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FDA: MS Drug Linked to Circumstances of Stroke, Blood Vessel Wall Tears

Posted in News on 30th November 2018
Most cases occurred within 1 day of receiving Lemtrada

Most cases occurred within 1 day of receiving Lemtrada

The Food and Drug Administration (FDA) has issued a warning regarding rare cases of ischemic and hemorrhagic stroke and cervicocephalic arterial dissection in patients with multiple sclerosis (MS) shortly after receiving Lemtrada (alemtuzumab; Sanofi Genzyme). Alemtuzumab, a monoclonal antibody, is also approved for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) under the brand name Campath (alemtuzumab; Sanofi Genzyme).

Sine the approval of Lemtrada in 2014, the Agency has identified 13 cases worldwide of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after the patient received Lemtrada; 1 patient who suffered a hemorrhagic stroke died. Most cases (12/13) occurred within 1 day of receiving Lemtrada; 1 patient reported symptoms 3 days after starting treatment. While the etiology is unknown, the adverse events appear to have occurred within the same time frame as cytokine release syndrome, an inflammatory response associated with Lemtrada use. Reports of ischemic stroke and intracerebral hemorrhage have also been documented in patients treated with Campath for B-cell CLL and other leukemias/lymphomas.

The prescribing information and Medication Guide for Lemtrada have been updated with a new warning to reflect these risks. In addition, the risk of stroke has been added to the existing Boxed Warning. The Campath drug labeling has also been updated to include these risks in the Adverse Reactions section under Postmarketing Experience.

Healthcare professionals should advise patients at each infusion to seek medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection. Patients who complain of symptoms suggestive of these conditions should be promptly evaluated.

Novel Blood Take a look at for Irritable Bowel Syndrome Now Accessible

Posted in News on 11th October 2018
A positive result indicates that a patient has IBS-D with positive predictive value of >90%

A positive result indicates that a patient has IBS-D with positive predictive value of >90%

Gemelli Biotech has announced the launch of ibs-smart, a second-generation blood test that aids in the diagnosis of diarrhea predominant and mixed-type irritable bowel syndrome (IBS-D and IBS-M).

Once the testing kit with the blood sample is received, results are available within 48 hours and are sent directly to the prescribing physician. A positive result indicates that a patient has IBS-D with positive predictive value of >90%; the test does not provide definitive results for patients with constipation predominant IBS. The Company notes that while it is generally not known whether medications affect the test, it is possible that advanced anti-inflammatory drugs may potentially reduce antibodies and result in a false negative test.

“Replacing the traditional path of invasive, expensive procedures from CT scans to multiple colonoscopies with a simple blood test allows for a faster diagnosis. A faster diagnosis most importantly means a faster path to treatment and reduced costs,” stated Matt Mitcho, Gemelli Biotech’s CEO.

Cardiac and blood

Posted in Normodyne on 3rd October 2018

Human trial identifies frequent blood strain medicine as secure, efficient remedy for diabetes

Posted in News on 10th July 2018

Researchers on the College of Alabama at Birmingham Complete Diabetes Middle have found a secure and efficient novel remedy to cut back insulin necessities and hypoglycemic episodes in grownup topics with latest onset Sort 1 diabetes by selling the affected person’s personal beta cell operate and insulin manufacturing — the primary such discovery to focus on diabetes on this method.

The findings, revealed in the present day by Nature Medication, reveal that common oral administration of verapamil, a standard blood strain medicine first permitted for medical use in 1981, enabled sufferers to supply increased ranges of their very own insulin, limiting their want for insulin injections to stability out their blood sugar ranges.

The randomized, double-blind, placebo-controlled human trial recognized verapamil as a secure, efficient, and promising remedy — a groundbreaking discovering within the area of diabetes analysis.

“The info collected from our scientific trial offers us each indication to consider that people with Sort 1 diabetes have the promise of a remedy strategy that would scale back their exterior insulin necessities and enhance their blood sugar management and high quality of life, due to the results that verapamil has in selling the physique’s personal beta cell operate,” stated Anath Shalev, M.D., director of UAB’s Complete Diabetes Middle and principal investigator of the trial. “Whereas this analysis shouldn’t be an end-all remedy for Sort 1 diabetes, these findings are getting us nearer to disease-altering therapies that may allow people with Sort 1 diabetes to have extra management over their illness and keep a few of their physique’s personal insulin manufacturing.”

In 2014, Shalev’s UAB analysis lab found that verapamil utterly reversed Sort 1 diabetes in animal fashions and sought to check the results of the drug in human topics in a scientific trial, funded by a $ 2.1 million grant from the JDRF. Verapamil has been Meals and Drug Administration permitted and accessible for prescription for the remedy of hypertension for greater than three many years. Nonetheless, Shalev’s analysis marks the primary time that the drug has been examined for security and efficacy in treating Sort 1 diabetes.

Sort 1 diabetes happens as the results of one’s immune system attacking the beta cells within the pancreas that produce insulin to control and keep optimum blood sugar ranges. When beta cells are being destroyed, an individual’s capacity to supply insulin declines, inflicting blood sugar ranges to rise and making the individual an increasing number of depending on exterior insulin. The UAB scientific trial found that when a affected person takes verapamil, beta cell operate is preserved, enabling the physique to supply extra of its personal insulin. This lessened the scientific trial individuals’ reliance on exterior insulin, which all people with Sort 1 diabetes should have to successfully regulate their blood sugar ranges.

“At JDRF, we’re excited and inspired by the latest findings from the UAB Complete Diabetes Middle’s scientific trial. This information has the potential to alter how we take into consideration treating and in the end curing T1D,” explains Andrew Rakeman, Ph.D., assistant vp of analysis at JDRF. “We sit up for continued scientific research that can construct on and ensure these findings, increasing to further affected person populations and guiding how, when and in who verapamil may need probably the most impression in T1D.”

The verapamil scientific trial monitored 24 sufferers age 18 to 45, every over the course of 1 yr. Eleven sufferers acquired verapamil and 13 acquired placebo. All scientific trial individuals had been identified with Sort 1 diabetes inside three months of their begin within the trial and continued with their prescribed insulin pump remedy all through the length of the examine. Researchers monitored the placebo and verapamil teams’ whole every day dose of insulin, the quantity of insulin produced, the p.c change in insulin manufacturing, and their HbA1C ranges. As well as, the variety of hypoglycemic occasions that the sufferers skilled had been recorded, and the p.c of time every affected person registered in wholesome blood glucose ranges had been analyzed utilizing a steady glucose monitoring system.

“Though this can be a smaller pattern group, our trial outcomes give us promise that topics with Sort 1 diabetes have remedy choices and that we’re nearing a more practical solution to cope with this illness,” stated Fernando Ovalle, M.D., director of UAB’s Complete Diabetes Clinic and co-principal investigator of the examine. “Past verapamil permitting topics with Sort 1 diabetes the power to reside a life with much less exterior insulin dependence, these findings will impression the standard of life that they’ll have. Hopefully, by bettering total blood sugar management it’s going to additionally restrict their dangers for different comorbidities, together with coronary heart assault, blindness, kidney illness, and extra.”

Whereas this examine particularly addressed findings in grownup topics identified inside three months of the trial’s begin, Shalev notes that future long-term research are wanted to assist decide the impact of verapamil on each the pediatric Sort 1 diabetes inhabitants, and people with Sort 1 diabetes who’ve been residing with and/or identified with the illness longer than three months. Moreover, verapamil’s results on Sort 2 diabetes haven’t been examined or studied in potential managed trials; Shalev stated and future research that discover the potential for this routine to positively impression Sort 2 diabetes are due to this fact additionally wanted. Nonetheless, in mouse fashions of Sort 2 diabetes and in latest epidemiological research verapamil use has been related to decrease danger of growing Sort 2 diabetes and with higher blood sugar management.

“This trial’s outcomes affirm that we’re heading in the right direction and are getting into a brand new part of discovery because it pertains to this illness,” Shalev stated. “Diabetes impacts greater than 30 million folks in America alone, and hopefully our breakthrough will in the end result in approaches that may assist enhance the lives of all these affected by this illness.”


Research: Drug used to deal with blood loss could also be useful for some stroke sufferers

Posted in News on 17th May 2018

Sufferers with stroke brought on by bleeding on the mind (intracerebral hemorrhage) could profit from receiving a drug at the moment used to deal with blood loss from main trauma and bleeding after childbirth, a world trial has revealed.

The examine, led by specialists at The College of Nottingham and funded by the Nationwide Institute for Well being Analysis (NIHR) Well being Expertise Evaluation Program, discovered that giving tranexamic acid (TXA) to individuals who had skilled intracerebral hemorrhage decreased the variety of deaths within the early days following the stroke.

It additionally discovered that each the quantity of bleeding within the mind and variety of related severe problems had been decrease within the sufferers who had obtained the TXA remedy.

Nonetheless, the trial discovered no distinction within the quantity of people that had been left disabled or had died at three months after their stroke (the examine’s major end result). The researchers consider additional examine is required on bigger teams of sufferers to allow them to totally perceive the potential advantages.

The analysis is printed within the medical journal The Lancet and was introduced on the 4th European Stroke Convention in Gothenburg, Sweden on 16th Could.

Nikola Sprigg, Professor of Stroke Drugs on the Stroke Trials Unit within the College’s Division of Medical Neuroscience, led the trial. She stated: “Tranexamic acid is reasonable – costing lower than £15 per affected person – and broadly out there so has the potential for decreasing dying and incapacity the world over.”

“Whereas we failed to indicate important advantages three months after stroke, the discount in early deaths, quantity of bleeding on the mind and severe problems are indicators that this drug could also be of profit sooner or later. Extra trials are wanted, significantly specializing in giving remedy as quickly as attainable after the beginning of bleeding on this emergency situation.

“TICH-2 cements the place of the NIHR and the UK as key gamers on this planet of stroke analysis. A examine of this scale would merely not have been attainable with out help of the NIHR infrastructure. Alongside the massive stroke facilities, the contribution made by the community of smaller websites throughout the UK has been essential to the success of TICH-2.”

Round 150,000 individuals within the UK undergo a stroke yearly — nearly all of these are ischaemic strokes brought on by a blocked blood vessel on the mind which might be handled very efficiently in lots of circumstances with the usage of clot-busting medicine (thrombolysis) administered inside four.5 hours of the stroke.

Nonetheless, 15 per cent of all strokes — affecting round 22,000 individuals yearly — are brought on by hemorrhagic stroke when a blood vessel within the mind bursts, resulting in everlasting injury. Whereas all individuals with acute stroke profit from remedy on a stroke unit, there may be at the moment no particular remedy for hemorrhagic stroke and sadly many individuals affected will die inside just a few days. Those that do survive are sometimes left with debilitating disabilities together with paralysis and an incapability to talk.

A earlier small pilot examine by The College of Nottingham and funded by each the college and the charity the Stroke Affiliation, concluded bigger examine was wanted to precisely assess the effectiveness of the drug tranexamic acid. The drug was chosen for the examine after earlier analysis confirmed that it was profitable in stopping bleeding in individuals concerned in highway site visitors accidents.

For the most recent trial, individuals who had been identified as having had bleeding on the mind — confirmed by CT scan — had been supplied the prospect to participate within the examine. The place the particular person was too sick to determine, permission was requested of their household or shut mates. The place no household had been out there a health care provider unconnected with the examine determined if the affected person ought to participate.

The five-year TICH-2 trial recruited greater than 2,000 sufferers from 124 hospitals in 12 nations between 2013 and 2017. They had been randomly sorted into two affected person teams – one obtained TXA inside eight hours of their stroke and one other was given a saline placebo. Within the UK, greater than 80 hospitals took half within the examine with help from the NIHR scientific analysis community.

CT scans of the sufferers’ brains had been carried out 24 hours after their stroke and their progress was monitored and measured at day two and day seven after their stroke. The ultimate comply with up was carried out at 90 days.

The examine revealed that TXA didn’t enhance the result for sufferers after 90 days as there was no important distinction within the variety of sufferers who had subsequently died or had been left with disabilities between the TXA and placebo teams at three months.

Nonetheless, within the TXA group there have been fewer deaths by day seven following the stroke and, at day two, fewer individuals on TXA skilled a worsening of the bleed on their mind and had smaller quantities of blood within the mind in comparison with their management group counterparts. Additionally, the variety of sufferers who skilled related severe problems (corresponding to pneumonia and mind swelling) had been decrease within the sufferers who had obtained the TXA remedy in comparison with those that had management.

The trial additionally discovered proof that TXA could be more practical in sufferers with decrease blood stress as these with blood stress decrease than 170 mmHg had a extra favorable end result that these with 170mmHg and above. Different research have confirmed that the earlier TXA is given, the more practical it’s, and ideally it must be given inside lower than three hours of bleeding onset. On this examine just one third of sufferers got remedy inside three hours of stroke onset.

Because of this, the researchers have highlighted the necessity for additional research to seek out out whether or not giving an earlier dose of TXA could be useful for sufferers.