Rosuvastatin is potent and new statin?

• No doubt rosuvastatin is a good molecule for lipid lowering, but

doctor we need to see what does the data suggests?

• Rosuvastatin has Juipter trial where the inclusion criteria was:

Men (>50 years) and women (>60 years) who had no clinically
evident CVD, LDL-C levels <130 mg/dL and hsCRP levels ≥2
mg/L.

• As we can see it is a primary prevention trial with no data to

suggest on the secondary prevention aspect of the trial.

• It is very interesting to note that as per National Health and

Nutrition Examination Surveys in USA only 4 % of total US
population fulfilled the inclusion criteria of rosuvastatin.

• Where – as in HPS trial of ZOCOR which had over 20,000 patients

and was over 5 years long across multiple locations was
designed to evaluate the safety & effect on cardiovascular risk of
Simvastatin in a broad array of patients
1. Over 13,000 patients had prior CHD
2. Over 8000 patients had other vascular diseases including
treated hypertension
3. 5000 patients had diabetes
4. 4000 diabetic patients but without CHD
5. 5000 women
6. 5000 elderly over 70 years
7. Mean LDL was 135 mg/dl
8. 3400 patients with < 100 mg/dl LDL

I am sure this is the patient profile that comes to your clinic regularly.

I would like to ask if there is a patient type who comes to your clinic
regularly and has not been included in HPS trial?

• Rosuvastatin clearly has benefits in primary prevention

patients with elevated hs-CRP and other risk factors but if
we closely observe the label of Rosuvastatin it is startling
to know that As per Label: In subgroup analysis of JUPITER
subjects with a hsCRP ≥2 mg/L and no other traditional risk
 factors other than age, there was no significant treatment
benefit with rosuvastatin treatment.

• So it leaves us wondering whether hs-CRP leads to cardiac

events or is it vice-versa, as its well documented many
other complications like arthritis can also lead to increase
in hs-CRP that is precisely the guidelines have not given a
go ahead for hs-CRP as an independent CV risk marker.

• Hard cardiovascular end points in secondary prevention

still needed for rosuvastatin.

• I am sure you would not disagree that the whole point of

reducing cholesterol, we are told, is to prevent events,
after all? But crestor labels clearly says data for CV
mortality & morbidity for rosuvastatin in post-event cases
which included diabetes has not been established.

• many a times we are told that a drug which benefit in

primary prevention would automatically benefit in
secondary prevention? Then I am sure you would want to
know why does rosuvastatin does not have any hard end-
point data in secondary prevention?

• One of the rosuvastatin trial Meteor which was designed to

access benefit of it in secondary prevention for middle-age
men did not produce any result.

Revision: Questions to ask & discussion points

• Rosuvastatin has hard core data for primary prevention and you
may like to use it for the same! But in the absence of secondary
prevention data would you still use rosuvastatin for your diabetic
patients & high risk patients with prior events & multiple risk
factors?

• If an elderly patient with elevated hs-CRP and an addition risk

factor like smoking or hypertention comes to your clinic,
rosuvastatin would be the statin of choice but ZOCOR deserves
its place in secondary prevention patients.

• I am very sure doctor you would agree with me that one of the
core objective of cholesterol lowering is to prevent events and
 give the patients prolonged quality of life. ZOCOR has shown
consistent mortality benefits in both its trial i.e HPS & 4S. 4S
included high risk patients where is showed 42% reduction in
coronary mortality and 30% reduction in overall mortality.
Whereas in the larger trial HPS which had broad array of patients
it showed 18% reduction in overall mortality and 13% reduction
in overall mortality. And HPS diabetes sub arm which had over
5000 diabetic patients showed 20% reduction in coronary
mortality.
• Rosuvastatin is a potent statin on bio-markers but its efficacy on
hard-core end points in secondary prevention patients is yet to
be established.

• If I tell you that though ZOCOR being a prescription drug is

allowed to use as OTC drug in UK, I am sure you would agree the
faith of authorities on the safety of ZOCOR. No other statin has
got this much faith among medical fraternity than ZOCOR.

• Though you know well doctor ZOCOR was launched only last year
and we were not there to promote this wonderful drug, but you
would be pleasantly surprised to know ZOCOR is the highest
selling statins in terms of volume of old as well as new
prescriptions worldwide. Globally the medical fraternity has
strong faith in ZOCOR and we would request you to show the
faith in this product based on decades of efficacy, experience &
evidence.

• I would not call ZOCOR an old drug, but a vintage drug, aspirin
has been in market over 100 years and is still going strong, so is
the case with ZOCOR with over 2 decades of experience.
Associating with this brand would help giving you the freedom of
thought that your patient is in safe hands.

• More importantly as we have discussed diabetic dyslipidemia

needs management different from normal dyslipidemia due to
presence of more small dense LDL-C particles. A drug may lower
total LDL-C but it may not proportionately lower LDL- particles.
ZOCOR has shown to significantly benefit diabetic patients even
without prior CHD ( talk about HPS –diabetes trial & mortality
benefits of 20%)

• We do not want all your patients to be put on ZOCOR, you are

the best judge but ZOCOR has strongest evidence in post-event
patients and especially diabetes and am sure you would pass on
the benefit of this drug to your patients.
NOW YOU DECIDE WHAT ABOUT YOUSELF & YOUR FAMILY HEALTH