Synopsis: Exenatide is an injectable peptide that is currently in the second phase of clinical trials to treat Type 2 Diabetes, helps reduce the symptoms associated with Idiopathic Intercranial Hypertension, which causes blinding headaches new research finds.
Source: University of Birmingham
Patients who suffer from blinding headaches commonly referred to by the name of Idiopathic Intercranial Hypertension (IIH) can be treated using an injectable peptide for Type 2 Diabetes, according to a brand new study has revealed.
The study, which was published in Brain Today, the journal discusses a phase two study of a drug known as exenatide which is a GLP-1 antagonist, which could be a cure for IIH.
The IIH Pressure Trial led by neurologists of Birmingham’s University of Birmingham in Birmingham and University Hospitals Birmingham discovered that seven patients who were regularly injected with the drug, which is currently available for the treatment of Type 2 Diabetes, led to a decrease in the cerebral pressure over the short (2.5hrs and 24 hours) as well as long-term (12 weeks) measures.
The study also witnessed substantial reductions of the frequency of headaches throughout the 12 weeks in which participants participated in, having an average 7.7 less than the average number of days in a month with headaches when compared to the baseline, and only 1.5 less than the baseline group.
Alex Sinclair is Professor of Neurology at the Institute of Metabolism and Systems Research at the University of Birmingham, an Honorary Consultant Neurologist at the University Hospitals Birmingham NHS Foundation Trust and the Principal Investigator in the project. The Professor Alex Sinclair said:
“This is a major study for the debilitating and rare condition IIH which could result in women and men becoming blind and suffering from every day headaches. There are currently no approved medications to treat IIH and this trial is an important step in the right direction for IIH patients.
“We are thrilled to learn that the second phase of the trial led to our group experiencing lower pressure in the brain immediately and also after 12 weeks, and almost 8 fewer days of headaches over the 12 weeks, and that all of the women could carry on the treatment with no adverse consequences. We are now hoping to see an even larger study of exenatide, which will help ease the pressure on the thousands of people in the world who suffer in IIH.”
A shot in the arm to treat IIH treatment
Idiopathic intracranial hypertension (IIH) is a chronic condition that increases the pressure of the brain. It can cause long-lasting headaches as well as permanent loss of sight. The disease, which usually results in patients suffering from a diminished standard of living primarily affects women between the ages 25 and 36. Weight increase is a significant risk factor for developing IIH and it is also a reason for relapses.
The once-insane notion that it is rare, the prevalence of IIH is increasing dramatically as a result of the worldwide rise in obesity and there has been a 350 percent percent increase in incidence in the past 10 years. There are currently no licensed medicines available and the existing ones which are sold off-label are often hampered by a variety of adverse negative side adverse effects.
The most significant finding was the quick effect of the drug and results showed that the pressure in the brain was dramatically diminished within just two and a half hours after taking the drug. The rapid time to action is crucial in the case of a disease that could result in rapid blindness if not treated.
Dr. James Mitchell, Lecturer in Neurology at the University of Birmingham and first author of the paper , said:
“The results from this clinical trial provide an indication to discover ways to treat IIH. While we must conduct more trials before a treatment is available to patients in the near future, it is encouraging to see the impressive outcomes of this trial which resulted in a significant improvement for patients who were in the treatment arm . the treatment could be useful for other diseases that cause elevated levels of brain pressure.”
In this study, the medication was administered by injection twice a day into the subcutaneous tissues. To decrease the requirement for regular injections in the near future, a once weekly subcutaneous injection known as Presendin will be tested through University of Birmingham Start-up company, Invex Therapeutics.
Shelly Williamson, the Chair of the charity for patients IIH UK said:
“This is an amazing development. The discovery of new drugs is crucially essential to IIH as this study provides hope to the many people suffering from the disease. We look at the next steps, and watching the drug being tested in two massive Clinical trials in Phase 3.”
IIH Advance IIH Advance is a Phase 3 clinical trial for adolescents conducted in the UK and supported by University of Birmingham and IIH Evolve is being conducted in adults around the world and is and is sponsored by Invex Therapeutics. In the end, the goal is to establish enough evidence to permit that the medication to be approved to be used by IIH people in the near future.
Concerning this problem and the latest research in pharmacology
Author: Tim Mayo
Source:University of Birmingham
ContactTim Mayo University of Birmingham
ImageThe Image is owned by Neuroscience News and was created by DALL E 2 AI Technology
Origin ResearchOpen access.
“The effects of GLP-1RA exenatide in Idiopathic intracranial Hypertension: A controlled clinical study” written by Alex Sinclair et al. Brain
Abstract
The impact of GLP-1RA exenatide in the idiopathic intracranial Hypertension: a randomized clinical study
Treatments for reducing pressure in the intracranial space are a unmet requirement. The results of preclinical studies have revealed an entirely new strategy to reduce intracranial pressure by glucagon-like protein-1 (GLP-1) receptors to signal.
We translate these findings to patients by conducting a placebo-controlled, randomized double-blind test to determine the impact of exenatide an agonist of the GLP-1 receptor, on intracranial pressure in patients with idiopathic intracranial hypertension. Telemetric intracranial pressure vessels allowed continuous intracranial pressure monitoring. The study enrolled adult women suffering from chronic idiopathic intracranial hypertension (intracranial pressure >25 cmCSF as well as papilloedema) who received either subcutaneous or oral exenatide. The primary outcome measures were intracranial tension at 2.5 hours, 24 hours and 12 weeks, and alpha established at a priori of less than 0.1.
Of the 16 women who were who were recruited, 15 of them participated in the trial (mean age of 28+ 9 Body mass index 38.1 +- 6.2 kg/m 2, intracranial pressure 30.6 + 5.1 cmCSF). Exenatide significantly and significantly reduced intracranial pressure by 2.5 hours -5.7 + 2.9 cmCSF ( P = 0.048) and 24 hours -6.4 + 2.9 cmCSF ( P = 0.030) as well as twelve weeks -5.6 + 3.0 cmCSF ( P = 0.058). There were no serious safety warnings observed.
These results provide the confidence needed for the phase 3 trial for Idiopathic intracranial Hypertension. It also highlights the possibility of using GLP-1 receptor antagonists in various conditions that result in increased intracranial pressure.
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