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Post by EveningOfTheDay on Oct 27, 2015 10:47:32 GMT -5
I believe the reason they chose afrezza is because praluent itself is injected and they likely don't want any skin reactions that might arise from injected insulin to be blamed on praluent: "The most common side effects of Praluent include itching, swelling, pain, or bruising where injection is given..." Furthermore, you seem to have a knack for completely disregarding positive or possibly positive factors that might not suit your personal interpretation of the story. ...and, if I might add, a faulty logic, as your statement and quotation clearly demonstrate.
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Post by EveningOfTheDay on Oct 27, 2015 10:53:20 GMT -5
Its a good news, bad news story. Let me try and thread that needle, and I admit I'm in a bit of a dark mood this morning. Good news. SNY runs a long trial with Afrezza , so wont drop it. Bad news. They dont want to prove Afrezza the blockbuster many of us here believe it could be , obsoleting many other diabetic and cholesterol lowering drugs. So this limbo status continues for 2, 3 or how many years. This clinical trial does nothing to justify to insurers to improve their coverage, nor to does it suggest to doctors a new protocol where nothing other than Afrezza and metformin is all most T2s needs (as do probably most pre-diabetics as that will nix their CVD risk too) Law and behold, Sanofi might not be dropping Afrezza after all. Well, since it was a ridiculous notion anyway, I am rather not surprise nor impressed by this apparent "good news". As for your "bad news" perspective, in my humble opinion, it just does not hold water, no matter how you look at it. With aloha.
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Post by od on Oct 27, 2015 10:53:57 GMT -5
Afrezza will be blamed? What are you talking about again? This seems like another attempt to diffuse a good news story? You seem to have a glass empty type of view of all things Afrezza... Its a good news, bad news story. Let me try and thread that needle, and I admit I'm in a bit of a dark mood this morning. Good news. SNY runs a long trial with Afrezza , so wont drop it. