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Research ArticlePractice

Simplified lipid guidelines

Prevention and management of cardiovascular disease in primary care

G. Michael Allan, Adrienne J. Lindblad, Ann Comeau, John Coppola, Brianne Hudson, Marco Mannarino, Cindy McMinis, Raj Padwal, Christine Schelstraete, Kelly Zarnke, Scott Garrison, Candra Cotton, Christina Korownyk, James McCormack, Sharon Nickel and Michael R. Kolber
Canadian Family Physician October 2015; 61 (10) 857-867;
G. Michael Allan
Professor and Director of Evidence-based Medicine in the Department of Family Medicine at the University of Alberta in Edmonton and Director of the Evidence and CPD program of the Alberta College of Family Physicians.
MD CCFP
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  • For correspondence: mgallan@ualberta.ca
Adrienne J. Lindblad
Knowledge Translation and Evidence Coordinator for the Alberta College of Family Physicians and Associate Clinical Professor in the Department of Family Medicine at the University of Alberta.
ACPR PharmD
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Ann Comeau
Primary Care Manager and a nurse practitioner for the Edmonton Southside Primary Care Network.
MN NP CCN(C)
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John Coppola
Clinical Assistant Professor in the Department of Family Medicine in the Cumming School of Medicine at the University of Calgary in Alberta.
MD CCFP
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Brianne Hudson
Family physician in Grande Prairie, Alta.
MD CCFP
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Marco Mannarino
Assistant Clinical Professor and Clinic Preceptor in the Department of Family Medicine at the University of Alberta.
MD CCFP
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Cindy McMinis
Clinical Practice Leader in Pharmacy Services for Alberta Health Services in Wainwright, Alta.
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Raj Padwal
Associate Professor in Clinical Epidemiology, Clinical Pharmacology, and General Internal Medicine and Director of the Hypertension Clinic at the University of Alberta.
MD MSc
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Christine Schelstraete
Virtual care nurse for MyHome Health pilot project in the Sherwood Park-Strathcona County Primary Care Network in Alberta.
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Kelly Zarnke
Associate Professor of Medicine and Head of the Division of General Internal Medicine in the Faculty of Medicine at the University of Calgary and Section Chief of General Internal Medicine for the Alberta Health Services Calgary Zone.
MD MSc FRCPC
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Scott Garrison
Associate Professor in the Department of Family Medicine at the University of Alberta.
MD PhD CCFP
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Candra Cotton
Clinical pharmacist at Saint-Vincent Hospital in Ottawa, Ont.
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Christina Korownyk
Associate Professor in the Department of Family Medicine at the University of Alberta.
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James McCormack
Professor in the Faculty of Pharmaceutical Sciences at the University of British Columbia in Vancouver.
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Sharon Nickel
Coordinator of the Evidence and CPD program of the Alberta College of Family Physicians.
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Michael R. Kolber
Associate Professor in the Department of Family Medicine at the University of Alberta.
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    Figure 1.

    Lipid algorithm: For primary or secondary prevention; excludes those with familial hypercholesterolemia.

    ALT—alanine transaminase, ASA—acetylsalicylic acid, CK—creatine kinase, CVD—cardiovascular disease.

    *Clinicians can initiate lipid testing and risk estimation early if high clinical suspicion exists (ie, if there are compelling risk factors such as family history, hypertension, diabetes, or smoking). Regardless, testing before age 35 y is not recommended for by far most patients, and risk estimation tools do not include patients younger than 35 y. Primary prevention screening beyond age 75 y is generally not recommended.

    †Risk can be calculated using a number of risk calculators, but each clinician should use the same one consistently. The Framingham risk calculator has been validated in a Canadian population and is likely preferred. The following calculator has been created for this guideline: http://chd.bestsciencemedicine.com/calc2html#basic.

    ‡Lifestyle interventions include smoking cessation, exercise, and the Mediterranean diet. Exercise should include > 150 min in > 4 sessions of moderate (brisk walking) to vigorous exercise weekly.

