Pravastatin reduces carotid intima-media thickness progression in an asymptomatic hypercholesterolemic mediterranean population: the Carotid Atherosclerosis Italian Ultrasound Study

Am J Med. 1996 Dec;101(6):627-34. doi: 10.1016/s0002-9343(96)00333-6.


Purpose: The Carotid Atherosclerosis Italian Ultrasound Study (CAIUS) was performed to test the effects of lipid lowering on the progression of carotid intima-media thickness (IMT) in 305 asymptomatic patients from a Mediterranean country.

Patients and methods: Eligibility included hypercholesterolemia (baseline means: low-density lipoprotein [LDL] = 4.68 mmol/L, high-density lipoprotein [HDL] = 1.37 mmol/L), and at least one 1.3 < IMT < 3.5 mm in the carotid arteries. Patients (mean age 55 years, 53% male) were assigned to pravastatin (40 mg/day, n = 151) or placebo (n not equal to 154). Ultrasound imaging was used to quantify IMT at baseline, and semiannually thereafter for up to 3 years. The mean of the 12 maximum IMTs (MMaxIMT), was calculated for each patient visit, and used to determine each patient's longitudinal progression slope. The intention-to-treat group difference in the MMaxIMT progression was chosen a priori as the primary end point.

Results: Five serious cardiovascular events (1 fatal myocardial infarction), and 7 drop-outs for cancer were registered. In the pravastatin group, LDL decreased -0.22 after 3 months versus -0.01 in the placebo group, and remained substantially unchanged afterward (-0.23 versus +0.01 at 36 months, respectively). Progression of the MMaxIMT was 0.009 +/- 0.0027 versus -0.0043 +/- 0.0028 mm/year (mean +/- SE, P < 0.0007) in the placebo and pravastatin groups, respectively. IMT progression slopes diverged after 6 months of treatment.

Conclusions: Pravastatin stops the progression of carotid IMT in asymptomatic, moderately hypercholesterolemic men and women. This finding extends the beneficial effects of cholesterol lowering to the primary prevention of atherosclerosis in a population with relatively low cardiovascular event rates, and suggests that this benefit is mediated by specific morphological effects on early stages of plaque development.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Anticholesteremic Agents / pharmacology*
  • Carotid Stenosis / blood
  • Carotid Stenosis / diagnostic imaging
  • Carotid Stenosis / pathology*
  • Carotid Stenosis / prevention & control*
  • Disease Progression
  • Double-Blind Method
  • Female
  • Humans
  • Hypercholesterolemia / blood
  • Hypercholesterolemia / diagnostic imaging
  • Hypercholesterolemia / drug therapy*
  • Hypercholesterolemia / pathology*
  • Italy
  • Lipids / blood
  • Male
  • Middle Aged
  • Pravastatin / pharmacology*
  • Treatment Outcome
  • Tunica Intima / diagnostic imaging
  • Tunica Intima / drug effects*
  • Tunica Intima / pathology
  • Tunica Media / diagnostic imaging
  • Tunica Media / drug effects*
  • Tunica Media / pathology
  • Ultrasonography


  • Anticholesteremic Agents
  • Lipids
  • Pravastatin