The Wall Street Journal is reporting on a study published in the journal Cancer, and described by Reuters that links statins to reducing the risk of prostate cancer. According to the report:
The researchers found that men who died of prostate cancer were half as likely to have taken a statin at any time, and for any duration, than men in the "control" group. Those with fatal cancers were 63 percent less likely to have ever taken a statin, according to findings published in Cancer.
I would love for statins to reduce the risk of prostate cancer. Readers of this blog know I am relatively pro-statin, in the right patient population. However, this study is too limited to make an actual connection, and I would not recommend taking statins solely for prostate cancer prevention.
What did the researchers do? The looked at the medical records of 380 men who died of prostate cancer and matched them with the records of another 380 men who did not have prostate cancer. They use statistical techniques to adjust for difference such as age, weight and other medications.
What's the problem with the study? First, if the study findings are correct, such a study that uses medical records and then looks back in time can not prove causation. It only proves association. This means that the study doesn't prove that taking a statin will ward off prostate cancer. Rather, the results mean that men who had died of prostate cancer were less likely to take a statin. This is a big difference. There are multiple examples where a confirmed association did not result into a confirmed causation (Vitamin E/C and Folic Acid for preventing heart attacks). In addition, there are many reasons that the association is in fact not correct. Perhaps men who had been diagnosed with prostate cancer chose not to take statins, even if their doctors recommended it, because they were more concerned about the prostate cancer? Perhaps men who did not have prostate cancer were extremely health conscious and were more aggressive about both doing things to prevent cancer (exercise, diet, etc.) as well as being more aggressive about taking statin medications for high cholesterol?
Why this might be true? The only way to truly determine causation is to perform a randomized clinical trial (RCT). Only a RCT can both eliminate some of the confounding variables (i.e. were the men without prostate cancer more aggressive about their overall health) and demonstrate the primary ingredient for causation: that exposure always precedes the outcome. If factor "A" is believed to cause a disease, then it is clear that factor "A" must necessarily always precede the occurrence of the disease.
However, there are two findings from this study that support causation. First, is dose-response relationship. Only the newer, more potent statins showed benefit. Taking a lower potency statin was not protective. The second is biologic plausibility. According to the Reuters report, Dr. Stephen Freedland, who studies prostate cancer at the Duke University Medical Center in Durham, but wasn't involved in the new study was quoted as stating that statins may protect against fatal prostate cancer through their known cholesterol-lowering effects, mentioning that cholesterol is a "key nutrient" for cancer cells, so lower cholesterol levels in the body could prevent more aggressive forms of cancer from developing.
Bottom Line: This study is exciting and will hopefully lead to randomized trials which can prove whether or not taking a statin will prevent prostate cancer. For now, there is very limited evidence to suggest this would actually work, and men should not start taking a statin just to lower their risk of prostate cancer.
Friday, December 30, 2011
Wednesday, December 7, 2011
More Evidence that Lantus Causes Cancer
There is a new study reported in Bloomberg this morning that Sanofi’s Lantus Doubled Cancer Risk in Study of Diabetics. The study, which was presented yesterday at the San Antonio Breast Cancer Symposium retrospecitvely evaluated medical records of 23,266 patients in southern Sweden and determined that diabetics who used Lantus had a 2.9-fold greater chance of cancer, while those who took the generic drug metformin had an 8 percent lower risk.
I have previously blogged about this back in 2009 when the first reports surfaced about the link between Lantus and cancer. (See A New Problem With Insulin: Cancer , Lantus Causes Cancer! Why Doesn't Anyone Seem Care? and Lantus and Cancer- A Closer Look Is Not Reassuring )
Back in 2009, when the story broke, the FDA acknowledged the potential link but stated that the data was insufficient and recommended that patients not stop taking Lantus, at least without discussing this with their physicians. They stated that they were "currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus." However, we didn't hear much until January, 2011 when they released an update declaring that they had reviewed the four 2009 studies and has "determined that the evidence presented in the studies is inconclusive", and in addition had reviewed results from a 5 year study (sponsored by the makers of Lantus) which did not show an increased risk but was "not specifically designed to evaluate cancer outcomes," concluding, "at this time, FDA has not concluded that Lantus increases the risk of cancer. Our review is ongoing, including review of information from a current clinical trial." With the new study reported today, it will be interesting to see whether the FDA chooses to give and update or reveals and additional information, such as a VA data set they are supposed to be evaluating.
