LDL cholesterol and cardiovascular outcomes?

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1 LDL cholesterol and cardiovascular outcomes? Prof Kausik Ray, BSc (hons), MBChB, FRCP, MD, MPhil (Cantab), FACC, FESC Professor of Cardiovascular Disease Prevention St Georges University of London Honorary Consultant Cardiologist St Georges Hospital

2 Hazard ratio Emerging Risk Factors Collaboration participants and > incident CHD events Adjusted for age and sex only Further adjusted for several risk factors Triglyceride HDL-C Non-HDL-C Usual mean level (mg/dl) Usual mean level (mg/dl) Usual mean level (mg/dl) The Emerging Risk Factors Collaboration. JAMA 2009;302(18):

3 Associations of major lipids and apoproteins with CHD LDL-C, per 0.84 mmol/l Non-HDL-C, per 1.10 mmol/l Apo B, per 29mg/dl HR % Cl HDL-C, per 0.38 mmol/l Apo A-I, per 29mg/dl Non HDL-C/HDL-C, per 1.53 Unit Apo B/ Apo A-I, per 0.27 Unit TG, per 60% change Adjusted for confounding factors and lipid markers The Emerging Risk factors Collaboration JAMA 2009;302;

4 Does LDL-C lowering reduce CVD risk in general?

5 LDL-C Level at Beginning and End of Therapy (mg/dl) Usual-Dose Statin Therapy Established As Standard for CHD Patients Regardless of Baseline LDL-C Statin vs Placebo 4S Simvastatin LIPID Pravastatin CARE Pravastatin HPS Simvastatin 20 mg 40 mg 40 mg 40 mg Relative Risk Reduction* Event Rate* On Statin 34% 24% 24% 27% 19.0% 12.3% 10.2% 8.7% * End points cited (not primary end points): 4S and TNT=CHD death, nonfatal MI, and cardiac resuscitation; LIPID, CARE, and HPS=CHD death and nonfatal MI. Scandinavian Simvastatin Survival Study Group. Lancet. 1994;344: ; Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. N Engl J Med. 1998;339: ; Sacks FM et al. N Engl J Med. 1996;335: ; Heart Protection Study Collaborative Group. Lancet. 2002;360:

6 HPS: Effects of Simvastatin on First Major Vascular Event According to Baseline LDL-C STATIN PLACEBO (n=10269) (n=10267) Risk ratio and 95% CI LDL-C (mg/dl) < / / / / / /4349 ALL PATIENTS (19.8%) (25.2%) 24% reduction p< Heart Protection Study Collaborative Group. Lancet 2002; 360: STATIN better STATIN worse

7 High risk vs high LDL-C?

8 Cumulative Incidence (%) ASCOT-LLA: Primary Prevention in HTN Nonfatal MI and Fatal CHD 4 Atorvastatin 10 mg Number of events 100 Placebo Number of events Baseline LDL 132 mg/dl 3.0% 36% reduction 2 1.9% 1 HR = 0.64 ( ) p= Years Sever PS et al, for the ASCOT Investigators. Lancet. 2003;361:

9 Cumulative Hazard (%) CARDS-Cumulative Hazard for Primary Endpoint Relative Risk -37% (95% CI: -52, -17) P=0.001 Placebo 127 events Atorvastatin 10mg 83 events Placebo Atorva Years

10 CTT Collaboration Effects on Major Coronary Events per mmol/l LDL Cholesterol Reduction Subdivided by Baseline Lipid Values Groups (mmol/l) Events (%) Treatment Control Total cholesterol: (6 9) 940 (8 6) (7 0) 2246 (9 4) > (8 8) 1220 (12 1) LDL cholesterol: (6 8) 1443 (8 7) (7 3) 1814 (9 6) > (9 3) 1120 (12 9) HDL cholesterol: (9 3) 1538 (12 1) (7 4) 1270 (10 2) > (6 2) 1595 (8 1) Triglycerides: (7 3) 1521 (9 6) (7 1) 1304 (9 8) > (7 9) 1564 (10 2) Overall 3337 (7 4) 4420 (9 8) RR & CI (Treatment : Control) Heterogeneity/trend p-value p = 0 7 p = 0 5 p = 0 8 p = ( ) p < Treatment Control better better CTT Collaborators. Lancet. 2005; 366:

11 Proportional Reduction in Event Rate (SE) Cholesterol Trialist Collaboration Meta-Analysis of Dyslipidemia Trials 50% Major Vascular Events 40% 30% 20% 10% 0% -10% Reduction in LDL Cholesterol (mmol/l) Adapted from CTT Collaborators. Lancet. 2005; 366:

12 Source: The Lancet 2005; 366: (DOI: /S (05) ) Terms and Conditions

13 If a little is good, then is a bit more better?

14 All-Cause Death or Major CV Events in All Randomized Subjects % with Event Pravastatin 40mg (26.3%) Atorvastatin 80mg (22.4%) 16% RR (P = 0.005) Months of Follow-up Cannon CP, et al. NEJM 2004;350:

15 MCVE Cumulative Hazard (%) Major CV Event* (%) Is there benefit from an LDL of 2 mmol/l vs 2.6mmol/L in stable CAD? IDEAL TNT 16 Simvastatin 20/40-13% RRR 15 Atorvastatin 10 mg 12 Atorvastatin 80 Atorvastatin 80 mg -22% RRR HR = 0.87, P= Years Since Randomization 0 HR = 0.78, P< Time (years) *CHD death, nonfatal non-procedure-related MI, resuscitated cardiac arrest, fatal or nonfatal stroke. LaRosa JC, et al. NEJM. 2005; 352: Pedersen TR, et al. JAMA. 2005; 294:

