Authors
Shepherd J, Blauw GJ, Murphy MB, et al.
Title
Pravastatin in elderly individuals at risk of vascular disease
References
Lancet. 2002 Nov 23;360(9346):1623-30
Background
Although statins reduce coronary and cerebrovascular morbidity and mortality in middle-aged individuals, their efficacy and safety in elderly people is not fully established.
Purpose
To determine the benefits of pravastatin treatment in an elderly cohort of men and women with, or at high risk of developing, cardiovascular disease and stroke.
Design
  • Multicenter, randomized, double blinded placebo controlled trial
  • 5804 patients aged 70-82 years with a history of, or risk factors for, vascular disease
  • Total cholesterol 4.0-9.0 mmol/L and triglyceride <6.0 mmol/L
Exclusion Criteria
  • Individuals with poor cognitive function (MMSE<24)
  • Recent stroke, MI or amputation for vascular disase <6mos prior to study entry
  • History of malignancy with past 5 years
  • Atrial fibrillation
  • Concurrent lipid lowering therapy
  • Congestive heart failure NYHA III-IV
  • Significantly abnormal lab findings (CBC, Cr, CK)
Follow-Up
Mean 3.2 years (2.8-4.0)
Treatment Regimen
  • Pravastatin 40mg/day or placebo
  • Follow-up visits every 3 months for a minimum of 3 years. Compliance, lipid and routine blood work assessed at each visit.
Results

Primary Endpoints

Pravastatinn
n=2913		 Placebo
n=2891		Hazard Ratiop
Combined cardiac death, or non-fatal MI or fatal or non-fatal stroke
14.1%16.2%0.85 (0.74-0.97)0.014

Secondary Outcomes

(see paper for complete list)

Pravastatinn
n=2913		 Placebo
n=2891		Hazard Ratiop
Cardiac death or non-fatal MI
10.1%12.2%0.81 (0.69-0.94)0.006
Fatal or non-fatal stroke
4.7%4.5%1.03 (0.81-1.31)0.81
Summary
Pravastatin given for 3 years reduced the risk of coronary disease in elderly individuals and therefore extends the treatment strategy currently used in middle-aged people.