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Post by mannmade on Sept 6, 2016 14:38:04 GMT -5
HOME / HEALTH NEWS Older drug may help Type 1 diabetics' heart health By Serena Gordon, HealthDay News | Sept. 6, 2016 at 12:21 PM Comments0 Comments share with facebook share with twitter
TUESDAY, Sept. 6, 2016 -- An inexpensive medication normally given to people with type 2 diabetes may help preserve heart health in people with the less common form of diabetes -- type 1, a small new study finds. Metformin is the standard first-line treatment for type 2 diabetes to help bring blood sugar levels down. It also appears to help repair damaged blood cells by increasing the number of blood vessel (vascular) stem cells, researchers said.
"We have shown -- both in test tube and in patients -- the mechanism behind the cardioprotective effects of metformin," said the study's senior author, Dr. Jolanta Weaver. She's a senior lecturer in diabetes medicine at Newcastle University in England.
"This is likely to lead to the development of new drugs for heart disease in diabetes," she added.
Sanjoy Duttais is assistant vice president of translational development at JDRF, a nonprofit organization that funds type 1 diabetes research. He expressed enthusiasm for the new findings.
"This was an extremely well-designed and conducted study. They have shown which cardiovascular biomarkers go up and down with metformin. But these are markers only. For a drug to be approved or widely accepted, researchers have to demonstrate hard outcomes," explained Dutta.
JDRF has funded such a study by a different group of researchers that will be done next summer, Dutta said.
That study will look at whether or not people over 40 with type 1 diabetes had less plaque buildup (atherosclerosis) in their blood vessels over three years if they took metformin.
Type 1 diabetes is an autoimmune disease that causes the body's immune system to destroy the body's insulin-producing cells. Without sufficient insulin, the body can't process the carbohydrates from food to provide the body's cells with fuel.
Heart disease is the leading cause of premature death in people with type 1 diabetes. Even with good blood sugar control, the risk of heart attack or stroke is twice as high for people with type 1 diabetes compared to people without it, the researchers said.
The new study included 23 adults with type 1 diabetes who were treated with metformin for eight weeks. None had overt signs of heart disease. Their average age was 46.
The starting dose was 500 milligrams a day, which was increased to 2,000 mg a day if tolerated, Weaver said.
These people were compared to 23 healthy age- and sex-matched volunteers without type 1 diabetes. They were also compared to nine people with type 1 diabetes who weren't given metformin. Their average age was 47.
The people with diabetes were asked to keep their blood sugar control similar to what it was before the metformin. The researchers didn't want an improvement in blood sugar levels to affect the findings.
The researchers saw a number of markers indicating blood vessel repair go up in patients taking metformin. And on the flip side, cells associated with blood vessel damage were reduced in people taking metformin.
Metformin is an older drug, already approved in the United States for treating type 2 diabetes. Brand names include Glumetza, Glucophage, Riomet and Fortamet. The most common side effects are gastrointestinal problems such as nausea and diarrhea.
Dutta said these side effects tend to go away with time. Or, he said, there are medications that can help lessen the side effects.
Weaver said the researchers plan to follow the health of their patients. But, she added, a larger, randomized trial is needed to better know the heart protective effects of metformin in people with type 1 diabetes.
However, because the drug is already approved, doctors can prescribe it "off-label" to patients with type 1 diabetes, Dutta said.
"I am sure doctors will prescribe it at least in a subset of patients who have a very high risk of cardiovascular disease," he said.
Weaver said along with the potential heart protective benefits shown in this study, metformin also helped the patients in the study achieve better blood sugar control, and it helped them lessen variations in blood glucose levels.
Findings from the study were published in Cardiovascular Diabetology.
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Post by mannmade on Sept 6, 2016 14:26:36 GMT -5
Sports is very patient.. And puts up a lot of good info that personally I like and saves me time to have to go find...
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Post by mannmade on Sept 5, 2016 15:45:36 GMT -5
I hope the trials will be formatted to correct the mistakes made in the adult trials. We all know AFREZZA needs to be administered differently than RAA's otherwise other than safety it may be the same set of issues all over again.
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Post by mannmade on Sept 2, 2016 23:47:06 GMT -5
By the way, I believe there is a fairly popular diabetes drug product on the market that has a warning against taking if patient has Thyroid cancer and I seriously doubt many patients get tested for thyroid cancer before taking this drug which as I recall is one of the more popular ones. Not exactly the same thing but patients will take it and doctors do not test for thyroid cancer in most cases as i understand it before prescribing. So does not seem to be a worry in this situation.
