Trial Outcomes & Findings for An Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Trial (MK-0653A-043-10) (NCT NCT01077830)

Results Overview

Any incidence of cancer reported during follow-up that was assessed by the Expert Review Committee to be a new case of cancer. The crude new cancer rates for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of New Cancers reported was then divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude New Cancer Rate.

Recruitment status

COMPLETED

Target enrollment

1392 participants

Primary outcome timeframe

up to 21 Months after the end of the SEAS (base) study

Results posted on

2022-02-09

Participant Flow

All participants from five countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who completed the SEAS base study and who were known to be alive at the end of the base study.

Of the 1873 participants in the SEAS base study, 1392 were eligible for inclusion in this follow-up study. Of these 1392 participants, 33 were excluded due to incomplete base study data or because follow-up data could not be obtained, leaving 1359 participants in the follow-up study.

Participant milestones

Participant milestones
Measure	Ezetimibe/Simvastatin 10/40 mg Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study	Placebo Participantss who received placebo in the base study
Overall Study STARTED	677	682
Overall Study COMPLETED	677	682
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Trial (MK-0653A-043-10)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ezetimibe/Simvastatin 10/40 mg n=677 Participants Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study	Placebo n=682 Participants Participants who received placebo in the base study	Total n=1359 Participants Total of all reporting groups
Age, Customized < 50 years	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Age, Customized 50 to 59 years	92 Participants n=99 Participants	91 Participants n=107 Participants	183 Participants n=206 Participants
Age, Customized 60 to 69 years	160 Participants n=99 Participants	189 Participants n=107 Participants	349 Participants n=206 Participants
Age, Customized 70 to 79 years	250 Participants n=99 Participants	234 Participants n=107 Participants	484 Participants n=206 Participants
Age, Customized ≥80 years	171 Participants n=99 Participants	165 Participants n=107 Participants	336 Participants n=206 Participants
Sex: Female, Male Female	267 Participants n=99 Participants	272 Participants n=107 Participants	539 Participants n=206 Participants
Sex: Female, Male Male	410 Participants n=99 Participants	410 Participants n=107 Participants	820 Participants n=206 Participants

PRIMARY outcome

Timeframe: up to 21 Months after the end of the SEAS (base) study

Population: Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period.

Any incidence of cancer reported during follow-up that was assessed by the Expert Review Committee to be a new case of cancer. The crude new cancer rates for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of New Cancers reported was then divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude New Cancer Rate.

Outcome measures

Outcome measures
Measure	Ezetimibe/Simvastatin 10/40 mg n=595 Participants Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study	Placebo n=599 Participants Participants who received placebo in the base study
Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort	1.14 per 100 participant-years Interval 0.65 to 2.01	2.07 per 100 participant-years Interval 1.36 to 3.15

SECONDARY outcome

Timeframe: up to 21 Months after the end of the base study

Population: Primary analysis population was Follow-Up Total Cohort defined as all participants enrolled in the study.

All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain cause of death. The crude rates of death for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths (any cause) reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Rate of Death.

Outcome measures

Outcome measures
Measure	Ezetimibe/Simvastatin 10/40 mg n=677 Participants Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study	Placebo n=682 Participants Participants who received placebo in the base study
Crude Rate of Death (Any Cause) - Follow-up Total Cohort	3.59 per 100 participant-years Interval 2.67 to 4.85	2.70 per 100 participant-years Interval 1.92 to 3.8

SECONDARY outcome

Timeframe: up to 21 Months after the end of the base study

Population: Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period.

All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain if cancer was cause of death. The crude rates of death due to cancer for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths due to Cancer reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude Rate of Death Due to Cancer.

Outcome measures

Outcome measures
Measure	Ezetimibe/Simvastatin 10/40 mg n=595 Participants Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study	Placebo n=599 Participants Participants who received placebo in the base study
Crude Rate of Death Due to Cancer - Follow-up Primary Cohort	0.38 per 100 participant-years Interval 0.14 to 1.01	0.28 per 100 participant-years Interval 0.09 to 0.86

Adverse Events

Ezetimibe/Simvastatin 10/40 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
Publication restrictions are in place

Restriction type: OTHER