Early prevention of Type 1 diabetes human trials
Filed under: Type 1, Childhood, Drugs, Research
ImmunoMod has received an FDA Orphan Drug Grant award to pursue human trials focused on preventing the onset of Type 1 Diabetes by protecting beta cell function in early-stage diabetic youth.
When diabetes is first diagnosed, a short window of time known as "the honeymoon stage" exists to preserve the body's ability to create insulin. During this critical stage an individual has the best chance to protect the beta cells and stop the onset of the disease. Studies have shown that regeneration of damaged cells can occur if beta cells can be preserved. The problem to date has been the inability to prolong the preservation of these beta cells.
While some treatments have decelerated beta cell destruction, their effects have been temporary, caused toxic effects and required continuous treatment. ImmunoMod appears to effectively and safely protect beta cells for prolonged periods of time. The goal is to retard or reverse the destruction of these cells during the honeymoon phase, when cells first begin to lose function, which typically lasts about six months. I wonder if it's possible to reintroduce the honeymoon stage for Type 1 diabetics who have already been diabetic for decades?
[RESEARCH] Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006
Objective To determine the impact of the European Union’s Clinical Trials Directive on the number of academic drug trials carried out in Denmark.
Design Retrospective review of applications for drug trials to the Danish Medicines Agency, 1993-2006.
Review methods Applications for drug trials for alternate years were classified as academic or commercial trials. A random subset of academic trials was reviewed for number of participants in and intended monitoring of the trials.
Results Academic and commercial drug trials showed an identical steady decline from 1993 to 2006 and no noticeable change after 2004 when good clinical practice became mandatory for academic trials.
Conclusion The Clinical Trials Directive introduced in May 2004 to ensure good clinical practice for academic drug trials was not associated with a decline in research activity in Denmark; presumably because good clinical practice units had already been in place in Danish universities since 1999. With such an infrastructure academic researchers can do drug trials under the same regulations as drug companies.
None the wiser - Meet SmartCell
Filed under: Type 1, Type 2, Childhood, Adult Onset, Lifestyle, Drugs, Research, Products
Thanks to nano-technology and five brilliant scholars - a once a day injection to automatically detect blood sugar and release insulin to keep it in range is on the horizon.
SmartInsulin contains nano-sized particles that release insulin in proportion to blood glucose levels. These particles slowly break down and release insulin into the blood stream, regulating the blood sugar. Once the blood sugar is at normal levels, the particles close back up. This substantially reduces the likelihood of hypos - one of the greatest concerns for diabetics. SmartInsulin will minimize insulin dosages, decrease pain due to relentless blood sugar monitoring, dramatically improve blood sugar control, and will reduce diabetic complications.
The team of 5 students, called SmartCells, won the grand prize in an Entrepreneurship Competition for its work on the monitoring device. SmartCells team member Todd Zion invented the technology as part of his Ph.D. research in chemical engineering at MIT. Zion had an additional incentive for researching this disease. "Type 1 runs in my family. There's a genetic predisposition for it," Zion said. "I also have family members who have Type 2 diabetes. It hits home a little bit closer when someone you know has the disease."
As of April 1, 2007 SmartCells, Inc. received notice that it has been awarded $394,363 in first-year funding for a multi-year Phase 1 SBIR grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The grant was awarded to support development and testing of multimeric aptamers for use in SmartCells' glucose-regulated insulin formulations. Multi-wha? Can someone explain to me what a multimeric aptamers is?
[RESEARCH] Adherence to prescribed antihypertensive drug treatments: longitudinal study of electronically compiled dosing histories
Objective To describe characteristics of dosing history in patients prescribed a once a day antihypertensive medication.
Design Longitudinal database study.
Setting Clinical studies archived in database for 1989-2006.
Participants Patients who participated in the studies whose dosing histories were available through electronic monitoring.
Main outcome measures Persistence with prescribed antihypertensive treatment and execution of their once a day drug dosing regimens.
