EBM

[Guest guest]

This new study offers support for the expanded use of

Statins¡­.. Not!

Seitz, DC

From ¡°Journal Watch Lipid management Alert-July 23, 2009¡±:

Summary and Comment

Statins for Primary Prevention of Cardiovascular Disease

Statin users were less likely to experience major

adverse coronary or cerebrovascular events.

Statins

clearly confer substantial benefit in people with established cardiovascular

(CV) disease (secondary prevention); however, the magnitude of benefit in

people without CV disease (primary prevention) is less clear. In this

meta-analysis of 10 randomized controlled trials that involved 70,000 patients,

investigators assessed the effects of statins in people without CV disease but

with CV risk factors.

Participants

(mean age, 63; 34% women) were followed for an average of 4.1 years. Compared

with participants in the statin group, significantly more participants in the

control group died (5.1% vs. 5.7%; odds ratio, 0.88), had major adverse

coronary events (4.1% vs. 5.4%; OR, 0.70), or had major adverse cerebrovascular

events (1.9% vs. 2.3%; OR, 0.81). Also, no significant differences in treatment

benefits were noted between men and women, younger and older participants, and

those with and without diabetes. Notably, statin use was not associated with

excess risk for cancer.

Comment: In this meta-analysis, statins significantly lowered

risks for death, major adverse coronary events, and major adverse

cerebrovascular events in patients without established CV disease but with CV

risk factors. These results, however, should be

interpreted with caution: Whereas the relative risk reductions are impressive,

the absolute risk reductions are small. The authors acknowledge that " the

absolute treatment benefit . . . would certainly be less than 1%, and

significant numbers " of patients (i.e., 100) would need to be treated for 4 years to prevent 1 adverse CV

event.

¡ª

S. Mueller, MD, MPH, FACP

Published in Journal Watch General Medicine July 16, 2009

Citation(s):

Brugts JJ et al. The

benefits of statins in people without established cardiovascular disease but

with cardiovascular risk factors: Meta-analysis of randomised controlled

trials. BMJ 2009 Jun 30;

338:b2376. (http://dx.doi.org/10.1136/bmj.b2376)

The original full journal article is free, open access. What is

important (to me) is that the benefit is mild, and is probably due to the

anti-inflammatory action of the statins, not from cholesterol lowering. So why

not decrease inflammation via nutrition, or even supplementation rather than

screwing with cholesterol production???? $$$$$$$$$$!!!!!!!!

From Medical News Today:

Decreasing

Markers Of Inflammation Is As Important For Statin Action As Decreasing Ldl

Cholesterol (Jupiter Study)

03 Apr

2009

A follow-up study on the JUPITER* trial has revealed that a key component of

the action of statins is reduction of high sensitivity c-reactive protein

(hsCRP), a marker of inflammation, as well as reducing levels of bad

cholesterol. The findings are published in an Article published Online First and

in an upcoming edition of The Lancet.

Publication of the Article coincides with the announcement of the findings at

the American College

of Cardiology (ACC) meeting in Florida, USA.

Present guidelines for statin therapy emphasise the goal of reducing LDL or

'bad' cholesterol. However, statin therapy works best in the presence of

inflammation, which is characterised by increased concentrations of the

biomarker hsCRP. It is thought that reducing levels of hsCRP helps prevent

inflammatory cell adhesion - the process by which inflammation promotes cells

sticking together and forming plaques in arteries. Reducing hsCRP could also

help by preventing these cells sticking to the endothelium (or inner lining) of

the artery, and favourably affect metal-containing enzymes key to plaque

stability.

In this study, lead investigator Dr Ridker (Center for Cardiovascular

Disease Prevention, Brigham and Women's Hospital, Boston, MA, USA) and colleagues followed-up

15,548 initially healthy men and women from the JUPITER study - 87% of the

original participants of that trial. They assessed the effects of rosuvastatin

20mg versus placebo on rates of non-fatal heart attack, non-fatal stroke,

hospital admission for unstable angina, arterial revascularisation, or

cardiovascular death. Concentrations of LDL were measured (¡Ý 1.8mmol/L or

<1.8mmol/L) as was hsCRP (¡Ý2mg/L or < 2mg/L).

The researchers found that, compared with placebo, participants given

rosuvastatin who achieved LDL cholesterol less than 1.8 mmol/L had a 55% reduction

in vascular events, and those achieving hsCRP less than 2mg/L a 62% reduction.

Patients who achieved both LDL less than 1.8 mmol/L and hsCRP less than 2 mg/L

saw a 65% reduction in vascular events, versus a 33% reduction in those who

achieved only one or neither target. Participants who achieved the LDL target

plus a hsCRP concentration of 1 mg/L or less saw a 79% reduction in vascular

events. Furthermore, the researchers showed that achieved hsCRP concentrations

predicted events even if lipid-based endpoints other than LDL cholesterol

concentration were used.

Despite these results, the authors emphasise that for primary prevention in low

risk populations, initial interventions 'should remain lifestyle

recommendations for dietary restriction, exercise, and smoking cessation'. They

conclude: " However, as our findings have shown, for people choosing to

start pharmacological prophylaxis, reductions in both LDL cholesterol and hsCRP

are indicators of the success of treatment with statin therapy. "

In an accompanying Comment, Dr Jean-Pierre Despr¨¦s, Centre de Recherche de

l'Institut Universitaire de Cardiologie et de Pneumologie de Qu¨¦bec, Qu¨¦bec

City, Canada, says: " Despite the fact that regular exercise is a

remarkable and cheap 'polypill', a comparison of the absolute reduction in risk

for coronary heart disease that is gained after statin treatment versus that

with a lifestyle-modification programme aimed at weight loss and improved

fitness is unlikely to happen in the near future. "

He concludes: " To immediately translate these findings into clinical

practice without appropriate and careful discussion of their implications is

not prudent. Hopefully, focus on the JUPITER trial will spur constructive and

responsible dialogues to prioritise clinical and public health actions for

primary prevention of cardiovascular disease. "

DOI:10.1016/S0140-6736(09)60447-5

The Lancet

Notes

*JUPITER study= Justification for the Use of statins in Prevention: an

Intervention Trial Evaluating Rosuvastatin

Source

Tony Kirby

Press Officer

The Lancet

32

town Road

Camden

London

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England