    Adapted from Toward Optimized Practice.16

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  • Screening and testing
    • Initiating screening: In patients without CVD (primary prevention), we suggest lipid testing as part of global CVD risk estimation in men at age ≥ 40 y and women at age ≥ 50 y (moderate-level evidence).

      • -Testing can be considered earlier for patients with known traditional CVD risk factors including, but not limited to, hypertension, family history of premature CVD, diabetes, and smoking (low-level evidence).

    • Repeat screening: For patients not taking lipid-lowering therapy, we suggest lipid testing as part of global CVD risk estimation, performed no more than every 5 y (moderate-level evidence). Global CVD risk estimation can be repeated sooner if other CVD risk factors develop in the interim.

    • Patients do not need to fast for lipid testing. Nonfasting lipid levels can be used to calculate global CVD risk (moderate-level evidence).


    Risk assessments
    • Primary prevention: We encourage risk estimation with a CVD risk calculator (eg, Framingham) every time lipid testing is performed. Testing and risk estimation should be performed starting at age 40 y in men and 50 y in women (or earlier if indicated by other risk factors) until age 75 y (low-level evidence).

      • -Primary prevention in patients with diabetes mellitus: We encourage risk estimation as above (low-level evidence).

      • -Primary prevention in patients with CKD: We recommend using a CVD risk calculator (eg, QRISK2) that includes CKD in its estimation of risk (low-level evidence).

    • We discourage risk estimation for the following patients:

      • -Those with pre-existing CVD, as they are automatically at high risk (high-level evidence).

      • -Those < 40 y (without additional risk factors) and those > 75 y, as risk equations are not based on patients in these age ranges (low-level evidence).

      • -Patients taking lipid therapy, as calculators are not designed to adjust for changes with lipid therapy (low-level evidence). If risk calculation is desired for patients taking lipid therapy, pretreatment lipid levels should be used and risk should be adjusted for known benefits of statin or ASA therapy.

    • We discourage the use of biomarkers as part of risk assessment until further evidence is available (moderate-level evidence).


    Interventions
    • Lifestyle interventions, including but not limited to smoking cessation, Mediterranean diet, and exercise, should be discussed with all patients (high-level evidence).

    • Secondary-prevention patients: We strongly encourage clinicians to discuss the risks and benefits of high-intensity statin therapy with patients (high-level evidence).

    • Primary-prevention patients: We suggest clinicians discuss the risks and benefits of moderate- or high-intensity statins with their patients based on an individual’s risk of CVD (high-level evidence).

      • -For patients with a 10-y CVD risk of < 10%, we suggest retesting lipid levels in 5 y with risk estimation (moderate-level evidence).

      • -For patients with a 10-y CVD risk of 10%–19%, we suggest clinicians discuss initiation of statins (preferably moderate-intensity statins) with patients (high-level evidence).

      • -For patients with a 10-y CVD risk of ≥ 20%, we strongly encourage clinicians to discuss initiation of statins (preferably high-intensity) with patients (high-level evidence).

    • Patients who are elderly (based on frailty as much as age) or those with renal impairment can be offered lower-intensity statin therapy (low-level evidence).

    • Primary prevention patients > 75 y: We discourage routinely testing lipid levels, estimating CVD risk, and prescribing statins (moderate-level evidence).

      • -Some patients > 75 y whose life expectancy and overall health status are good can be offered statin therapy for primary prevention, but this should be left to the clinician and patient’s discretion (low-level evidence).

    • Secondary prevention patients > 75 y: We strongly encourage clinicians to discuss the risks and benefits of moderate-intensity statins with patients (high-level evidence).

      • -Patients already taking and tolerating a statin should not have their statin stopped or reduced just because they have aged beyond 75 y (low-level evidence).

    • In patients ≥ 65 y, pravastatin should likely not be considered first-line therapy until uncertainty surrounding cancer in this subgroup with this drug is resolved (moderate-level evidence).

    • Patients who do not tolerate a specific statin regimen should be offered a lower-intensity regimen, with either the same or a different statin, or a short drug holiday followed by rechallenge to help clarify if statins are related to the intolerance (low-level evidence).

