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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.
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The following risks have been reported by the FDA and other sources as being associated with the use of Lipitor and/or other Statin drugs. Common side effects of taking Statin drugs are:
● Nausea
● Vomiting
● Constipation
● Diarrhea
● Headache
● Rash
● Weakness
● Muscle pain
● Liver failure
● Rhabdomyolysis
● Memory loss (Transient Global Amnesia)
● Neuropathy
Rhabdomyolysis is the medical term for the breakdown of muscle fibers that results in their release into the bloodstream. This is a serious side effect, often beginning as muscle pain and progressing to loss of muscle cells, kidney failure, and death. Patients suffering from this side effect sometimes feel muscle pain or tenderness and may feel weak.
More frequently this occurs when statins are used in combination with other drugs
(some of which cause rhabdomyolysis themselves) or with drugs that prevent elimination of statins, in turn raising the levels of statins in the blood. Since rhabdomyolysis can be fatal, unexplained joint/muscle pain that occurs while taking statins should be brought to the attention of a healthcare provider for immediate evaluation. Since other drugs taken in conjunction with statins can increase the risk of rhabdomyolysis, it is important that your doctor know exactly what medications you are on - these include niacin, which some people take as a supplement for high cholesterol and which, with statins, can increase the risk of rhabdomyolysis.
Besides muscle pain, the other major symptom of rhabdomyolysis is dark, red, or cola colored urine, which is the manifest of muscle breakdown. Analysis of the urine and blood will show high levels of the muscle protein myoglobin in patients with this condition.
Quitting the statin use usually stops rhabdomyolysis in its tracks and leads to full recovery.
For susceptible individuals, the use of a statin drug can interfere with proper functioning of peripheral nerves. Researchers assume that the build-up of statins in the body causes neuropathy in some individuals. If left undiagnosed, neuropathy can lead to deterioration of the muscles and paralysis. This can lead to problems swallowing, breathing, and complications of the heart – as these all involve muscle groups. In the extreme case, severe neuropathy as a side effect to statin use can lead to death.
Tell us what you think are the five biggest risks in taking Statin drugs to lower cholesterol or reduce associated heart problems. Please add your opinions in the comments section below. We will address benefits to these drugs in subsequent posts.
We are interested in hearing from patients, doctors, pharmacists, medical researchers and anyone else with an opinion on this issue.
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Survey Finds Physicians Often Dismiss Complaints About Drugs’ Side Effects
By Ishani Ganguli
Special to The Washington Post
Tuesday, August 28, 2007; Page HE04
On many online message boards and Internet chat rooms, anxious patients share details about the muscle pain and memory loss they have noticed since they started taking statins to lower their cholesterol. A new study suggests these people may be seeking validation for good reason: Some of their complaints might otherwise be going unheard.
According to a survey of 650 patients published last week in Drug Safety, a peer-reviewed journal, doctors frequently ignored or dismissed patients’ concerns about such side effects. The study suggests this pattern of reaction goes beyond statins to other drugs.
When doctors fail to recognize a patient’s symptoms as drug side effects, more than that patient’s care is put at risk. Because the doctor makes no “adverse event report” to the Food and Drug Administration, the regulatory agency may underestimate the problem, and other doctors and patients may assume the drug is safer than it is.
Researchers from the University of California at San Diego had been investigating the side effects of statins when they noticed the problem.
“Person after person spontaneously [told] us that their doctors told them that symptoms like muscle pain couldn’t have come from the drug. We were surprised at how prevalent that experience was,” said Beatrice Golomb, associate professor of medicine and the study’s lead researcher.
Tens of millions of people worldwide take statins such as Lipitor and Zocor. Many experts view them as something of a panacea for everything from stroke and cancer to arthritis, although they do pose a risk of side effects in some patients, ranging from muscle injury to liver and kidney dysfunction.