According to the Bloomberg article, a Sanofi study from Sweden, Norway, Finland, Denmark and Scotland is complete and will be submitted to health authorities this month. In addition, U.S. study will be finished in early 2012, while a final report from Europe will come later. All of these studies combined will involve more than a million patients, which will hopefully be enough to give a more conclusive answer.
To be clear, I am not 100% convinced that Lantus causes cancer. However, there is another long acting insulin (Levemir) which has similar efficacy to Lantus, has not been associated with cancer, and has a substantially different affinity for the insulin like growth factor (IGF) receptors that are implicated in the possible connection. Given the mounting evidence of a cancer link with an equally effective product that appears to be safer, I can't see any reason to prescribe Lantus when Levemir is available.
I have previously blogged about this back in 2009 when the first reports surfaced about the link between Lantus and cancer. (See A New Problem With Insulin: Cancer , Lantus Causes Cancer! Why Doesn't Anyone Seem Care? and Lantus and Cancer- A Closer Look Is Not Reassuring )
Back in 2009, when the story broke, the FDA acknowledged the potential link but stated that the data was insufficient and recommended that patients not stop taking Lantus, at least without discussing this with their physicians. They stated that they were "currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus." However, we didn't hear much until January, 2011 when they released an update declaring that they had reviewed the four 2009 studies and has "determined that the evidence presented in the studies is inconclusive", and in addition had reviewed results from a 5 year study (sponsored by the makers of Lantus) which did not show an increased risk but was "not specifically designed to evaluate cancer outcomes," concluding, "at this time, FDA has not concluded that Lantus increases the risk of cancer. Our review is ongoing, including review of information from a current clinical trial." With the new study reported today, it will be interesting to see whether the FDA chooses to give and update or reveals and additional information, such as a VA data set they are supposed to be evaluating.
According to the Bloomberg article, a Sanofi study from Sweden, Norway, Finland, Denmark and Scotland is complete and will be submitted to health authorities this month. In addition, U.S. study will be finished in early 2012, while a final report from Europe will come later. All of these studies combined will involve more than a million patients, which will hopefully be enough to give a more conclusive answer.
To be clear, I am not 100% convinced that Lantus causes cancer. However, there is another long acting insulin (Levemir) which has similar efficacy to Lantus, has not been associated with cancer, and has a substantially different affinity for the insulin like growth factor (IGF) receptors that are implicated in the possible connection. Given the mounting evidence of a cancer link with an equally effective product that appears to be safer, I can't see any reason to prescribe Lantus when Levemir is available.
Monday, October 24, 2011
Industry Funded Studies
One of the advantages of being a blogger is the comments, feedback and communications I receive from readers. Though not all of it is positive, many of these interactions with people from across the globe that I do not know has been quite enjoyable for me personally.
One email I received from a reader had to do with industry funded studies. This is not an uncommon concern, and one that frequently shows up on this blog and others. The email encapsulates many people's concerns with industry funded studies.
Dear Dr. Mintz,
I am staring at my computer unable to formulate the words to express my opinion on a very important subject. I do not want to come across as rude, condemning or complaining, yet I am compelled to share with the medical community my honest patient perspective.
I view the medical profession as one of the most respected on earth. But it isn't perfect. As a patient I become very discouraged when I see a medical professional look towards industry funded drug studies to make medical decisions.
Now for the painfully honest part. When I see a Doctor subscribe to "results" from an industry funded drug study, my image of that physician goes to pot in a heartbeat. "How can he/she be so gullible" and "Incompetent" are thoughts that pass through my mind. I quickly lose trust in that physician's ability to make smart decisions in my health care, and the doctor loses my business.
On on the contrary, I asked a physician what he thought about industry funded drug studies, he answered "I ignore them." This doctor won me over in three words.
Obviously it takes excellent academic ability to become a physician, but I look for more than that. I look for wisdom and integrity when choosing a physician.
There is no question that industry studies are biased by nature. The drug company is beholden to its stockholders to increase sales. Therefore, they have a fiduciary obligation to make sure that their research puts their products in the best light. This is not unlike any product in the US where a manufacturer does research stating that people prefer it or it works better than a competitor. Unlike these products, medications are heavily regulated in the United States. Thus, for a medication to get approval or to make any claims, all studies, including ones funded by the industry have to go through the FDA.
