What to Know About Pravastatin

Statin Drug to Treat High Cholesterol and Lower Cardiac Risks

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Pravastatin is an oral drug used to treat high cholesterol and prevent cardiovascular disease in people at high risk. Pravastatin belongs to a class of drugs known as statins that block an enzyme called HMG-CoA which the body uses to produce cholesterol and other fatty substances (lipids). By doing so, pravastatin can prevent the build-up of fat in the arteries (known as atherosclerosis) and reduce the risk of heart attack, stroke, and other cardiovascular diseases.

Pravastatin was first approved by the U.S. Food and Drug Administration (FDA) in 1991 under the brand name Pravachol. Today, it is available in generic form under its chemical name pravastatin.

Uses

Pravastatin is approved for use in adults and children as young as 8. It is used in conjunction with a low-fat diet and prescribed under to following circumstances:

Pravastatin is recommended if all other conservative measures, such as diet, exercise, and weight reduction, have not improved cholesterol levels.

Before Taking

The very fact that you have high cholesterol doesn't necessarily mean that you need statin drugs. In many cases, lifestyle changes, like regular exercise, a heart-healthy diet, weight loss, and the cessation of smoking, are all that is needed to normalize blood lipid levels.

If these interventions fail to provide relief or you have multiple cardiovascular risk factors, your doctor may recommend treatment. In 2018, the American College of Cardiology (ACC) and the American Heart Association (AHA) issued updated guidance on the appropriate use of statins, including when and how to start treatment.

The decision to start pravastatin is largely based on your age, your LDL blood test results, and whether you have or are at risk of atherosclerosis-induced cardiovascular disease (ASCVD).

According to the ACC/AHA guidelines, statin therapy should be started based on the following criteria:

  • Adults with ASCVD: start with a high-intensity statin
  • Adults at high risk of ASCVD with an LDL over 70: start with a high-intensity statin
  • Adults with an LDL over 190: start with a high-intensity statin
  • Adults 40 to 75 with diabetes and an LDL over 70:: start with a moderate-intensity statin, increasing to a high-intensity statin if the calculated 10-year risk of ASCVD is high
  • Adults 40 to 75 with an elevated risk of ASCVD: may be treated based on a review of your ASCVD risk factors (such as an LDL over 160 mg/dL, metabolic syndrome, premature menopause, etc.)
  • Adults 40 to 75 at high risk of ASCVD with an LDL over 70: may be treated on a case-by-case basis, ideally using a coronary artery calcium (CAC) scan to establish risk
  • Adults and children under 40 or adults over 75: may be treated on a case-by-case basis, weighing the benefits and risks of treatment

Precautions and Contraindications

Pravastatin, as with other statin drugs, is mainly metabolized in the liver. The long-term use of the drug may cause liver toxicity in around 1.2 percent of users, according to premarket research issued by the FDA. The people most likely affected are those with pre-existing liver dysfunction.

Due to the risk of liver injury, pravastatin is contraindicated for use in people with active liver disease or the persistent, unexplained elevation of liver enzymes.

Pravastatin is also contraindicated during pregnancy. Cholesterol is vital to the development of a fetus, and any deprivation of cholesterol may affect normal cell development. The same applies to breastfeeding since the drug can be passed through breastmilk to the nursing baby.

Even though pravastatin is classified as Pregnancy Category X, meaning that cases of fetal harm have been reported in animals and humans, the FDA concluded that the incidences of birth defects, miscarriage, and fetal death did not exceed what would be expected in the general population.

Finally, pravastatin should not be used in people with a known hypersensitivity to the drug or any of the inactive ingredients in the tablet.

Other Statins

Pravastatin is only one of several commonly prescribed statins. Others include:

There are also fixed-dose combination drugs used to treat high cholesterol and other related conditions, including Advicor (lovastatin + niacin), Caduet (atorvastatin + amlodipine) and Vytorin (simvastatin + ezetimibe).

Comparatively speaking, pravastatin tends to be less effective than many of its counterparts. This is because it binds to a less available receptor on target cells, meaning that more of the drug remains in circulation than is actively blocking HMG-CoA.

According to a 2017 review in the International Journal of Endocrinology and Metabolism, pravastatin was the second least effective statin next to Lescol in terms of its ability to improve LDL, HDL, and triglyceride levels.

This shouldn't suggest that pravastatin doesn't have a place in treatment. Not only might it be useful in people with mild to moderate hypercholesterolemia, but it can also be used when drug resistance or intolerance develops to another statin drug.

