Side Effects from Lipitor

‘Justifying’ Statins—and Ignoring Possible Side-Effects Like Diabetes

admin — Tue, 06 Jan 2009 03:55:04 +0000

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?

Doctors Found to be Relying On “Skewed” Information—What’s a Lipitor-Taker to Believe?

admin — Fri, 19 Dec 2008 17:16:37 +0000

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.

Statins May Cause Eye Disorder

Mon, 01 Dec 2008 18:40:25 +0000

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?

Lipitor vs. Zocor

Mon, 24 Nov 2008 17:39:08 +0000

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!

Lipitor Can Cause Severe Muscle Problems

Fri, 21 Nov 2008 20:20:20 +0000

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!

Statins Prevent Heart Disease in People with Normal Cholesterol Levels

Mon, 17 Nov 2008 19:58:54 +0000

A new study reported in the New England Journal of Medicine shows that taking statin drugs like Crestor or Lipitor may prevent heart disease even if you don’t have high cholesterol levels.

The study looked to test whether statins could prevent heart disease in patients with normal cholesterol levels but high C-reactive protein (CRP) levels. C-reactive protein is a biomarker used to measure the levels of inflammation, which is thought to play a role in half of all cardiac events. Inflammation has a compound effect on the amount of LDL cholesterol absorbed by artery walls and can lead to further plaque buildup (See our article on The Role of Inflammation in Heart Attacks).

The clinical trial included 17,802 men and women from different parts the world with cholesterol levels less than 130 mg/dL and CRP levels above 2.0 mg/L. Participants were given 20 mg of rosuvastatin (Crestor) or a placebo.

After 2 years, the 5 year study was ended because the endpoints had been met. The results showed that statins lowered the risk of cardiac events by 44 percent. The statins were shown to lower LDL cholesterol by 50% and CRP levels by 37%. The total number of deaths was 20% less in participants taking statins compared to the placebo group.

The new findings could rework who is eligible for statins, potentially adding 10 million more Americans to the existing 36 million already taking a statin drug. Currently, only people with high LDL cholesterol levels are prescribed statins. This study may help validate CRP levels as an additional test to determine people at a higher risk for heart disease.

Do you think statins should be prescribed to people who don’t have high cholesterol levels? Please share your opinions and experiences with statin drugs!

Statins May Prevent Prostate Cancer Detection

Wed, 05 Nov 2008 17:12:55 +0000

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!

The Role of Inflammation in Heart Attacks

Fri, 24 Oct 2008 17:32:09 +0000

It’s typically thought that if you have good cholesterol levels you are safe from a heart attack. Yet, almost half of all cardiac events happen in people with normal cholesterol levels, indicating that something else is at play. Inflammation may be the cause, which is showing to play a significant role in atherosclerosis, the process where fat deposits build up along the inner lining of the artery.

Inflammation, caused by an increase in white blood cells, is the body’s natural immune response to infection, injury, or other harmful stimuli. When there are higher levels of LDL cholesterol in your bloodstream, your body reacts against it with this immune response. As blood flow increases, more LDL cholesterol can be absorbed in the artery walls causing even more inflammation. Thus, inflammation has a snowball effect, compounding the amount of LDL cholesterol absorbed into your cells. The more absorbed cholesterol, the more plaque you have. Eventually the plaque breaks apart and can cause a heart attack or stroke by clotting and blocking blood flow.

Determining your level of inflammation may help to predict your risk of a heart attack or stroke beyond just looking at your cholesterol levels. Inflammation levels can be found by measuring your blood for C-reactive protein (CRP), which is released by your body when inflammation occurs. Research shows that the higher your CRP levels, the higher your chance of experiencing a cardiac event. One study showed that people with higher CRP levels were twice as likely to have a heart attack as those who had lower levels.

Treatment for inflammation turns out to be similar to the treatment of high cholesterol. In addition to lowering cholesterol levels, statins have been shown to reduce CRP levels and inflammation. Still, lifestyle changes are typically recommended as the first line of defense, as statins have potential adverse effects. A healthy diet low in saturated fat, exercise, and quitting smoking and drinking are all things you can do to lower both CRP levels and LDL cholesterol.

Please share your thoughts and experiences! Have you or someone you know experienced side effects from taking Lipitor?

Pfizer Cuts Research for Lipitor

Thu, 16 Oct 2008 19:56:02 +0000

Pfizer is moving research dollars away from Lipitor and heart disease research so that it can go after potential profits in cancer, diabetes and Alzheimer’s disease drugs. Lipitor has been Pfizer’s blockbuster drug as well as the highest selling pill on record. Last year, Lipitor made almost $13 billion in revenue, accounting for 25% of Pfizer’s sales.

A major reason for Pfizer’s shift in direction is its soon-to-expire patent protection on Lipitor in 2011. Furthermore, Lipitor has been losing part of its market in the last couple years to the generic form of its rival, Zocor, produced by Merck. This started when Merck’s patent ran out and health insurance companies began initiatives to support the generic form of Zocor called Simvastatin. Since then, patients have been switching over to this cheaper cholesterol lowering drug.

In addition to stopping research, Pfizer will sell several of its current early stage heart disease medicines because they don’t believe they will be profitable enough.

As Pfizer restructures, they will also be starting three new business branches in 2009. The branches will include primary care, specialty care, and emerging markets. The primary care branch will continue to work with doctors to increase and promote the use of Lipitor like drugs.

What do you think of Pfizer’s choice to stop research in heart disease medicines? What effects do you think this will have on the current market? Please share your opinions!

Rate A Drug

admin — Fri, 10 Oct 2008 21:24:23 +0000

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.