研究报告认为关节炎药物与心脏病发作危险有关(下)
Even though the anti-inflammatory effects of COX-2 inhibitors may alleviate the artery disease atherosclerosis, the possibility that the drugs increase the risk of cardiovascular complications needs to be studied, Topol and his colleagues suggest.
"Given the remarkable exposure and popularity of this new class of medications, we believe that it is mandatory to conduct a trial specifically assessing cardiovascular risk and benefit of these agents," they conclude.
, 百拇医药
But according to an official at Merck & Co., the maker of rofecoxib, the Food and Drug Administration has already been presented with additional research that shows that the drug does not pose an extra cardiovascular risk.
"What they don't review is a lot of other information that we have that addresses the same question" of whether rofecoxib affects the risk of cardiovascular complications, Dr. Laura Demopoulos, the senior director of cardiovascular clinical research at the Whitehouse Station, New Jersey-based company, told Reuters Health in an interview.
, 百拇医药
In a review of studies including more than 28,000 patients, there was no difference in the rates of heart attack among patients taking rofecoxib, other NSAIDs or placebo, Demopoulos said.
That information is "very reassuring," she said.
The additional data will be presented this week at the European League Against Rheumatism's annual meeting, according to a Merck press release.
In a statement released in response to the report, Merck also pointed out that the researchers compared the rofecoxib study, which enrolled patients with rheumatoid arthritis, with the placebo groups from studies that did not include patients with rheumatoid arthritis.
, http://www.100md.com
"To compare a group of patients taking Vioxx for rheumatoid arthritis with a placebo group of patients who do not have rheumatoid arthritis is inappropriate and misleading because one would expect a higher rate of cardiovascular events in the rheumatoid arthritis group, regardless of any medications," according to the statement.
In a new release issued by Pharmacia and Pfizer, the makers of celecoxib, the two companies "strongly support the cardiovascular safety profile of Celebrex."
, 百拇医药
"The article in JAMA is not based upon any new clinical study," according to the release. "The companies believe it is essential to exercise extreme caution in drawing any conclusions from this type of analysis."
Pharmacia and Pfizer assert that the analysis is "misleading," since some of the patients in the celecoxib study were taking aspirin, too, but patients in the placebo groups were not taking aspirin. When the analysis is limited to celecoxib patients not taking aspirin, the heart attack rate is lower than of patients taking placebo, according to the two companies., 百拇医药
"Given the remarkable exposure and popularity of this new class of medications, we believe that it is mandatory to conduct a trial specifically assessing cardiovascular risk and benefit of these agents," they conclude.
, 百拇医药
But according to an official at Merck & Co., the maker of rofecoxib, the Food and Drug Administration has already been presented with additional research that shows that the drug does not pose an extra cardiovascular risk.
"What they don't review is a lot of other information that we have that addresses the same question" of whether rofecoxib affects the risk of cardiovascular complications, Dr. Laura Demopoulos, the senior director of cardiovascular clinical research at the Whitehouse Station, New Jersey-based company, told Reuters Health in an interview.
, 百拇医药
In a review of studies including more than 28,000 patients, there was no difference in the rates of heart attack among patients taking rofecoxib, other NSAIDs or placebo, Demopoulos said.
That information is "very reassuring," she said.
The additional data will be presented this week at the European League Against Rheumatism's annual meeting, according to a Merck press release.
In a statement released in response to the report, Merck also pointed out that the researchers compared the rofecoxib study, which enrolled patients with rheumatoid arthritis, with the placebo groups from studies that did not include patients with rheumatoid arthritis.
, http://www.100md.com
"To compare a group of patients taking Vioxx for rheumatoid arthritis with a placebo group of patients who do not have rheumatoid arthritis is inappropriate and misleading because one would expect a higher rate of cardiovascular events in the rheumatoid arthritis group, regardless of any medications," according to the statement.
In a new release issued by Pharmacia and Pfizer, the makers of celecoxib, the two companies "strongly support the cardiovascular safety profile of Celebrex."
, 百拇医药
"The article in JAMA is not based upon any new clinical study," according to the release. "The companies believe it is essential to exercise extreme caution in drawing any conclusions from this type of analysis."
Pharmacia and Pfizer assert that the analysis is "misleading," since some of the patients in the celecoxib study were taking aspirin, too, but patients in the placebo groups were not taking aspirin. When the analysis is limited to celecoxib patients not taking aspirin, the heart attack rate is lower than of patients taking placebo, according to the two companies., 百拇医药