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Apolipoprotein B and Cardiovascular Disease Risk: Position Statement from the AACC Lipoproteins and Vascular Diseases Division Working Group on Best Practices

John H. Contois, Joseph P. McConnell, Amar A. Sethi, Gyorgy Csako, Sridevi Devaraj, Daniel M. Hoefner, G. Russell Warnick
DOI: 10.1373/clinchem.2008.118356 Published February 2009
John H. Contois
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Joseph P. McConnell
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Amar A. Sethi
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Gyorgy Csako
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Sridevi Devaraj
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Daniel M. Hoefner
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G. Russell Warnick
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    Figure 1.

    Relative risk of CHD [adapted from Thompson and Danesh (37)].

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    Table 1.

    Prospective studies of apo B and LDL-P: comparison with LDL-C.

    StudyComparisonapo BLDL-CMatching and/or adjustment variables
    Salonen et al. (48)NS1No dataSex, age, TC, smoking, CVD history, mean arterial BP
    Stampfer et al. (49)Quintile 5 vs 12.50 (1.31–4.75)No LDL-CAge, smoking
    Sigurdsson et al. (50)1 SD1.32 (P < 0.001)No LDL-C
    Coleman et al. (51)Tertile 3 vs 12.4 (1.0–4.7)No LDL-C
    Wald et al. (52)Quintile 5 vs 17.02 (3.96–12.5)No LDL-C
    Lamarche et al. (39)1 SD1.44 (1.22–1.67)No LDL-CAge, SBP, diabetes, smoking, medications
    Cremer et al. (53)Quintile 5 vs 18.7 (5.2–14.5)13.2 (7.4–23.6)Age, smoking, alcohol use, family history
    Sweetnam et al. (54)1 SD1.20 (1.05–1.37)No dataDBP, smoking, BMI, ischemia at baseline
    Gotto et al. (46)Baseline 1 year treatmentP = 0.002NSTreatment group, age, sex, marital status, hypertension, smoking, family history
    P < 0.001NS
    Walldius et al. (38)1 SDM, 1.33 (1.17–1.51); W, 1.53 (1.25–1.88)M, 1.14 (1.01–1.28); W, 0.85 (0.69–1.05)Age, TC, TG, apo B, LDL-C
    Simons et al. (55)1 SD1.28 (1.15–1.42)1.28 (1.14–1.42)Age, BMI, sex, family history, SBP, BP medications, smoking, diabetes, TC, HDL-C, TG
    Sharrett et al. (45)Quintile 5 vs 1M, 2.4; W, 2.8M, 2.5; W, 2.7Smoking, BP, diabetes, medications
    Talmud et al. (41)1 SD1.42 (1.19–1.70)1.31 (1.12–1.52)Age, clinic, HDL-C
    Blake et al. (44)Quartile 4 vs 12.43 (1.23–4.82)2.06 (1.03–4.12)Age, smoking, treatment group
    Shai et al. (42)1 SD, quintile 5 vs 11.8 (1.5–2.2); 4.7 (2.5–8.9)1.4 (1.2–1.6); 2.7 (1.6–4.6)Fasting status, age, smoking, month of blood draw
    Jiang et al. (43)Quartile 4 vs 12.31 (1.23–4.35)1.74 (0.99–3.06)Age, BMI, family history of MI, smoking, physical activity, alcohol intake, fasting status, hypertension, aspirin use, Hb A1c
    St-Pierre et al. (40)Tertile 3 vs 17 years, 2.4 (1.5–3.8); 13 years, 1.6 (1.0–2.5)No dataAge, BMI, SBP, diabetes, smoking, medications, TG, HDL-C
    Ridker et al. (47)Quintile 5 vs 12.50 (1.68–3.72)1.62 (1.17–2.25)Age, smoking, BP, diabetes, BMI
    Meisinger et al. (56)1 SDM, 1.49 (1.25–1.78); W, 1.73 (1.32–2.27)M, 1.49 (1.25–1.78); W, 1.79 (1.40–2.30)Diabetes, smoking, BMI, hypertension, age, alcohol use
    Pischon et al. (58)Quintile 5 vs 12.98 (1.76–5.06)2.07 (1.24–3.45)Age, smoking, month of blood draw, BMI, family history of premature MI, diabetes, alcohol use, physical activity
    Continued on page 412
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    Table 1A.

