Had the DSMB halted IMPROVE-IT due to safety reasons, it would have been a great shock.
FORBES: Cholesterol Drug Heart Study Continues, But Will Merck's Vytorin Really IMPROVE-IT?
As Merck announced, the DSMB gave the green light for the study to continue for another year.
FORBES: Cholesterol Drug Heart Study Continues, But Will Merck's Vytorin Really IMPROVE-IT?
Like all major outcome studies, the IMPROVE-IT trial is being monitored by an independent data safety monitoring board (DSMB).
FORBES: Cholesterol Drug Heart Study Continues, But Will Merck's Vytorin Really IMPROVE-IT?
"I do not think a DSMB for ENHANCE was necessary, " says Steven Nissen, head of cardiology at the Cleveland Clinic.
The DSMB concluded that it was clear that use of antiretrovirals by HIV-infected individuals with relatively healthier immune systems substantially reduced transmission to their partners.
FORBES: Could AIDS Disappear If Enough Patients Get Treated?
According to the company, the DSMB recommendation was based on an increase in the risk of major adverse cardiac events (MACE) in patients randomized to OMT alone.
FORBES: New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR
The DSMB meets periodically to review the safety results to date (Merck is blind to these data) to be certain that patients on Vytorin are not experiencing any unexpected safety issues.
FORBES: Cholesterol Drug Heart Study Continues, But Will Merck's Vytorin Really IMPROVE-IT?
Following a positive interim analysis showing that fractional flow-reserve-guided PCI was superior to optimal medical treatment, an independent Data and Safety Monitoring Board (DSMB) has recommended that patient enrollment in the ongoing FAME II trial be stopped.
FORBES: New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR
This study had neither a steering committee, as a group of experts who regularly convened to discuss the trial and its data, nor a data safety monitoring board (DSMB), which carefully watches study information to make sure patients are not harmed.
As a result of the positive interim analysis, the FAME II independent Data Safety Monitoring Board (DSMB) has recommended investigators stop patient enrollment in this trial as the DSMB considers it unethical to continue to randomize patients to optimal medical therapy (OMT) alone.
FORBES: New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR
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