•
If you heard anything about the much-trumpeted JUPITER (which, ironically, stands for ‘Justification for the Use of Statins in Primary Prevention; an Intervention Trial Evaluating Rosuvastatin’) trial of the statin drug Crestor, sponsored by its maker AstraZenica , you no doubt positively skipped off to your doctor’s office to beg for a statin drug. Heck, if the buzz says that statin use can cut heart attack risk by about 50 percent and journalists begin suggesting that we put statins in the water supply, why wouldn’t you?
Well, you might not skip quite so fast if you look beyond the headlines.
The trial first screened 90,000 men over 50 and women over 60 for inclusion, eventually excluding most of them because of other conditions such as arthritis or use of other medications. So first you’d have to ask yourself whether you, like some 80 percent of us, would also have been excluded from the trial. The combination of normal levels of cholesterol but elevated levels of inflammation marker C-Reactive Protein (CRP) found in the remaining 17,802 patients isn’t all that common.
Taking Crestor did apparently cut the risk of cardiovascular problems in that group by roughly 50 percent. However, while cutting a risk from 1.8 percent to 0.9 percent is certainly significant, even the higher risk wouldn’t exactly have kept you awake at night.
Furthermore, what the headlines didn’t focus on was the apparent increased risk of diabetes.
0.6 percent more people (3 percent of statin-users as compared to 2.4 percent of placebo users) reportedly developed diabetes, which is also statistically significant. Diabetes can in itself eventually lead to an increased risk of heart attack.
And because the study, designed to last for four years, was halted after less than two years, medical researchers will not be able to determine whether the early benefits will hold up over the long term. Nor will they determine whether longer-tem use is safe, nor whether other risks might show up. According to the drug company it ended the trial on independent advice so that placebo-takers could enjoy the same outstanding benefits of taking a statin drug. One can only hope that worry that an increased risk of diabetes could become more marked over the long haul wasn’t a factor in the decision.
What did you think about the JUPITER trial? Did, or would, the results influence you to take a statin drug?
•
Leave a comment
•
Pill-takers, beware. A new study from UCSF found that doctors frequently rely on “skewed” information when they’re learning about new drugs or drug trials—reports in medical journals that are biased both of terms of what they don’t choose to publish (unfavorable results) and what they do publish (some rather selective data that may differ from what was reported to the FDA).
In theory, doctors have access to the same complex information that the FDA gets about drug trials. In practice, they usually get information about new drugs and drug trials from medical journals.
Many such reports are quietly sponsored by drug companies and may be “skewed” to show their drugs in a favorable light. They might be written by a company medical writer or physician that has been involved in developing the drug, or by a ghostwriter attributing the article to a physician.
UCSF’s team of medical investigators, led by Lisa A. Bero, examined 164 drug trials that took place over two years. They then looked at write-ups of the trials in medical journals and found that trials with favorable outcomes were about five times more likely to be published than those with unfavorable outcomes. Worse, there were sometimes discrepancies between the results the FDA received and the facts submitted to the medical journals. Approximately one-fourth of the results of trials testing the effectiveness of new drugs still had not been published five years after approval by the FDA.
What that boils down to is that your doctor may very well not be getting complete, unbiased and accurate information before he prescribes all those little pills in your medicine cabinet.
And at a time when doctors are increasingly prescribing drugs Lipitor and other statins for ever-larger groups of people, cheered on by trials like the JUPITER trial that are sponsored by drug companies, it could be very important for them—and you—to understand that.
Read about the full results of the UCSF study in the online medical journal of the Public Library of Science, PloS Medicine.
•
Leave a comment
•
A recent study by the Oregon Health & Science University shows that the cholesterol lowering statin drugs may cause a muscular eye disorder.
Dr. F.W. Fraunfelder led the study, looking at reports of double vision (diplopia), drooping of the upper eyelid (ptosis), and loss of full range of motion of the eyes (ophthalmoplegia) in the databases of the National Registry of Drug-Induced Ocular Side Effects, the World Health Organization, and the Food and Drug Administration.