    Prospective studies of apo B and LDL-P: comparison with LDL-C. (Continued from page 411)

    StudyComparisonapo BLDL-CMatching and/or adjustment variables
    Ingelsson et al. (57)1 SDM, 1.35 (1.18–1.55); W, 1.42 (1.18–1.73)M, 1.10 (0.96–1.27); W, 1.19 (0.98–1.45)Age, SBP, antihypertension medications, diabetes, smoking
    Benn et al. (60)Tertile 3 vs 1M, 1.4 (1.1–1.8); W, 1.5 (1.1–2.1)“less predictive”Age, TC, LDL-C, HDL-C, TG, BMI, hypertension, diabetes, smoking
    Mora et al. (59)Quintile 5 vs 12.57 (1.98–3.33)1.74 (1.40–2.16)Age, treatment group, smoking, menopausal hormone use, BP, BMI, diabetes
    Pedersen et al. (61)–10 mg/dL−5.3% risk (placebo)−3.3% risk (placebo)Sex, age, qualifying MI, smoking, hypertension
    −5.1% risk (baseline)2.9% risk (baseline)
    −8.8% risk (on-trial)−7.2% risk (on-trial)
    Moss et al. (62)Quartile 4 vs 1–31.82 (1.10–3.00)No dataDiabetes, MI, electrocardiogram infarct type, pulmonary congestion, sex, ejection fraction
    van Lennep et al. (63)On-trial, 1 unit3.21 (1.10–9.35)1.16 (0.80–1.67)Age [LDL-C, mmol/L; apo B, g/L]
    Simes et al. (64)Baseline, 1 unit2.07 (1.32–3.22)1.28 (1.10–1.46)Age, sex, hypertension, diabetes, smoking, stroke or TIA, PVD, previous revascularization, stable angina, and qualifying event. [LDL-C, mmol/L; apo B, g/L]
    On-trial, 1 unit2.10 (1.21–3.64)1.20 (1.00–1.45)
    Corsetti et al. (65)1 unit2.02 (1.10–3.69)No dataCalcium channel blockers
    Otvos et al. (66)Baseline, 1 SD1.12 (0.99–1.27)1.10 (0.97–1.25)Treatment group, age, hypertension, smoking, BMI, diabetes
    On-trial, 1 SD1.07 (0.94–1.23)1.08 (0.95–1.23)
      • View popup
      Table 2.

      Prospective studies of LDL-P in comparison with LDL-C.

      StudyComparisonLDL-PLDL-CMatching and/or adjustment variables
      Blake et al. (44)Quartile 4 vs 14.17 (1.96–8.87)2.06 (1.03–4.12)Age, smoking, treatment group
      Kuller et al. (67)Quartile 4 vs 1M, NS; W, 2.59M, NS1; W, 3.34Age, race
      Rosenson et al. (68)Above vs below median2.1 (0.7–5.8)1.4 (0.5–3.9)Age, race, baseline lumen diameter
      El Harchaoui et al. (69)Quartile 4 vs 11.78 (1.34–2.37)1.22 (0.92–1.61)Smoking, SBP, LDL-C or LDL-P
      Otvos et al. (66)Baseline, 1 SD1.20 (1.05–1.37)1.10 (0.97–1.25)Treatment group, age, hypertension, smoking, BMI, diabetes
      On-trial, 1 SD1.28 (1.12–1.47)1.08 (0.95–1.23)
      Cromwell et al. (70)1 SDM, 1.24 (1.10–1.39); W, 1.33 (1.17–1.50)M, 1.06 (0.94–1.20); W, 1.18 (1.02–1.37)Age, SBP, DBP, smoking, medications
      Mora et al. (59)Quintile 5 vs 12.51 (1.91–3.30)1.74 (1.40–2.16)
        • View popup
        Table 3.

