In my recent post All in for Crestor, I discussed how the SATURN study comparing Crestor to Lipitor was likely a make or break study for AstraZenca's cholesterol pill. As mentioned, because Lipitor will soon go generic in November, AZ needed to give insurance companies a reason to pay for the more expensive branded pill, then the soon to be generic and cheaper version of Lipitor, which has been the number one selling drug in the country.
As reported in Pharmalot's post Disappointing Crestor Results For AstraZeneca (see the official AstraZeneca statement here ), the just released results of SATURN show that the 40mg dose of Crestor was numerically but not statistically significantly better and reducing plaque build up (as measured by % change) as the 80mg dose of Lipitor. As secondary measure, plaque buildup as measured by volume was statistically significant, but since this was not the primary outcome of the study, it is likely enough for insurers to give Crestor a favorable status on their formulary lists.
Bottom Line: Crestor is a great drug. It reduces LDL better than Lipitor. We know that from outcome studies of all statins, that the lower the LDL with a statin, the more you decrease heart attacks and strokes. In addition, despite it's potency, it has very good tolerability. Certain patients that might need 80mg of Lipitor, might not be able to tolerate side effects at that high of a dose, and might end up doing better on 20mg or 40mg of Crestor. That said, starting in 2012, unless AZ cuts the price on Crestor drastically, it may be a challenge to get the prescription approved for patients.
Showing posts with label SATURN. Show all posts
Showing posts with label SATURN. Show all posts
Friday, September 2, 2011
Tuesday, August 16, 2011
All In For Crestor
The American Heart Association will be holding its annual meeting this November. Cardiobrief.org just posted the announced "late-breaking" clinical trials. These are the big name trials that usually grab a lot of headlines. One of the trials is the AIM-HIGH trial which showed that Niacian didn't really do much in patients whose bad cholesterol or LDL was controlled with a statin (see my post What to do about Niacin? )
Another very important study will also be presented that same November 15th, 2011: Comparison of the Progression of Coronary Atherosclerosis for Two High Efficacy Statin Regimens with Different HDL Effects: SATURN Study Results. The SATURN study is the Astra Zeneca (makers of Crestor) study comparing high dose Crestor (40mg) with high dose Lipitor (80mg).
Patients in the SATURN study will have known cardiac disease as indicated by a need for coronary angiography (angiogram) and angiographic evidence of coronary disease. The main end point is is IVUS-assessed change in the percent atheroma volume in a >40-mm segment of a single coronary artery; which is a "doctor" way of saying they are going to look for plaque build up in the artery. This is the same end point used in the famous (or infamous) ENHANCE trial which showed that adding Zetia to simvastatin (zetia + simvastatin = Vytorin) did absolutely nothing to plaque build up ( Vytorin and Zetia: What to do now? )
What's interesting about SATURN is that the LDL lowering properties of the highest doses of Crestor and Lipitor are about the same. However, at those doses Crestor raises the HDL or good cholesterol by about 8% where Lipitor only raises HDL by 3%. Other studies have shown that plaque build up in the arteries (atherosclerosis) that causes heart attacks and strokes, is not just about LDL, but also about HDL. Other studies looking at high doses of Crestor when compared to placebo show that it can prevent plaque build up and possibly even lead to regression. The Lipitor data on this is less robust.
The timing of the results at the AHA is particularly interesting, since it will coincide with Lipitor going generic. Zocor or simvastatin has been generic for a while, and works well in many patients. However, patients requiring more aggressive reduction in their cholesterol will not meet their goals on simvastatin and high dose simvastatin is associated with side effects, which prompted a recent FDA warning. (See Don't Take High Dose Simvastatin). Thus, the need for a generic potent statin like Lipitor is huge. However, this could mean that insurers will make it very, very difficult for patients to get Crestor. UNLESS......... SATURN proves that high dose Crestor compared to high dose Lipitor significant reduces plaque build up in high risk patients.
Therefore, the SATURN trial is really a huge gamble for Astra Zeneca. When Merck's ENHANCE trial showed that Vytorin didn't really do more than the generic statin, prescribing rates dropped precipitously. Crestor likely faces the same fate is SATURN turns out to be a negative study.
Another very important study will also be presented that same November 15th, 2011: Comparison of the Progression of Coronary Atherosclerosis for Two High Efficacy Statin Regimens with Different HDL Effects: SATURN Study Results. The SATURN study is the Astra Zeneca (makers of Crestor) study comparing high dose Crestor (40mg) with high dose Lipitor (80mg).
Patients in the SATURN study will have known cardiac disease as indicated by a need for coronary angiography (angiogram) and angiographic evidence of coronary disease. The main end point is is IVUS-assessed change in the percent atheroma volume in a >40-mm segment of a single coronary artery; which is a "doctor" way of saying they are going to look for plaque build up in the artery. This is the same end point used in the famous (or infamous) ENHANCE trial which showed that adding Zetia to simvastatin (zetia + simvastatin = Vytorin) did absolutely nothing to plaque build up ( Vytorin and Zetia: What to do now? )
What's interesting about SATURN is that the LDL lowering properties of the highest doses of Crestor and Lipitor are about the same. However, at those doses Crestor raises the HDL or good cholesterol by about 8% where Lipitor only raises HDL by 3%. Other studies have shown that plaque build up in the arteries (atherosclerosis) that causes heart attacks and strokes, is not just about LDL, but also about HDL. Other studies looking at high doses of Crestor when compared to placebo show that it can prevent plaque build up and possibly even lead to regression. The Lipitor data on this is less robust.
The timing of the results at the AHA is particularly interesting, since it will coincide with Lipitor going generic. Zocor or simvastatin has been generic for a while, and works well in many patients. However, patients requiring more aggressive reduction in their cholesterol will not meet their goals on simvastatin and high dose simvastatin is associated with side effects, which prompted a recent FDA warning. (See Don't Take High Dose Simvastatin). Thus, the need for a generic potent statin like Lipitor is huge. However, this could mean that insurers will make it very, very difficult for patients to get Crestor. UNLESS......... SATURN proves that high dose Crestor compared to high dose Lipitor significant reduces plaque build up in high risk patients.
Therefore, the SATURN trial is really a huge gamble for Astra Zeneca. When Merck's ENHANCE trial showed that Vytorin didn't really do more than the generic statin, prescribing rates dropped precipitously. Crestor likely faces the same fate is SATURN turns out to be a negative study.
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