Here's the real problem:
Almost all research done on medications is funded by the industry. I would love it if instead of relying on industry sponsored studies, I could rely on non-biased information. However, when it comes to medications, these studies are few and far between. In 2005, the industry spent close to $40 billion dollars on research. Compare this to the entire NIH budget that same year of less than $30 billion. Also, understand that the NIH spends very little money on actual drug studies. They focus more on finding a cure to cancer, not whether expensive medicine X is just as good as the older generic medication.
When I want to know whether to buy product X vs. product Y, I can go to an independent source such as Consumer Reports, which does their own, independent research. There is really no such independent source for drug information. In fact, prescription drugs is one of the only areas that Consumer Reports does not do their own research. All their recommendations on which medicine is "right for you" come from drug company sponsored studies.
If we ignored all industry funded studies, we be ignoring most of the data. In addition, since these studies are heavily regulated, we would be ignoring mainly good, helpful data, even if biased. The simple alternative is to fund the NIH or similar organization equally to the drug companies in order to do independent research. Of course this would likely require significant government spending, which is likely a non-starter.
The good news is that independent comparisons of treatment, called comparative effective research, are starting to be done, and (whether you like health care reform or not), there is funding for this research in the Affordable Care Act. Unfortunately, this funding is not nearly enough to compete with the drug companies. Thus, unless you are willing to pay considerably more in taxes or drop some needed services, physicians and patients still need to rely on industry funded research. Many studies from the industry are actually quite good and useful, though, because of inherent bias, should always be looked at with a skeptical eye.
One email I received from a reader had to do with industry funded studies. This is not an uncommon concern, and one that frequently shows up on this blog and others. The email encapsulates many people's concerns with industry funded studies.
Dear Dr. Mintz,
I am staring at my computer unable to formulate the words to express my opinion on a very important subject. I do not want to come across as rude, condemning or complaining, yet I am compelled to share with the medical community my honest patient perspective.
I view the medical profession as one of the most respected on earth. But it isn't perfect. As a patient I become very discouraged when I see a medical professional look towards industry funded drug studies to make medical decisions.
Now for the painfully honest part. When I see a Doctor subscribe to "results" from an industry funded drug study, my image of that physician goes to pot in a heartbeat. "How can he/she be so gullible" and "Incompetent" are thoughts that pass through my mind. I quickly lose trust in that physician's ability to make smart decisions in my health care, and the doctor loses my business.
On on the contrary, I asked a physician what he thought about industry funded drug studies, he answered "I ignore them." This doctor won me over in three words.
Obviously it takes excellent academic ability to become a physician, but I look for more than that. I look for wisdom and integrity when choosing a physician.
There is no question that industry studies are biased by nature. The drug company is beholden to its stockholders to increase sales. Therefore, they have a fiduciary obligation to make sure that their research puts their products in the best light. This is not unlike any product in the US where a manufacturer does research stating that people prefer it or it works better than a competitor. Unlike these products, medications are heavily regulated in the United States. Thus, for a medication to get approval or to make any claims, all studies, including ones funded by the industry have to go through the FDA.
Here's the real problem:
Almost all research done on medications is funded by the industry. I would love it if instead of relying on industry sponsored studies, I could rely on non-biased information. However, when it comes to medications, these studies are few and far between. In 2005, the industry spent close to $40 billion dollars on research. Compare this to the entire NIH budget that same year of less than $30 billion. Also, understand that the NIH spends very little money on actual drug studies. They focus more on finding a cure to cancer, not whether expensive medicine X is just as good as the older generic medication.
When I want to know whether to buy product X vs. product Y, I can go to an independent source such as Consumer Reports, which does their own, independent research. There is really no such independent source for drug information. In fact, prescription drugs is one of the only areas that Consumer Reports does not do their own research. All their recommendations on which medicine is "right for you" come from drug company sponsored studies.
If we ignored all industry funded studies, we be ignoring most of the data. In addition, since these studies are heavily regulated, we would be ignoring mainly good, helpful data, even if biased. The simple alternative is to fund the NIH or similar organization equally to the drug companies in order to do independent research. Of course this would likely require significant government spending, which is likely a non-starter.
The good news is that independent comparisons of treatment, called comparative effective research, are starting to be done, and (whether you like health care reform or not), there is funding for this research in the Affordable Care Act. Unfortunately, this funding is not nearly enough to compete with the drug companies. Thus, unless you are willing to pay considerably more in taxes or drop some needed services, physicians and patients still need to rely on industry funded research. Many studies from the industry are actually quite good and useful, though, because of inherent bias, should always be looked at with a skeptical eye.
