Journal Club Summary
Methodology Score: 3.5/5
Usefulness Score: 1.5/5
Sharifi M, Bay C, Skrocki L, Rahimi F, Mehdipour M; “MOPETT” Investigators.
Am J Cardiol. 2013 Jan 15;111(2):273-7
This single-center, open label, randomized control trial found that administration of half-dose tPA in patients with “moderate” pulmonary embolus resulted in a significant reduction in pulmonary artery systolic pressure at 28 months as measured by ECHO, compared to standard treatment. JC attendee discussion centered around the fact that the endpoint was not necessarily clinically relevant and that the authors designated this half-dose tPA as “safe-dose tPA” despite providing no evidence that this is the case. Based on this article we would not change our current management of PE.
By: Dr. Sebastian Dewhirst
(Presented April 2013)
Epi lesson – Determining Safety of a Therapeutic Agent
Many therapeutic interventions can have rare but important and sometimes fatal adverse effects. The only way to determine the safety of interventions in this case is to conduct large population studies, often via administrative databases (hence phase 4 of clinical trials designed to evaluate drugs). The critical reader will be wary of small RCTs who purport to have demonstrated safety as an outcome. By: Dr. Lisa Calder