Should Crestor & Statins Become Mass Market?
AstraZeneca plc (NYSE: AZN) is seeing a possible serious win this morning on good news from its Crestor presentation showing that it cuts heart attack and stroke risks even in healthy adults.
The company showed sata from its JUPITER study (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvast) demonstrated that CRESTOR® 20 mg significantly reduced major cardiovascular (CV) events by a dramatic 44% compared to placebo among men and women with elevated hsCRP but low to normal cholesterol levels. CV events were defined in the study as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes.
Some other results were huge as well. The combined risk of heart attack, stroke or CV death was reduced by nearly half (47%), risk of heart attack was cut by more than half (54%), risk of stroke was cut by nearly half (48%), and total mortality was significantly reduced by 20%. These results were accompanied by a median LDL-C reduction of 50% resulting in an on-treatment median LDL-C of 55 mg/dL.
This data is being presented at American Heart Association Scientific Sessions and were also published online by the New England Journal of Medicine.
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Is Fish Oil & Red Yeast Rice Better Than Statins in Cholesterol Treatment?
University studies and private hospital studies are frequently deemed as difficult for Joe Q. Public to get in on from an investment or financial angle. But sometimes there is an opportunity to go against other established drug companies with blockbuster or mega-blockbuster drugs.
What if you were absolutely convinced scientifically that Red Rice Yeast & Fish Oil administered in certain controlled doses combined with education and regular habit reviews was as effective or more effective than traditional statins and pharmaceutical grade cholesterol treatments. While this is likely going to depend heavily on genetics and depend heavily upon the trial groups, a study is out that showed some phenomenal results that compared this head to head with patients taking Zocor, the statin from Merck & Co. (NYSE: MRK).
We want to stipulate that this is a small group and that it really looks like the results may be skewed because of behavior. But the results area start and in an extreme could lead to many forms of alternative treatments.
The Mayo Clinic has issued some data that will at worst lead to much broader study comparisons. The extreme case could be catastrophic for major pharmaceutical drug makers of statins as these are billions of dollars per year in the U.S. alone.
In the July issue of Mayo Clinic Proceedings, a group of researchers from Pennsylvania examine whether an alternative approach to treating high blood cholesterol may provide an effective treatment option for patients who are unable or unwilling to take statins.
Researchers followed 74 patients with high blood cholesterol who met standard criteria for using statin therapy, and they were then randomly assigned to either the alternative treatment group or the statin group and followed for three months.
The alternative treatment group participants received daily fish oil and red yeast rice supplements, AND they were enrolled in a 12-week multidisciplinary lifestyle program that involved weekly 3.5-hour educational meetings led by a cardiologist, dietitian, exercise physiologist and several alternative or relaxation practitioners. The statin group received 40 milligrams of Zocor daily, as well as printed materials about diet and exercise recommendations.
At the end of the three-month period, participants from both groups underwent blood cholesterol testing to determine the percentage change in LDL cholesterol. There was a reduction in LDL cholesterol levels in both groups, but here is the breakdown of the results:
- The alternative treatment group saw a 42.4% reduction, and the statin group saw a 39.6% reduction.
- Members of the alternative therapy group also had a substantial reduction in triglycerides, another form of fat found in the blood, and lost more weight.
The doctor quoted acknowledged that a larger, multi-center trial with longer follow-up is necessary to determine long-term compliance with the alternative regimen. It noted that previous studies involving diet and exercise have found a high rate of patients are either unable to or unwilling to follow lifestyle recommendations. This study also noted that the “excellent adherence” in the alternative group was undoubtedly related to the intensive follow-up, education and support provided for this group.
This is an interesting finding when you consider the behavioral aspect. Those who have to attend meetings and those who stick to a regimen do well. But giving prescription drugs and just some educational material might not be the best bets here. How many of us are lazy? Many. How many of us get around to reading everything we are supposed to read? How many of us don’t want to bother? Many, on both counts.
I am no doctor but there are certain things that become evident if you have gotten the chance to deal with doctors and medicine. Without trying to damn an entire nation’s habits, it has grown more and more obvious that Americans would rather just take a magic pill rather than get to the heart of the matter (no pun intended). Diet and exercise alone unfortunately doesn’t work for everyone. Some are just pre-disposed to high cholesterol, high blood pressure, or heart and arterial problems.
What percentage of those with high cholesterol and other physical diseases or issues would be helped with diet and exercise? The answer is many, albeit an undefined amount. Those will vary greatly depending on many factors from your race, your weight, your family history, your occupation, your general health levels, your activity, and your diet.
Regardless of how effective fish oil and red rice yeast combined with follow-on education and monitoring works, it is highly unlikely that Joe Public in America is going to make such a huge jump where everyone becomes fit and where everyone actually does what they are supposed to do (even what the KNOW they should do).
But this leaves a real opening here, and one that isn’t good for Big Pharma. Zocor is off of its exclusivity, but Merck recorded $876.5 million in 2007 sales from it (down from $2.8 Billion in 2006 when it had exclusivity). Merck’s Cozaar/Hyzaar to treat blood pressure saw $3.35 Billion in 2007 sales, and while that isn’t part of this study you know that many of the benefits in other regimens can further aid in this fight as well. Guess how much Pfizer (NYSE: PFE) shows Lipitor’s 2007 sales to lower LDL cholesterol. The answer is $12.675 Billion. Over at AstraZeneca (NYSE: AZN), Crestor counted for nearly $2.8 Billion in 2007 sales.
It would be highly unlikely that such a study, even of broadened out significantly and even if results continued to show superiority, would kill drugs in the statin class to lower LDL cholesterol. We are a nation addicted to prescriptions. But the key here seems to be the rigorous “behavior modification” on top of the use of “alternative regimens” or traditional prescription medicines is key.
Now imagine if we could apply the same theory over to Type II diabetes. OK, time to get off the soapbox.
Jon Ogg
July 8, 2008