Global BulletinAll NewsFDA Approval AlertWomen in Oncology
Expert InterviewsAround the PracticeBetween the LinesFace OffFrom All AnglesMeeting of the MindsOncViewPodcastsTraining AcademyTreatment Algorithms with the Oncology BrothersVideos
Conferences
All JournalsEditorial BoardFor AuthorsYear in Review
Frontline ForumSatellite Sessions
CME/CE
Awareness MonthNurse Practitioners/Physician's AssistantsPartnersSponsoredSponsored Media
Career CenterSubscribe
Adverse Effects
Brain Cancer
Breast CancerBreast CancerBreast Cancer
Gastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal Cancer
Genitourinary CancersGenitourinary CancersGenitourinary CancersGenitourinary Cancers
Gynecologic CancersGynecologic CancersGynecologic CancersGynecologic Cancers
Head & Neck Cancer
Hematologic OncologyHematologic OncologyHematologic OncologyHematologic Oncology
InfectionInfection
Leukemia
Lung CancerLung CancerLung Cancer
Lymphoma
Neuroendocrine Tumors
Oncology
Pediatric Cancers
Radiation Oncology
Sarcoma
Screening
Skin Cancer & Melanoma
Surgery
Thyroid Cancer
Spotlight -
  • Radiation Oncology
  • Surgery
Adverse Effects
Brain Cancer
Breast CancerBreast CancerBreast Cancer
Gastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal Cancer
Genitourinary CancersGenitourinary CancersGenitourinary CancersGenitourinary Cancers
Gynecologic CancersGynecologic CancersGynecologic CancersGynecologic Cancers
Head & Neck Cancer
Hematologic OncologyHematologic OncologyHematologic OncologyHematologic Oncology
InfectionInfection
Leukemia
Lung CancerLung CancerLung Cancer
Lymphoma
Neuroendocrine Tumors
Oncology
Pediatric Cancers
Radiation Oncology
Sarcoma
Screening
Skin Cancer & Melanoma
Surgery
Thyroid Cancer
    • Conferences
    • CME/CE
    • Career Center
    • Subscribe
Advertisement

SEAS leader tags statin-ezetimibe cancer link as most likely a matter of chance

November 1, 2008
By Barabra Boughton
Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 17 No 11
Volume 17
Issue 11

MUNICH-Final results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial were released at the 2008 European Society of Cardiology Congress, and the lead researcher urged oncologists to continue treatment for their patients who are also on cholesterol-lowering drugs.

MUNICH-Final results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial were released at the 2008 European Society of Cardiology Congress, and the lead researcher urged oncologists to continue treatment for their patients who are also on cholesterol-lowering drugs.

In 2001, Terje Pedersen, MD, PhD, and his colleagues began enrolling 1,873 patients with aortic stenosis. The trial was designed to evaluate the risk of cardiovascular events and cardiovascular mortality among patients taking the combination lipid-lowering regimen.

But the group unexpectedly found that the combination therapy-when compared with placebo-seemed to increase cancer risk and mortality. During a median follow- up of 52 months, there was an increase in both the incidence of cancer (101 vs 65 patients; hazard ratio, 1.55) and cancerrelated deaths [37 vs 20 deaths; hazard ratio, 1.78 (see Table)].

“It was a totally unexpected finding-and one that we think is actually quite implausible,” Dr. Pedersen, professor of medicine in the Center for Preventive Medicine at Ulleval University Hospital in Norway, told Oncology News International. “It’s difficult to believe that patients will develop a cancer within a span of four years that will lead to death-merely by taking cholesterol-lowering pills.”

Last month, U.S. Food and Drug Administration announced that it would continue to monitor a possible increased cancer risk in association with the use of simvastin (Zocor) and ezetimibe (Zetia), which are marketed in combination as Vytorin. The agency also said that it was awaiting results from the SEAS trial that would take six months to review (see “Common cholesterol drugs may be linked to escalated cancer risk,” September 2008, page 6).

Dr. Pedersen noted that the cancer-related findings of the SEAS trial are based on small numbers and could be due to chance. He also noted that the diff erences between the treatment and placebo groups did not relate to any particular type of cancer and did not become larger with more prolonged treatment (see Figure).