16 Meta-Analysis of Intensive Statin Therapy All Endpoints Odds Ratio (95% CI) Odds Reduction High Dose Event Rates No./Total (%) Std Dose Coronary Death or Any Cardiovascular Event OR, % CI, P= % 3972/13798 (28.8) 4445/13750 (32.3) Coronary Death or MI OR, % CI, p= % 1097/13798 (8.0) 1288/13750 (9.4) Cardiovascular Death OR, % CI, p= % 462/13798 (3.3) 520/13750 (3.8) Non-Cardiovascular Death OR, % CI, p= % 340/13798 (2.5) 331/13750 (2.4) Total Mortality OR, % CI, P=0.20-6% 808/13798 (5.9) 857/13750 (6.2) Stroke OR % CI, p= % 316/13798 (2.3) 381/13750 (2.8) High-dose statin better High-dose statin worse Cannon CP, et al. JACC 2006; 48:

17 Source: The Lancet 2010; 376: (DOI: /S (10) ) Terms and Conditions

18 PROVE IT-TIMI 22: Relationship Between Month 4 LDL and Long-Term Risk of Death or Major CV Event Hazard Ratio > Referent > (0.59, 1.07) > (0.50, 0.92) < (0.40, 0.91) Lower Better Higher Better *Adjusted for age, gender, DM, prior MI, baseline LDL Wiviott SD, Cannon, Ray et al. JACC. 2005

19

20

21 Event rates by achieved LDL-C in trials Optimal standard Minimum audit standard 30 ATP III JBS2 ESC GMS 2 Prevention Stable CHD % with CHD event Prevention Mean LDL-C level at follow-up (mmol/l) Ray IJCP 2007, 61,

22 The dyslipidaemia of intra-abdominal obesity and Type 2 diabetes VLDL LDL HDL Normal Insulin resistance VLDL triglycerides VLDL apo B LDL apo B Particle number Particle size (small,dense) HDL cholesterol Particle number Particle size (small,dense)

23 Risk ratio (95% CI) Risk ratios for coronary heart disease across fifths of usual lipids or apolipoproteins Non-HDL-C ApoB ApoAI HDL-C Mean Z-score Analyses on participants (involving 4499 cases of CHD) from 22 studies. Regression analyses were stratified, where appropriate, by sex and trial arm.*adjusted for age, systolic blood pressure, smoking status, history of diabetes, body mass index; furthermore Analyses of non-hdl-c were adjusted for HDL-C and triglyceride, analyses of apolipoprotein B were adjusted for apolipoprotein AI and triglyceride, analyses of HDL-C were adjusted for non-hdl-c and triglyceride, and analyses of apolipoprotein AI were adjusted for apolipoprotein B and triglyceride. Studies with fewer than 10 cases were excluded from the analysis.

24 Boekholt JAMA 2012

25 Is LDL-C lowering safe in general?

26 Source: The Lancet 2005; 366: (DOI: /S (05) ) Terms and Conditions

27 Source: The Lancet 2005; 366: (DOI: /S (05) ) Terms and Conditions

28 PROVE IT Safety Results: Side Effects Atorvastatin 80 mg LDL (mmmol/l) Event* <1.04 p value Myositis or Myalgia (AE) NS CK > 3x ULN NS CK > 10x ULN NS Rhabdomyolysis NS ALT > 3X ULN NS Wiviott, et al. JACC. 2005

29 Statins cause Diabetes! Does this attenuate benefit?

30 Statins increase risk of Dysglycaemia Sattar N, Ray. Lancet 2010; 375:

31 Statins and DYSGLYCAEMIA vs CVD Risk Preiss... Ray. JAMA 2011;305:

32 Prognosis of Patients with New- Onset T2DM Incidence of MCVE n / N (%) With new-onset T2DM 157 / 1,387 (11.3%) TNT, IDEAL and SPARCL Without newonset T2DM 1,884/ 17,472 (10.8%) Diabetes at baseline* 832 / 4,761 (17.5%) With new-onset T2DM 76 / 756 (10.1%) TNT, IDEAL and SPARCL Atorvastatin 80 mg groups Without newonset T2DM 867 / 8,684 (10.0%) Diabetes at baseline* 358 / 2,359 (15.2%) Univariate analysis** (HR=1.03, 95% CI , p=0.83) (HR=0.90, 95% CI , p=0.59) Multivariate analysis** (HR=1.02, 95% CI , p=0.69) (HR=0.87, 95% CI , p=0.49) *Patients were excluded from the new-onset T2DM study **MCVEs in patients with and without new-onset T2DM were assessed with an extensive time-dependent Cox proportional hazard analysis Waters DD et al. JACC. 2011;

33 JUPITER HR for rosuvastain vs placebo for those developing DM 0.63 ( ) HR overall 0.56 ( )

34 Summary LDL-C lowering offers similar proportional reductions among those with and without vascular disease The magnitude of benefit is related to the degree of LDL-C reduction LDL-C lowering is safe in general In the future we should be looking at non- HDL-C or apo B for risk assessment

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