      • -Any statin intensity is preferred to non-statin lipid-lowering therapy (moderate-level evidence).

      • -Alternate daily dosing can be considered if a patient does not tolerate daily dosing (low-level evidence).

      • -In patients who have severe reactions like rhabdomyolysis, retrial might not be appropriate (low-level evidence).

    • In primary prevention, non-statin lipid-lowering drugs should not be used as first-line monotherapy or in combination with statins (high-level evidence).

    • In secondary prevention, ezetimibe can be considered in discussion with patients as add-on therapy to statins, but owing to the higher relative benefit of statins, statin therapy should be maximized first (to high intensity) (high-level evidence).


    Follow-up
    • The use of cholesterol targets for reducing CVD is not required (high-level evidence).

    • We suggest that the monitoring of repeat lipid levels after a patient begins lipid-lowering therapy is not required (low-level evidence).

      • -Adherence to statins can be improved with patient reinforcement.

    • We suggest that testing for baseline CK or ALT levels in healthy individuals before starting statin therapy is generally unnecessary (low-level evidence). The evidence against testing baseline ALT or CK levels is poor and some clinicians might prefer to test one or both.

    • Routine monitoring of CK and ALT levels should be reserved for those patients who are symptomatic or who are at higher risk of adverse events. Frequency should be determined at the discretion of the attending clinician (moderate-level evidence).


    Primary prevention with ASA
    • We discourage the use of ASA for patients without previous CVD and an estimated 10-y CVD risk < 20% (high-level evidence).

    • We suggest ASA can be considered in primary prevention if the 10-y CVD risk is ≥ 20% and bleeding risk is low (low-level evidence).

      • -Use of ASA for primary CVD prevention should be considered after statin therapy has been discussed (high-level evidence).

    • Patients offered ASA should be informed of the potential benefits and harms of ASA use (low-level evidence).

    • ALT—alanine transaminase, ASA—acetylsalicylic acid, CT—creatine kinase, CKD—chronic kidney disease, CVD—cardiovascular disease.

    • View popup
    Table 1.

    Evidence quality rating

    QUALITY RATINGEVIDENCE
    High
    • High-quality RCTs: High-quality includes good design, low risk of bias, and confidence in the estimate

    • Systematic reviews of high-quality RCTs

    Moderate
    • RCTs with important limitations: Limitations of RCTs could include inadequate power, poor follow-up, missing quality elements like allocation concealment, per-protocol analysis, etc

    • High-quality observational studies: High-quality observational studies typically include prospective cohort studies of large populations mirroring Canadian populations and adequate adjustment for confounding

    • Systematic reviews of RCTs with important limitations or high-quality observation studies

    Low
    • RCTs with profound limitations: Profound limitations in RCTs include those listed above but larger and multiple concerns (eg, a trial grossly underpowered for clinical outcomes, CIs that include meaningful harm and benefit, 50% loss to follow-up, etc)

    • Observational studies with important limitations: Observational studies with important limitations might include retrospective studies, small or specific subpopulations, high-risk confounding, etc

    • Other lower evidence studies like case series or studies without patient-oriented outcomes (physiologic studies)

    • Systematic reviews including any of these studies

    • RCT—randomized controlled trials.

    • Adapted from Stone et al.2

  • University of Edinburgh Cardiovascular Risk Calculator: http://cvrisk.mvm.ed.ac.uk/calculator/calc.asp
    • Offers 3 different databases to compare calculated risk; has different display options (some will show statin risk reduction)


    Best Science Medicine: http://bestsciencemedicine.com/chd/calc2.html#basic
    • Offers 3 different databases, including Framingham and QRISK2, to compare risks; shows potential benefit of different interventions


    QRISK2: www.qrisk.org
    • Includes chronic kidney disease in risk estimation

    • ↵* This list is not meant to be all encompassing or to encourage use of one over another. It is simply some suggestions of possible calculators.

    • View popup
    Table 2.