Liane perhaps you know which drug I am speaking about as I can't recall the name.
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Post by mannmade on Sept 2, 2016 23:29:48 GMT -5
Earlier diabetes diagnosis linked to worse mid-life heart health By Lisa Rapaport,Reuters 10 hours ago Comments Like Reblog on Tumblr Share Tweet Email (Reuters Health) - When people develop diabetes early in life they may also be more likely to experience heart problems in middle age, a study suggests. Cardiovascular disease has long been linked to diabetes in older adults. The new study, however, offers fresh evidence that getting diabetes as a younger adult may exacerbate or accelerate the erosion of heart function as people age. “Diabetes is toxic to the heart since it affects many important components of the machinery,” said Dr. Genevieve Derumeaux, a researcher at Henri Mondor Hospital in Creteil, France and author of an editorial accompanying the study. In particular, diabetes can damage the left ventricle, the bottom left chamber of the heart responsible for pushing oxygen-rich blood out into the circulatory system, Derumeaux said by email. Over time, diabetes can make it harder for the chamber to fill with blood and pump blood out into the body. Globally, about one in 10 adults have diabetes, according to the World Health Organization. Most have type 2 diabetes, which is associated with obesity and aging and occurs when the body can’t make or process enough of the hormone insulin. Medications as well as lifestyle changes such as improved diet and exercise habits can help manage diabetes and keep symptoms in check. When diabetes isn’t well managed, however, dangerous spikes in blood sugar can eventually lead to blindness, amputations, kidney failure, heart disease and stroke. For the current study, researchers examined data on nearly 3,200 adults over a 25-year period starting in 1985 when they were between 18 and 30 years old. After initial medical exams, participants received a series of seven additional checkups during the study period. The exams included assessments of blood sugar and the ability to process the hormone insulin, as well as imaging tests known as echocardiograms to determine heart health. By the end of the study, the participants who lived the most years with diabetes were much more likely to have heart damage than their peers without diabetes or participants who only developed the condition more recently, the study found. When people developed what’s known as insulin resistance, a failure to process the hormone, they were also much more likely to experience heart damage by the end of the study. One limitation of the study is that researchers lacked data on diabetic complications, making it impossible for them to assess how specific problems that developed with this disease might influence the odds of heart damage, the authors note in the Journal of the American College of Cardiology. Even so, the findings point to the importance of preventing the onset of diabetes and controlling blood sugar properly if the condition does develop, the authors conclude. “Cumulative exposure to diabetes and higher insulin resistance from early adulthood to middle age are risk factors for adverse cardiac dysfunction later in life,” lead study author Dr. Satoru Kishi, a diabetes researcher at Mitsui Memorial Hospital in Tokyo, said by email. SOURCE: bit.ly/2bxiXEd and bit.ly/2cmLnXj Journal of the American College of Cardiology, online August 17, 2016
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Post by mannmade on Sept 2, 2016 12:31:19 GMT -5
6 of one 1/2 dozen of another... Not to sound too defensive... Just a little... Read my posts and you will know where I stand...
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Post by mannmade on Sept 2, 2016 12:24:19 GMT -5
Yes think it is the stripes...
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Post by mannmade on Sept 2, 2016 12:22:24 GMT -5
I have posted this before but seems relevant again... I had dinner with Sam F and he told me regarding the lung safety issue the following: "When I weigh the chance for the POSSIBILITY of cancer or other lung issues related to using AFREZZA which have yet to show themselves in any statistical meaningful way (with all the testing of 1,000's of patients over the course of the trials) versus the CERTAINTY that with my Hba1c in the 10''s (he admitted to being out of control most of his life despite a rigorous work out regime and watching what he ate) prior to starting AFREZZA (he is now in non-diabetic range) that I would likely go blind, suffer kidney and heart damage and loss of limbs... It was really a very clear choice for me. The market says otherwise. Personally, I would agree with Sam F, except his opinion isn't the only one that matters. I would not want physicians making personal decisions like that about my healthcare. As much as I hate that doctors are being careful prescribing something they're not familiar/comfortable with, I have to honor and respect that because it's that very practice that likely keeps many more people safe. There are countless cancer inhibitors that have been rejected by the FDA after showing promising results, yet patients can't get their hands on it because it didn't pass their standards. Some successful drugs have killed specific ethnicities then get pulled off the market. Afrezza has proven to be safe enough in the near term. I hope as much as anyone that no adverse effects come from chronic use. But caution exists for a reason and that's all I've been trying to share. If I was a doctor I would inform all my diabetic patients about Afrezza so they could make the best choice for themselves. But I think it would be imprudent for one to do so without mentioning that there isn't enough evidence yet to support the safety of chronic use. And I can't speak for any of the doctors I have talked to. I'm just explaining as best as I can why I think they said what they said. I did some of my own research to try to understand and after doing so, I think they are being too conservative, but it's their license and conscience to do with what they please. Do no harm was their oath. They don't see insulin as being the major issue. Maybe if, like Sam, all other boxes could be checked, they may be more aggressive with their treatment. Who knows. I don't disagree with you that it is a doctors choice, but I have dealt with many doctors regarding AFREZZA and let's be honest... Many doctors don't even take the time to understand it and the real world benefits... Many doctors don't like change and go by the motto "don't be the first and don't be the last..." I just met a T2 today in the gym who has an Hba1c in the 7's with BG's often in the high 300's. He is on two different meds one of which is an injectable. After speaking with him today he is going to talk with his endo about AFREZZA. As for Sam's comment yes opinions may vary and there are many but to me it makes a lot of sense and is very rational/logical... Cost benefit is a sound basis for making such decisions... And the known costs in this case are quite high and irreversible...