Sunday, October 9, 2011
PSA: To Screen or Not to Screen
There has been much confusion/concern/media attention since the recent announcement (see the NY Times article US Panel Says No to Prostate Screening for Healthy Men) that PSA tesing was no longer recommended by the US Preventative Services Task Force. (Here's the full version of their draft recommendation.) There are many responses out there (Tara Parker Pope's Answering Questions about the PSA test is a good one), but I believe there is still more to say on the issue.
Before answering the question regarding whether we should follow the USPSTF's new recommendation, please consider...
1. The USPSTF is the same group that says
-Women shouldn't get mammograms before 50
- Recommends against teaching self-breast examination
-States that screening for testicular cancer is harmful
-Only recommends screening for diabetes in patients with high blood pressure
-Recommends against screening for depression for most primary care doctors
(I am not stating that I necessarily disagree with these recommendations. However, it is important to understand where USPSTF is coming from when considering their PSA recommendation).
2. Prostate cancer is still a leading cancer killer for men in the US.
From NY Times:
One in six men in the United States will eventually be found to have prostate cancer, making it the second most common form of cancer in men after skin cancer. An estimated 32,050 men died of prostate cancer last year and 217,730 men received the diagnosis.
The new recommendations come from findings of two large studies. One in the US that showed no benefit in saving lives, and one in Europe that showed only some benefit. The US study have some major limitations, including that many of the men in the placebo/no-screening group actually got screened, so I will focus on the European study.
The European Randomized Study of Screening for Prostate Cancer looked at close to 200,000 men between 50-74 for about 9 years. Not surprisingly they found almost double the rate of prostate cancer in the screened group compared to the non-screened group (8.2% vs. 4.8%). More importantly, they reduced the rate of death by about 20%. Unfortunately, most of the men treated for prostate cancer did not benefit. They found that for every 1410 screened, there were 48 additional cases of prostate cancer found, that if treated would only prevent one death from prostate cancer. In other words, if you are treated for prostate cancer, there's only about 1/50 chance it will save your life. Now, if the treatment were without side effects, then besides costs, there would be no reason not to screen. (My friend Dr. Stewart Segal in his post PSA Confusion suggests covert rationing is one motivation behind the USPSTF's recommendation). The problem is that there are side effects with treatment, and not inconsequential ones. There is about a 20-30% chance of impotence, incontinence or both.
However, there seems to be two things not discussed in any of the reports:
1. Though the writers of the guideline seem to give value/risk of the harms of treatment, they do not address the potential benefits of the piece of mind from a negative screen. In the European study, over 90% of men had a negative screening over the course of almost a decade. In other words, the vast majority of men screened had the piece of mind knowing that probably didn't have to worry about prostate cancer. (There is also additional evidence that men 65 and older with a very low PSA will likely never get prostate cancer, and screening should be stopped).
2. Just because you are diagnosed with prostate cancer, doesn't mean you need to treat it. Given the complications as a result of prostate cancer treatment, and the fact that prostate cancer tends to progress slowly, especially after the first year, watchful waiting is a reasonable approach. If in fact, if the cancer remains stable, treatment can be deferred potentially indefinitely. However, without the diagnosis, watchful waiting can not occur.
Bottom Line: There is no right answer for everyone. Patients, in consultation with their doctor, need to make a decision that's right for them. If you are a healthy person, with no cancer risks, worry about side effects and complications of medical treatment, and realize that there's a 98% chance that screening for prostate cancer will not save your life, you should not get a PSA test or prostate exam. However, if you are someone that is very fearful of cancer, would have substantial piece of mind if you were one of the 90% of men that tested negative, and if you did get diagnosed with prostate cancer are willing risk treatment knowing there is only a 1/50 chance it will save your life, but about a 20-30% chance you will get side effects from treatment, then you should get tested.
Wednesday, September 14, 2011
Is meaningful use the right incentive to get physician's to use EMR's?
Before I took over one of the classes that now teach at the medical school, I asked students why the value of that class was so low. One of the reasons they gave was that it was so hard to do well in the class, and there were so many other things to study, students only put in enough effort to pass. In other words, incentives are only good if they are both valued and attainable.
