Another win for Amgen and ESA sales...Good news only 5 patients died!!
Amgen’s Anemia Medicine Linked to Higher Risk in Heart-Attack Patients
By Rob Waters - May 10, 2011
A drug sold by Amgen Inc. (AMGN) and Johnson & Johnson (JNJ) for people with anemia didn’t reduce heart damage in patients who’d experienced heart attacks and may increase the chances of recurrence or death, a study found.
Epogen, approved in 1989 as the first drug for Thousand Oaks, California-based Amgen, is used by patients undergoing kidney dialysis to boost their depleted red blood cells. J&J sells the drug as Procrit, mostly for cancer patients getting chemotherapy. While animal studies suggested the medicine might reduce heart damage, today’s findings in the Journal of the American Medical Association found the opposite.
Sales of Procrit, Epogen and Amgen’s longer-acting version, Aranesp, declined to $6.9 billion in 2010 from $9.8 billion in 2006 after reports emerged in 2007 that the drugs increased the risk of heart attacks and stroke when given at high doses. The study results suggest doctors should be cautious in using the treatments for patients at risk of heart disease, said Deepak Bhatt, chief of cardiology at the V.A. Boston Healthcare System.
“The bottom line is that while there was a lot of excitement based on animal studies, now that we’ve tested it, we find it actually is not helpful and may in some cases be detrimental,” said Samer Najjar, the study’s lead author and the medical director of the heart failure and heart transplantation program at Washington Hospital Center in Washington D.C.
In the study, heart-attack patients were given angioplasties to open their clogged arteries. Within four hours of the procedure, they were given an injection of a placebo or erythropoietin alfa, the chemical name for Epogen and Procrit.
Doctors later used magnetic resonance imaging to measure the area of heart damage, Najjar said.
No Difference Seen
The hope, based on “impressive” findings in animal studies, was that the drug would shrink the amount of muscle damage, Najjar said in a telephone interview today. Instead, he and his colleagues at 28 hospitals in the U.S. saw no difference in the extent of damage. In a subgroup of 21 patients ages 70 and older, patients treated with the drug had more heart damage than those who got the placebo.
In addition, five patients who were given the drug died, had new blood clots form or had strokes or second heart attacks, complications that didn’t occur in any of the placebo patients, the study found.
Patients with kidney disease have about a 50 percent higher risk of heart disease, Bhatt said. That means doctors need to be particularly careful in deciding when to give their patients erythropoietin and at what doses, he said.
Christine Regan, an Amgen spokeswoman declined to comment. Lisa Vaga, a spokeswoman for New Brunswick, New Jersey-based J&J said in an e-mail that because Procrit isn’t approved for limiting damage from heart attacks, “we cannot provide perspectives on this study.”
The study was funded by a grant from the U.S. National Institute on Aging.
Amgen’s Anemia Medicine Linked to Higher Risk in Heart-Attack Patients
By Rob Waters - May 10, 2011
A drug sold by Amgen Inc. (AMGN) and Johnson & Johnson (JNJ) for people with anemia didn’t reduce heart damage in patients who’d experienced heart attacks and may increase the chances of recurrence or death, a study found.
Epogen, approved in 1989 as the first drug for Thousand Oaks, California-based Amgen, is used by patients undergoing kidney dialysis to boost their depleted red blood cells. J&J sells the drug as Procrit, mostly for cancer patients getting chemotherapy. While animal studies suggested the medicine might reduce heart damage, today’s findings in the Journal of the American Medical Association found the opposite.
Sales of Procrit, Epogen and Amgen’s longer-acting version, Aranesp, declined to $6.9 billion in 2010 from $9.8 billion in 2006 after reports emerged in 2007 that the drugs increased the risk of heart attacks and stroke when given at high doses. The study results suggest doctors should be cautious in using the treatments for patients at risk of heart disease, said Deepak Bhatt, chief of cardiology at the V.A. Boston Healthcare System.
“The bottom line is that while there was a lot of excitement based on animal studies, now that we’ve tested it, we find it actually is not helpful and may in some cases be detrimental,” said Samer Najjar, the study’s lead author and the medical director of the heart failure and heart transplantation program at Washington Hospital Center in Washington D.C.
In the study, heart-attack patients were given angioplasties to open their clogged arteries. Within four hours of the procedure, they were given an injection of a placebo or erythropoietin alfa, the chemical name for Epogen and Procrit.
Doctors later used magnetic resonance imaging to measure the area of heart damage, Najjar said.
No Difference Seen
The hope, based on “impressive” findings in animal studies, was that the drug would shrink the amount of muscle damage, Najjar said in a telephone interview today. Instead, he and his colleagues at 28 hospitals in the U.S. saw no difference in the extent of damage. In a subgroup of 21 patients ages 70 and older, patients treated with the drug had more heart damage than those who got the placebo.
In addition, five patients who were given the drug died, had new blood clots form or had strokes or second heart attacks, complications that didn’t occur in any of the placebo patients, the study found.
Patients with kidney disease have about a 50 percent higher risk of heart disease, Bhatt said. That means doctors need to be particularly careful in deciding when to give their patients erythropoietin and at what doses, he said.
Christine Regan, an Amgen spokeswoman declined to comment. Lisa Vaga, a spokeswoman for New Brunswick, New Jersey-based J&J said in an e-mail that because Procrit isn’t approved for limiting damage from heart attacks, “we cannot provide perspectives on this study.”
The study was funded by a grant from the U.S. National Institute on Aging.