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Post by mannmade on Sept 2, 2016 12:11:40 GMT -5
This is the list on the "Find a Doctor" page with the blurb "Looking to find a doctor who can prescribe AFREZZA for you"? Color me cautious, but I wonder what that really means. All the page says is that those doctors have "experience with AFREZZA" which could mean a lot of things. I'm not at all sure it means a particular doctor on the list has ever prescribed Afrezza. Maybe all it means is that a rep visited and spoke to a doctor? That is a far cry from that doctor ever having prescribed Afrezza, or even being likely to do so. The list probably includes providers who have registered with MannKind Cares, even if they have not yet prescribed. Here's the important meaning of the list for me... You need their consent to post their names and so am guessing they are willing to prescribe, which is all that matters to me at this point... Willing doctors!!!! And where there is a will there is way... If not why would Mnkd put them on the list?
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Post by mannmade on Sept 1, 2016 21:26:08 GMT -5
I have posted this before but seems relevant again... I had dinner with Sam F and he told me regarding the lung safety issue the following:
"When I weigh the chance for the POSSIBILITY of cancer or other lung issues related to using AFREZZA which have yet to show themselves in any statistical meaningful way (with all the testing of 1,000's of patients over the course of the trials) versus the CERTAINTY that with my Hba1c in the 10''s (he admitted to being out of control most of his life despite a rigorous work out regime and watching what he ate) prior to starting AFREZZA (he is now in non-diabetic range) that I would likely go blind, suffer kidney and heart damage and loss of limbs... It was really a very clear choice for me.
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Post by mannmade on Sept 1, 2016 19:39:17 GMT -5
Don't you find it amazing someone would write an article of length on a company they have no interest?! Perhaps you should not run amok reproducing this kind of tripe. Not sure what your position is here. Fud pumper? Steve, are you talking to me? As I was the original poster of this article. Personally I do not like Tripe and will always take a cheese burger and fries over tripe any day... As for running amok I prefer running in a straight line or following a path like I used to when running track, cross country and marathons... If you don't already know my position then we can pm and I will clarify for you. Regardless, I believe all information regarding Mannkind is relevant even if it is FUD for several reasons: 1. Not for me to decide who this information will or will not benefit, 2. I personally believe when I invest I want to know who is out there as part of the "collective conversation," positive and negative 3. I like to assess the veracity for myself and determine if there is anything to the article that might effect my thoughts about my investment which I may need to adjust. Eg; lots of FUD the past week and a half and so bought a serious amount of leaps for 01.18 at $1 strike at .17 and .18 cents. Believe the are back up to .21 today. 4. If I determine it is pure FUD then it may still have value with respect to my gauging the timing of my next investment into the stock as part of item 3 above. 5. I copy and paste the whole article so no one has to click on a link and pay the author... 6. Lastly knowing the FUD arguments and being able to provide myself with a rational answer as to why they are FUD allows me to feel more confident in my investment at times like this. I wish you the best of luck with Mnkd... .
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Post by mannmade on Sept 1, 2016 19:13:04 GMT -5
Believe Matt P said Agreement still in effect thru September if I recall correctly.
