New Drug Reportedly Slashes Heart Deaths
A controversial new clot-dissolving drug has dramatically reduced deaths among heart attack patients in a soon-to-be published European study, a U.S. pioneer in the field said Tuesday.
In the study, less than 3% of the patients treated with the drug TPA had died by 14 days after their heart attack, and less than 4% had died after three months. This compared to an expected death rate of about 15%.
“This is the lowest ever recorded, as far as I can tell,” said Dr. Eugene Braunwald at a symposium in Los Angeles. “ . . . The point is, we now actually are approaching rock bottom.”
TPA is one of several new clot-dissolving drugs that are revolutionizing the treatment of heart attack patients. Approved last November, it has become the fastest-selling new drug in history, even though it costs 10 times more than other heart attack drugs.
The extraordinary expense of the drug--which is injected shortly after a heart attack at a cost of $2,332 per patient--prompted federal officials to opt against covering the cost of TPA treatment for Medicare patients. Officials said last month that the drug’s relative merits did not justify the added public expense.
The case is seen as a test of the government’s attempts to rein in health care costs.
“I think it’s an unfortunate decision,” Braunwald remarked Tuesday when asked about the decision by the federal Health Care Financing Administration on TPA. “ . . . You’re talking about the No. 1 killer in this country. This is an extraordinary development.”
Braunwald, a renowned cardiologist from Harvard University who was at Cedars-Sinai Medical Center to receive an award for work on cardiovascular disease, presented unpublished data he said he had been given by European researchers who recently studied 721 heart attack patients.
The European Cooperative Study Group compared mortality in two groups of patients--those given TPA three to five hours after a heart attack and those given a placebo. The group found TPA had reduced mortality by 58% at 14 days after the attack and by 46% at three months.
The data from the study, which Braunwald said is scheduled to be published in the coming months, also indicates a 35% reduction in many of the non-fatal consequences of heart attacks, such as shock and the accumulation of fluid in the lungs.
Braunwald noted that the criteria used for admitting patients to the study could skew the overall mortality rate. High-risk patients are sometimes excluded from such studies.
TPA, or tissue plasminogen activator, is a genetically engineered copy of a protein the body produces naturally. If given shortly after a heart attack, it is capable of dissolving the fatty deposits that block blood flow to the heart.
Beta Blockers
The drug is just one of several clot dissolvers recently made available or currently undergoing testing. Other treatments being explored include the use of drugs called beta blockers to reduce heart attack damage and the role of aspirin in reducing heart attacks.
Braunwald, who is involved in an ongoing federally sponsored TPA study, said there has been little work comparing TPA and streptokinase, another clot-dissolving drug which costs far less than TPA and has been found to be highly effective in reducing heart attack deaths.
European Study
He contended that data from a large, federally funded, U.S. study and the European study indicate that TPA is more effective at opening clogged arteries and has fewer side-effects than streptokinase.
He said both drugs have been linked to bleeding complications and eventual re-clogging of arteries. He said streptokinase had also been tied to allergic reactions and low blood pressure when given too rapidly.
Braunwald is a professor and chairman of Harvard’s department of medicine and physician-in-chief of the Brigham and Women’s Hospital and Beth Israel Hospital in Boston.
