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Hypoglycemia Following Antifungal Tx in Affected person With Kind 1 Diabetes

Posted in News on 8th November 2018
Micafungin is a member of the echinocandin class of antifungal agents

Micafungin is a member of the echinocandin class of antifungal agents

A recent report published in The Journal of Clinical Endocrinology and Metabolism, describes the case of a patient with type 1 diabetes mellitus (T1DM) who developed hypoglycemia following antifungal therapy for a severe infection.

The 29-year-old female patient had a long history of uncontrolled T1DM and was diagnosed with cervical necrotizing fasciitis with mediastinal spread after presenting for evaluation of worsening dysphagia and dyspnea. Several debridement surgeries as well as broad spectrum antibiotics and antifungal therapy were required to treat her. At admission, she had an HbA1c of 13.4%; due to worsening infection, continuous tube feeds, and multiple surgeries, her insulin needs subsequently increased.

To provide broader antimicrobial coverage, micafungin, a member of the echinocandin class of antifungal agents, was initiated. After administration of micafungin, the patient’s insulin requirement dropped to 0 for more than 48 hours. Upon discontinuing micafungin and switching to a different antifungal, her insulin needs increased again.

“This is the first report of decreased insulin requirements in a patient with T1DM correlating with micafungin administration,” noted the authors. While the exact mechanism by which micafungin induces hypoglycemia has yet to be established, they hypothesized that the agent reduces blood glucose levels through inhibition of sodium-glucose transporter-1 (SGLT1) function.

FDA: Instances of Uncommon Gangrene of Genital Space Tied to Diabetes Drug Class

Posted in News on 31st August 2018
The FDA is requiring a new warning be added to the prescribing information and patient Medication Guide of all SGLT2 inhibitors.

The FDA is requiring a new warning be added to the prescribing information and patient Medication Guide of all SGLT2 inhibitors.

Necrotizing fasciitis of the perineum, also known as Fournier’s gangrene, is a serious infection of the genitals and area around the genitals. Over a 5-year period (March 2013 to May 2018), the FDA identified 12 cases (7 men and 5 women) of Fournier’s gangrene in patients taking an SGLT2 inhibitor. The infection developed within several months of the patients starting SGLT2 therapy and the drug was discontinued in most cases. All patients required surgery and there was 1 reported death. 

SGLT2 inhibitors are currently approved as adjunct to diet and exercise to lower blood glucose in adults with type 2 diabetes. They work by causing the kidneys to remove sugar from the body through the urine. Approved drugs in the SGLT2 inhibitor class include: 

As a result, the FDA is requiring a new warning be added to the prescribing information and patient Medication Guide of all SGLT2 inhibitors. Healthcare professionals should assess patients for Fournier’s gangrene if they present with symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4ºF, or feel general malaise. 

Treatment should be initiated immediately with broad-spectrum antibiotics and surgical debridement if needed. The SGLT2 inhibitor should be discontinued and the patient’s glucose levels should be closely monitored; alternative treatment for glycemic control should be considered.

Medical trial examines affect of high-dose omega-Three and vitamin D on halting kind 1 diabetes

Posted in News on 15th July 2018

Scientists from the Diabetes Analysis Institute (DRI) on the College of Miami Miller Faculty of Drugs right now introduced the launch of a brand new scientific trial that may assess the affect of high-dose omega-Three fatty acids and vitamin D supplementation on halting the development of kind 1 diabetes (T1D). The DRI has obtained FDA IND clearance to proceed with the Part I/IIa trial, named the POSEIDON Research (Pilot examine of Omega-Three and Vitamin D Excessive Doses in T1D), to check the consequences of the proposed intervention in youngsters and adults newly recognized and in these with longer-standing T1D to judge any advantage of early and late interventions.

A number of scientific studies have recommended that using high-dose omega-Three and vitamin D, each of which have recognized anti-inflammatory and immunomodulatory properties, could provide a possible useful impact on autoimmune situations, like kind 1 diabetes. DRI researchers hypothesize that the therapy could delay or forestall the illness.

“My impetus for beginning this examine is to find out if modulating irritation and immunity may halt, or at the least delay, the development of kind 1 diabetes. Irritation could also be one of many triggers for autoimmunity that results in the onset of the illness, but in addition has an impact on insulin resistance and, subsequently, islet dysfunction,” mentioned Camillo Ricordi, M.D., examine sponsor and Director of the Diabetes Analysis Institute on the Miller Faculty of Drugs. “Outcomes from our latest case research analyzing the function of omega-Three/vitamin D in preserving beta cell operate in three pediatric topics with kind 1 diabetes warrant additional investigation of this potential therapeutic technique,” continued Dr. Ricordi, referring to his latest findings in collaboration with Italian facilities in Rome and Novara, together with these printed in European Assessment for Medical and Pharmacological Sciences.

