Neurology & Neurosurgery Journal Scan, December 2008
Neurology & Neurosurgery Journal Scan, December 2008
This Journal Scan reviews important articles in neurology and neurosurgery. Summarized below are key findings from select articles in the Archives of Neurology, Expert Review of Neurotherapeutics, and The New England Journal of Medicine. Links to the article abstracts are also provided. (If available, full-text articles are also included; in some cases, access to full-text articles requires registration at the specific journal's Web site.)
Ridker P, Danielson E, Fonseca F, et al
N Eng J Med. 2008;359:2195-2207
The Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) was a randomized, double-blind, placebo-controlled, multicenter trial. It tested the hypothesis that apparently healthy persons with elevated high-sensitivity C-reactive protein (HS-CRP) levels but without hyperlipidemia might experience fewer cardiovascular events if treated with statins. The study sample comprised 17,802 healthy men and women with low-density lipoprotein (LDL) cholesterol levels <130 mg/dL (3.4 mmol/L) and HS-CRP levels ≥ 2.0 mg/L. Participants were randomly assigned to receive 20 mg of rosuvastatin or placebo daily. The composite main outcome measure was myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes. When the data and safety monitoring board noted a significant reduction in the primary endpoint in the rosuvastatin group, the trial was stopped after a median follow-up of 1.9 years (maximum, 5.0 years). The rosuvastatin group had a 50% reduction in LDL cholesterol levels and a 37% reduction in HS-CRP levels. The rates of the main composite outcome were 0.77 per 100 person-years of follow-up in the rosuvastatin group and 1.36 per 100 person-years in the placebo group (hazard ratio [HR] for rosuvastatin, 0.56; 95% confidence interval [CI], 0.46-0.69; P < .001). Corresponding rates for stroke were 0.18 and 0.34 (HR, 0.52; 95% CI, 0.34-0.79; P = .002), and for the combined end point of myocardial infarction, stroke, or death from cardiovascular causes, rates were 0.45 and 0.85 (HR, 0.53; 95% CI, 0.40-0.69; P < .001). All subgroups evaluated had similar findings. Although rates of myopathy or cancer were not increased in the rosuvastatin group, this group did have a higher incidence of physician-reported diabetes than in the placebo group.
This trial suggests that rosuvastatin was associated with significant reductions in the incidence of stroke and of other major cardiovascular events in apparently healthy persons without hyperlipidemia but with elevated HS-CRP levels. However, study limitations include inability to determine the effect of statins in people with both low cholesterol and low HS-CRP; median follow-up < 2 years, which prevented determination of the effects of longer-term therapy; and evaluation of the use of rosuvastatin to prevent first cardiovascular events, which resulted in lower absolute event rates than would be expected in patients with a history of vascular disease. The study findings support the notion that atherothrombosis is in some ways an immune disorder, which may stimulate development of targeted antiinflammatory drugs as potential vascular therapeutic agents. When considering whether attempts at preventing cardiovascular events with statin therapy are justified, the absolute benefits of treatment must be sufficiently large to justify the associated risks (eg, diabetes) and costs. Long-term safety data are clearly needed before low-risk individuals should be subjected to long-term statin treatment.
Abstract
Full Text
Rosuvastatin to Prevent Vascular Events in Men and Women With Elevated C-Reactive Protein
This Journal Scan reviews important articles in neurology and neurosurgery. Summarized below are key findings from select articles in the Archives of Neurology, Expert Review of Neurotherapeutics, and The New England Journal of Medicine. Links to the article abstracts are also provided. (If available, full-text articles are also included; in some cases, access to full-text articles requires registration at the specific journal's Web site.)
Ridker P, Danielson E, Fonseca F, et al
N Eng J Med. 2008;359:2195-2207
Summary
The Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) was a randomized, double-blind, placebo-controlled, multicenter trial. It tested the hypothesis that apparently healthy persons with elevated high-sensitivity C-reactive protein (HS-CRP) levels but without hyperlipidemia might experience fewer cardiovascular events if treated with statins. The study sample comprised 17,802 healthy men and women with low-density lipoprotein (LDL) cholesterol levels <130 mg/dL (3.4 mmol/L) and HS-CRP levels ≥ 2.0 mg/L. Participants were randomly assigned to receive 20 mg of rosuvastatin or placebo daily. The composite main outcome measure was myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes. When the data and safety monitoring board noted a significant reduction in the primary endpoint in the rosuvastatin group, the trial was stopped after a median follow-up of 1.9 years (maximum, 5.0 years). The rosuvastatin group had a 50% reduction in LDL cholesterol levels and a 37% reduction in HS-CRP levels. The rates of the main composite outcome were 0.77 per 100 person-years of follow-up in the rosuvastatin group and 1.36 per 100 person-years in the placebo group (hazard ratio [HR] for rosuvastatin, 0.56; 95% confidence interval [CI], 0.46-0.69; P < .001). Corresponding rates for stroke were 0.18 and 0.34 (HR, 0.52; 95% CI, 0.34-0.79; P = .002), and for the combined end point of myocardial infarction, stroke, or death from cardiovascular causes, rates were 0.45 and 0.85 (HR, 0.53; 95% CI, 0.40-0.69; P < .001). All subgroups evaluated had similar findings. Although rates of myopathy or cancer were not increased in the rosuvastatin group, this group did have a higher incidence of physician-reported diabetes than in the placebo group.
Viewpoint
This trial suggests that rosuvastatin was associated with significant reductions in the incidence of stroke and of other major cardiovascular events in apparently healthy persons without hyperlipidemia but with elevated HS-CRP levels. However, study limitations include inability to determine the effect of statins in people with both low cholesterol and low HS-CRP; median follow-up < 2 years, which prevented determination of the effects of longer-term therapy; and evaluation of the use of rosuvastatin to prevent first cardiovascular events, which resulted in lower absolute event rates than would be expected in patients with a history of vascular disease. The study findings support the notion that atherothrombosis is in some ways an immune disorder, which may stimulate development of targeted antiinflammatory drugs as potential vascular therapeutic agents. When considering whether attempts at preventing cardiovascular events with statin therapy are justified, the absolute benefits of treatment must be sufficiently large to justify the associated risks (eg, diabetes) and costs. Long-term safety data are clearly needed before low-risk individuals should be subjected to long-term statin treatment.
Abstract
Full Text
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