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Study protocol
Fabrice Bonnet
Centre Hospitalier Universitaire de Bordeaux
Corresponding Author
ORCiD: https://orcid.org/0000-0001-5927-4178
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background The risk/benefit ratio of using statins for cardiovascular (CV) primary prevention in elderly people has not been established. The main objectives of the present study are to assess the cost-effectiveness of statin cessation and to examine the non-inferiority of statin cessation in terms of mortality in patients aged 75 and over treated with statins for primary prevention.
Methods The Statins In The Elderly (SITE) Study is an ongoing 3-year follow-up, open-label comparative multi-centre randomised clinical trial that is being conducted in two parallel groups in outpatient primary care offices. Participants meeting the following criteria are being included: people aged 75 years and older being treated with statins as primary prevention for CV events who provide informed consent. After randomisation, patients in the statin-cessation strategy are instructed to withdraw their treatment. In the comparison strategy, patients continue their statin treatment at the usual dosage. The cost-effectiveness of the statin-cessation strategy compared to continuing statins will be estimated through the incremental cost per quality-adjusted life years (QALY) gained at 36 months based on the perspective of the French healthcare system. Overall mortality will be the primary clinical endpoint. We assumed that the mortality rate at 3 years will be 15%. The sample size was computed to achieve 90% power in showing the non-inferiority of statin cessation, assuming a non-inferiority margin of 5% of the between-group difference in overall mortality. In total, the SITE study will include 2,430 individuals.
Discussion There is some debate regarding the value of statins in people over 75 years old, especially for primary prevention, due to a lack of evidence of their efficacy in this population, potential compliance-related events, drug-drug interactions and side effects that could impair quality of life. Data from clinical trials guide the initiation of medication therapy for primary or secondary prevention of CV disease but do not define the timing, safety, or risks of discontinuing the agents. The SITE study is one of the first to examine whether treatment cessation is a cost-effective strategy that has no adverse effects on the prognosis of people over 75 years old formerly treated with statins. Trial registration This research has been registered at clinicaltrials.gov under number NCT02547883, 11 September 2015, https://clinicaltrials.gov/ct2/show/NCT02547883
Keywords
Primary prevention, Statins, Elderly patients, Cost-effectiveness analysis, Mortality
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CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Review #2 received
Received 15 Mar, 2020
Editorial decision: Accept
On 15 Mar, 2020
Reviewer #2 agreed
On 09 Mar, 2020
Reviewer #1 agreed
On 08 Mar, 2020
Review #1 received
Received 08 Mar, 2020
Reviewers invited
Invitations sent on 01 Mar, 2020
Editor assigned
On 28 Feb, 2020
Submission checks complete
On 27 Feb, 2020
No comments provided
Editorial decision: Minor revision
On 24 Feb, 2020
Review #3 received
Received 10 Feb, 2020
Review #2 received
Received 10 Feb, 2020
Reviewer #3 agreed
On 09 Feb, 2020
Review #1 received
Received 13 Jan, 2020
Reviewer #2 agreed
On 29 Dec, 2019
Reviewer #1 agreed
On 26 Dec, 2019
Reviewers invited
Invitations sent on 23 Dec, 2019
Editor assigned
On 17 Dec, 2019
Submission checks complete
On 16 Dec, 2019
Version 1
Posted 06 Sep, 2019
No comments provided
Review #3 received
Received 27 Nov, 2019
Editorial decision: Major revision
On 27 Nov, 2019
Review #2 received
Received 23 Nov, 2019
Reviewer #3 agreed
On 06 Nov, 2019
Reviewer #2 agreed
On 03 Nov, 2019
Review #1 received
Received 30 Oct, 2019
Reviewer #1 agreed
On 19 Oct, 2019
Reviewers invited
Invitations sent on 18 Oct, 2019
Editor assigned
On 10 Oct, 2019
Submission checks complete
On 03 Sep, 2019
First submitted
On 29 Aug, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Integrative & Complementary Medicine
