Physician Statin Update
Appendix 15
Statin Update Contents:
1. 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk
2. Open Label Form
3. Treating Physician Statin Update Letter
4. Primary Care Physician Statin Update Letter
2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk
Calculate the patient’s estimated 10-year ASCVD risk with the ACC/AHA CV Risk Calculator. If less than
7.5%, enroll the patient.
If their 10-Year ASCVD risk is > 7.5%, they may be enrolled, but the physician letter with their calculated
CV risk score must be sent to the patient and their primary physician. They should also be advised to
discuss with their primary physician (see Treating Physician Statin Update in this appendix). A copy of
the completed physician letter and recommendation should be documented in their study file.
Download the “CV Risk Calculator” at http://static.heart.org/ahamah/risk/Omnibus_Risk_Estimator.xls
Enter the patient’s values in column “C”. Tab through each entry to obtain the correct “Your 10-Year
ASCVD Risk %” (% will be in 13-B). Unit abbreviations are found in column “B”.
Due to changes in Statin treatment the following informational guidelines are to be provided
to the patient’s physicians.

Treating Physician Statin Update (This form should be distributed to the treating site
Hematology/Oncology Physician and/or Radiation Oncology Physician.

Primary Care Physician Statin Update Letter: This letter should be sent/mailed to the
patient’s Primary Care Physician
If the study participant should have statin therapy initiated, complete the Open Label
Form and submit to the Data Management Center.
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CCCWFU CCOP Research Base # 98213
Study Title: Preventing Anthracycline Cardiovascular
Toxicity with Statins (PREVENT)
Appendix 15: Physician Statin Update
Patient Initials:
PID:
Site Name:
Staff Completing Form:
Date:
Open Label Form
If the study participant and their primary care physician elect to initiate statin therapy, they
will be counseled to stop their study drug and notify the respective investigators at their
study site. They will still be allowed to participate in all other aspects of the trial as an
open label statin user.
Date new medication initiated: __________________
Indicate lipid-lowering medication change below:
□ Atorvastatin (Lipitor)
□ Fluvastatin (Lescol)
□ Lovastatin (Mevacor)
□ Pravastatin (Pravachol)
□ Simvastatin (Zocor)
□ Rosuvastatin (Crestor)
□ Nicolar
□ Niaspan
□ Colestid
□ Questran
□ Questran Light
□ WelChol
□ Atromid
□ Tricor
□ Lopid
□ Other (Specify) __________________________________________________
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Treating Physician Statin Update
Since the study inception and development of the inclusion/exclusion criteria, guidelines
regarding the potential administration of statins have been released by the ACC/AHA on
November 12, 2013. These new guidelines suggest the use of a calculator to assess
cardiovascular risk with subsequent initiation of statin therapy based on that risk.
Concomitant with the release of the guidelines, however, have been several articles
suggesting that the calibration of the calculator was somewhat imperfect, particularly in
regards to data from both the Nurses’ Health and Physicians’ Health studies.
As a result of these controversies, the study investigators elected to leave the initial entry
and exclusion criteria intact. Importantly however, their respective primary care
physician will be mailed a letter raising their awareness to the publication of these
guidelines. If the study participant and their primary care physician elect to initiate statin
therapy, they will be counseled to stop their study drug and notify the respective
investigators at their study site. They will still be allowed to participate in all other
aspects of the trial as an open label statin user. Data analyses regarding intention to
treat as well as treatment effect will be performed.
The participant has an ACC/AHA CV risk score of ________________.
2013 ACC/AHA Guidelines of the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in
Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines
A copy of lab is attached.
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Primary Care Physician Statin Update Letter
[INSERT DATE]
Dear Physician:
I would like to notify you that your patient, _______________________, has agreed to
participate in a randomized, placebo-controlled trial (PREVENT - Preventing Anthracycline
Cardiotoxicity with Statins) of atorvastatin in treated for Stage I-III breast cancer or
lymphoma. This study initiates in January 2014 and will run through January 2019. Each
participant will be enrolled for a 2-year period within that 5 years. Participants, at the
initiation of their chemotherapy, will be randomized to 40 mg of atorvastatin versus
placebo. The primary outcomes of the study will be related to cardiovascular magnetic
resonance imaging assessments of cardiac and vascular function.
On November 12, 2013, guidelines regarding the potential administration of statins were
released by the ACC/AHA. These new guidelines suggest the use of a calculator to
assess cardiovascular risk with subsequent initiation of statin therapy based on that risk.
Concomitant with the release of the guidelines, however, there have been several articles
suggesting that the calibration of the calculator was somewhat imperfect, particularly in
regards to data from both the Nurses’ Health and Physicians’ Health studies.
The participant has an ACC/AHA CV risk score of ________________.
2013 ACC/AHA Guidelines of the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in
Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines
Upon receipt of this letter, if you determine that your patient needs to initiate statin
therapy and stop their study drug (atorvastatin or placebo), they should notify the
respective investigators at their study site and return all study drug. Your patient will still
be allowed to participate in all other aspects of the trial as an open label statin user.
Data analyses regarding intention to treat as well as treatment effect will be performed.
Sincerely,
[INSERT SITE PRINCIPAL INVESTIGATOR]
A copy of lab is attached.
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