lunes, 5 de septiembre de 2011

AstraZeneca's Crestor fails to show significant benefit over Pfizer's Lipitor: study

Tie announced in SATURN rosuvastatin-atorvastatin face-off
September 2, 2011

In a rare randomized comparison of two competing statins in patients with documented coronary disease, treatment with rosuvastatin (Crestor, AstraZeneca) and with atorvastatin (Lipitor, Pfizer) had similar effects after two years on the trial's primary end point, percent atheroma volume (PAV) by intravascular ultrasound (IVUS), trial sponsor AstraZeneca said today in a limited announcement for investors [1].
The primary end point in the Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN) targeted a prespecified >40 mm coronary segment. It started enrollment in 2008 and completed it last year, as reported by heartwire, and the company says "further data and analyses will be presented by the study's academic investigators at the American Heart Association [2011] Scientific Sessions on Tuesday, November 15."

As stated in a company press release, The PAV results "demonstrated a numerically greater reduction in favor of [rosuvastatin] vs atorvastatin but did not reach statistical significance."

For a secondary IVUS end point, change from baseline in total atheroma volume (TAV), rosuvastatin demonstrated a statistically significant reduction compared with atorvastatin.
The trial will also look at lipid and inflammation biomarkers.
The 1385 patients in the trial, which wasn't powered for clinical end points [2], were required to have a clinical indication for coronary angiography or at least one significant coronary lesion by angiography.

  1. AstraZeneca. AstraZeneca announces top-line results from SATURN study [press release]. September 2, 2011. Available here.
  2. Nicholls SJ, Borgman M, Nissen SE, et al. Impact of statins on progression of atherosclerosis: Rationale and design of SATURN (Study of Coronary Atheroma by Intravascular Ultrasound: effect of Rosuvastatin versus Atorvastatin). Curr Med Res Opin 2011; 27:1119-1129.

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