Canadian patients who were trying Pfizer Inc.'s new cholesterol treatment, torcetrapib, are being asked to stop immediately, the drug maker's Canadian arm told the Globe and Mail Monday.
The news comes after Pfizer said Saturday it had halted development of its key new cholesterol treatment. An independent board monitoring a study for torcetrapib recommended that the work end because of an unexpected number of deaths.
About 75,000 heart attacks occur every year in Canada, where one in three deaths are due to heart disease and stroke. Pfizer's drug hasn't yet been approved for use in Canada but it was being tested.
“Some Canadians were taking torcetrapib, absolutely” said Sophie McCann, Pfizer Canada's spokeswoman in Montreal.
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The drug was being tested at 25 sites in different hospitals across Canada, Ms. McCann said late yesterday. About 1,200 Canadians were involved in the trials, though not all of those were taking torcetrapid as part of the trial. Ms. McCann couldn't say how many were taking the new treatment, nor whether any Canadians have died from taking it.
Pfizer was planning to sell torcetrapib in combination with best-selling drug cholesterol treatment Lipitor. Pfizer Inc. said 82 patients taking the combination of torcetrapib died, compared with 51 deaths in the arm of the study where patients were taking Lipitor alone, the Associated Press reported.
Pfizer Canada will now have to get in touch with Health Canada, tell them about the halt and explain its plan to stop all clinical trials.
“What it means for us today is we get in contact with Health Canada and we have to get in contact with the research centres to make sure that every patient has been contacted and to make sure the medication is stopped,” Ms. McCann said.
Pfizer has already contacted all 25 of the sites in Canada, she said.
Health Canada said it's had preliminary talks with Pfizer Canada and has requested more information relating to its Canadian clinical trials from the drug maker.
“This information has been requested in order to ensure that Pfizer Canada is taking the appropriate follow-up steps, for example notifying all the physicians and patients involved in the relevant trials,” a Health Canada spokeswoman said.
About 250 research centres across the world, including Canada, Europe and Australia, were involved in torcetrapib drug trials, Ms. McCann said.
Each arm of the study had 7,500 patients. Pfizer said the study didn't raise any questions about Lipitor's safety.
