Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease

Linh Bao Nguyen, Mercer University College of Pharmacy

 

According to the American College of Cardiology/American Heart Association (ACC/AHA), patients 40-75 years of age, without diabetes, and with a low-density lipoprotein level from 70-190 mg/dL are recommended to take a moderate intensity statin. [1]

A review of 35 studies states that the elevation of liver enzymes is the primary concern when treating Chinese people with statin drugs due to the high prevalence of hepatitis in China.  It is stated that there is no large randomized trial of rosuvastatin conducted in Chinese people. [2]

 

 

Title: Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease
Design Double-blind, randomized, placebo-controlled trial; N= 12,705
Objective To evaluate cholesterol-lowering therapy with a stain in persons at intermediate cardiovascular risk
Study Groups Rosuvastatin group (n= 6,361); placebo group (n= 6,344)
Methods Eligible patients received both active treatments for blood-pressure lowering and cholesterol lowering for four weeks. Patients with 80% or more compliance were randomized to either take rosuvastatin 10 mg or placebo daily. Lipid levels were measured at baseline, one year, three years, and at the end of the study.
Duration April 2007 to November 2010
Primary Outcome Measure First co-primary outcome: composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; second co-primary outcome: composite of resuscitated cardiac arrest, heart failure, and revascularization
Baseline Characteristics Rosuvastatin group (n= 6,361) Placebo group (n= 6,344)
Age (years) 65.8 65.7
Female (%) 46.4 46.1
Total cholesterol (mg/dl) 201.5 201.3
Low-density lipoprotein (LDL) (mg/dL) 127.8 127.9
High-density lipoprotein (HDL) (mg/dL) 44.7 44.9
Triglycerides (mg/dL) 128.8 126.5
Chinese (%) 29.1 29.0
Hispanic (%) 27.4 27.6
White (%) 20.2 19.9
South Asian (%) 14.6 14.6
Other Asian (%) 5.4 5.6
Black (%) 1.8 1.8
Other ethnic group (%) 1.5 1.6
Results Rosuvastatin group (n= 6,361) Placebo group (n= 6,344) Hazard ratio (95% CI) p value
First co-primary outcome (%) 3.7 4.8 0.76 (0.64-0.91) 0.002
Second co-primary outcome (%) 4.4 5.7 0.75 (0.64-0.88) < 0.001
Adverse Events Common Adverse Events: muscle pain or weakness: 5.8%
Serious Adverse Events: hospitalized for cardiovascular causes 4.4%; rhabdomyolysis or myopathy 0.03%; cataract surgery 3.8%; and deep-vein thrombosis or pulmonary embolism 0.2%
Percentage that Discontinued due to Adverse Events: 1.3% due to muscle symptoms
Study Author Conclusions Treatment with rosuvastatin at a dose of 10 mg per day resulted in a significantly lower risk of cardiovascular events than placebo in an intermediate-risk, ethnically diverse population without cardiovascular disease.

 

The results from the study support the recommendation from ACC/AHA in treating patients with intermediate risk for cardiovascular diseases in various ethnic groups. The study also suggests that low dose rosuvastatin is safe and effective to prevent cardiovascular diseases without routine blood tests. However, because the elevation of liver enzymes was not mentioned in the adverse events, more studies are needed to address this concern in Chinese people.

 

References

  1. Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.J Am Coll Cardiol. 2014;63(25_PA):2889-2934. doi: 10.1016/j.jacc.2013.11.002.
  2. Wang Z, Ge J. Managing hypercholesterolemia and preventing cardiovascular events in elderly and younger Chinese adults: focus on rosuvastatin. Clin Interv Aging. 2014;9:1-8.
  3. Yusuf S, Bosch J, Dagenais G, et al. Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease. N Engl J Med. 2016;374(21):2021-31.

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