Statins are known to cause muscle problems in some patients, but this is the first report linking statins to muscle problems of the eye. Statins work by preventing cholesterol from forming. This may be good for preventing heart disease, but can cause problems in muscle by preventing the tissue from repairing and regenerating normally. Other muscle problems experienced by statin users include muscle aching, pain, inflammation, weakness, and deterioration of the tissue.
The eye disorder was rare, occurring in 0.1 percent of patients, but those who were taking gemfibrozil (another cholesterol lowering drug) at the same time as statins were at a higher risk with 0.5 to 2.5 percent occurrence.
Of the 256 patients reported on, 23 lost eye range of motion, 8 had drooping upper eyelids, and 18 people experienced both double vision and drooping eyelids. All patients’ symptoms went away after they stopped taking statins. The study was unable to determine which eye muscles were involved based from the patient database information or how long it took for them to fully recover.
Please share your thoughts and experiences! Have you or someone you know experienced side effects from taking Lipitor?
•
•
Leave a comment
•
Millions of patients in the U.S. use cholesterol lowering drugs like Lipitor (made by Pfizer) or Zocor (made by Merck) in an effort to lower heart disease risk. Last year, the patent protection for Zocor expired and the generic form of it called simvastatin was put on the market. Since generic simvastatin became available, health insurers have been pressuring doctors and patients to switch from brand name cholesterol lowering drugs like Lipitor to this similar and much cheaper generic form of Zocor.
Price is the main reason people are switching to the generic simvastatin. Currently it costs about $2 per day for Lipitor, but with the generic brand it is closer to 35 cents or less. Switching over could save billions of dollars in health care costs.
Both Lipitor and Zocor are from a drug class called statins. Statins work by inhibiting the enzyme that produces cholesterol. Other cholesterol-lowering drugs from this class include Crestor (rosuvastatin), Pravachol (pravastatin), Lescol (fluvastatin), and Mevacor (lovastatin).
Compared to Lipitor, Zocor (simvastatin) is less potent. Therefore, if you were taking 10 mg of Lipitor, you would have to take 20 mg of the generic Zocor. Currently, the highest dose you can get of Zocor is 80 mg (equal to 40 mg of Lipitor). This means that if you are presently taking more than 40 mg of Lipitor you will not be able to get a strong enough dose. For most people this shouldn’t be a problem.
By law, the generic version of Zocor is required to contain the same active ingredients as the brand name. They also have to the same dosage, potency, quality, function, and approval from the FDA.
Both Lipitor and Zocor share similar side effects because they are from the same statin drug class. Not all of the side effects are known; some patients experience headache, muscle pain and weakness, muscle tissue breakdown (rhabdomyolysis), memory loss, postoperative delirium, and others. (For more side effects check out: Five Biggest Risk Factors in Taking Lipitor or Other Statins)
What do you think? Have you experienced any differences since switching to the generic form of Zocor? Please share your experiences!
•
Leave a comment
•
More and more evidence is pointing towards statin drugs causing muscle pain and even debilitating muscle problems.
There are generally three types of muscle trauma that people experience from statin medications, says Dr. William Shiel, a specialist in muscle and joint conditions. The first is muscle aching, which typically goes away within a couple weeks after stopping statin treatment. The second experience is muscle pain and mild muscle inflammation with or without a feeling of weakness. A blood test may reveal elevated levels of CPK enzymes which typically mean that the skeletal muscle is injured or under stress. This can take up to a few months to heal. The third condition (rhabdomyolysis) is most serious involving severe muscle inflammation, weakness, and the breakdown of muscle. Patients experience muscle damage and pain throughout their entire body. Elevated CPK enzymes can also accumulate and damage the kidney.
