It is your doctors and hospitals responsibility to follow this research and implement it if proven successful. But are they doing that? Has the board of directors set proper goals for their stroke medical professionals?
Human Tissue Kallikrein Shows Promise for Ischaemic Stroke
By Nancy Melville
YORK, Me -- March 23, 2021 -- DM199, the first recombinant formulation of human tissue kallikrein (KLK1), shows a favourable safety and tolerability profile in the treatment of ischaemic stroke, according to a study presented at the 2021 Virtual International Stroke Conference (ISC).
The results of the study also suggest a possible reduction in recurrence of severe stroke, providing potentially critical information to prevent a recurrent stroke.
“The trial met its primary safety and tolerability endpoints, with DM199 treatment appearing safe for patients with ischaemic stroke,” said Bruce C. Campbell, MD, Royal Melbourne Hospital, Melbourne, Australia. “While the trial was not designed to demonstrate a statistically significant improvement in outcomes, a subgroup analysis showed a statistically significant reduction in severe stroke recurrences.”
The ReMEDy trial included 92 adult patients (mean age, 71 years) from 12 sites in Australia between 2018 and 2019. All patients had a National Institutes of Health Stroke Scale (NIHSS) score of 6 to 25 that remained more than 1 hour after thrombolysis or thrombectomy.
Patients were randomised to receive DM199 (n = 47) or placebo (n = 45) within 24 hours of the onset of a moderate to severe ischaemic stroke. Treatment included an initial intravenous injection of DM199 or placebo, followed by subsequent subcutaneous injections every 3 days for the first 3 weeks after the stroke.
The most common adverse effects were constipation, nausea, and headache. The difference between the number of patients experiencing serious adverse effects in the DM199 and placebo groups was not statistically significant (43% vs 31%; P = .29).
Although none of the serious adverse effects were determined to be definitely related to the study drug, 1 case of flushing was judged to probably be related to the drug. Three serious adverse events, including slow heart rate, facial swelling, and reversible liver function abnormality 56 days after treatment initiation, were considered to be possibly related to DM199.
No significant differences were observed in either group in terms of clinical or functional outcomes; however, severe recurrent stroke occurred in 2% of patients treated with DM199 versus 15.6% in the placebo group at 90 days, for a 13% absolute reduction (P = .03), according to post hoc analysis.
In an exploratory analysis of 46 patients who were not treated with mechanical clot removal, 36% of the patients receiving DM199 versus 14% of those receiving placebo achieved full or nearly full recovery at 90 days (P = .15). The mortality rate was 12% in the DM199 group versus 24% in the placebo group (P = .44).
“Currently, a phase 2/3 study is being initiated with DM199 in the United States, focused on patients with small-vessel occlusion stroke who are not receiving mechanical clot removal or thrombolytic treatment, a group that currently has no therapeutic alternative,” said Dr. Campbell.
Funding for the study was provided by DiaMedica Therapeutics.
ISC is sponsored by the American Heart Association and the American Stroke Association.
[Presentation title: Safety and Tolerability of Recombinant Human Tissue Kallikrein (DM199) in Acute Ischemic Stroke: the ReMEDy Randomized Clinical Trial. Abstract LB7]
YORK, Me -- March 23, 2021 -- DM199, the first recombinant formulation of human tissue kallikrein (KLK1), shows a favourable safety and tolerability profile in the treatment of ischaemic stroke, according to a study presented at the 2021 Virtual International Stroke Conference (ISC).
The results of the study also suggest a possible reduction in recurrence of severe stroke, providing potentially critical information to prevent a recurrent stroke.
“The trial met its primary safety and tolerability endpoints, with DM199 treatment appearing safe for patients with ischaemic stroke,” said Bruce C. Campbell, MD, Royal Melbourne Hospital, Melbourne, Australia. “While the trial was not designed to demonstrate a statistically significant improvement in outcomes, a subgroup analysis showed a statistically significant reduction in severe stroke recurrences.”
The ReMEDy trial included 92 adult patients (mean age, 71 years) from 12 sites in Australia between 2018 and 2019. All patients had a National Institutes of Health Stroke Scale (NIHSS) score of 6 to 25 that remained more than 1 hour after thrombolysis or thrombectomy.
Patients were randomised to receive DM199 (n = 47) or placebo (n = 45) within 24 hours of the onset of a moderate to severe ischaemic stroke. Treatment included an initial intravenous injection of DM199 or placebo, followed by subsequent subcutaneous injections every 3 days for the first 3 weeks after the stroke.
The most common adverse effects were constipation, nausea, and headache. The difference between the number of patients experiencing serious adverse effects in the DM199 and placebo groups was not statistically significant (43% vs 31%; P = .29).
Although none of the serious adverse effects were determined to be definitely related to the study drug, 1 case of flushing was judged to probably be related to the drug. Three serious adverse events, including slow heart rate, facial swelling, and reversible liver function abnormality 56 days after treatment initiation, were considered to be possibly related to DM199.
No significant differences were observed in either group in terms of clinical or functional outcomes; however, severe recurrent stroke occurred in 2% of patients treated with DM199 versus 15.6% in the placebo group at 90 days, for a 13% absolute reduction (P = .03), according to post hoc analysis.
In an exploratory analysis of 46 patients who were not treated with mechanical clot removal, 36% of the patients receiving DM199 versus 14% of those receiving placebo achieved full or nearly full recovery at 90 days (P = .15). The mortality rate was 12% in the DM199 group versus 24% in the placebo group (P = .44).
“Currently, a phase 2/3 study is being initiated with DM199 in the United States, focused on patients with small-vessel occlusion stroke who are not receiving mechanical clot removal or thrombolytic treatment, a group that currently has no therapeutic alternative,” said Dr. Campbell.
Funding for the study was provided by DiaMedica Therapeutics.
ISC is sponsored by the American Heart Association and the American Stroke Association.
[Presentation title: Safety and Tolerability of Recombinant Human Tissue Kallikrein (DM199) in Acute Ischemic Stroke: the ReMEDy Randomized Clinical Trial. Abstract LB7]
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