There were no significant differences in any of the individual components of the primary endpoint.
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"Clearly we're disappointed that we didn't meet the primary endpoint, " says RussellMedfordRussell Medford, chief executive of AtheroGenics.
"Clearly we're disappointed that we didn't meet the primary endpoint, " says Russell Medford , chief executive of AtheroGenics.
The primary endpoint was the time to first major vascular event, defined as the composite of non-fatal MI or coronary death, any stroke or any arterial revascularization.
"The independent panel recommended focusing the primary endpoint to the common carotid artery to expedite the reporting of the study findings, " the companies said in a press release Nov. 19.
Also reported in the manuscript were 6 month results of 35 patients in the control group who received renal denervation after the primary endpoint was assessed at six months post randomization (referred to as the crossover group).
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Nevertheless, while the primary endpoint in the PRE-SURGE 2 trial does not appear to have any dose response, as you noted, the endpoints in PRE-SURGE 1 and the secondary endpoints in PRE-SURGE 2 appear to trend slightly better with the 160 mg dose.
Patients don't care if a drug meets the original primary endpoint of Dendreon's study, an improvement in X-rays, says Penson.
"We recommend using any weakness in the stock associated with the missed primary endpoint as an opportunity to initiate or add to a position in Genentech, " wrote Jason Kantor , an analyst at W.R.
In other words, the study lost because of the choice of primary endpoint.
The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least six months.
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The trial did not meet its primary endpoint, a joint rank analysis of function and survival, and no efficacy was seen in the individual components of function or survival.
After 4.8 years of follow-up a primary endpoint event (the composite of MI, stroke, and death from CV causes) occurred in 3.8% of patients in the Mediterranean diet extra-virgin olive oil group, 3.4% in the Mediterranean diet with nuts group, and 4.4% of patients in the control group.
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It's unlikely Schering and Merck knew the full results of the study and suppressed them, otherwise they would never have made a controversial decision to change the study's main goal or primary endpoint.
If the trial were run again with a different main goal, or primary endpoint, it would likely succeed.
Merck announced today that the HPS2-THRIVE ( H eart P rotection S tudy 2- T reatment of H DL to R educe the I ncidence of V ascular E vents) study did not meet its primary endpoint.
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