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Sanjay Kaul, MD: The Crestor JUPITER indication label expansion

Dr. Kaul comments on Crestor

February 10, 2010

The HCC received comments from Dr. Sanjay Kaul about the recent label expansion for AstraZeneca’s Crestor drug. Dr. Kaul was a voting member of the FDA advisory panel for this indication.

Dr. Kaul: Here are my comments for whatever they are worth. There are 2 elements of the FDA’s approval of rosuvastatin that are noteworthy.

First, the label is appropriately conservative in that only a claim for reducing the risk of stroke, MI and revascularization procedures is allowed. Two other component events (hospitalization for unstable angina and death from cardiovascular causes) of the primary quintuple composite endpoint were not allowed in the claim because rosuvastatin failed to impact these outcomes. The reduction in total mortality with rosuvastatin was driven by reduced risk from non-cardiovascular causes of death, principally cancer-related mortality, which is likely to be a spurious observation.

(Editorial note: See The HCC interview with Dr. Guyatt who first said this last year; that the cardiac deaths were not reduced in he JUPITER trial)

Second, the new label includes one additional cardiovascular risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease in addition to the age and elevated hsCRP required for patients to be enrolled in the pivotal JUPITER trial. In JUPITER the treatment benefit was observed only in the group of patients that had at least one additional risk factor (nearly 50% of the individuals enrolled). Patients with age and elevated hsCRP alone (nearly 25% of the patients) failed to exhibit a significant treatment benefit.

The implication of this specific language in the label is that the FDA did not endorse hsCRP for either risk stratification or for therapeutic triage. The NCEP ATP III guidelines already offer statins as an optional treatment for primary prevention in individuals with at least 2 risk factors and LDL levels in the range of 100-129mg/dl.

In my opinion, the label is firmly anchored in evidence and appropriately conservative.

Sanjay Kaul, MD

Professor, Cardiologist

Cedars Sinai Medical Center

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