Merck and Schering-Plough postponed their earnings announcements today to wait for an update on a study of Vytorin, the cholesterol drug they co-market. (A description of the study, which looked at the drug in patients with a condition known as aortic stenosis, is online here.)
vytorinShares of both companies are down so far today. We’re watching a webcast where the researchers are going over the data.
The results of the trial show that Vytorin reduced bad cholesterol by 61%, on average, compared with patients taking a placebo. There was no change in aortic valve disease between the groups, though there was a reduction of atherosclerotic events in the treatment group. A surprising finding was that more patients taking Vytorin died of cancer (39 or 4.1%) than those taking placebo (23 or 2.5%). The researchers noted that there was no significant increase in any type of cancer and that the findings come from small numbers of events.
Here’s what they’re saying.
1:22 Terje Pedersen, the leader of the research, said the researchers would rather have presented the data at a conference or published them in a journal. But they’re releasing the data to the public today because “there are a lot of rumors out there” about Vytorin and “we found it very difficult to maintain secrecy” about the results.
1:27 He’s describing aortic stenosis. Studies have suggested that risk is related to smoking, high blood pressure and elevated bad, or LDL cholesterol — the same risk factors for heart attacks. So maybe cholesterol drugs that lower the risk for heart attacks can help with aortic stenosis.
1:34 There were two groups of patients. One group received Vytorin, the other received placebo. The primary measure was a combination of factors that included several measures of events associated with aortic stenosis and other cardiovascular problems such as heart attacks.
1:38 The treated group had a big drop in LDL cholesterol. This is “substantially lower than we have seen” with other Vytorin studies.
1:39 There was no significant difference primary endpoint. But a secondary endpoint of ischemic events was significantly lower in the Vytorin group.
1:40 A “disturbing” safety signal: The rate of cancer deaths and serious problems associated with cancer was higher in the group that took Vytorin, compared to the group that took placebos. The difference was statistically significant. It’s possible that they patients who were randomized to the placebo group had a higher risk for cancer before the study began.
1:44 Sir Richard Peto of Oxford was part of a team brought in to analyze the cancer findings. He’s on the call now. He says the results don’t look like what you would expect if the drug was causing cancer. “It was many different types of cancer,” which you wouldn’t expect to see if the drug caused a particular kind of cancer. “This isn’t the sort of drug that would be expected to produce a material effect on cancer.” And, he said, the numbers weren’t “really much beyond what could be expected to arise” by chance.
1:47 Peto’s group went back and analyzed data from other Vytorin trials. The ongoing SHARP trial and IMPROVE-IT trials “do not support” the idea that Vytorin increases the risk of cancer. Those trials are much larger than the SEAS trial being reported here.
1:50 “These trials together to not provide credible evidence” that the drug raises the risk of cancer. “We should not be diverted for fears of cancer.”
1:51 Lots of statin trials show that statins and cholesterol lowering don’t increase the risk of cancer risk, Peto says. (Vytorin is a combination of a statin and another drug.)
1:57 “There is in these data no credible evidence of an overall increase in cancer.”
2:03 “These conclusions have already been reported to regulatory agencies.”
2:09 The IMPROVE-IT trial is continuing, says a researcher who briefly joined the conference by phone.
2:19 One of the researchers notes that this is the first trial to show that Vytorin appears to lower the rate of ischemic events such as heart attacks. (It’s possible, though, that the benefit comes only from the statin contained in Vytorin, and that adding the second drug adds no benefit.)
2:28 IMPROVE-IT has 11,000 people enrolled and is planning to enroll several thousand more, a researcher said. Data aren’t expected until 2011. That study (described here) is comparing Vytorin against a generic statin alone.
2:31 A reporter calling in points out that the lower rate of ischemic events is a secondary endpoint. A researcher notes that the confidence intervals on that finding are wide, and more research is needed on that issue.
作者:admin@医学,生命科学 2011-09-07 17:14