Pharmacy professor questions Vytorin use


Published: Saturday, January 26, 2008 at 6:01 a.m.
Last Modified: Saturday, January 26, 2008 at 12:09 a.m.

Two weeks ago, the television advertisements touting the cholesterol-lowering drug were everywhere. Their message: You get your bad cholesterol from two sources, food and family. The solution: Take Vytorin.

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The drug Vytorin is shown.

Special to The Sun

Facts

FYI: Statins

VYTORIN

  • Combines Zocor (a statin) and Zetia.

  • Effective in reducing LDL (bad) cholesterol levels.

  • Shown in a newly-released study to be no more effective than Zocor (or a generic statin) in reducing plaque buildup in neck arteries.

  • Side effects may include headache, joint pain, gas.

ZOCOR, LIPITOR, CRESTOR
  • Three of many statins designed to block production of cholesterol in the liver.

  • Lowers LDL (bad) cholesterol.

  • Studies show it boosts HDL (good) cholesterol, reduces artery inflammation.

  • Side effects of statins can include aching muscles, elevated liver enzymes.

ZETIA
  • Blocks absorption of LDL cholesterol in the liver.

  • Often prescribed to patients who cannot tolerate the side effects of statins.

  • Has been shown to lower LDL, but was not effective in boosting HDL, reducing artery inflammation.

  • Side effects can include muscle pain, headaches, nausea and fever.

IF YOU TAKE VYTORIN:
  • Don't stop the medication on your own.

  • Talk with your doctor about what the options are.

  • Consider whether a generic statin would work as well or better.

- Paul Doering, UF professor of pharmacy practice

Then came the release of a study that was nearly 2 years old, showing that Vytorin, among the most widely used prescription medications, was no better at slowing the building of plaque in your arteries than a much cheaper, generic form of statin.

Patients who were paying $3 a pill for their prescription Vytorin were left scratching their heads. Should they stop? Should they switch?

Paul Doering, a distinguished service professor in the department of pharmacy practice at the University of Florida's College of Pharmacy, has some definite views on Vytorin and the marketing behind it.

Behind the urgent headlines, Doering said, there is actually some good news for consumers.

"The key issue is not a question of safety, but whether people who have been taking this medicine have been wasting their time, effort and money," he said. "There is no urgency for people to stop it tomorrow, lest they die of a heart attack."

Vytorin (and a sister drug, Zetia) has been a proven money-maker for the parent drug companies in the four years since it was introduced. In 2006, 18 million prescriptions were written for Vytorin and 14 million for Zetia. Merck and Schering-Plough, which make the two and split the profits, report the drugs generate annual sales of $5 billion.

Vytorin is actually a combination of two earlier drugs - the statin Zocor and the nonstatin Zetia - that was touted as a one-two punch that would be more effective than a statin alone. Statins inhibit the production of cholesterol in the liver, and the nonstatin Zetia keeps cholesterol from being absorbed in the intestine.

The makers of Lipitor, a statin-like drug that is also widely advertised on television, claim it has been prescribed for 26 million Americans.

The potential market for any new cholesterol-lowering drug is huge. According to the Centers for Disease Control and Prevention, approximately a fifth of U.S. adults over 20 years of age have elevated cholesterol, and 23 million suffer from heart disease. Heart disease and stroke are two of the three leading causes of death.

So Doering was not surprised to hear that Vytorin's parent companies might have delayed reporting on a study involving just 720 patients, but one that seems to indicate their drug wasn't as effective as advertised. "They appear to have been sitting on this data for a couple of years while their cash registers were ringing. That raises questions about whether they're honest and open," Doering said.

"The company is standing by its drug, but I understand a typical doctor's office is getting 22 phone calls a day from patients asking what they should do," he noted.

Because the research has not yet been published in full form, doctors are as confused about the results as their patients are, according to Doering. The drug companies have taken out full-page ads in newspapers to reassure people that Vytorin is a safe and effective medication.

A Florida grandmother who was paying $100 a month for her Vytorin has filed suit against the drug companies for misleading advertising.

The FDA announced Friday it is taking a closer look at whether any changes need to be made to how cholesterol-lowering drugs are regulated. The government agency estimates it will take another six months to fully evaluate the data for Vytorin compared with a generic statin.

Doering said consumers need to recognize that there is a reason drug companies promote the newest, latest formula of a medication. The makers of Vytorin hold the patent on their new medication, while cholesterol-lowering statins that have been around far longer are now out of patent and available in generic form.

"Consumer Reports Best Buy Drugs" notes that Vytorin is considerably more expensive than simvastatin, a generic form of Zocor produced by several different pharmaceutical companies. A month's worth of Vytorin averaged $120, while simvastatin was $40 to $75, depending on dosage, the consumer guide reports. Most health care plans have a lower co-pay for a generic than for brand-name drugs.

Guidelines for physicians suggest Vytorin should not be a doctor's first choice for a patient who has been unable to control cholesterol levels through diet and exercise.

Instead, doctors are advised to start their patients with the generic simvastatin, then move to higher doses of brand-name statins such as Lipitor or Crestor. Zetia and Vytorin are for patients who don't get enough benefit from these drugs, or who can't take higher doses of statins because of their side effects, which can include muscle aches and elevated liver enzymes.

"This may be a good time for people to get a tried-and-true therapy and save some money at the same time," advised Doering.

"People ask me, 'Would you ever consider taking a generic?' Not only would I consider it, I do."

Diane Chun can be reached at 352-374-5041 or chund@gvillesun.com

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