Deans' stroke musings

Changing stroke rehab and research worldwide now.Time is Brain!Just think of all the trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 493 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It's quite disgusting that this information is not available from every stroke association and doctors group.
My back ground story is here:http://oc1dean.blogspot.com/2010/11/my-background-story_8.html

Friday, August 4, 2017

Tenecteplase Not Better or Safer in Ischemic Stroke than alteplase

Totally worthless research using the useless subjective Rankin scale. No references to % that fully recovered. That is the goal of all stroke drugs if survivors are asked.
https://www.medpagetoday.com/Cardiology/Strokes/67060?

First head-to-head trial shows no advantage against alteplase

  • by Senior Associate Editor, MedPage Today
Thrombolytic drug tenecteplase (TNKase) wasn't more safe or effective than alteplase (Activase) in treatment of mostly mild acute ischemic strokes in the first head-to-head trial.
The primary outcome of excellent functional outcome (modified Rankin Scale score 0-1) at 3 months was achieved by 64% of patients randomized to tenecteplase versus 63% on alteplase (OR 1.08, 95% CI 0.84-1.38), Nicola Logallo, PhD, of Haukeland University Hospital in Bergen in Norway, and colleagues reported online in the Lancet Neurology.
While these findings were actually a failure for the superiority-designed phase III trial, Brian Silver, MD, of Rhode Island Hospital in Providence, suggested the findings were actually "encouraging with respect to having an alternative agent that is less expensive."
A recent study of Centers for Medicare and Medicaid data showed that alteplase costs have more than doubled since 2005, to about $6,400 per 100-mg vial in 2014, which was about half of the payment to hospitals in 2013.
While alteplase is off-patent, no biosimilar has been announced as under development and it remains as the only thrombolytic with an indication in acute ischemic stroke. Both tenecteplase and alteplase are marketed in the U.S. by Genentech, which has told MedPage Today it has no plans to develop an indication in stroke for tenecteplase beyond the one it has in acute MI.
"If a non-inferiority study is positive, then I think many people would change drugs not just because of cost, but also because of convenience -- tenecteplase can be given as a bolus over a couple of minutes, while alteplase has to be given as a bolus followed by an infusion over an hour," Silver noted. "Hospital transfer for patients eligible for mechanical thrombectomy would be much simpler."
One surprise in NOR-TEST was the lack of advantage to tenecteplase in intracerebral hemorrhage (ICH), which had been seen in prior studies. Any ICH at 24 to 48 hours occurred in 9% of both groups. Symptomatic ICH at that point occurred in 3% of tenecteplase-treated patients and 2% of alteplase-treated patients (P=0.70).
One reason might have been the fairly low proportion of patients with severe stroke in the trial, which had a lower than expected median NIHSS score at admission of 4, the researchers suggested.
The frequency of serious adverse events overall was identical between groups (26% in both). The 3-month mortality rate was 5% with both treatments, 0.4 mg/kg tenecteplase (to a maximum of 40 mg) and 0.9 mg/kg alteplase (to a maximum of 90 mg).
The 1,100-patient, single-blind trial included acute ischemic strokes eligible for thrombolysis and admitted within 4.5 hours of symptom onset or awakening with symptoms or those eligible for bridging therapy before thrombectomy.
"Since our results might not be completely generalizable to patients with severe neurological impairment at admission, future phase 3 studies should investigate the safety and efficacy of tenecteplase in patients with severe stroke," the researchers wrote.
The study was funded by a grant from the Research Council of Norway.
Boehringer Ingelheim -- which markets Genetech outside the U.S., Canada, and Japan -- financed research meetings for all the study investigators and study nurses, twice a year during the study period.
The researchers disclosed no relevant relationships with industry.

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