
  • Ramey, Dena Rosen, BA
  • Emneus, Martha, MSc
  • Iachina, Maria, MSc, PhD
  • Stavem, Knut, MD, MPH, PhD
  • Bolin, Kristian, PhD
  • McNally, Richard, PhD
  • Busch-Sørensen, Michael, MD
  • Willenheimer, Ronnie, MD, PhD
  • Egstrup, Kenneth, MD, PhD
  • Kesäniemi, Y. Antero, MD, PhD
  • Ray, Simon, MD
  • Basta, Nermine, MSc
  • Kent, Christi, RN, BSN
  • Pedersen, Terje R., MD, PhD
subjects:
  • Abridged Index Medicus
  • Aged
  • Aged, 80 and over
  • Analysis
  • Anticholesteremic Agents - adverse effects
  • Anticholesteremic Agents - therapeutic use
  • Aortic valve stenosis
  • Aortic Valve Stenosis - drug therapy
  • Azetidines - adverse effects
  • Azetidines - therapeutic use
  • Cancer
  • Cancer patients
  • Cardiac and Cardiovascular Systems
  • Cardiovascular
  • Clinical Medicine
  • Clinical trials
  • Confidence intervals
  • Disease Progression
  • Double-Blind Method
  • Drug Therapy, Combination
  • Europe - epidemiology
  • Ezetimibe
  • Family medical history
  • Female
  • Follow-Up Studies
  • Gender
  • Health Care Service and Management, Health Policy and Services and Health Economy
  • Health risk assessment
  • Humans
  • Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi
  • Incidence
  • Kardiologi
  • Klinisk medicin
  • Male
  • Medical and Health Sciences
  • Medical diagnosis
  • Medicin och hälsovetenskap
  • Middle Aged
  • Mortality
  • Neoplasms - epidemiology
  • Neoplasms - etiology
  • Patient outcomes
  • Registries
  • Retrospective Studies
  • Risk Assessment - methods
  • Simvastatin
  • Simvastatin - adverse effects
  • Simvastatin - therapeutic use
  • Skin cancer
  • Survival Rate - trends
  • Time Factors
ispartof: The American journal of cardiology, 2014, Vol.114 (10), p.1518-1522
description: 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.
language: eng
source:
identifier: ISSN: 0002-9149
fulltext: no_fulltext
issn:
  • 0002-9149
  • 1879-1913
  • 1879-1913
url: Link


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titleIncidence of Cancer and Mortality in Patients from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) Trial
creatorGreen, Anders, MD, PhD, DrMedSci ; Ramey, Dena Rosen, BA ; Emneus, Martha, MSc ; Iachina, Maria, MSc, PhD ; Stavem, Knut, MD, MPH, PhD ; Bolin, Kristian, PhD ; McNally, Richard, PhD ; Busch-Sørensen, Michael, MD ; Willenheimer, Ronnie, MD, PhD ; Egstrup, Kenneth, MD, PhD ; Kesäniemi, Y. Antero, MD, PhD ; Ray, Simon, MD ; Basta, Nermine, MSc ; Kent, Christi, RN, BSN ; Pedersen, Terje R., MD, PhD
creatorcontribGreen, Anders, MD, PhD, DrMedSci ; Ramey, Dena Rosen, BA ; Emneus, Martha, MSc ; Iachina, Maria, MSc, PhD ; Stavem, Knut, MD, MPH, PhD ; Bolin, Kristian, PhD ; McNally, Richard, PhD ; Busch-Sørensen, Michael, MD ; Willenheimer, Ronnie, MD, PhD ; Egstrup, Kenneth, MD, PhD ; Kesäniemi, Y. Antero, MD, PhD ; Ray, Simon, MD ; Basta, Nermine, MSc ; Kent, Christi, RN, BSN ; Pedersen, Terje R., MD, PhD ; Centrum för hälsoekonomi (CHEGU) ; Handelshögskolan ; Centre for Health Economics ; Göteborgs universitet ; Gothenburg University ; School of Business, Economics, and Law
descriptionThe 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.
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languageeng
publisherUnited States: Elsevier Inc
subjectAbridged Index Medicus ; Aged ; Aged, 80 and over ; Analysis ; Anticholesteremic Agents - adverse effects ; Anticholesteremic Agents - therapeutic use ; Aortic valve stenosis ; Aortic Valve Stenosis - drug therapy ; Azetidines - adverse effects ; Azetidines - therapeutic use ; Cancer ; Cancer patients ; Cardiac and Cardiovascular Systems ; Cardiovascular ; Clinical Medicine ; Clinical trials ; Confidence intervals ; Disease Progression ; Double-Blind Method ; Drug Therapy, Combination ; Europe - epidemiology ; Ezetimibe ; Family medical history ; Female ; Follow-Up Studies ; Gender ; Health Care Service and Management, Health Policy and Services and Health Economy ; Health risk assessment ; Humans ; Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi ; Incidence ; Kardiologi ; Klinisk medicin ; Male ; Medical and Health Sciences ; Medical diagnosis ; Medicin och hälsovetenskap ; Middle Aged ; Mortality ; Neoplasms - epidemiology ; Neoplasms - etiology ; Patient outcomes ; Registries ; Retrospective Studies ; Risk Assessment - methods ; Simvastatin ; Simvastatin - adverse effects ; Simvastatin - therapeutic use ; Skin cancer ; Survival Rate - trends ; Time Factors
ispartofThe American journal of cardiology, 2014, Vol.114 (10), p.1518-1522
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0Incidence of Cancer and Mortality in Patients from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) Trial
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descriptionThe 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.
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titleIncidence of Cancer and Mortality in Patients from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) Trial
authorGreen, Anders, MD, PhD, DrMedSci ; Ramey, Dena Rosen, BA ; Emneus, Martha, MSc ; Iachina, Maria, MSc, PhD ; Stavem, Knut, MD, MPH, PhD ; Bolin, Kristian, PhD ; McNally, Richard, PhD ; Busch-Sørensen, Michael, MD ; Willenheimer, Ronnie, MD, PhD ; Egstrup, Kenneth, MD, PhD ; Kesäniemi, Y. Antero, MD, PhD ; Ray, Simon, MD ; Basta, Nermine, MSc ; Kent, Christi, RN, BSN ; Pedersen, Terje R., MD, PhD
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6Aortic valve stenosis
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8Azetidines - adverse effects
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32Klinisk medicin
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34Medical and Health Sciences
35Medical diagnosis
36Medicin och hälsovetenskap
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38Mortality
39Neoplasms - epidemiology
40Neoplasms - etiology
41Patient outcomes
42Registries
43Retrospective Studies
44Risk Assessment - methods
45Simvastatin
46Simvastatin - adverse effects
47Simvastatin - therapeutic use
48Skin cancer
49Survival Rate - trends
50Time Factors
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atitleIncidence of Cancer and Mortality in Patients from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) Trial
jtitleThe American journal of cardiology
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abstractThe 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.
copUnited States
pubElsevier Inc
pmid25267716
doi10.1016/j.amjcard.2014.08.016