2. PROACTION is looking at the wrong group of patients.
3. PROACTION will not be able to show the following endpoints: economic benefits of natrecor and reduced length of hospital stay.
4. PROACTION might be able to show decrease admission rates with natrecor use, but they'll have to find a study performed somewhere else in the past showing the admission rate of patients with CHF when given NTG in the ER. This is a bit convoluted.
5. They should be able to show that PROACTION is safe to use in the ER setting.
I'm disappointed by the PROACTION study design and I'll be interested in what they say in the July CC, but i'm not holding my breath. It looks like PROACTION will not make natrecor "standard of care" and thus will not be the catalyst we need to move this sloth stock up.
To get to "standard of care" we need either: (1) definitive pharmacoeconomic benefits of natrecor or (2) morbidity & mortality benefits. They might be able to show the latter with the ADHERE study, but this won't be done for at least 2-3 years.
If anyone's got the actual enrollment guidelines for PROACTION, post it -- it might help clear some issues up.
PROACTION (Prospective Randomized Outcomes Study of Acutely Decompensated Congestive Heart Failure Treated Initially in Outpatients with Natrecor) is a pilot study designed to compare the clinical effects, safety profile and economic impact of standard therapy plus Natrecor to standard therapy plus placebo in 250 acute CHF patients treated in the Emergency Department (ED)/Observation Unit (OU). The majority of the one million hospitalizations each year for this indication begin in either the ED or the OU. Standard therapy will consist of any treatments physicians would typically use for these patients. Scios expects to complete this study in the third quarter of 2001.
�This study is designed to look at numerous measures that factor in the overall cost of hospitalization for patients with acute CHF,� said Charles L. Emerman, M.D., Chairman, Department of Emergency Medicine, The Cleveland Clinic Foundation and MetroHealth Medical Center. �We will examine admission to the hospital following evaluation and treatment in the ED/OU, and other pharmacoeconomic measures. We believe Natrecor�s fixed-dose administration compared to the titration schedule and safety profile of existing therapies may result in a lower overall cost of care for patients hospitalized with acute CHF.�
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.