        Effectiveness of statin treatment at reducing LDL-C, non–HDL-C, apo B, and LDL-P.1

        Reduction on therapy, %Mean on-treatment concentrationMean on-treatment percentile
        ApoB studies (n = 17 035)
         LDL-C42.199.2 mg/dL21
         Non–HDL-C39.6127.0 mg/dL29
         apo B33.1101.6 mg/dL55
        LDL-P Studies (n = 889)
         LDL-C35.9105.2 mg/dL27
         LDL-P30.61459 nmol/L51
          • View popup
          Table 4.

          Population distributions of LDL-C, non–HDL-C, apo B, and LDL-P in the Framingham Offspring Study.

          PercentileLDL-C, mg/dLNon–HDL-C, mg/dLLDL-P, nmol/Lapo B, mg/dL
          2708372054
          5789485062
          108810494069
          20100119110078
          30111132122085
          40120143133091
          50130153144097
          601391631540103
          701491751670110
          801601871820118
          901762052020130
          951912242210140
          • View popup
          Table 5.

          Suggested treatment goal for apo B and non–HDL-P with “equivalent” cutoffs for LDL-C.

          apo B, mg/dLLDL-C, mg/dLNon–HDL-C, mg/dLLDL-P, nmol/L
          <70<80
          <80<100<120<1100
          <100<130<150<1400
          • View popup
          Table 6.

          Comparison of LDL-C and apo B.

          ParameterLDL-Capo B
          Nature of target analyteLDL is not a unique molecular species but a heterogeneous and polydisperse population of particles with varying chemical composition and physicochemical properties. Therefore, LDL is defined functionally in terms of the method used to separate it from other lipoproteins.apo B is well defined as a molecular species (apo B-100 and apo B-48). Although methods for measuring apo B-48 are available, routine “apo B” methods measure either apo B-100 or total apo B.
          Reference materialStandard Reference Material (SRM) 1951b (frozen human serum preparations) certified by the National Institute of Standards and Technology (NIST), Gaithersburg, MD. LDL-C determined by β-quantification (see below) at CDC, USA. Level I, 113.2 (3.1) mg/dL or 2.93 (0.08) mmol/L; level II, 152.6 (3.0) mg/dL. Note: Direct comparison with the “reference method” β-quantification (see below) is considered the only reliable accuracy test for an LDL-C method at present.1International Reference Material SP3–07 (a human serum preparation in liquid-stabilized form) developed by IFCC Standardization Project and endorsed by WHO.2 Accuracy-based mass value of 1.22 g/L [3.95 (0.08) mmol/L] assigned to apo B.2
          Comparison methodsVarious ultracentrifugation methods sometimes combined with chemical precipitation agents [e.g., dextran sulfate or phosphotungstate with MgCl2, heparin with MnCl2, and polyethylene glycol (PEG) 6000].13Behring (now Siemens) Nephelometer at the Northwest Lipid Research Laboratories (NWLRL), University of Washington, Seattle, WA.4
          Reference methodβ-Quantification.13 Widely accepted (including CDC in USA) but not formally credentialed.13 Defines LDL as a population of particles with hydrated density ≥1.006 kg/L and precipitation by polyanion-metal ions.Not defined.
          Definitive methodNot defined.Not defined.
          Principle of analytical methods for quantitationDifferent methodologies are based on different physicochemical properties of LDL particlesAll methodologies are based on the antigenicity of apo B and involve the use of specific anti-apo B antibodies.

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          Clinical Chemistry: 55 (3)
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          Apolipoprotein B and Cardiovascular Disease Risk: Position Statement from the AACC Lipoproteins and Vascular Diseases Division Working Group on Best Practices
          John H. Contois, Joseph P. McConnell, Amar A. Sethi, Gyorgy Csako, Sridevi Devaraj, Daniel M. Hoefner, G. Russell Warnick
          Clinical Chemistry Mar 2009, 55 (3) 407-419; DOI: 10.1373/clinchem.2008.118356
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          Apolipoprotein B and Cardiovascular Disease Risk: Position Statement from the AACC Lipoproteins and Vascular Diseases Division Working Group on Best Practices
          John H. Contois, Joseph P. McConnell, Amar A. Sethi, Gyorgy Csako, Sridevi Devaraj, Daniel M. Hoefner, G. Russell Warnick
          Clinical Chemistry Mar 2009, 55 (3) 407-419; DOI: 10.1373/clinchem.2008.118356

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