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  • hoonie_k hoonie_k Feb 11, 2002 10:36 PM Flag

    SCIOS CC on PROACTION Part 1

    heldnova,

    thanks for clearing up the study design a bit -- comparison groups are between natrecor + standard rx and placebo + standard rx. i just listened to the CC again to see if i could better understand the "55%" hospital admittance number she was quoting. this percentage actually just refers to the overall study (natrecor population + placebo popln). she states: "without knowing if this is natrecor or standard care, only 55% of the patients [in the PROACTION study] were admitted to the hospital." in other words the 55% admittance rate just applies to the study population as a WHOLE not just the natrecor group of patients. the natrecor admittance rate must have been somewhat lower than the admittance rate for the control group, because Dr. Horton answers "yes" when the analyst asks her directly about this issue -- she wouldn't lie to the analyst, right? however, i'm afraid that the difference in admittance rate between natrecor and non-natrecor patient groups will not be statistically significant due to the small size of the study.

    since they enrolled 250 patients, only about 130 got admitted in total, which leaves us with only two small groups of patients to compare for changes regarding hospital stay & economic endpoints -- about 65 in the natrecor treated group and 65 in the control group. allowing for a conservative lost-to-followup or drop percentage, we're probably left with about 55-60 patients in each group. Dr. Horton was probably hoping to get 100+ patients in each arm, given her comment about incorrectly assuming a "historical" admittance rate of 80-90% from the ER. showing economic end-points would be still have been tough had they enrolled 100 patients in each arm. i really wished they had enrolled more patients into this trial because equivocal results won't help; in fact, this will only help the skeptics of natrecor. Scios needs some NEW data to push this drug towards standard of care. the publishing of the VMAC results will give SCIOS a short-term boost, but again, its old data from 2000 that should have been published a while back.

    hk

 
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