Results The database contained dosing histories of 4783 patients with hypertension. The data came from 21 phase IV clinical studies, with lengths ranging from 30 to 330 days and involving 43 different antihypertensive drugs, including angiotensin II receptor blockers (n=2088), calcium channel blockers (n=937), angiotensin converting enzyme inhibitors (n=665), β blockers (n=195), and diuretics (n=155). About half of the patients who were prescribed an antihypertensive drug had stopped taking it within one year. On any day, patients who were still engaged with the drug dosing regimen omitted about 10% of the scheduled doses: 42% of these omissions were of a single day’s dose, whereas 43% were part of a sequence of several days (three or more days—that is, drug "holidays"). Almost half of the patients had at least one drug holiday a year. The likelihood that a patient would discontinue treatment early was inversely related to the quality of his or her daily execution of the dosing regimen.
Conclusions Early discontinuation of treatment and suboptimal daily execution of the prescribed regimens are the most common facets of poor adherence with once a day antihypertensive drug treatments. The shortfalls in drug exposure that these dosing errors create might be a common cause of low rates of blood pressure control and high variability in responses to prescribed antihypertensive drugs.
Hypertension drug may help people with Muscular Dystrophy
Filed under: Research
For those of you who are familiar with the drug called Losartan, you know that it is often prescribed to treat hypertension. You may also know that it is known to block TGF-beta activity. But what you probably didn't know -- just as researchers didn't until a recent discovery -- is that Losartan may also aid in treating Muscular Dystrophy.
Our always busy friends over at the Johns Hopkins Medical Center found that by treating mice, that had been genetically altered to have Duchenne Muscular Dystrophy (DMD), with Losartan demonstrated completely restored ability to regenerate muscle after injury. And, what's more, mice treated with Losartan also showed strength levels equal to that of mice without DMD. By contrast, the mice with DMD that were not treated with Losartan had large patches of scar tissue in place of muscle after injury, and during strength tests performed very poorly.
Further research on the effects of Losartan on Muscular Dystrophy still needs to be completed. In the interim, the researchers' findings can be reviewed online in this week's Nature Medicine.
Permalink | Email this | Linking Blogs | CommentsReporting drug side effects - One click away!
Filed under: Type 1, Type 2, Childhood, Adult Onset, Drugs, Allie Beatty, Support, Personalities
A recent study found that 87% of patients who experienced an adverse symptom from a prescribed drug spoke to their doctor. However less than half of the doctors went through with filing the adverse event paperwork to notify the drug manufacturer. Why is this?
The research was published in the latest issue of Drug Safety. Doctors dismissed patients' complaints, and told them their symptoms were not connected to use of the drug. One doctor commented that the time it takes to complete the adverse event drug paperwork is time-consuming, and often not worth it unless it is life threatening. Would Hippocrates have accepted that answer? Please review your Hippocratic Oath, doc.
Your doctor is too busy to file the necessary paperwork to notify the FDA a drug is potentially harmful. What is a patient to do? Good question and here's an answer! If you experienced any adverse side effects from the use of a prescription drug, please let the FDA know. Click BEGIN and bring this monkey business to an end!
Read | Permalink | Email this | Linking Blogs | CommentsPopular diabetes drug Avandia poses heart attack risk for type 2 diabetics
Filed under: Type 2, Adult Onset, Drugs
When my mom was first diagnosed with diabetes in the late 1990s, her internist prescribed Rezulin, a popular diabetes drug approved in 1997. Then one day the phone rang. Her internist called to alert her Rezulin was causing fatal liver failure and he wanted her off the drug immediately.
Now Avandia, a popular diabetes drug which helps sensitize the body to insulin, is on the hotseat. A recent study published in the New England Journal of Medicine by Dr. Steven Nissen and statistician Kathy Wolski at the Cleveland Clinic suggests Avandia significantly raises the risk of heart attack for type 2 diabetics.
Nissen pooled results of nearly 28,000 people across dozens of studies, revealing a 43 percent higher risk of heart attack for Avandia users compared to diabetics prescribed different drugs or no diabetes medication at all. Two-thirds of type 2 diabetics die of heart problems. With a 43 percent higher risk, Avandia may be downright dangerous.
GlaxoSmithKline PLC, maker of Avandia, disputes Nissen's analysis, but admitted a similar review revealed a 30 percent increased risk. I don't know about you, but a 30 percent higher risk of heart attack frightens me. Glaxo did say further rigorous studies did not confirm an excess risk.
I suspect the phones will soon be ringing in the homes of Avandia-prescribed type 2 diabetics. And it's not good news.
Accidental Diabetes Drug
Filed under: Type 2, Adult Onset, Drugs, Research
Much like a roadblock, but with a fortuitous outcome -- an experimental heart drug didn't achieve the primary goal of a late-stage trial but it did dramatically reduce the risk patients would develop diabetes.