Jill Slade, assistant professor of radiology and osteopathic manipulative medicine at MSU, believes that the muscle damage caused by statin drugs is underestimated. Her current study is following 50 patients on statin medications to track their muscle integrity through magnetic resonance imaging. “While statins have tremendously helped millions of Americans lower their cholesterol and improve their cardiac health, we need to be confident we are not causing other problems in the body,” Slade said. “Statins work by preventing cholesterol from forming. While this is a good thing inside structures such as liver cells, it can be problematic in places such as muscle cells.”
A recent study at the University of Alabama supports this. It shows that statins may prevent skeletal muscle from repairing and regenerating normally due to the anti-proliferative effects of the drug. The researchers also agree that the current 7 percent of patients reporting skeletal muscle problems may not be accurate. Dr. Anna Thalacker-Mercer said, “It is possible that older adults may not be able to distinguish between muscle pain related to a statin effect or an effect of aging and therefore adverse effects of statins in older adults may be under-reported.”
Dr. Shiel stated that it is important for patients and doctors to be extra aware of this potential side effect because it is easier to treat the sooner it is found. “When discovered late, it can lead to serious injury—not only to the muscles but also potentially to the kidneys and heart.” In 2001 the FDA pulled one statin drug, Baycol, off the market because it was shown to be the cause of 31 deaths from muscle tissue breakdown (rhabdomyolysis). From Dr. Shiel’s experience, “Of all causes [of muscle pain] statin drugs are what I see as the most common culprits.”
What do you think? Have you experienced any muscle pain after taking statin drugs like Lipitor? Please leave a comment about any side effects or experiences you have had with this drug!
•
•
Leave a comment
•
A recent study shows that the cholesterol-lowering statin drugs like Lipitor reduce the blood marker for prostate cancer but don’t necessarily decrease the risk of developing it. Prostate specific antigen (PSA) is a protein produced by the prostate gland that is usually present in small amounts for healthy people. Higher PSA levels occur when there is prostate cancer, and testing for this protein is currently the most effective way to screen for this disease. Statins seem to lower PSA levels but don’t necessarily lower the risk of cancer. This can potentially cause men who would otherwise be diagnosed and treated for the cancer to be passed over as cancer free.
The study included 1,214 men without prostate cancer who were prescribed statin drugs between 1990 and 2006. Duke researchers found that PSA levels dropped 4.1 percent on average. PSA levels appeared to drop the most in patients who took higher doses of statin drugs and experienced larger decreases in LDL cholesterol.
Further tests are needed to determine if statins may help to prevent and treat prostate cancer, or if they only lower PSA levels.
Have you experienced any side effects from using statin drugs? Please share your experiences and opinions!
•
Leave a comment
•
RateADrug.com is an interesting new site where users from the community rate their experience in using different prescription drugs. Currently there are over 3,000 medications to view and share experiences about. Detailed surveys include things such as drug effectiveness, how much and how long you have been taking the drug, changes in well being, side effects, and user comments about the drug.
This is a good way for patients to stay updated with the most current side effects as well as learn about new alternative treatments. Additionally, after you fill in your experiences with your drug, you will receive your personal risk/benefit analysis based from your question responses. This gives you a score from 1 to 10 for both your side effects and positive effects so that you can see how this drug is working for you and how that compares to other users. It’s also great because you can forward all of your surveys along with comments to your doctor, family member or caregiver to keep them informed about any changes in your health caused from existing or new medications.
Go to RateADrug.com to take the Lipitor drug survey and see what people are saying about it.
•
Leave a comment
•
Statins may increase risk of postoperative delirium in elderly patients according to a recent article published by the Canadian Medical Association Journal. Delirium is a sudden and severe change in cognitive function causing confusion, inability to concentrate, and sometimes hallucinations. It is commonly experienced after surgery in people over 70, and it can cause delayed recovery, increased hospital costs, and anxiety for the patient. Sometimes the patient never fully recovers and stays at a permanent level of dysfunction.
