Drug Category statin
What the drug does This drug blocks an enzyme in the body’s chemical reaction that makes cholesterol.
WARNINGS
LIVER Do not take atorvastatin if you have active liver disease, alcoholism or unexplained elevated liver enzymes. Atorvastatin can irritate the liver, cause jaundice and liver failure. Liver enzyme blood tests should be measured before starting atorvastatin, after being on it for three months, after any increase in the dose, and twice a year as long as you are on it.
MUSCLE DESTRUCTION Atorvastatin and all drugs in this class can cause muscle pain, weakness, fever and massive muscle destruction, clogging the kidneys with muscle proteins and causing kidney failure. Patients should be aware of the common side effect of muscle soreness so that they are not mistakenly labeled with fibromyalgia.
RECENT BLEEDING STROKE It should not be used in patients with a recent stroke caused by bleeding into the brain.
Frequent effects reported while on atorvastatin include infection, headache, accidental injury, flu, stomach pain, back pain, allergic reaction, weakness; constipation, nausea, diarrhea, acid indigestion, excess gas; bronchitis, runny nose, sinus infection or sore throat; rash; joint and muscle pain; insomnia, dizziness; urinary tract infection, blood in the urine, protein in the urine; swelling; chest pain.
Additional reports while on atorvastatin include sudden swelling of lips and throat that can block breathing and cause death, hives and swelling, blistering rash, fatigue, tendon tears, death from liver failure. Rarely statin drugs can cause memory problems and transient global amnesia, where the memory is completely gone for a short period. Patients should be aware of this possible side effect so that they are not mistakenly labeled with dementia or Alzheimer’s.
Other possible unwanted effects Lab dogs on high doses of a statin drug can get bleeding into the brain and other brain injuries. In humans who had a bleeding stroke in the last six months, normal doses of atorvastatin increases the chance of more bleeding into the brain. Lab rats on high doses can get small testicles and abnormal sperm. It causes birth defects in lab rats.
Safety
CANCER There is conflicting evidence regarding statin drugs and cancer. Very low cholesterol levels are associated with a higher chance of finding cancer. Elderly patients on statins have higher cancer rates. On the other hand, a statin may lower the risk of liver cancer in younger diabetics, and it might slightly lower aggressive cancers of the breast, colon and prostate in younger patients.
DEMENTIA Some of the statin drugs, such as atorvastatin, are small enough to cross into the brain. In the short run, the anti-inflammatory effect of statins seems to protect against dementia. But after a few years it appears that statin drugs may actually increase dementia. This may be because cholesterol is very important part of the walls and lining of nerve and brain cells, and stripping the brain of its cholesterol could slow down nerve impulses.
MEMORY Rarely atorvastatin can cause amnesia. Personality changes with severe mental instability have been reported. Patients should be aware of these possible side effects so that they are not mistakenly labeled with mental illness or with Alzheimer’s.
INCREASING REPORTS Increasing long term side effects are being reported. This is probably because of the trend to get all adults to lower their cholesterol, even if they never had a heart problem or other risk factor. Low risk patients are not likely to die off from heart disease or stroke (whether or not they are on a statin drug). Since low risk patients live longer anyway, they are more likely to suffer drug side effects compared to high risk patients – high risk patients tend to drop out due to heart disease or stroke before they get long term drug side effects.
Special precautions Liver toxicity from this drug is more likely to happen if you are an alcoholic or if you already have liver disease. This drug should not be used while pregnant or breast feeding.
Interactions
Blood levels of atorvastatin can go high if you are also on the blood pressure drugs diltiazem or amlodipine, or if you are drinking grapefruit juice. Atorvastatin can change the blood level of digoxin or birth control pills.
Muscle destruction with kidney failure is more likely to happen while taking a statin drug if you are also on fibric acid derivatives (given to lower the cholesterol), the B vitamin niacin (given to lower cholesterol), the antibiotics erythromycin or clarithromycin, the antiviral drug ritinovir alone or in combination with saquinavir or lopinavir, or anti-fungal drugs in the azole group, or the drug given for preventing rejection of a transplanted organ, cyclosporine.
