Wednesday, March 29, 2006

Study supports aggressive use of atorvastatin (Lipitor)

The antidyslipidemics market is driven by the statins, which account for 87% of this segment. However, as many statins are expected to face patent expiry in the coming decade manufacturers are looking to novel products to protect their franchise. Such products include combination such as Pfizer's atorvastatin/torcetrapib. For further information on the future of antidyslipidemics see our recent features:
Another trend in the antidyslipidemics market is the move towards more aggressive therapy (ie multiple agents; higher doses; prolonged treatment; broader use etc). Atorvastatin (Lipitor), which has been approved at 10, 20, 40 and 80mg, has been shown to reduce coronary events and revascularization procedures in patients with multiple risk factors for coronary heart disease. Recent studies with atorvastatin 80 mg support the overall safety of this dose during long-term treatment. However, physicians appear reluctant to use high doses of statins.

Today's edition of LeadDiscovery's DailyUpdates service (29th March, 2006) features a journal article that presents the results of a retrospective analysis of pooled data from 49 clinical trials of atorvastatin in 14,236 patients.

The study found that similar numbers of patients experienced at least 1 adverse event whether they were treated with placebo, atorvastatin 10 mg or atorvastatin 80 mg. Withdrawals due to treatment-related adverse events were also similar. Treatment-associated myalgia was not different between the two doses while no cases of rhabdomyolysis were reported in any group. Persistent elevations in hepatic transaminases was observed in 0.1%, 0.6%, and 0.2% of patients in the atorvastatin 10 mg, atorvastatin 80 mg, and placebo groups, respectively. The study authors conclude that atorvastatin 80 mg has a positive safety profile.

According to Datamonitor, responsible for the publication of the features mentioned above, sales of Lipitor across the seven major markets are expected to reach $12.4 billion in 2006.

Moreover, Dr Duncan Emerton, senior cardiovascular analyst at Datamonitor, predicts that greater uptake of atorvastatin 80mg would increase Lipitor revenues for Pfizer due to its higher price. "Recent positive clinical trial data from the ASTEROID trial for AstraZeneca's rosuvastatin (Crestor) has had a huge impact on uptake of Crestor in the US in a very short space of time. As such, this data has the potential to positively impact sales of Lipitor due to migration of current lower-dose Lipitor users to the higher, more expensive dose. As to whether or not this data is sufficiently robust to cause physicians who currently prescribe other statins to migrate to high-dose Lipitor, my gut-feel is that Pfizer will see negligible migration from the competition due to physician and patient familiarity with other statins and no real compelling reason to switch."


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