What to Know About Pravastatin

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.

These block an enzyme called HMG-CoA, which the body uses to produce cholesterol and other lipids (fatty substances). By doing so, pravastatin can help prevent the build-up of atherosclerosis (fat in the arteries) and reduce the risk of heart attack, stroke, and other cardiovascular diseases.

Pravastatin was first approved by the 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:

• To improve abnormal lipid levels, including triglycerides, harmful low-density lipoprotein (LDL) cholesterol, and healthy high-density lipoprotein (HDL) cholesterol
• To reduce the risk of a heart attack in people with high cholesterol but no other signs of coronary heart disease
• To reduce the risk of a heart attack, ischemic stroke, or a transient ischemic attack ("brief mini-stroke") in people with clinical signs of coronary heart disease
• To slow or prevent the progression of atherosclerosis
• To reduce the risk of having to undergo a cardiac bypass
• To treat an inherited disorder called familial dysbetalipoproteinemia which causes high triglycerides and LDL cholesterol and low HDL cholesterol
• To treat children aged 8 and over who have familial hypercholesterolemia, an inherited disease characterized by abnormal 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 smoking cessation, are effective for normalizing blood lipid levels.

If these interventions aren't effective or you have multiple cardiovascular risk factors, your healthcare provider 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.

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 aged 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 aged 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 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. Long-term use of the drug may cause liver toxicity in around 1.2% of users, according to premarket research issued by the FDA. The people most likely affected are those with pre-existing liver dysfunction.

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

Cases of fetal harm involving pravastatin have been reported in animals and humans. People taking pravastatin should notify their healthcare provider if they become pregnant.

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:

• Crestor (rosuvastatin)
• Lescol (fluvastatin)
• Lipitor (atorvastatin)
• Livalo (pitavastatin)
• Mevacor (lovastatin)
• Zocor (simvastatin)

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.

This shouldn't suggest that pravastatin doesn't have a place in treatment. It can be useful for people who have mild to moderate hypercholesterolemia, and 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 that's low in saturated fat and cholesterol. The dosage varies by age as follows:

• Adults: 40 mg once daily, only increasing to 80 mg if needed for those who did not reach their LDL-C goal with the lower dose
• 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 age 75 due to the higher likelihood of renal impairment.

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). Pravastatin is sensitive to ultraviolet (UV) exposure from the sun. To avoid excessive exposure, keep the tablets stored in their original light-resistant container.

Side Effects

Pravastatin may cause side effects in some people. Between 85 and 90% of statin users will not experience any side effects at all, according to the American College of Cardiology.

Common

The most common side effects of this medication are:

• Dizziness
• Headaches
• Depression
• Anxiety
• Nervousness
• Sleep disturbance
• Shortness of breath
• Blurred vision
• Fatigue
• Muscle aches
• Joint pain
• Nausea
• Vomiting
• Upper respiratory infection
• Diarrhea

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

Severe

On rare occasions, statin drugs may cause potentially serious side effects. In 2015, the FDA issued a special announcement regarding the safety of statin drugs in general.

Serious side effects associated with statin use are:

• Increased glucose and hemoglobin A1C (Hb A1C) levels (increasing the risk of new-onset diabetes)
• Memory loss and confusion
• Severe myopathy (muscle weakness)
• Rhabdomyolysis (potentially life-threatening muscle damage)
• Hepatotoxicity (liver damage)

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

• Being female
• Having a smaller body size
• Being 80 years old or older
• Taking multiple cholesterol-lowering drugs
• Having kidney or liver disease
• Drinking alcohol excessively
• Having a neuromuscular or endocrine disease like myasthenia gravis, myopathy, or hypothyroidism

Warnings and Interactions

With pravastatin, many of the interactions can increase the risk of severe myopathy or rhabdomyolysis.

Drugs that interact with pravastatin include:

• Cyclosporine
• Clarithromycin
• Colchicine
• Gemfibrozil
• Niacin
• Other statin drugs

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 healthcare provider 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 kidney tests should be routinely monitored irrespective of your pretreatment condition. Your blood glucose and Hb A1C should also be monitored.