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Arch Intern Med 1999;159:2661-2667

Reduced Coronary Events in Simvastatin-Treated Subjects with CHD and Diabetes or Impaired Fasting Glucose: Subgroup Analyses in the Scandinavian Simvastatin Survival Study. Haffner SM, Alexander CM, Cook TJ, Boccuzzi SJ, Musliner TA, Pedersen TR, Kjekshus J, Pyorala K for the 4S Group.

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Arch Intern Med 1999;159:2661-2667

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  1. Reduced Coronary Events in Simvastatin-Treated Subjects with CHD and Diabetes or Impaired Fasting Glucose: Subgroup Analyses in the Scandinavian Simvastatin Survival Study Haffner SM, Alexander CM, Cook TJ, Boccuzzi SJ, Musliner TA, Pedersen TR, Kjekshus J, Pyorala K for the 4S Group Arch Intern Med 1999;159:2661-2667

  2. Expanded 4S Diabetes Analysis • Diabetes Mellitus by History • 202 Subjects (Original 4S Diabetes Subgroup) • FG > 126 mg/dl, but No History of Diabetes • 281 Subjects • Impaired Fasting Glucose (FG 110-125 mg/dl) • 678 Subjects • Normal (FG < 110 mg/dl) • 3,237 Subjects Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

  3. Rationale & Goals Rationale • New ADA Diagnostic Criteria for DM (FG > 126 mg/dl) • New Category of IFG (FG 110-125 mg/dl) Goals • Confirm previous data • Perform analysis of 4S subjects with IFG Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

  4. Baseline Characteristics Normal IFG DM-FG DM - Hx n 3237 678 281 202 Age 59 59 59 60 Male (%) 80 84 89 78 SBP 138 139 141 147 Tot-C 261 261 261 259 LDL-C 189 189 186 189 HDL-C 46 45 44 44 TG 130 137 142 153 FG 95 117 136 175 Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

  5. Percent Change in Lipids and Lipoproteins in 4S Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

  6. Incidence of Major CHD Events by Glucose Status in the 4S Placebo Group NFG (n=1631) IFG (n=335) DM-FG (n=135) DM-history (n=97) Baseline Glucose Status Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

  7. 4S ~ Major Coronary Heart Disease Events RR = 0.68 0.62 0.58 p value = <0.001 0.003 0.001 n = 1631/1606 335/343 232/251 Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

  8. 4S & Revascularizations RR = 0.67 0.57 0.52 p value = <0.001 0.01 0.005 n = 1631/1606 335/343 232/251 Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

  9. 4S ~ Total Mortality RR = 0.72 0.57 0.79 p value = 0.005 0.02 0.34 n = 1631/1606 335/343 232/251 Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

  10. IFG Subjects (n=678) 0.45 CHD Mortality p=0.007 0.57 Tot Mortality p=0.02 0.57 Revascularization p=0.009 0.62 MCE p=0.003 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 Relative Risk Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

  11. Diabetic Subjects (n=483) 0.72 CHD Mortality p=0.26 0.79 Tot Mortality p=0.34 0.52 Revascularization p=0.005 0.58 MCE p=0.001 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 Relative Risk Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

  12. Major CHD Events NFG Simvastatin NFG Placebo IFG Simvastatin IFG Placebo DM Simvastatin DM Placebo Arch Intern Med 1999;159:2661-2667

  13. Effects of Simvastatin on Major Coronary Events by Glucose Status Stratified by Level of Lipid Parameters Arch Intern Med 1999;159:2661-2667

  14. Absolute and Relative Risk Benefit of Simvastatin Therapy by Glucose Status for Major Coronary Events NFG IFG DM Simvastatin group, No. (%) 299/1606 (18.6) 67/343 (19.5) 59/251 (23.5) Placebo group, No. (%) 428/1631 (26.2) 102/335 (30.5) 87/232 (37.5) Relative risk 0.68 0.62 0.58 P relative risk <0.001 0.003 0.001 Absolute benefit (Kaplan-Meier year 6 estimate) 8.02/100 cases 12.11/100 cases 13.85/100 cases Number needed to treat 12 8 7 Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

  15. Summary - Diabetes Mellitus • Higher event rate in diabetes group, by history, compared to other groups • In combined DM group (by history and fasting glucose): • Major Coronary Events were reduced by 42% (p=0.001) • Revascularizations were reduced by 48% (p=0.005) • Total and coronary mortality were reduced, but reductions not significant due to small sample size Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

  16. Summary - Impaired Fasting Glucose • Reduced total mortality by 43% (p=0.02) • Reduced coronary mortality by 55% (p=0.007) • Reduced major coronary events by 38% (p=0.003) • Reduced the need for revascularization procedures by 43% (p=0.009) Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

  17. Conclusions • This analysis confirms and extends the benefit of cholesterol lowering with simvastatin in an expanded cohort of patients with diabetes and overt CHD • CHD patients with impaired fasting glucose (FG 110 to 125 mg/dL) benefit from treatment with simvastatin by significant & substantial reductions in total and coronary mortality, major CHD events and revascularizations. Haffner SM, et al. Arch Intern Med 1999;159:2661-2667

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