PHARMA: A little more info on Crestor

Nov 5, 2003• 1

There’s a little more info about the adverse events with Crestor, in a report called What’s the Matter with Crestor? from Friedman, Billings, Ramsey & Co Research. (I couldn’t find a way to get the report without opening a brokerage account!).

The research suggests so far that Crestor is not doing as well in the marketplace as was expected, and is being outpaced by Schering & Merck’s non-statin, LDL-lowering drug Zetia, which can be taken in addition to statins or by itself, and is useful for at least the 5% of population that cannot tolerate statins. The report says

Data indicate that thus far, Crestor’s launch has been significantly slower than that of Zetia, a non-statin cholesterol-lowering drug, comparing total script volumes at similar times after launch. This is underscored by the fact that two recent comparator weeks for Zetia include the Christmas and New Years holidays, weeks that are typically slow for prescription volumes, and surprisingly, Zetia is still exceeding Crestor on an absolute basis. Crestor also lags Zetia in NRx market share, according to prescription audit data, holding 2.22% NRx share compared to Zetia’s 2.65% at similar periods in the launch trajectory, a better comparison than total prescriptions in our view, because it is less dependent on the absolute size of the market.

Translation for non-pharma folks is that Crestor hasn’t taken up as well as it might have done. Meanwhile the report also goes onto to confirm some of the issues around safety. You’ll recall that Public Citizen, and The Lancet have been bringing this issue to the forefront.

According to the Medicines and Healthcare Products Regulatory Agency in the U.K., there have been 41 reports reflecting 45 muscular reactions associated with Crestor use. Of those reports, 35 were associated with the 10mg dose of the product, and notably, 3 of the reactions involved moderately increased levels of Creatine Phosphokinase (219-436 IU/L), according to data from the agency. Based on our research, normal Creatine Phosphokinase levels are in the 30-170 IU/L range and elevations associated with severe rhabdomyolysis are typically in the 35,000 IU/L range and up. The U.K. agency cautions that suspected adverse reactions are not necessarily caused by the drug and may relate to other factors such as underlying illnesses or other medicines; however, we believe that the early reports of muscle-related adverse events at the most common starting dose are notable.

I repeat that I am not a scientist or physician and have little understanding of the seriousness of these findings. However, 35 of 45 muscle problems were reported on the 10mg dose– 1/4 of the dose that concerned The Lancet, and there were three reports of increased Creatine Phosphokinase which is a precursor to rhabdomyolysis. The question is whether the medical community views this as minor or whether they perceive that these very initial results are indicators of more trouble to come.

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