Of 790 ERICH subjects for whom sufficient data were available, 145 had been given hyperosmolar therapy as of the end of 2012. They were matched with controls, for whom there were no significant differences in all the variables considered in the propensity scoring model analysis.
Using the Modified Rankin Scale, they considered a three-month score of 3 (slight disability) or lower to be a “good” outcome, while anything over 3 was a “bad” outcome. [The scale measures the degree of disability or dependence in daily living activities from 0, for no disability, to 6 for death.]
Approximately 77 percent — 112 of the 145 patients who received hyperosmolar therapy — had a bad outcome, while 33 had a good outcome. Among those who did not receive hyperosmolar treatment, only 92 had a bad outcome, while 53 had a good outcome (p =.0055).
“In our study, the use of hyperosmolar therapy was associated with worse three-month outcomes even after matching for variables associated with worse outcomes,” Dr. Shah said. “This questions the efficacy and safety of hyperosmolar therapy in primary ICH.”
There are a few reasons why hyperosmolar therapy might yield worse outcomes, Dr. Shah said. “We believe that the problems with the use (of the therapy) in primary ICH are related to the difference in pathophysiology. There is a component of cytotoxic edema and a mass effect of the clot itself, which are refractory to hyperosmolar therapy.” He added that disruption of the blood-brain barrier might also play a role.
Dr. Shah said the study was limited in that the data are not truly randomized. Plus, the effects of mannitol compared with hypertonic saline couldn’t be assessed because many patients actually received both.
“The data [were] also limited regarding the strength of the agent, the duration of the therapy, and treatment setting,” he said.
More work is needed, he said, to further understand the role of this therapy for these patients — specifically, to define the patient populations that might benefit versus those who might not, the outcomes associated with the different hyperosmolar agents used, and the outcomes related to administration by bolus or infusion.
Read the full story with commentary from outside experts in the June 5 issue of Neurology Today. Our previous coverage of ICH is available here: http://bit.ly/ICH-NT.