Patients were randomly assigned to receive chest compression alone or chest compression plus rescue breathing. The primary outcome was survival to hospital discharge. Secondary outcomes included a favorable neurologic outcome at discharge.
Results: Of the 1941 patients who met the inclusion criteria, 981 were randomly assigned to receive chest compression alone and 960 to receive chest compression plus rescue breathing. We observed no significant difference between the two groups in the proportion of patients who survived to hospital discharge (12.5% with chest compression
alone and 11.0% with chest compression plus rescue breathing, P=0.31) or in the proportion who survived with a favorable neurologic outcome in the two sites that assessed this secondary outcome (14.4% and 11.5%, respectively; ACP-196 P=0.13). Prespecified subgroup analyses showed a trend toward a higher proportion of patients surviving to hospital discharge with chest compression alone as compared with chest compression plus rescue breathing for patients
with a cardiac cause of arrest (15.5% vs. 12.3%, P=0.09) and selleck inhibitor for those with shockable rhythms (31.9% vs. 25.7%, P=0.09).
Conclusions: Dispatcher instruction consisting of chest compression alone did not increase the survival rate overall, although there was a trend toward better outcomes in key clinical subgroups. The results Sucrase support a strategy for CPR performed by laypersons that emphasizes chest compression and minimizes the role of rescue breathing. (Funded in part by the Laerdal Foundation for Acute Medicine and the Medic One Foundation; ClinicalTrials.gov number, NCT00219687.)
N Engl J Med 2010;363:423-33.”
“Immunosuppressants are considered critical dose/narrow therapeutic index drugs and there is the lingering suspicion among physicians and patients that generic versions may differ in quality and therapeutic efficacy from the brand name drug. The innovator’s and the generic active drug molecule are exactly the same and are produced following exactly the same tight rules of good
manufacturing practice. Upon oral administration, the drug molecule separates from the formulation and passes the membranes of gut mucosa cells; from this point on, the formulation has no influence on the kinetics of a drug and its biological effects. As formulations may differ, bioequivalence testing in healthy volunteer studies establishes equal relative oral bioavailability. Due to the number of patients required to achieve sufficient statistical power, to test the therapeutic equivalence of two formulations of the same drug with the same bioavailability is an unrealistic goal. An often overlooked fact is that the approval by drug regulatory agencies of several post-approval versions of the innovators’ immunosuppressants is based on the identical guidelines used for approval of generics.