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Post by mannmade on Sept 1, 2016 19:11:24 GMT -5
I like it a lot as well... Couple of suggestions on my end as follows:
1. Doctors' list should be by each state in alphabetical order not by doctors last name. Then can see under each state what docs prescribe by last name in alpha order Say's manmade insulin but should also say only human insulin (and only monomeric) with less additives, eg: Zinc
Was just a glance so this was it for me. But I like much better than Sanofi...
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Post by mannmade on Sept 1, 2016 12:21:12 GMT -5
Elizabeth Warren just demanded Mylan come clean about one of the biggest secrets in pharma
Linette Lopez 24h 15,003 48 FACEBOOK LINKEDIN TWITTER elizabeth Warren Sen. Elizabeth Warren Reuters Sen. Elizabeth Warren (D-Massachusetts) has demanded that the CEO of drug company Mylan, Heather Bresch, answer a very uncomfortable question for those in the drug industry: What exactly is going on with your patient assistance programs?
This question is vital because Bresch and her company are in the midst of a firestorm. Last week, consumer rage over a 500% price increase to the company's flagship product, the EpiPen, hit a fever pitch.
The ubiquitous antiallergy shot can be lifesaving, and many children are required to purchase a two-pen pack every year.
One pack costs $608. In 2007, before Mylan bought the drug, it cost $100. The cost to make the EpiPen still sits at around $3.
Bresch, meanwhile, took home about $18 million in compensation last year and stands to make a lot more if she can substantially increase her company's earnings per share by 2018.
So on Tuesday, Warren sent an eight-page letter to Bresch signed by 20 senators, including former presidential candidate Bernie Sanders (I-Vermont), demanding to know more about Mylan's patient assistance programs.
Last week, Bresch said the company would expand these programs to give more people access to the drug — something you see across the drug industry these days.
Warren, however, doesn't buy that.
"These changes will help some customers who are struggling to afford EpiPens. Your discount programs, however, represent a well-defined industry tactic to keep costs high through a complex shell game," Warren wrote.
"When patients receive short-term co-pay assistance for expensive drugs, they may be insulated from price hikes, but insurance companies, the government, and employers still bear the burden of these excessive prices. In turn, those costs are eventually passed on to consumers in the form of higher premiums."
Mylan CEO Heather Bresch CNBC screenshot
If the car is smoking... This isn't the first time Warren has asked about these programs.
In April, executives from Valeant Pharmaceuticals were in the hot seat. Valeant came under fire for its price increases last fall once Congress got wind that it jacked up the prices of two lifesaving heart medications, Nitropress and Isuprel, by 525% and 212%, respectively.
Valeant said it would solve this problem in part through patient assistance programs.
Warren, again, was not satisfied.
"You double the price, even if you get a waiver to the customer, you make a lot of money," Warren said during the Valeant hearing. "What is the return on investment to Valeant on the money you're currently putting into the patient-assistance programs?"
No one could answer.
"Don't tell me you've never done the analysis," Warren continued. "By doing this you ... keep the patient on the more expensive drug and then you ... recoup whatever from the insurance company."
Business Insider has repeatedly asked Valeant about its patient assistance programs as well and has yet to receive any concrete answers about who manages it and how it works.
Look under the hood EpiPen AP/Rich Pedroncelli In Mylan's case, Warren wants a breakdown of: how many people have used Mylan's coupons and programs, how much they save, how many people Mylan expects will save money now that the programs have been expanded, how much discounted EpiPens have cost insurers, how consumers are directed to these assistance options, details about its EpiPen4Schools program, and more.
One of the most important questions she asked was about how these programs interact with Medicare and Medicaid. The answer should be that they don't.
"It is illegal for consumers covered under Medicare or Medicaid to use the savings card, nor can these consumers access EpiPens through the patient assistance program," Warren wrote.
She got on Valeant's case about this in April, too.
Warren also had important questions about Mylan's new generic version of EpiPen that will be brought to market in a number of weeks.
"Mylan claims that the branded version of the EpiPen and the 'authorized generic' are 'identical,'" Warren wrote. "Given that the $300 generic and $600 branded EpiPen are functionally equivalent, how does Mylan justify the higher price of the branded EpiPen? ... Will Mylan commit to not rationing the product or sale of the authorized generic version of EpiPen?"
Solid questions.
Mylan has until September 12 to answer these questions. Rep. Elijah Cummings (D-Maryland) has also requested a House hearing on the matter in September. Tick tock.
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Post by mannmade on Sept 1, 2016 11:58:54 GMT -5
Seems to me, t add to what Baba said, why bother. You only lower the share price that much more for the next round of financing as one month's expenses will not be enough to put off the need for more by 1st Q.
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