And the first thing I want to share with you is that we know that “Lipid lowering treatment with statin in patients without cardiorenal syndrome”, and what I mean is general population   without renal or cardiac disease or people with previous CV events and without significant kidney disease, have got a huge benefit in terms of CV outcome when treated with statins and with a dose response relationship.

And what we can clearly see in this picture is that both in primary prevention in people with “high” levels of LDL cholesterol that in secondary prevention, albeit in people with previous CV events, with a wide range of basal LDL cholesterol, treatment with statins has shown a very significant effect in reducing most CV  atherosclerotic  events, mainly fatal and non fatal MI. From this slide we can also see that  the lower the LDL cholesterol levels achieved with the treatment the higher the CV benefit observed.

Per quanto riguarda la terapia con statine nella disfunzione renale lieve sono disponibili analisi post-hoc di alcuni grandi trial che hanno suggerito come il trattamento con questi farmaci sia in grado di ridurre l’incidenza di eventi cardiovascolare di circa il 30 – 40 %.

Patients with moderate CKD are at increased risk of myocardial infarction, stroke and vascular death compared to patients with more preserved kidney function.

A subgroup analysis of the JUPITER study investigated the effects of rosuvastatin on CV events in 3,267 patients with moderate Chronic Kidney Disease (CKD) (estimated Glomerular Filtration Rate < 60 ml/min/1.73 m2) at study entry.

Treatment with rosuvastatin 20 mg reduced the risk of major CV events* by 45% (HR 0.55, 95% CI: 0.38-0.82, p=0.002) and total mortality by 44% (HR 0.56, 95% CI: 0.37-0.85, p=0.005) compared to placebo. Median eGFR at 12 months was marginally improved among those randomly allocated to rosuvastatin as compared to placebo (66.8 vs 66.6 ml/min/1.73m2, P = 0.02). Importantly, there was no significant difference in eGFR between rosuvastatin and placebo at 12 months in the subgroup of patients with CKD (53.0 vs 52.8 ml/min/1.73m2, p=0.44).

Adverse event rates associated with rosuvastatin were similar in the JUPITER trial among those with and without moderate CKD.

* Primary endpoint in the JUPITER study was reduction in risk of non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina, arterial revascularization, or confirmed cardiovascular death

References

Ridker PM et al. Efficacy of rosuvastatin among men and women with moderate chronic kidney disease and elevated high-sensitivity C-reactive protein. A secondary analysis from the JUPITER (Justification for the Use of Statins in Prevention- an Intervention Trial Evaluating Rosuvastatin) trial. JACC 2010; 55; doi:10.1016/j.jacc.2010.01.020

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In a subgroup of 3267 patients with impaired renal function (eGFR < 60 ml/min/1.73 m2) from the JUPITER study, treatment with rosuvastatin 20 mg reduced the risk of major cardiovascular events by 45% compared to placebo after 2.3 years of follow-up (HR 0.55; 95% CI: 0.38-0.82, p=0.002). The CKD group of patients had a 54% increase in the risk of major CV events compared to the non-CKD group (HR 1.54, 95% CI: 1.23-1.92, p=0.0002).

Additonally, treatment with rosuvastatin 20 mg resulted in a 44% reduction in the risk of  total mortality (HR 0.56, 95% CI 0.37-0.85, p=0.005) compared to placebo.

Reference

Ridker PM, MacFadyen J, Cressman M, Glynn RJ. Efficacy of rosuvastatin among men and women with moderate chronic kidney disease and elevated high-sensitivity C-reactive protein. J Am Coll Cardiol. 2010 ;55(12):1266-1273.