By Jay S. Cohen, M.D.
From the MedicationSense E-Newsletter
What is Crestor and What is the Problem?
Crestor is the newest statin and the strongest statin yet. Statins are the highly touted drugs for reducing cholesterol. Studies clearly show that statins improve cholesterol numbers (by lowering LDL and raising HDL) and may reduce C-reactive protein. Statins impede atherosclerosis, reduce heart attacks and strokes, and cardiac death. Thus, the statins Lipitor and Zocor are not only the #1 and #2 top-selling drugs in America, but also household names.
Other statins include Pravachol, Mevacor, and Lescol--and now ultra-potent Crestor. Until 2001, there was another statin: Baycol. It was then the newest statin and a potent statin--until it was withdrawn because of dozens of deaths. Is Crestor another Lipitor or another Baycol? Although Crestor has been on the market only a year, it has already been linked to numerous cases of severe muscle breakdown, kidney toxicity, and deaths. Public Citizen recently petitioned the FDA to ban Crestor.
The Marketing of Super-Strong Crestor
Crestor's introduction in August 2003 provides a textbook example of how marketing strategies can supersede medical science and common sense. Taking a page from Lipitor's highly successful marketing campaign in 1997, Crestor is now being aggressively marketed as the strongest statin of all.
The manufacturer's recommended initial dose of Crestor is 10 mg/day (except for people with kidney problems). This dosage is so strong that Crestor's advertising can boast it is stronger than equivalent doses of any other statin. This is quite a claim, because Lipitor and Zocor are pretty strong themselves. Indeed, their top-selling status has been built on their own advertising about their power to reduce cholesterol and LDL-cholesterol (LDL-C) levels.
But more isn't necessarily better with most medications, including statins. As I've written in medical journal articles and in my upcoming book (What You Need To Know About Statin Drugs And Their Natural Alternatives),1 the standard starting doses of Lipitor and Zocor are often double or quadruple the amounts that millions of people actually need, triggering many avoidable side effects.
So what can we say about super-strong Crestor, which is even stronger? We can say that the drug company-recommended, super-strong initial 10-mg dose of Crestor has already been linked to severe toxicities.1A This should not surprise anyone.
Excessive Doses = More Side Effects
One of my basic principles is: The best dose of any medication is the least amount that works. Medical science agrees. Most people with elevated cholesterol or LDL-C have mild-to-moderate elevations. For many, dietary interventions are enough. For others, modest statin doses are often plenty. But the recommended initial doses of Lipitor, Zocor, and Pravachol are strong, yet that's what doctors prescribe to most people, even to people who don't need such strong statin therapy. This is the crux of the problem of statin side effects such as muscle aches, joint pains, abdominal discomfort, memory and cognitive impairment.2-6 Side effects are a major reason that 60 percent to 75 percent of people started on statins quit treatment.7,8 The average time until they discontinue treatment: eight months. Many people quit within a few months.
Liver injury, liver toxicity, and death are also concerns with statins. Like other statin side effects, these reactions are dose-related: the greater the dose, the greater the risk. Dr. W.C. Roberts, the editor-in-chief of the American Journal of Cardiology, warns:
"With each doubling of the [statin] dose, the frequency of liver enzyme elevations [indicating liver irritation or injury] also doubles.9"
Nerve injuries have now been documented in people taking statins long-term.10, 11 The incidence is low, perhaps one in 2,000 to 5,000, but with millions taking statins, this adverse effect will afflict thousands of people each year. These injuries can be severe and permanent, and even mild nerve injuries can take months to fade away.
Doctors cannot anticipate who will develop a long-term side effect with statins, but doctors should (but usually don't) anticipate that they will occur in some people. The only defense: using the least amount of medication you need.
Do We Need a Stronger Statin?
The standard starting dose of Crestor is 10 mg, which reduces LDL-C a whopping 46 percent to 52 percent.12 Some people, especially those with serious coronary disease, require this degree of LDL-C reduction, but most people with elevated cholesterol require only 20 percent to 30 percent reductions--and therefore much less medication.
Crestor's manufacturer does recommend a lower 5-mg dose for people requiring "less aggressive LDL-C reductions.12" Yet, 5-mg Crestor reduces LDL-C 42 percent, still far more than most people with elevated cholesterol need.
And remember, this 42 percent LDL-C reduction represents the average among study subjects. Many people get even greater reductions with this dosage. In one study, 5 mg of Crestor reduced LDL-C as much as 71 percent in subjects.13 This is an impressive number, but reducing cholesterol too aggressively is believed to be a trigger for cognitive, memory, and mood problems with statins. And too low cholesterol levels aren't good either, because cholesterol is a necessary building block in human cells and a substrate of many of our hormones.
So contrary to Crestor's marketing, we shouldn't be overly impressed with which statin is strongest. You don't want the strongest statin. You want the mildest statin that works for you.
Lower, Safer Doses of Crestor Work--But Your Doctor Doesn't Know About Them
The lowest marketed dose of Crestor is 5 mg. Yet, studies show that 2.5 mg of Crestor reduces LDL-C 40 percent, and just 1 mg reduces LDL-C 34 percent, on average.13, 14 These doses are still stronger than the standard initial doses of Pravachol, Mevacor, Zocor, and Lescol, and they would certainly be strong enough for most people with elevated cholesterol. Indeed, the lead author of one Crestor study stated:
"Even at 1 mg/day, rosuvastatin [Crestor] reduced LDL-C by 35 percent, the same percentage reduction seen with simvastatin [Zocor] 20 and 40 mg.14"
Yet, you won't find any information about this in the Crestor package insert,12 pharmacy slips, or the "Physicians' Desk Reference."2 Crestor's manufacturer isn't going to inform you or your doctor about lower Crestor doses that aren't available, even if they are effective--and safer.
This goes right to the heart of the issue of informed consent. Your right of informed consent is denied if you aren't given enough information to make an intelligent choice.15 You aren't alone: one study showed that only 9 percent of office patients receive enough information to fulfill their right of informed consent.16 No wonder medication side effects continue to be one of the leading causes of death in America.