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If you have any medical questions or concerns, please talk to your healthcare provider. The articles on Health Guide are underpinned by peer-reviewed research and information drawn from medical societies and governmental agencies. However, they are not a substitute for professional medical advice, diagnosis, or treatment.
According to the U.S. Food and Drug Administration (FDA), generic drugs and brand-name drugs should be equivalent in approved dosage, safety, strength, route of administration, quality, and performance characteristics. Essentially, they should be the same medication except in name (FDA, 2018).
Generic medications are typically only sold once the patents and exclusivities protecting the brand-name version end. Once the patent expires, drug companies must meet strict standards to demonstrate that the generic version effectively provides the same clinical benefits.
Initially sold by Pfizer under the brand name Lipitor, the FDA approved atorvastatin in 1996; once the brand name patent expired in November 2011, a generic version swiftly entered the market.
The widely used statin, also known as an HMG-CoA reductase inhibitor, is FDA-approved to reduce elevated total cholesterol, low-density lipoprotein (LDL), and triglycerides, as well as to increase high-density lipoprotein (HDL) levels. It also helps reduce the risk of heart disease and stroke (FDA, 2017).
Are generic atorvastatin and Lipitor really equivalent?
Aside from atorvastatin, there are several other FDA-approved statin drugs used to lower LDL cholesterol: fluvastatin (brand name Lescol), rosuvastatin (brand name Crestor), lovastatin (brand name Mevacor), pitavastatin (brand name Livalo), pravastatin (brand name Pravachol), and simvastatin (brand name Zocor).
A 2017 study of 266 people taking proprietary atorvastatin (Lipitor) or generic atorvastatin (atorvastatin calcium) looked at this question. They found no statistically significant difference between the drugs in lowering total cholesterol, low-density lipoprotein cholesterol, or triglyceride levels. The researchers concluded that switching people from branded medications to less expensive generic versions is clinically sound and a sensible approach to lowering health care costs (Loch, 2017).
Another study looked at people aged 65 years and older hospitalized for acute coronary syndrome (ACS) and prescribed Lipitor or generic atorvastatin once they went home. The results suggested no significant difference in clinical outcomes within one year of starting the drug. The researchers stated that their findings should reassure people about the effectiveness of generic atorvastatin products when used in routine clinical practice for the ACS population (Jackevicius, 2016).
Generic atorvastatin and brand name Lipitor are both available as an oral tablet taken once per day.
Similarly, they share the same standard daily dose for adults. Dosing usually begins at 10 mg to 20 mg, then progresses to higher doses like 10 mg, 20 mg, 40 mg, or 80 mg daily. The pediatric dose (children 10-17 years of age) of atorvastatin starts at 10 mg orally per day, then proceeds to a daily maintenance dose of 10 mg to 20 mg (FDA, 2017).
Your healthcare provider will work with you to determine the most appropriate dose depending on your therapeutic goals and response to the drug.
One of the most common uses for atorvastatin is to treat hyperlipidemia, which occurs when you have high cholesterol and triglycerides levels in the blood. The body uses cholesterol to create substances like hormones, bile acids, and vitamin D, and triglycerides provide the body with energy. Too much cholesterol causes a buildup of plaques in artery walls, restricting blood flow and increasing the risk of heart attacks and strokes (HHS, 2005).
The problem with hyperlipidemia is that it doesn’t cause any noticeable symptoms, so it can be tricky to diagnose. Healthcare providers rely on routine blood tests and patient history to identify a possible link to the condition (Hill, 2020). During your appointment, your healthcare professional may ask about the following to determine your heart disease risk (Hill, 2020):
- Family history of cardiovascular disease, high cholesterol, high triglyceride levels
- Diet and exercise habits
- Tobacco, alcohol, and drug use
- History of coronary artery disease
- Your risk factors for coronary heart disease, like high blood pressure
- Symptoms of peripheral arterial disease or angina (chest pain)
Atorvastatin is used to treat high cholesterol and triglycerides along with dietary modifications, like choosing a low-fat diet and eating high-fiber foods. Other uses for atorvastatin include (FDA, 2017):
- For people with cardiovascular risk factors, atorvastatin can decrease the risk of heart attacks and strokes. Cardiovascular risk factors include age, smoking, high blood pressure, diabetes, low HDL (“good” cholesterol), or a family history of early heart disease.
- Atorvastatin can reduce the likelihood of heart surgery, as well as lower the risk of heart attacks and strokes in people with heart disease.
- Adults with homozygous familial hypercholesterolemia and primary dysbetalipoproteinemia, disorders that cause abnormal cholesterol levels, can have lower cholesterol levels with atorvastatin.
- In pediatric patients (aged 10-17 years) with heterozygous familial hypercholesterolemia (a genetic condition where the body cannot remove cholesterol normally), it can decrease cholesterol levels.
Atorvastatin and moderations
Hyperlipidemia is a progressive, life-long disease. When left untreated, people can develop cardiovascular disease, leading to heart attacks, strokes, and even death. Luckily, most people can manage hyperlipidemia with medication, diet, and lifestyle modifications.
According to the American Heart Association, diet is one method in your arsenal for lowering your cholesterol. Cut back on the trans and saturated fats found in red meat and fried foods, and focus on a heart-healthy approach to eating that emphasizes fruits, vegetables, and whole grains (AHA, 2017).
Exercise is another essential part of the solution and can help increase the effectiveness of the medication. The AHA recommends 150 minutes, or 2.5 hours, per week of moderate-intensity physical activity such as walking, running, swimming, or cycling (AHA, 2017).
