Cholesterol drugs safe, even after a decade of use

Cholesterol-lowering drugs continue to produce benefits without any serious safety problems, such as increased cancer risk, even after more than a decade of use, researchers said Wednesday.

The finding from a large British clinical study following patients for 11 years provides reassurance for people at risk of heart attacks who are typically prescribed such medicines indefinitely.

So-called statin drugs are not without side effects. They can cause nausea, muscle pain, and occasional kidney and liver damage.

But long-term follow-up in the 20,000-patient Heart Protection Study (HPS) found no evidence that statins increased the risk of non-vascular mortality or made patients more likely to develop cancer.

Richard Bulbulia of the University of Oxford’s Clinical Trial Service Unit, one of the leaders of the trial, said the persistence of the benefit and the long-term evidence of safety was “remarkable.”

Outside experts agreed it was reassuring. Some past studies have indicated a possible cancer risk with statins, although a major analysis by U.S. researchers three years ago concluded there was no causal link.

“Concerns should be put to rest, and doctors should feel reassured about the long-term safety of this life-saving treatment for patients at increased cardiovascular risk,” Payal Kohli and Christopher Cannon of Boston’s Brigham and Women’s Hospital wrote in a commentary in the Lancet medical journal, which published the results online.

Side Effects of Cholesterol-Lowering Statin Drugs

Here’s a quick list of known side effects caused by taking statin drugs. People who take statins have suffered ravaging health consequences, including permanent damage to their liver, muscles and nervous system. Statins frequently cause people to lose their memories or feel confused. Here’s the full list:

- Nausea
- Irritability and short tempers
- Hostility
- Homicidal impulses
- Rapid loss of mental clarity
- Amnesia
- Kidney failure
- Diarrhea
- Muscle aching and weakness
- Tingling or cramping in the legs
- Inability to walk
- Problems sleeping
- Constipation
- Impaired muscle formation
- Erectile dysfunction
- Temperature regulation problems
- Nerve damage
- Mental confusion
- Liver damage and abnormalities
- Neuropathy
- Destruction of CoQ10, a vital nutrient for health

The HPS study assessed the benefits of 40 milligrams daily of simvastatin, the active ingredient of Merck & Co’s now off-patent drug Zocor, or placebo.

It found a 23 percent reduction in heart attack, stroke and vascular disease after five years in those on treatment - and the benefit persisted largely unchanged for a further six years when statin use, which was encouraged, was similar in both groups of patients.

While the FDA has deemed statins to be safe to use for their intended purpose, no drug is totally without side effects in susceptible individuals. As the use of statin drugs continues to increase and people have been taking statins for a prolonged period that is significantly longer than the time period required for testing drugs, the side effects of statins affects more people than ever before.

Since the drug companies that manufacture statins have become aware of the incidence of serious side effects, they added a warning to statin advertising that was not present in the earliest advertising. This warning states, “Unexplained muscle pain and weakness could be a sign of a rare but serious side effect and should be reported to your doctor right away.” People who take statin drugs need to heed this warning immediately because in extreme cases the side effects of statins can be fatal.

Muscle pain and muscle weakness are two of the main side effects of statin drugs. While muscle pain and muscle weakness sound ordinary enough, due to the manner in which statin side effects can act in the body they are potentially dangerous side effects of statin use. Another is memory loss. Anyone who is taking statin drugs for any reason should be aware of these side effects and their symptoms. The medical establishment recommends that anyone who suspects they are experiencing any of the possible statin side effects consult with their medical professional.

Other popular statin medicines include Pfizer’s top-selling Lipitor, which is due to lose patent protection in the United States at the end of this month, and AstraZeneca’s Crestor.

With many years of statin experience behind us, few clinicians would argue the effectiveness of the statin class of drugs in reducing cardiovascular disease risk.
The adverse side effects from these drugs are another matter as the numbers of people on Lipitor (atorvastatin) rapidly increase and the side effect reports flood in. If you are on Lipitor or are planning to start taking Lipitor, you must read my books.

Five years ago when I started this research, reported side effects were primarily “a few aches and pains and occasional liver intolerance”, arguably an acceptable price for society to pay for such a beneficial class of drugs.

No longer does this come even close to the truth. Of great concern today are the growing numbers of adverse drug reports associated with the use of Lipitor and the other stronger statin drugs, reflecting dysfunction of many different body systems.

By Dr. Duane Graveline, M.D., M.P.H.



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