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HPS: Heart Protection Study

HPS: Heart Protection Study. Purpose To determine whether simvastatin reduces mortality and vascular events in patients with and without coronary disease, but all at high risk, and with a broad range of baseline cholesterol levels Reference

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HPS: Heart Protection Study

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  1. HPS: Heart Protection Study Purpose To determine whether simvastatin reduces mortality and vascular events in patients with and without coronary disease, but all at high risk, and with a broad range of baseline cholesterol levels Reference HPS Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002;360:7–22.

  2. HPS: Heart Protection Study - TRIAL DESIGN - Design Multicenter, randomized, double-blind, placebo-controlled Patients 20,536 patients aged 40–80 years, with and without coronary heart disease, but all at high risk, and with broad range of baseline total cholesterol: all >135mg/dL (>3.5mmol/L), mean 230 mg/dL (5.9 mmol/L) Follow up and primary endpoint Primary endpoint: all-cause mortality. Mean 5 years follow up. Treatment Placebo or simvastatin 40 mg daily

  3. Cerebrovascular disease 1820 9 Peripheral arterial disease 2701 13 Diabetes mellitus 3982 19 HPS: Heart Protection Study - TRIAL DESIGN continued- Baseline characteristics No. % of total All patients 20,536 Men 15,454 75 Women 5082 25 History of coronary disease Previous MI 8510 41 Other 4876 24 Other risk factors in absence of coronary diseasea 7150 35 a Some patients had more than one of these conditions. HPS Collaborative Group. Lancet 2002; 360 :7 Ð 22.

  4. HPS: Heart Protection Study- RESULTS - • All-cause mortality in simvastatin group significantly reduced compared with placebo (12.9 vs. 14.7%, P<0.0003); reduction was attributed largely to significant reduction in coronary death: • Other vascular death reduced but with marginal significance • Nonvascular death reduced but not significantly • First major vascular event rate significantly reduced, as were the individual event rates (fatal/nonfatal MI, fatal/nonfatal stroke, and revascularization) • No difference in new cancers (7.9 vs 7.8%, rate ratio 1.0, P=0.9) except nonmelanoma skin cancer (2.4 vs 2.0%) • No difference in withdrawal due to myopathy (0.5% in both groups)

  5. HPS: Heart Protection Study- RESULTS continued - Cause-specific mortality Cause of death Simvastatin Placebo Death rate ratio (95% CI) (n=10,269) (n=10,267) No. (%) No. (%) Simvastatin better Placebo better Vascular causes Coronary 587 (5.7) 707 (6.9) Other vascular 194 (1.9) 230 (2.2) RR=0.83 (0.75–0.91) P<0.0001 Subtotal: any vascular 781 (7.6) 937 (9.1) Non-vascular causes Neoplastic 359 (3.5) 345 (3.4) Respiratory 90 (0.9) 114 (1.1) Other medical 82 (0.8) 90 (0.9) Nonmedical 16 (0.2) 21 (0.2) RR=0.95(0.85–1.07) P=0.4 Subtotal: any nonvascular 547 (5.3) 570 (5.6) RR=0.87(0.81–0.94) P<0.0003 ANY DEATH 1328 (12.9) 1507 (14.7) 0.4 0.6 0.8 1.0 1.2 1.4 Dashed line indicates overall RR for a subtotal HPS Collaborative Group. Lancet 2002;360:7–22.

  6. Fatal or nonfatal stroke 585 (5.7) 444 (4.3) 0.75 (0.66–0.85) <0.0001 Revascularization 1205 (11.7) 939 (9.1) 0.76 (0.70–0.83) <0.0001 Any major vascular eventa 2585 (25.2) 2033 (19.8) 0.76 (0.72–0.81) <0.0001 HPS: Heart Protection Study- RESULTS continued - First major vascular event Placebo Simvastatin Event rate ratio P (n=10,267) (n=10,269) (95% CI) No. (%) No. (%) Nonfatal MI or coronary death 1212 (11.8) 898 (8.7) 0.73 (0.67–0.79) <0.0001 aData are for patients having first event of each type, hence non-additivity HPS Collaborative Group. Lancet 2002;360:7–22.

  7. HPS: Heart Protection Study- SUMMARY - In high-risk patients with a broad range of baseline cholesterol values, simvastatin reduced: • All-cause mortality • Coronary deaths • Major vascular events

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