Pitavastatin (LIVALO): 8th Cholesterol-Lowering Statin Marketed in the U.S.

Pitavastatin (LIVALO), a cholesterol-lowering statin, should not be taken until at least seven years after its market approval (August 2016). The risks of long-term pitavastatin use are unknown, and it has been found no more effective than other statins on the market.

Pitavastatin is the eighth cholesterol-lowering statin to be marketed in the U.S., and is one of the seven that remains on the market. It was approved by the Food and Drug Administration (FDA) in August 2009, has been sold in Korea and Thailand since 2008, and has been used in Japan since 2003. The drug is manufactured by the multinational Japanese firm Kowa Company Ltd., which now has facilities in the U.S.

Cerivastatin (BAYCOL), another cholesterol-lowering statin, was withdrawn from the market in August 2001 because of deaths due to rhabdomyolysis (the rapid breakdown of muscles). Rhabdomyolysis — an adverse effect of all statin drugs — can lead to kidney failure and, in some cases, death.

Table 1 lists the statin drugs that have been marketed in the U.S. for lowering cholesterol.

The FDA’s basis of approval for pitavastatin

The FDA based its approval of pitavastatin on the results of studies comparing the drug to atorvastatin (LIPITOR), simvastatin (ZOCOR), pravastatin (PRAVACHOL) and a placebo. Effective statins reduced the level of low-density lipoprotein cholesterol (LDL-C), sometimes called “bad” cholesterol.

Pitavastatin was found to be better than a placebo at lowering LDL-C. In the studies comparing pitavastatin to the statin drugs mentioned above, it was found to have the same effectiveness as the other statins.

However, despite the drug’s effectiveness in lowering LDL-C, the FDA-approved product label for pitavastatin says, “The effect of LIVALO on cardiovascular morbidity and mortality has not been determined.” This statement means that no one knows if pitavastatin will actually lower the risks of heart attack, stroke or early death in users since its clinical trials were so short (only three to four months in duration).

The benefits of most other statins are documented by “gold standard” randomized clinical trials and are listed in the Indications & Usage sections of the professional labels for these drugs. Consumers also can check the documented benefits of individual statins and other drugs in the National Library of Medicine’s compilation of professional labels on the DailyMed website: http://dailymed.nlm.nih.gov/dailymed/about.cfm.

Pitavastatin safety

Pitavastatin’s adverse effects are similar to those of other statins. One of its most concerning effects is the muscle pain and weakness that can be a sign of rhabdomyolysis.

Pitavastatin doses greater than 4 milligrams have been associated with an increased risk of severe muscle pain and weakness. All statins, including pitavastatin, are capable of causing fetal malformation (birth defects) and thus must not be used during pregnancy.

Additionally, pitavastatin has the potential to cause clinically important drug interactions with a variety of drugs including cyclosporine (NEORAL, SANDIMMUNE), erythromycin (E-MYCEN, EES, ERYTHROCIN), rifampin (RIFADIN, RIMACTANE), niacin (NICOLAR), protease inhibitors and fibrates. Consumers can find more details about these potential interactions listed in the drug’s professional product label, which is available on the DailyMed website.

We invoked the Health Research Group’s Seven-Year Rule for pitavastatin because of its lack of long-term safety information and because there is no evidence that it will protect users from heart attacks, strokes or death. On top of these concerns is the fact that the other statins on the market have shown benefits for specific groups of patients that are greater than or equal to pitavastatin’s benefits.

The editors of the highly respected Medical Letter on Drugs and Therapeutics, an independent source of drug information for doctors and pharmacists, concluded its review of pitavastatin simply, saying that “there is no good reason to use it.”

What You Can Do

You should wait until August 2016 to take pitavastatin. Other cholesterol-lowering drugs should be used in addition to a diet restricted in saturated fat and cholesterol, and only when the response to diet and other drug measures has been inadequate.

If you are already using pitavastatin, ask your doctor about switching to another statin that has been approved for a longer time and that has been shown to have clinical benefits.

Though there is no danger in stopping your statin treatment abruptly, you should always consult your doctor before changing or stopping drug treatments.

Consumers may report serious adverse events with drugs to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail, fax or phone.

Online: www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088

Table 1. Statin Drugs

*Do Not Use on WorstPills.org
****Do Not Use for Seven Years on WorstPills.org