However, the data have been submitted to an independent academic group for analysis, along with results from two other clinical trials that analyzed cholesterol-lowering drugs, SHARP (Study of Heart and Renal Protection) and IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Effi cacy International Trial).

SEAS results have been published online in The New England Journal of Medicine (September 2, 2008). In an accompanying NEJM editorial, Thomas R. Fleming, PhD, noted that interim analysis from IMPROVE-IT and SHARP did indicate an increase in the number of cancer-related deaths associated with active vs control therapy-and a 34% increased risk of cancer-related mortality among those taking simvastatin-ezetimibe.

While Dr. Fleming noted that the interim nature of the data from the IMPROVE-IT and SHARP trials is problematic, he also called for more research to clarify the connection between simvasatin-ezetimibe and cancer, preferably through completed randomized trials.

“Such confirmation is especially important in the case of agents such as ezetimibe, for which there are safety signals of major illness or death and evidence of efficacy that is limited to documented eff ects on a biomarker,” Dr. Fleming said.

Dr. Pedersen said he believed that the cancer- related findings in the SEAS, IMPROVEIT, and SHARP trials can be explained by chance, and that cholesterol-lowering drugs do not pose an increased cancer risk.

“I’m not about to recommend that any of my patients stop taking ezetimibe based on these findings,” Dr. Pedersen said.

He added that oncologists who face concern from their patients about cholesterollowering drugs and cancer risk should not stop treatment but should explain the results from the various trials.

Articles in this issue

Move to abandon anthracyclines in adjuvant breast cancer care is premature
Elaine Jaffe: At the forefront of clinical lymphoma biology
Clinical trials struggle to recruit, retain patients
Global financial woes threaten new UK radiotherapy centers
UK health service urges drug cost cuts
Birth length of at least 50 cm may bump up breast ca risk
Obama, NCCN win endorsements in online poll surveys
Colonoscopy proves cost-effective in young patients
Philips Healthcare extends contract for image-guided oncology
US Oncology teams with RTOG to boost trial enrollment
Court finds Roche infringed on Amgen’s erythropoietin patents
Advanced colon ca: Is sequential treatment preferred?
Infusion confusion: Quick fixes for keeping reimbursement on track
Would a higher dose make a difference?
Cancer film festival salutes international documentaries
Recent Videos
7 experts are featured in this series.
7 experts are featured in this series.
In the SWOG S2409 PRISM trial, over 800 patients with small cell lung cancer will receive different treatment regimens based on their disease subtype.
2 KOLs are featured in this series.
2 KOLs are featured in this series.
Related Content
Advertisement

Data from the phase 3 evERA trial show a trend towards improved overall survival with giredestrant plus everolimus in this breast cancer population.

Giredestrant Combo Significantly Boosts PFS in ER+ Advanced Breast Cancer

Russ Conroy
September 22nd 2025
Article

Data from the phase 3 evERA trial show a trend towards improved overall survival with giredestrant plus everolimus in this breast cancer population.


How To Discuss Death? A Conversation of Mortality in Cancer Care

How To Discuss Death? A Conversation of Mortality in Cancer Care

Daniel C. McFarland, DO;William Breitbart, MD
September 22nd 2025
Podcast

Daniel C. McFarland, DO, and guest William S. Breitbart, MD, discuss the critical role of meaning-centered therapy in addressing the psychosocial needs of patients with cancer.


Cytokine release syndrome occurred in 36.1% of patients, with 22.2% being grade 1 and 13.9% being grade 2.

Is There Space for Single-Agent Mosunetuzumab in Frontline MZL Care?

Tim Cortese
September 22nd 2025
Article

Results from the phase 2 MorningSun trial demonstrated that outpatient, subcutaneous single-agent mosunetuzumab was efficacious in patients with marginal zone lymphoma.


Panelists and presenters attending World GU 2025 shared their perspectives on optimizing the management of prostate, kidney, and bladder cancers.