Is it proven to work? Yes and No. Please read the following carefully to find which category you fit into:
FATS Atorvastatin does decrease the levels of various fats including total cholesterol, LDL and triglycerides. It increases HDL.
PATIENTS WHO ALREADY HAVE HEART DISEASE In patients who already have heart problems, atorvastatin is effective. It takes around 20 patients with heart disease to be treated daily for 5 years to prevent another heart attack in one of them.
HIGH RISK PATIENTS WHO DO NOT HAVE HEART DISEASE In people with high blood pressure and at least three other risks for heart disease, atorvastatin is slightly effective in preventing their first heart attack.
Here are the numbers from a study done by the drug maker: If 100 high risk people who are not taking atorvastatin go along for about three and a half years, 3 of them would have a heart attack. If we follow 100 other people who have the same high risks, but we give them atrovastatin every day for about three and a half years, 2 of them would still have a heart attack. So that means that whether or not high risk people are taking atorvastatin, 2 are going to have a heart attack anyway.
In other words, atorvastatin seems to save one out of a hundred high risk patients from having their first heart attack during three and a half years. Meanwhile the other 99 are taking the drug every day, getting liver tests twice a year and may be experiencing side effects; all the while they are not the one person who is going to benefit from being on the drug. This is called number needed to treat: this study showed that it takes 100 high risk patients to be treated for about three and a half years to prevent a heart attack in one person.
In similar studies done by other researchers, the number needed to treat was much higher. They showed that 250 high risk patients needed to take the drug for 5 years in order to save one person from his first heart attack. That means that 249 out of 250 are on the drug every day for 5 years without any benefits.
DEATH FROM HEART PROBLEMS In people who are not diabetic, and have not had a heart attack, but who have risk factors for heart disease, atorvastatin does not decrease the death rate from heart attacks or other heart and blood vessel problems.
STROKE Atorvastatin does not significantly lower the rate of stroke or death from stroke in non-diabetics who have other heart risk factors.
NEED FOR ANGIOPLASTY OR BYPASS In patients with risk factors who are not diabetic, atorvastatin can decrease the need for opening up a blocked blood vessel.
DEATH OVERALL In people who have not already had a heart problem, atorvastatin does not decrease the overall death rate from all causes combined; it does not prolong life.
DIABETICS There are conflicting studies about whether statins will help diabetics.
In large studies sponsored by the drug makers, atorvastatin was reported to help prevent the first heart attack in diabetics who also had an additional risk factor for heart disease. Their studies showed that for every 100 of these diabetics there were 13 heart attacks over four years. For every 100 of these diabetics on atorvastatin, there were only 8 heart attacks over four years. This means that taking atorvastatin every day for four years prevented five heart attacks in every 100 people. On the flip side, we can look at it like this, 95 out of 100 of these diabetics will not get any benefit from taking atorvastatin every day for over four years. In several other studies, there was no significant benefit to diabetics on statin drugs.
In diabetics, atorvastatin does not lessen the need for getting angioplasty, stent or bypass.
There is a slight trend toward fewer strokes in diabetics on atorvastatin.
Atorvastatin has been shown to reduce the death rate in diabetics in some studies but not in others.
PATIENTS WHO DO NOT HAVE MULTIPLE HEART RISK FACTORS There is no proof that lowering cholesterol in low risk patients will prevent heart attacks, stroke or prolong life in patients who do not have multiple heart risk factors.
ELDERLY The older a person gets, the more he is at risk of a heart problem but the less important his cholesterol level is. Therefore the cholesterol lowering drugs don’t work as well as we age. In fact, death rates from all causes combined are higher in elderly people who have the lowest cholesterol levels.
WOMEN Some studies show a small benefit for women, others do not. Taken all together, studies have not conclusively shown that women benefit from the statin drugs. This may be because women tend to get heart problems about a decade later than men, and statin drugs are less effective the older we get.
HIGHER DOSES of atorvastatin do not further lower the heart deaths or the need for opening blocked vessels. There is a slight trend toward fewer heart attacks and stroke at higher doses. However, the higher drug dose was also associated with a slight trend toward higher overall death rates from all causes.