The DRI plans to enroll 56 adults and youngsters within the two-arm, open-label examine. The investigators will evaluate youngsters and adults with kind 1 diabetes, each newly recognized and people greater than six months post-diagnosis, who take both vitamin D alone or together with omega-Three fatty acids. The contributors shall be handled for one yr, adopted by a one-year remark interval to measure any long-term impact on blood sugar management, improve in endogenous insulin manufacturing, and different outcomes.

Members shall be randomized to both 25-hydroxyvitamin D (cholecalciferol) alone, or together with ultra-refined omega-Three EPA/DHA derived from fish oil. Though preliminary dosing shall be primarily based on components like age and physique weight, investigators will monitor and modify vitamin D dosing each 4 months. They may even modify the omega-Three fatty acids dosage primarily based on month-to-month monitoring of the ratio of arachidonic acid to eicosapentaenoic acid (AA/EPA).

The next AA/EPA ratio is taken into account detrimental as a result of AA is believed to advertise irritation and reduce the regulatory cells that would defend towards autoimmunity, whereas EPA could be protecting. Extra EPA may enhance different situations the place irritation performs a key function.

“Reversing autoimmunity could possibly be useful effectively past topics with kind 1 diabetes. In actual fact, related methods needs to be examined in different autoimmune illnesses like Crohn’s, rheumatoid arthritis and lupus erythematous,” Dr. Ricordi mentioned.

All contributors will obtain normal diabetes therapy with insulin and dietary management.

“If mixture omega-Three and vitamin D remedy is ready to delay development or halt autoimmunity in kind 1 diabetes, that is anticipated to end in retention of insulin secretion, minimal use of exogenous insulin, and improved metabolic management thus minimizing the dangers related to unstable blood glucose ranges,” Dr. Ricordi mentioned.

Supply:

https://www.diabetesresearch.org/DRI-launches-POSEIDON-clinical-trial-to-explore-the-effects-of-omega-Three-and-vitamin-d-in-type-1-diabetes

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.”

Supply:

http://www.uab.edu/information/analysis/merchandise/9585-human-clinical-trial-reveals-verapamil-as-an-effective-type-1-diabetes-therapy

Add-On Antihypertensives In contrast in Sufferers With Diabetes on ACEIs, ARBs

Posted in News on 29th March 2018

March 28, 2018

Over the study period, there were 4707 significant kidney events

Over the examine interval, there have been 4707 vital kidney occasions

Calcium channel blockers had been related to a lowered danger of serious renal occasions when used as as add-on remedy in sufferers with diabetes taking both an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), based on a examine printed within the Medical Journal of the American Society of Nephrology. 

To analyze the security of add-on antihypertensive remedy in sufferers with diabetes taking ACEIs or ARBs, researchers carried out an observational, multicenter examine (N=21,987) to check medical outcomes (kidney occasions, cardiovascular occasions, loss of life) related to the addition of beta-blockers, dihydropyridine calcium channel blockers, loop diuretics or thiazide diuretics.

The composite vital kidney occasion finish level was outlined as the primary prevalence of ≥30% decline in eGFR to an eGFR <60mL/min/1.73m2, initiation of dialysis or kidney transplant. The composite cardiovascular endpoint, solely evaluated amongst these with out heart problems at baseline, was outlined as first prevalence of hospitalization for acute myocardial infarction (AMI), acute coronary syndrome, stroke or congestive coronary heart failure (CHF); coronary artery bypass grafting; or percutaneous coronary intervention.

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A complete of four,707 vital kidney occasions, 818 cardiovascular occasions, and 1,498 deaths had been recognized over the 5-year interval. The hazard ratios (HRs) for vital kidney occasions had been zero.81 (95% CI: zero.74–zero.89) for beta-blockers, zero.67 (95% CI: zero.58–zero.78) for calcium channel blockers, and 1.19 (95% CI: 1.00–1.41) for loop diuretics, all in contrast with thiazide diuretics. 

The HRs for cardiovascular occasions in contrast with thiazide diuretics had been 1.65 (95% CI: 1.39–1.96) for beta-blockers, 1.05 (95% CI: zero.80–1.39) for calcium channel blockers, and 1.55 (95% CI: 1.05–2.27) for loop diuretics. Furthermore, the HRs for mortality in contrast with thiazide diuretics had been 1.19 (95% CI: zero.97–1.44) for beta-blockers, zero.73 (95% CI: zero.52–1.03) for calcium channel blockers, and 1.67 (95% CI: 1.31–2.13) for loop diuretics. 

Primarily based on their findings, the authors concluded that in sufferers with diabetes on angiotensin-aldosterone system blockers, “in contrast with thiazide diuretics, calcium channel blockers had been related to a decrease danger of serious kidney occasions and an identical danger of cardiovascular occasions.”

For extra data go to asnjournals.org.

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