Obesity Drug Trial Put On Hold Due To Second Patient Death.
Zafgen Inc. announced that phase III clinical trial of beloranib, its experimental obesity drug to treat Prader-Willi syndrome, was placed on hold by FDA due to the death of second patient from a blockage in an artery
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Patients on glucocorticoids have fewer fractures at similar bone density
Study presented at a rheumatology meeting, on more than 20,200 patients referred for BMD, found fractures less prevalent in patients treated with glucocorticoids compared to non-users with similar bone density.
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Review Finds No Evidence TRT Causes, Worsens LUTS Or BPH.
While the Endocrine Society and other associations suggested severe LUTS as a contraindication to testosterone replacement therapy, a review published in Urology found no evidence that TRT causes or worsens LUTS or BPH.
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Cows’ Milk Taken At Night Found To Have Sedative Effects On Mice.
A mouse study published in the Journal of Medicinal Food found that milk taken from cows during the night had greater sedative effects than milk collected during the day. The reason suggested is that milk collected at night had 24% more tryptophan and about ten times as much melatonin as milk collected during the day.
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Insulin Pump Not Superior To Injections When Patients Are Equally Trained.
Insulin pumps among adults with type 1 diabetes did not lead to better glycemic control compared with similarly trained users of multiple daily insulin injections, according to the results of a trial from UK presented at the World Diabetes Congress. In a 267-patient study, HbA1c values dropped about a half a percent point from a baseline mean of around 9%, with no significant differences between pump and multiple injections at 24 months
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FDA Says SGLT2 Inhibitors Will Need New Warnings.
The FDA said SGLT2 will need new warnings on the risks of ketoacidosis, urinary tract infections, and other serious illnesses. More than 70 cases of ketoacidosis have been reported, as well as 19 life-threatening cases of urosepsis and pyelonephritis.
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Eli Lilly Ends Development Of Diabetes Treatment.
Eli Lilly decided to end its development of insulin peglispro, due to unresolved questions about changes in liver fat that evolved during late-stage testing of the drug. The decision is based on the understanding that it would take more time and cost more than expected to understand the liver fat changes.
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FDA Approves Cheaper Version Of Popular Insulin Product.
FDA approved Basaglar (insulin glargine), a cheaper version of the world’s top-selling insulin from Sanofi. Basaglar is the first insulin product approved by the FDA through an expedited review pathway based upon the similarity of the drug to an already approved drug. It will be marketed by Eli Lilly and Boehringer Ingelheim after reaching a settlement with Sanofi. להמשך קריאה
Data Indicate Decline In New Diabetes Diagnoses In US. NBC News reviewed recent CDC and NIH data showing a decline in new diabetes diagnoses among American adults for the first time in 20 years
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J&J Loses Fourth Trial Tying Antipsychotic To Male Breast Growth.
Johnson & Johnson lost fourth trial in which a young man successfully claimed the company failed to warn that Risperdal could cause grow breasts. A Pennsylvania state court ordered J&J to pay $500,000.
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The discovery Metformin can be traced back to the pioneering work with extracts of the herb Galega officinalis. In medieval times, Galega officinalis was used in to relieve frequent urination. The plant was also given as a medicine in plague epidemics to promote perspiration, and widely used to stimulate lactation in cows. Still, the plant was too toxic for widespread agricultural usage. Although Galega officinalis successfully lowered blood glucose in diabetics, the quest for an active ingredient was slow in the early days of the last century. Studies in the late 1800s indicated that goat’s rue was rich in Guanidine, but it was shown to be toxic for clinical use. Thus for a while, attention turned to Galegine, a less toxic extract. Muller and Reinwein in 1927 experimented with self-administration of galegine, after which blood glucose levels were followed for 25 hours. The guanidine group included biguanides and synthalins. Metformin was first described in 1922, by Emil Werner and James Bell. In 1929, Slotta and Tschesche discovered its sugar-lowering action in rabbits. In late 1940s, while training at the Hôpital de la Pitié, French diabetologist Jean Sterne studied the antihyperglycemic properties of galegine, which is related in structure to metformin and had seen brief use by Garcia as an antidiabetic. Later, working at Laboratoires Aron in Paris, he was prompted by Garcia’s report to reinvestigate the blood sugar-lowering activity of metformin and several biguanide analogs. Sterne was the first to try metformin on humans for the treatment of diabetes; he coined the name “Glucophage” (glucose eater) for the drug and published his results in 1957. In the same year, an American group published similar results for phenformin, another biguanide discovered in 1957 by Ungar, Freedman and Seymour Shapiro. Clinical trials on phenformin begun in 1958 showed it to be effective, but with gastrointestinal side effects. The marketing of that drug was energetic by Ciba-Geigy, but sales began to decline from 1973 due to reports of lactic acidosis. In 1977, 385,000 patients with early-stage diabetes were taking phenformin in the US. However, in July the FDA declared the drug an “imminent hazard to the public health” and gave doctors 90 days to switch to an alternative treatment, finally banning it on November 15, 1978. The related drug metformin was considerably safer, with three cases of lactic acidosis per 100,000 patient-years compared to 64 cases per 100,000 patient-years, and mostly confined to patients with impaired renal function. Phenformin is metabolised by the liver while metformin is excreted in urine. Metformin became available in the British National Formulary in 1958 and was sold in the UK by a small Aron subsidiary called Rona. It was approved in Canada in 1972 and by the FDA only in 1994.