    Benefits of therapies

    THERAPYESTIMATED BENEFIT (RELATIVE RISK REDUCTION), %EXAMPLE IF BASELINE RISK ESTIMATED AT 20% OVER 10 Y
    ABSOLUTE RISK REDUCTION, %NUMBER NEEDED TO TREATNEW RISK ESTIMATE, %
    Smoking cessationRecalculate risk without smoking9*12*11*
    Mediterranean diet3061714
    Exercise3061714
    Statin intensity
      • Low2552015
      • Moderate3061714
      • High3571513
    Acetylsalicylic acid1225018
    • ↵* Example used a male smoker, 53 y old, with total cholesterol level of 5.0 mmol/L, high-density lipoprotein level of 1.2 mmol/L, and systolic blood pressure of 128 mm Hg; estimated risk from the Framingham risk assessment tool (from http://cvrisk.mvm.ed.ac.uk/calculator/calc.asp and http://bestsciencemedicine.com/chd/calc2.html) to attain a 20% risk over 10 y.

    • Adapted from Toward Optimized Practice.16

    • View popup
    Table 3.

    Statin dosing ranges and intensity

    INTENSITYSTATIN OPTIONS
    LowPravastatin 10–20 mg; lovastatin 10–20 mg; simvastatin 5–10 mg; atorvastatin 5 mg; rosuvastatin 2.5 mg
    ModeratePravastatin 40–80 mg; lovastatin 40–80 mg; simvastatin 20–40 mg; atorvastatin 10–20 mg; rosuvastatin 5–10 mg
    HighAtorvastatin 40–80 mg; rosuvastatin 20–40 mg
    • Adapted from Stone et al.2

    • View popup
    Table 4.

    Incidence rates per 100 000 person-years for muscle- and liver-related adverse effects with statins

    ADVERSE EFFECTINCIDENCE PER 100 000 PERSON-YDIFFERENCE (95% CI)
    STATINPLACEBO
    Elevated ALT level (> 3 times ULN)300200100 (64 to 140)
    Liver failure∼0.5NANA
    Elevated CK level (> 10 times ULN)836023 (−4 to 50)
    Myalgia (muscle pain, tenderness, weakness)51504960190 (−38 to 410)
    Myopathy (muscle pain, tenderness, weakness severe enough to stop pills; CK level not always specified)97925 (−17 to 27)
    Rhabdomyolysis (poorly defined, except for CK > 10 times ULN)4.42.81.6 (−2.4 to 5.5)
    • CK—creatine kinase, NA—not applicable, ULN—upper limit of normal.

    • Data from Law and Rudnicka.34

Additional Files

  • Figures
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  • CFPlus Additional Information

    This data supplement contains the evidence review document, a patient handout, the full disclosure of competing interests and an easy-to-print algorithm.

    Files in this Data Supplement:

    • Adobe PDF - EvidenceReview_Lipid_Guideline.pdf
    • Adobe PDF - PatientHandout.pdf
    • Adobe PDF - DisclosureofConflicts.pdf
    • Adobe PDF - LipidAlgorithm.pdf
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Canadian Family Physician: 61 (10)
Canadian Family Physician
Vol. 61, Issue 10
1 Oct 2015
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Simplified lipid guidelines
G. Michael Allan, Adrienne J. Lindblad, Ann Comeau, John Coppola, Brianne Hudson, Marco Mannarino, Cindy McMinis, Raj Padwal, Christine Schelstraete, Kelly Zarnke, Scott Garrison, Candra Cotton, Christina Korownyk, James McCormack, Sharon Nickel, Michael R. Kolber
Canadian Family Physician Oct 2015, 61 (10) 857-867;

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G. Michael Allan, Adrienne J. Lindblad, Ann Comeau, John Coppola, Brianne Hudson, Marco Mannarino, Cindy McMinis, Raj Padwal, Christine Schelstraete, Kelly Zarnke, Scott Garrison, Candra Cotton, Christina Korownyk, James McCormack, Sharon Nickel, Michael R. Kolber
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