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Fabrice Bonnet
Centre Hospitalier Universitaire de Bordeaux
Corresponding Author
ORCiD: https://orcid.org/0000-0001-5927-4178
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Review #2 received
Received 15 Mar, 2020
Editorial decision: Accept
On 15 Mar, 2020
Reviewer #2 agreed
On 09 Mar, 2020
Reviewer #1 agreed
On 08 Mar, 2020
Review #1 received
Received 08 Mar, 2020
Reviewers invited
Invitations sent on 01 Mar, 2020
Editor assigned
On 28 Feb, 2020
Submission checks complete
On 27 Feb, 2020
No comments provided
Editorial decision: Minor revision
On 24 Feb, 2020
Review #3 received
Received 10 Feb, 2020
Review #2 received
Received 10 Feb, 2020
Reviewer #3 agreed
On 09 Feb, 2020
Review #1 received
Received 13 Jan, 2020
Reviewer #2 agreed
On 29 Dec, 2019
Reviewer #1 agreed
On 26 Dec, 2019
Reviewers invited
Invitations sent on 23 Dec, 2019
Editor assigned
On 17 Dec, 2019
Submission checks complete
On 16 Dec, 2019
Version 1
Posted 06 Sep, 2019
No comments provided
Review #3 received
Received 27 Nov, 2019
Editorial decision: Major revision
On 27 Nov, 2019
Review #2 received
Received 23 Nov, 2019
Reviewer #3 agreed
On 06 Nov, 2019
Reviewer #2 agreed
On 03 Nov, 2019
Review #1 received
Received 30 Oct, 2019
Reviewer #1 agreed
On 19 Oct, 2019
Reviewers invited
Invitations sent on 18 Oct, 2019
Editor assigned
On 10 Oct, 2019
Submission checks complete
On 03 Sep, 2019
First submitted
On 29 Aug, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Integrative & Complementary Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background The risk/benefit ratio of using statins for cardiovascular (CV) primary prevention in elderly people has not been established. The main objectives of the present study are to assess the cost-effectiveness of statin cessation and to examine the non-inferiority of statin cessation in terms of mortality in patients aged 75 and over treated with statins for primary prevention.
Methods The Statins In The Elderly (SITE) Study is an ongoing 3-year follow-up, open-label comparative multi-centre randomised clinical trial that is being conducted in two parallel groups in outpatient primary care offices. Participants meeting the following criteria are being included: people aged 75 years and older being treated with statins as primary prevention for CV events who provide informed consent. After randomisation, patients in the statin-cessation strategy are instructed to withdraw their treatment. In the comparison strategy, patients continue their statin treatment at the usual dosage. The cost-effectiveness of the statin-cessation strategy compared to continuing statins will be estimated through the incremental cost per quality-adjusted life years (QALY) gained at 36 months based on the perspective of the French healthcare system. Overall mortality will be the primary clinical endpoint. We assumed that the mortality rate at 3 years will be 15%. The sample size was computed to achieve 90% power in showing the non-inferiority of statin cessation, assuming a non-inferiority margin of 5% of the between-group difference in overall mortality. In total, the SITE study will include 2,430 individuals.
Discussion There is some debate regarding the value of statins in people over 75 years old, especially for primary prevention, due to a lack of evidence of their efficacy in this population, potential compliance-related events, drug-drug interactions and side effects that could impair quality of life. Data from clinical trials guide the initiation of medication therapy for primary or secondary prevention of CV disease but do not define the timing, safety, or risks of discontinuing the agents. The SITE study is one of the first to examine whether treatment cessation is a cost-effective strategy that has no adverse effects on the prognosis of people over 75 years old formerly treated with statins. Trial registration This research has been registered at clinicaltrials.gov under number NCT02547883, 11 September 2015, https://clinicaltrials.gov/ct2/show/NCT02547883
This is a list of supplementary files associated with this preprint. Click to download.
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