Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 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:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. 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 lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Showing posts with label hypotension. Show all posts
Showing posts with label hypotension. Show all posts

Saturday, August 6, 2022

FDA places hold on phase 2/3 clinical trial of stroke therapy

What is your doctor's competence level on knowing about this research? NONE?

FDA places hold on phase 2/3 clinical trial of stroke therapy

Biopharmaceutical company DiaMedica Therapeutics Inc. announced that the FDA placed a clinical hold on its phase 2/3 ReMEDy2 trial of a synthetic protein therapy for treatment of acute ischemic stroke.

According to a press release, the hold was initiated following DiaMedica’s pausing of patient enrollment and submission of three serious adverse event reports to the FDA related to clinically significant, transient hypotension that occurred shortly after initiation of an IV dose of the therapeutic DM199. Blood pressure levels of the three patients recovered back to their baseline blood pressure within minutes after IV infusion was stopped, per the release.

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Source: Adobe Stock.

“Patient safety is very important as we plan and conduct our clinical studies,” Kirsten Gruis, MD, chief medical officer of DiaMedica, stated in the release. “Patient blood pressure is easily and routinely monitored in stroke patients, which is why our study sites were able to quickly identify the issue and immediately stop the dosing of DM199, after which the patients then recovered within minutes and suffered no injuries.”

DiaMedica stated it believes the adverse events resulted from switching to an IV bag formulated from different materials in the ReMEDy2 trial compared with the IV bag used in the prior phase 2 ReMEDy1 trial.

As a result of the hold, DiaMedica may not enroll any additional patients in the ReMEDy2 trial until it provides the FDA with analysis of the events leading to or causing the hypotension, provides suggested protocol modifications to address the mitigation of these events, supplies a rationale and supporting data for the protocol modifications, and the FDA notifies DiaMedica that it may resume enrollment.

“While having to pause enrollment in the ReMEDy2 trial was not desirable, we remain confident about the future potential of DM199 and are committed to refining the dosing procedures and methods that will further enhance patient safety,” DiaMedica President and CEO Rick Pauls said in the release.

Tuesday, March 13, 2018

More Deaths, Strokes Seen with Perioperative Beta Blocker One Year After Surgery

Be careful out there.
https://www.alphagalileo.org/ViewItem.aspx?ItemId=184440&CultureCode=en


During the 12 months after undergoing noncardiac surgery, patients with or at risk for heart disease who were treated with the beta blocker metoprolol for 30 days were less likely than patients who received a placebo to have a heart attack, but more likely to die or have a stroke, according to research presented at the American College of Cardiology’s 67th Annual Scientific Session.

These follow-up findings confirm that an increased risk for death or a stroke persists at one year post-surgery in patients treated with metoprolol, said P.J. Devereaux, MD, PhD, director of cardiology at McMaster University in Hamilton, Canada, and lead author of the study. Previously reported results from the same study at 30 days post-surgery showed a similar pattern, with a reduction in heart attacks but increases in deaths and strokes.

“Our results suggest at one year, for every 1,000 patients having noncardiac surgery, treatment with metoprolol would prevent heart attacks in 12 patients but would result in an excess of 13 deaths and six strokes,” Devereaux said. 

“While there is little doubt that some patients benefit from receiving beta blockers during the period immediately before and after noncardiac surgery, these data show that at least as many patients are seriously harmed,” he said. “These data tell us that we need to exercise caution when using beta blockers in this setting until we figure out how to mitigate the substantial risks and enable all patients to obtain the potential benefits of this intervention.”

Beta blockers work by slowing the heart rate and relaxing the blood vessels, which in turn reduces blood pressure. The problem, Devereaux said, is that during the period immediately after major noncardiac surgery (such as a hip or knee replacement, bowel resection or abdominal aortic aneurysm repair), patients are usually treated with opioid medications to relieve pain. The effects of those medications may mask drops in blood pressure or heart rate to dangerously low levels.

“Low blood pressure, or hypotension, is common in this setting and is a main contributor to the adverse effects resulting from perioperative beta blockers,” he said.

Patients who become hypotensive for whatever reason after surgery (e.g., sepsis, bleeding, heart failure) find their problem exacerbated when they are receiving a beta blocker, which further lowers blood pressure and makes treating hypotension more challenging. 

The PeriOperative Ischemic Evaluation (POISE) trial enrolled 8,351 patients in 23 countries. Eligible patients were 45 years or older and had a history of heart disease, blood-vessel disease, stroke, congestive heart failure or other health problems such as diabetes or impaired kidney function. Patients’ median age was 69 and 63 percent were men.

Patients were randomly assigned to receive metoprolol or a placebo, beginning a few hours before surgery and for 30 days afterward. Patients, health care providers and research staff, except those analyzing data, were blinded to which group received metoprolol and which received a placebo. The study’s primary endpoint was a composite of the combined rate of death from heart disease, nonfatal heart attack and nonfatal cardiac arrest after 30 days.

At one-year follow-up, fewer patients in the metoprolol group than in the placebo group had heart attacks (5 percent vs. 6.2 percent), but more patients in the metoprolol group had died (9.8 percent vs. 8.5 percent in the placebo group) or had a stroke (2 percent vs. 1.4 percent in the placebo group).

These results followed the same pattern that had previously been seen at the 30-day follow-up: statistically fewer heart attacks in the metoprolol group (4.2 percent vs. 5.7 percent in the placebo group), but statistically more deaths (3.1 percent vs. 2.3 percent in the placebo group) and strokes (1 percent vs. 0.5 percent in the placebo group).

According to Devereaux, some observers have suggested that the metoprolol dose received by patients in the POISE trial (200 mg per day) was too high and that a lower dose would have produced fewer adverse effects. However, a lower dose might also have decreased the drug’s effectiveness in reducing heart attacks, he said, noting that the metoprolol dose in POISE only resulted in a seven beats per minute lower heart rate compared with placebo.

“I believe the answer is more continuous patient monitoring during the immediate post-surgical period so that dangerous drops in heart rate or blood pressure are promptly identified and treated,” he said.

Devereaux and his colleagues are currently conducting a study to test the effectiveness of remote automated patient monitors in reducing post-surgical cardiac complications.

This study was funded by the Canadian Institutes of Health Research.