Dosage

Pravastatin tablets are available by prescription in 10-milligram (mg), 20-mg, 40-mg, and 80-mg doses. The drug is intended for use with a restricted diet low in saturated fat and cholesterol. The dosage varies by age as follows:

  • Adults: 40 mg once daily, increasing to as 80 mg if needed
  • Adolescents 14 to 18: 40 mg once daily
  • Children 8 to 13: 20 mg once daily

It generally takes around four weeks before the full benefits of treatment are achieved.

Modifications

Pravastatin should be prescribed at a starting dose of 10 mg once daily for people with kidney disease to reduce the risk of further damage. The dose can then be increased if needed (generally to no more than 20 mg daily) as long as renal (kidney) function is not compromised.

Regular lipid panel and renal function tests would be regularly performed to track your response to treatment.

The dosage may also need to be reduced in adults over 75 given the greater likelihood of renal impairment. At the same time, doctors would need to assess if treatment is even appropriate.

According to the U.S. Preventative Services Task Force, there is insufficient evidence that statins are beneficial to elderly adults with no prior history of a heart attack or stroke.

How to Take and Store

Pravastatin can be taken with or without food. It has a relatively short drug half-life (90 minutes to two hours), meaning that you have to take it every day, ideally at the same time, to maintain optimal concentration in the blood.

Pravastatin is relatively stable when stored at room temperature. It is best kept at 77 F (25 C) but is generally okay at temperatures between 56 F (13 C) and 86 F (30 C). In addition to temperature, pravastatin is sensitive to ultraviolet (UV) exposure from the sun. To avoid excessive exposure, keep the tablets stored in their original light-resistant container.

If you forget to take a pravastatin dose on time, take it as soon as you remember. If it near the time of your next dose, skip the missed dose and continue as normal. Never double up doses.

Side Effects

As with all medications, pravastatin may cause side effects in some people. As concerning as the risks may be, between 85 percent and 90 percent of statin users will experience no side effects at all, according to the American College of Cardiology.

Common

The most common side effects (affecting at least 2 percent of users) were:

  • Headaches
  • Muscle aches
  • Joint pain
  • Nausea
  • Vomiting
  • Upper respiratory infection
  • Diarrhea

Most of these side effects are low-grade and gradually resolve as your body adapts to treatment. Other less common side effects include flushing, insomnia, loss of sex drive, hair loss, and taste disturbances.

Severe

On rare occasion, statin drugs may cause potentially serious side effects. Many of these were only noted in recent years as the FDA reviewed ongoing complaints from consumers and doctors alike. In 2015, the FDA went so far as to issue a special advisement regarding the safety of statin drugs in general.

Among some of the more serious (albeit common) side effects associated with statin use are:

Some of these side effects—myopathy and rhabdomyolysis particularly—require the immediate termination of treatment. Contact your doctor if you experience these or any other unusual symptom.

The risk of side effects, especially serious ones, is higher in people with the following risk factors:

  • Being female
  • Having a smaller body size
  • Being 80 or over
  • Taking multiple cholesterol-lowering drugs
  • Having kidney or liver disease
  • Drinking alcohol excessively
  • Having a neuromuscular or endocrine disease like muscular dystrophy or hypothyroidism

Warnings and Interactions

Drug interactions are common with all drugs, but, with pravastatin, many of the interactions can increase the risk of severe myopathy or rhabdomyolysis. Among the drugs interactions to look out for:

  • Cyclosporine: decrease pravastatin to 20 mg daily if used together
  • Clarithromycin: limit pravastatin to 40 mg daily if used together
  • Colchicine: a reduction of the pravastatin dose may be needed
  • Gemfibrozil: avoid using with pravastatin
  • Niacin: a reduction of the pravastatin dose may be needed
  • Other statin drugs: avoiding using together

Other drugs may increase the concentration of pravastatin in the blood (leading to toxicity) or, conversely, decrease the concentration (reducing the drug's effectiveness). Before starting pravastatin, speak with your doctor if you use any of the following drugs:

  • Antacids like Tagamet (cimetidine)
  • Antifungals like fluconazole
  • Bile-biding resins like cholestyramine and colestipol
  • Calcium channel blockers like Verelan (verapamil)
  • HIV drugs like Kaletra (ritonavir + lopinavir) or Prezista (darunavir)

In some cases, the interaction can be avoided by separating the doses by four to six hours. In others, a drug substitution may be needed.

To avoid liver or kidney injury, liver and renal enzymes should be routinely monitored irrespective of your pretreatment condition. Your blood glucose and Hb A1C should also be monitored. The tests are relatively inexpensive and usually do not require insurance preauthorization. Speak to your health insurer beforehand just to be sure.

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