Survey respondents, recruited via Web solicitations and other advertisements, were in their early 60s on average and mostly from the United States. Some of the solicitations were placed on Web sites where patients had posted complaints, raising the possibility that respondents were more apt to have had side effects than the average patient. Most said they’d complained to their doctors about such possible side effects as problems with memory or attention, or tingling or numbness in their hands and feet.
According to experts, muscle pain and other side effects occur in up to 30 percent of statin patients, by some estimates, and often lead doctors to stop or change a prescription. But patients surveyed said their doctors rarely linked their symptoms to statins — even when the symptoms were well-documented as side effects.
“Overwhelmingly, it was the patient that initiated that conversation” making the connection between the statin and their symptoms, Golomb said.
Many doctors instead attributed the symptoms to the normal aging process, denied their connection to statins or dismissed the symptoms altogether — missing opportunities to switch their patients’ prescriptions or otherwise mitigate the side effects, Golomb said.
Golomb speculated that doctors’ actions might reflect the relative dearth of information on the downsides of statins. “Ad campaigns that preserve statins’ miracle drug image are more powerful than education about side effects,” she said.
The findings raise important concerns about American drug safety monitoring, said Harvard Medical School professor Jerry Avorn, author of “Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs.”
“We already know that there is horrendous underreporting of side effects. Ninety to 99 percent of serious side effects are not reported by doctors,” he said.
Yet the FDA relies heavily on their reports. Tracking a drug’s safety once it hits pharmacies — so-called post-market surveillance — is a critical part of keeping patients safe, particularly since clinical trials with limited enrollees and a limited study period cannot catch every side effect.
Managed care deserves some of the blame, Avorn said. “Part of [the problem] is that doctors are granted so few minutes to deal with patient visits. It’s not as if doctors don’t care.”
Golomb and others worry that if even well-documented side effects aren’t being recognized by doctors, others will take much longer to surface. “A fifth of all drugs that fully pass FDA approval will ultimately have black box warnings or be withdrawn from market because of adverse effects,” Golomb said.
Some say that the FDA and drug companies should work harder to get feedback directly from patients. Getting drug surveillance reports from patients is common practice in New Zealand and other countries.
U.S. patients can report side effects to the FDA themselves — by logging onto the MedWatch Web site ( http://www.fda.gov/medwatch). But few know about this option, Avorn said.
The new study “points out that doctor reports on side effects is a very unreliable means of learning about the true extent of problems,” he said. “We ought to have a [better] mechanism for gathering information from patients. A lot of it will be noise, but there may be important signals there as well.”
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25. August 2008 at 5:12 pm :
I am acquainted with 6 individuals who think Lipitor therapy is directly associated with the onset of their diagnoses of Parkinson’s disease. Dr. Xuiemi Huang, UNC Chapel Hill has proposed a clinical trial to determine if statins cause Parkinson’s disease,following prior study showing low LDL is positively related to Parkinson’s disease. (http://www.unc.edu/news/archives/dec06/parkinsonsldl121806.htm)
I have also read of many instances in which individuals link use of fat soluble statins to the onset of ALS (lou gehrig disease).Recently, the Director of the World Health Organization Drug Monitoring System, Dr. Ralph Edwards, authored a report of an increased incidence of ALS-like syndrome and statin use:Statins, neuromuscular degenerative disease and an amyotrophic lateral sclerosis-like syndrome: an analysis of individual case safety reports from vigibase
http://tinyurl.com/6c3uha
There exists numerous studies concluding an “unmasking” of neuromuscular diseases such as McArdle’s Disease, Myastenia Gravis, mononeuropathy multiplex, carnitine palmityol transferase deficiency myopathy, etc.
The “CARE” clinical trial results included a 1500% relative risk increase in incidence of breast cancer in the women who participated. The explanation was that this was a “statistical anomoly”, though I have been unable to find WHAT the RR would have been given the “normal” number of breast cancer cases in the placebo group (there were 15 cancer cases in the statins groups, 1 in the placebo group, and there were supposed to be 7 in the placebo group. What Relative Risk does this “revised normal number” represent????