As this related to Electronic Medical Records (EMR's), achieving meaningful use is not easy. The technology for clinical decision support (a requirement) is not quite ready for prime time. Nor is there an easy way to share parts of the EMR with patients. In a study of almost 600 docs who had been using EMR's, most were confident that they would qualify for meaningful use and get bonuses for doing so. However, the survey also found that the majority of these physicians would not meet some of the criteria. Thus, though the financial incentive seems nice, the path to getting these incentive may be so unattainable that physicians won't waste the effort or expense.
More importantly, some of the "stuff" that's meaningful in meaningful use, may not have value for physicians. Policy makers that developed these criteria were understandably thinking on a population level (lowering blood sugar in a population of diabetics). However, physicians are used to dealing with patients one on one.
A recent survey of EMR using physicians was done over at Software Advice regarding the advantages of using EMR's. Granted 50 respondents may not accurately generalize to most physicians; however, some of the results are telling. What do doctors like about EMR's? Greater accessibility of charts, easier to read notes, more accurate patient information, and improved coordination of care by having the ability to share data. As a user of EMR's for well over a decade, I would concur with these findings. EMR's are far from perfect, but based on these advantages, I could never go back to paper. What "benefits" of EMR's did doctors not see as readily? Improving preventative care, opportunity to participate in pay for performance, improving clinical decision making, and reducing errors/improving patient safety.
Thus, under the current plan to increase EMR use by physicians, the financial incentives may be too hard to achieve and the purported benefits may not be easily perceived. This combination does not bode well for the adoption of EMR's by most physicians. Instead, policy makers might want to consider a different approach. First, rather than create a financial carrot that will be too difficult to achieve for most, use that money to reduce barriers to adopting EMR's in the first place. Second, instead of focusing on the benefits important to policy makers, focus on benefits that are important to physicians, such as making our work easier and more productive. This is important because EMR vendors design their products on what they believe will meet their customer's needs. The first EMR platforms focused on improvements in billing and coding to capture more revenue. Now, vendors are focused on helping physicians achieve meaningful use. If vendors focused on making a physicians work easier and more productive (and policy maker made it easier to adopt these tools), EMR adoption would be much greater than it is now.
As this related to Electronic Medical Records (EMR's), achieving meaningful use is not easy. The technology for clinical decision support (a requirement) is not quite ready for prime time. Nor is there an easy way to share parts of the EMR with patients. In a study of almost 600 docs who had been using EMR's, most were confident that they would qualify for meaningful use and get bonuses for doing so. However, the survey also found that the majority of these physicians would not meet some of the criteria. Thus, though the financial incentive seems nice, the path to getting these incentive may be so unattainable that physicians won't waste the effort or expense.
More importantly, some of the "stuff" that's meaningful in meaningful use, may not have value for physicians. Policy makers that developed these criteria were understandably thinking on a population level (lowering blood sugar in a population of diabetics). However, physicians are used to dealing with patients one on one.
A recent survey of EMR using physicians was done over at Software Advice regarding the advantages of using EMR's. Granted 50 respondents may not accurately generalize to most physicians; however, some of the results are telling. What do doctors like about EMR's? Greater accessibility of charts, easier to read notes, more accurate patient information, and improved coordination of care by having the ability to share data. As a user of EMR's for well over a decade, I would concur with these findings. EMR's are far from perfect, but based on these advantages, I could never go back to paper. What "benefits" of EMR's did doctors not see as readily? Improving preventative care, opportunity to participate in pay for performance, improving clinical decision making, and reducing errors/improving patient safety.
Thus, under the current plan to increase EMR use by physicians, the financial incentives may be too hard to achieve and the purported benefits may not be easily perceived. This combination does not bode well for the adoption of EMR's by most physicians. Instead, policy makers might want to consider a different approach. First, rather than create a financial carrot that will be too difficult to achieve for most, use that money to reduce barriers to adopting EMR's in the first place. Second, instead of focusing on the benefits important to policy makers, focus on benefits that are important to physicians, such as making our work easier and more productive. This is important because EMR vendors design their products on what they believe will meet their customer's needs. The first EMR platforms focused on improvements in billing and coding to capture more revenue. Now, vendors are focused on helping physicians achieve meaningful use. If vendors focused on making a physicians work easier and more productive (and policy maker made it easier to adopt these tools), EMR adoption would be much greater than it is now.
Friday, September 2, 2011
Disappointing Results for Crestor
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.
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.
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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