The study looked back at the medical records of over 280,000 patients in Ontario who were 65 or older and went in for elective surgery. About 7 percent of patients were using statins and just over 1 percent, or 3195 patients, experienced postoperative delirium. 1 in 90 patients using statins before their surgery experienced post-delirium, showing the risk to be 30 percent higher than those not using statins. The correlation seemed to be greater for patients using higher doses of statins and undergoing a longer surgery time. The risk between statins and delirium was not seen in any other cholesterol lowering drugs.
One theory is that statins may cause altered blood flow within the brain which would cause a temporary lack of oxygen to neurons and predispose patients to delirium. This shift in blood is produced by a change in endothelial nitric oxide synthase within small blood vessels. This is an effect caused by statins, which is not even related to lowering cholesterol or preventing heart disease.
Even though the percentage of people experiencing this is on the low end, it would affect many people due to the large number of elderly patients taking statins and undergoing surgery. One recommendation or compromise is to stop taking statins a few days before surgery and restart after.
•
•
Leave a comment
•
www.RateADrug.com has a page where you can rate your experience taking Lipitor as well as other statins. Here you can voice your opinions about side effects, benefits, and get an effectiveness score of the drug you are taking. Very interesting results…
Take the Lipitor Survey, click HERE
•
•
Leave a comment
•
An important new study has found that people who take statin drugs were about half as likely to develop dementia or clinically significant cognitive impairment as those who did not use statins (Neurology July 29, 2008; 71:344-355). This study was conducted by Mary Haan, epidemiology professor at the University of Michigan School of Public Health. Haan said “The bottom line is that if a person takes statins over a course of about 5-7 years, it reduces the risk of dementia by half, and that’s a really big change.”
The Alzheimer’s Society commented on the news, stating “The jury is still out on how effective they are, but this study adds to growing evidence that they may have some benefits.” Currently Nymox Pharmaceutical Corporation (NASDAQ:NYMX) holds U.S. and global patent rights for the use of statin drugs for prevention and treatment of Alzheimer’s disease (AD).
Haan said, “It’s likely that many people taking statins have already benefited unknowingly from the dementia fighting properties.” She continues, “We aren’t suggesting that people should take statins for purposes other than what they are indicated for, but hopefully this study and others will open the door to statin testing for dementia and other types of cognitive impairment.” The next step, Haan said, is to determine exactly how the statins work on the biochemical pathways involved in dementia.
Contrary reports on the effects of statins say the opposite - that statin use results in impaired brain functioning, coined ” Transient Global Amnesia, or TGA” including the story of Duane Graveline, MD, MPH, a retired family doctor and former NASA scientist/astronaut. He had been taking Lipitor for six weeks before he was found “wandering, confused, and reluctant to enter his own home because he didn’t recognize it or remember his wife’s name.” He was diagnosed as having transient global amnesia (TGA), but neither he nor his physician suspected that it was due to taking Lipitor. Six weeks later, after resuming the same dosage of Lipitor, the TGA returned. Dr. Graveline began to suspect the statin, and he contacted some physicians. After printing a letter in their column about the potential connection between Lipitor and TGA, they received hundreds of responses saying that they, too, had experienced severe memory loss while on Lipitor.
Still, memory loss is not a listed FDA side effect of statin drugs. One explanation, offered by Joel M. Kauffman, PhD, research professor of chemistry and biochemistry at the University of the Sciences in Philadelphia, is that “in drug trials, the pharmaceutical companies often divide similar adverse effects into six or seven different categories to keep the scarier side effects under 1%.” Kauffman illustrated this point with the example that amnesia could be divided into confusion, memory loss, senility, and cognitive impairment.
So some say that memory loss is a side effect of statin drugs, and others that say statins are a preventative for dementia. What do you think? Are these reports contradictory? Please leave your comments below.
•
Leave a comment
TONY N SMITH wrote:
Willie B. Beasley wrote:
30. December 2008 at 10:01 am :
I’ve been on simvastatin for 3 or 4 months and have experienced growing problems with diplopia over that time. (I had some minor problems with it before going on the drug.) I am relieved to have discovered a possible explanation for my problem and will talk with my family doctor and opthalmologist about this possibility. Thank you for this posting!