Gathering the Latest Multidisciplinary Care Insights Across World GU 2025

Manojkumar Bupathi, MD, MS;Benjamin Garmezy, MD;Mehmet Asim Bilen, MD;Sid Sadler;Kerry R. Schaffer, MD;Mark T. Fleming, MD;Jeff Yorio, MD;Mike Lattanzi, MD;Elizabeth Kessler, MD;Benjamin L. Maughan, MD, PharmD;Alan Tan, MD
September 18th 2025
Podcast

Panelists and presenters attending World GU 2025 shared their perspectives on optimizing the management of prostate, kidney, and bladder cancers.


3 Things You Should Know About Data Presented at ESMO GI

3 Things You Should Know About Data Presented at ESMO GI

ONCOLOGY Staff
September 22nd 2025
Article

New therapies for hepatobiliary cancers show promise, expanding treatment options for patients with advanced disease and challenging conditions.


Regarding safety, treatment-related adverse effects occurred in 93% of patients, with grade 3 or 4 TRAEs occurring in 60%.

Mosunetuzumab Treatment Combo Yields Responses in High-Risk MCL

Tim Cortese
September 21st 2025
Article

Michael Wang, MD, stated that results from this phase 2 trial were tremendous and showed that mosunetuzumab plus polatuzumab vedotin is viable in MCL.

Related Content
Advertisement

Data from the phase 3 evERA trial show a trend towards improved overall survival with giredestrant plus everolimus in this breast cancer population.

Giredestrant Combo Significantly Boosts PFS in ER+ Advanced Breast Cancer

Russ Conroy
September 22nd 2025
Article

Data from the phase 3 evERA trial show a trend towards improved overall survival with giredestrant plus everolimus in this breast cancer population.


How To Discuss Death? A Conversation of Mortality in Cancer Care

How To Discuss Death? A Conversation of Mortality in Cancer Care

Daniel C. McFarland, DO;William Breitbart, MD
September 22nd 2025
Podcast

Daniel C. McFarland, DO, and guest William S. Breitbart, MD, discuss the critical role of meaning-centered therapy in addressing the psychosocial needs of patients with cancer.


Cytokine release syndrome occurred in 36.1% of patients, with 22.2% being grade 1 and 13.9% being grade 2.

Is There Space for Single-Agent Mosunetuzumab in Frontline MZL Care?

Tim Cortese
September 22nd 2025
Article

Results from the phase 2 MorningSun trial demonstrated that outpatient, subcutaneous single-agent mosunetuzumab was efficacious in patients with marginal zone lymphoma.


Panelists and presenters attending World GU 2025 shared their perspectives on optimizing the management of prostate, kidney, and bladder cancers.

Gathering the Latest Multidisciplinary Care Insights Across World GU 2025

Manojkumar Bupathi, MD, MS;Benjamin Garmezy, MD;Mehmet Asim Bilen, MD;Sid Sadler;Kerry R. Schaffer, MD;Mark T. Fleming, MD;Jeff Yorio, MD;Mike Lattanzi, MD;Elizabeth Kessler, MD;Benjamin L. Maughan, MD, PharmD;Alan Tan, MD
September 18th 2025
Podcast

Panelists and presenters attending World GU 2025 shared their perspectives on optimizing the management of prostate, kidney, and bladder cancers.


3 Things You Should Know About Data Presented at ESMO GI

3 Things You Should Know About Data Presented at ESMO GI

ONCOLOGY Staff
September 22nd 2025
Article

New therapies for hepatobiliary cancers show promise, expanding treatment options for patients with advanced disease and challenging conditions.


Regarding safety, treatment-related adverse effects occurred in 93% of patients, with grade 3 or 4 TRAEs occurring in 60%.

Mosunetuzumab Treatment Combo Yields Responses in High-Risk MCL

Tim Cortese
September 21st 2025
Article

Michael Wang, MD, stated that results from this phase 2 trial were tremendous and showed that mosunetuzumab plus polatuzumab vedotin is viable in MCL.

Advertisement
About
Advertise
CureToday.com
OncLive.com
OncNursingNews.com
TargetedOnc.com
Editorial
Contact
Terms and Conditions
Privacy
Do Not Sell My Personal Information
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.