The anti-oxidant, anti-inflammatory drug, the first of its kind, reduced the risk of developing diabetes by 64% and demonstrated a small but statistically significant reduction in blood sugar after 12 months. The study included data from 6,144-patients. The company believes this finding to be a serendipitous outcome, despite the initial shortcomings of the trial objective. They need to confirm it in a large clinical trial. The impressive diabetes results may come as a surprise to investors who have abandoned AtheroGenics or who have been betting the drug will fail.
Heart patients in the study received either 300 milligrams of the drug or a placebo on top of a host of standard-of-care medicines they were already taking, such as aspirin, cholesterol-lowering statins, blood thinners and/or diabetes medicines.
The drug had an undesirable impact on blood fats, raising bad LDL cholesterol by about 12% and lowering good HDL cholesterol by roughly the same amount. There were also some potentially troubling safety signals with a trend toward more heart failure in those taking the drug. In spite of the undesirable affects on blood lipids, the drug has a profound effect on diabetes. Further research will be conducted on the efficacy of this drug in reducing the risk of developing diabetes.
[RESEARCH] Increasing antituberculosis drug resistance in the United Kingdom: analysis of national surveillance data
Objective To identify recent trends in, and factors associated with, resistance to antituberculosis drugs in England, Wales, and Northern Ireland.
Design Cohort of tuberculosis cases reported to the enhanced tuberculosis surveillance system matched to data on drug susceptibility and national strain typing data.
Setting England, Wales, and Northern Ireland 1998-2005.
Main outcome measures Unadjusted and adjusted odds ratios for drug resistance and associated factors. Proportion of multidrug resistant tuberculosis cases clustered.
Results 28 620 culture confirmed cases were available for analysis. The proportion of cases resistant to isoniazid increased from 5% to 7%. Rifampicin resistance increased from 1.0% to 1.2% and multidrug resistance from 0.8% to 0.9%. Ethambutol and pyrazinamide resistance remained stable at around 0.4% and 0.6%, respectively. Regression analyses showed a significant increase in isoniazid resistance outside London (odds ratio 1.04, 95% confidence interval 1.01 to 1.07, a year, associated with changes in age (0.98, 0.98 to 0.99, a year), place of birth (1.49, 1.16 to 1.92), and ethnicity (P<0.05). In London, the rise (1.05, 1.02 to 1.08, a year) was related mainly to an ongoing outbreak. Increases in rifampicin resistance (1.06, 1.01 to 1.11, a year) and multidrug resistance (1.06, 1.00 to 1.12, a year) were small. A fifth of patients with multidrug resistant tuberculosis in 2004-5 had indistinguishable strain types, and one case was identified as extensively drug resistant.
Conclusions The rise in isoniazid resistance reflects increasing numbers of patients from sub-Saharan Africa and the Indian subcontinent, who might have acquired resistance abroad, and inadequate control of transmission in London. The observed increases highlight the need for early case detection, rapid testing of susceptibility to drugs, and improved treatment completion.
Islet transplantation improves with drug combination
Filed under: Type 1, Childhood, Research
Islet transplantation is an exciting frontier of diabetes research as it can reverse diabetes. A recent study from researchers at the University of Alberta in Edmonton showed promising results when a combination of intensive insulin and heparin is used to garner better success of islet transplantation from a single donor.
Due to inefficiencies in islet harvest, islet transplants usually require harvesting from more than one donor. Not only does the drug combination yield more islets from a single donor, early results suggest patients receiving islets from one donor realize longer insulin independence. Study researchers hypothesized heparin, an anticoagulant, could prevent damage from clotting, while intensive insulin could relieve stress and inflammation on the islets during transplantation.
13 patients received the insulin/heparin (IH) combination. 6 of the 13 IH patients (46%) were able to give up insulin treatments. This was compared to a previous 66-patient cohort that had received islet transplants via intraportal cultured islet-alone infusions, followed by immune system suppression via three different drugs. Of these 66 patients, only 5 (8%) were able to give up insulin. Furthermore, 55% of patients reaching insulin dependence via one donor maintained independence after 60 months, compared to only 9% of patients receiving islets from more than one donor.
To learn more about the metabolic wonders of islets of Langerhan, please see this previous post.