It seems like common sense that diet and exercise can improve health, but there is actual data to support these recommendations. Researchers found that people who adopted lifestyle modifications, like eating a healthy diet, engaging in physical activity, not smoking, and no obesity, had a much lower risk of coronary artery disease events than those who didn’t practice these wellness habits. The risk was 50% lower in people with healthy lifestyle changes (Khera, 2016).
Lifestyle modifications can go a long way to improving your overall health and your risk for heart disease. However, some people don’t see enough change in their cholesterol numbers and need prescription drugs, like atorvastatin, to help.
Atorvastatin side effects
Before starting a new medication, it’s important to educate yourself on potential side effects and drug interactions. Atorvastatin has been linked to various adverse reactions. Although they are often mild, you should consult your healthcare provider for medical advice if any of these symptoms become more severe or do not go away.
Common side effects of Lipitor in placebo-controlled trials include (FDA, 2017):
- Cold symptoms
- Joint pain
- Pain in arms or legs
- Urinary tract infections
- Muscle pain, aches, or spasms (myalgia)
- Forgetfulness or memory loss
- Trouble sleeping (insomnia)
Less often, atorvastatin may cause more serious side effects. Call your healthcare provider or seek immediate medical attention if you experience any of the following (UpToDate, n.d.).
- Muscle disease (myopathy) or rhabdomyolysis
- Liver problems
- Chest pain
- Extreme tiredness
- Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- Severe skin rash (including erythema multiforme and Stevens-Johnson syndrome)
- Anaphylaxis (severe allergic reaction with swelling and difficulty breathing)
- Unusual bleeding or bruising
Atorvastatin can cause elevations in liver blood test levels, specifically in serum transaminases. Your provider may run baseline blood tests before starting atorvastatin (McIver, 2020). People with active liver disease should not take atorvastatin.
Seek medical advice right away if you have any symptoms of liver damage or failing liver function, like fatigue and weakness, loss of appetite, stomach pain, yellowing of your skin or the whites of your eyes, or dark urine. Another severe but rare side effect is rhabdomyolysis—muscle breakdown that can lead to kidney disease and even death. If you have muscle aches (which are not uncommon by themselves) and also have a fever, extreme tiredness, or dark-colored urine, this might be a sign of rhabdomyolysis. Get medical attention immediately.
Lastly, do not use atorvastatin if you are pregnant, trying to become pregnant, or breastfeeding because of the risk of adverse effects.
In summary, statins like atorvastatin are very effective at treating high cholesterol and lowering your risk of heart disease, especially when used along with lifestyle changes. Talk to your healthcare provider about the risk and benefits to see if atorvastatin is right for you.
- American Heart Association (AHA). (2017). Prevention and treatment of high cholesterol (hyperlipidemia). Retrieved on Oct. 8, 2020 from https://www.heart.org/en/health-topics/cholesterol/prevention-and-treatment-of-high-cholesterol-hyperlipidemia
- Hill, M. F. & Bordoni, B. (2020). Hyperlipidemia. StatPearls. Retrieved on Oct. 8, 2020 from https://www.ncbi.nlm.nih.gov/books/NBK559182/
- Jackevicius, C. A., Tu, J. V., Krumholz, H. M., Austin, P. C., Ross, J. S., Stukel, T. A., et al. (2016). Comparative effectiveness of generic atorvastatin and lipitor® in patients hospitalized with an acute coronary syndrome. Journal of the American Heart Association, 5(4): e003350. doi: 10.1161/JAHA.116.003350. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4859299/
- Khera, A.V., Emdin, C.A., Drake, I., Natarjan, P., & Bick, A.G. (2016). Genetic risk, Adherence to a healthy lifestyle, and coronary disease. New England Journal of Medicine, 375: 2349-2358. doi: 10.1056/NEJMoa1605086. Retreived from https://www.nejm.org/doi/full/10.1056/nejmoa1605086
- Loch, A., Bewersdorf, J. P., Kofink, D., Ismail, D., Abidin, I. Z., & Veriah, R. S. (2017). Generic atorvastatin is as effective as the brand-name drug (LIPITOR®) in lowering cholesterol levels: a cross-sectional retrospective cohort study. BMC Research Notes, 10(1), 291. doi: 10.1186/s13104-017-2617-6. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5514478/
- McIver, L. A. & Siddique, M. S. (2020). Atorvastatin. StatPearls. Retrieved Retrieved on Oct. 8, 2020 from https://www.ncbi.nlm.nih.gov/books/NBK430779/
- UpToDate. (n.d.). Atorvastatin: Drug Information. Retrieved on Oct. 8, 2020 from https://www.uptodate.com/contents/atorvastatin-drug-information
- U.S. Department of Health and Human Services (HHS). (2005). Your guide to lowering your cholesterol with TLC. Retrieved on Oct. 8, 2020 from https://www.nhlbi.nih.gov/files/docs/public/heart/chol_tlc.pdf
- U.S Food and Drug Administration (FDA). (2018). Generic drugs: questions & answers. Retrieved on Oct. 8, 2020 from https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers#q2
- U.S Food and Drug Administration (FDA). (May 2017). LIPITOR (atorvastatin calcium) tablets, for oral use. Retrieved on Oct. 8, 2020 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020702s067s069lbl.pdf
Dr. Chimene Richa is a board-certified Ophthalmologist and Senior Medical Writer/Reviewer at Ro.