Local cardiologists say the controversial heart drug Vytorin may not be the demon some people are making it out to be, but it isn’t a cure-all either.
The drug’s manufacturers, Merck and Schering-Plough, announced earlier this year that trial results show Vytorin doesn’t help reduce to plaque build-up in arteries, but it does reduce LDL, or “bad,” cholesterol.
These trial results don’t really say much, though, according to Dr. Deepu Nair, cardiologist at Palo Alto Medical Foundation’s Camino Medical Group in Mountain View.
“It wasn’t really testing the main thing we use this drug for,” said Dr. Nair. “I would say that the data are not clear.”
Most doctors prescribe the drug to reduce cholesterol, said Dr. Dominick Curatola, a cardiologist at El Camino Hospital. After the study results were announced, there was a frenzy of coverage in the national media, with some stories claiming the drug didn’t help at all and even caused cancer. As a result, Dr. Curatola’s office was inundated with calls from concerned patients, even though Dr. Curatola said he doesn’t prescribe it very much.
Usually, Curatola said, he prescribes statins to reduce cholesterol. The study, called “ENHANCE,” compared statins to Vytorin.
Dr. Nair said he prescribes Vytorin for people who don’t tolerate that statins or fibrates. In some cases, Dr. Curatola prescribes Vytorin to save the patient money: Some insurance companies will reimburse patients at a higher level for Vytorin than another drug.
Vytorin (pronounced vy-TOR-in) came out only four years ago. It is a combination of two other heart drugs, Zetia and Zocor. Zocor is a statin, a class of drugs that lowers cholesterol by reducing the absorption of it in the liver. Zetia works by blocking absorption of bad cholesterol in the intestine.
The study determined that Vytorin reduced LDL levels by 58 percent, compared with a 41 percent reduction with Zocor alone. The reduction was equal to 1 percent of a millimeter for Vytorin, versus a half percent of a millimeter for Zocor. These measurements are so small as to be insignificant, Dr. Curatola said.
One issue with the ENHANCE study is that it just wasn’t very big, Dr. Nair said. It studied 720 patients; two trials that will come out in about three years involve more than twice that number.
ENHANCE was also less than revealing because it looked at the thickness of the corroded artery — not cardiac events like a heart attack or stroke.
“That’s what we call a surrogate endpoint,” Dr. Nair said. “It doesn’t look at hard events like heart attacks.”
Some patients called his office after the news, and a couple of them quit taking the drug, Dr. Nair said. That may or may not be a good thing, but it’s hard to say, he said, because there just isn’t enough information about Vytorin yet.
“It was over-prescribed early on, just because we knew it reduced bad cholesterol,” he said. “The statins are still our first, second and third choice.”
“It was marketed so heavily without a real end-point trial, which is a lesson for physicians: We have to wait for the trials,” he said.
