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A Tale of Two Statins

Sunday, October 2, 2011 // Uncategorized

Lipitor (atorvastatin) should soon become generic.  The most potent statin, Crestor (rosuvastatin), is still protected by patent.  If it is not more effective than generic Lipitor, physicians will be pressured to prescribe the less expensive generic. Reduction in the volume of plaque is just one measure of efficacy.

A manufacturer sponsored trial failed to show a greater reduction  reduction in plaque volume by Crestor compared with Lipitor. This is a summary from Journal Watch.

Rosuvastatin Fails to Outperform Atorvastatin in High-Risk Patients
Rosuvastatin (Crestor) is not significantly better than atorvastatin (Lipitor) in slowing the progression of atherosclerosis, according to results from the SATURN trial.
The 2-year trial, conducted by rosuvastatin’s manufacturer, included some 1300 patients with coronary artery disease randomized to daily rosuvastatin (40 mg) or atorvastatin (80 mg). The study’s primary endpoint — change in atheroma volume on intravascular ultrasound — did not differ significantly between the groups, the manufacturer said in a press release, although the absolute numbers favored rosuvastatin.
The findings come in anticipation of generic atorvastatin hitting the market in November, the Wall Street Journal reports.

The following is the manufacturer’s press release.

AstraZeneca announces top-line results from SATURN study

Friday, 2 September 2011

AstraZeneca today announced top-line results from SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN). SATURN was designed to measure the impact of CRESTOR (rosuvastatin) 40 mg and atorvastatin 80 mg on the progression of atherosclerosis in high risk patients.

The results for the primary efficacy measure, which was change from baseline in percent atheroma volume (PAV) in a ≥40 mm segment of the targeted coronary artery as assessed by intravascular ultrasound (IVUS), demonstrated a numerically greater reduction in favour of CRESTOR versus atorvastatin but did not reach statistical significance.

For the secondary IVUS measure, which was change from baseline in total atheroma volume (TAV) within the targeted coronary artery, CRESTOR demonstrated a statistically significant reduction compared with atorvastatin.

Tolerability and efficacy of CRESTOR seen in SATURN were in line with previous studies and approved product labelling.

Further data and analyses will be presented by the study’s academic investigators at the American Heart Association Scientific Sessions (AHA) on Tuesday, 15 November.

NOTES TO EDITORS

About SATURN

SATURN is a 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study of approximately 1,300 patients, investigating the effects of treatment with rosuvastatin 40 mg and atorvastatin 80 mg on atherosclerotic disease burden as measured by IVUS in patients with coronary artery disease.

About PAV and TAV

Percent atheroma volume (PAV) and total atheroma volume (TAV) can be estimated as part of an intravascular ultrasound examination of a coronary artery. PAV and TAV are two different derivatives of the same measurements taken with a tiny ultrasound probe that is inserted inside the coronary artery. In effect, they take the same ultrasound data, but look at the volume of plaques, or fatty deposits, in different ways to represent what is happening in the patient’s artery.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

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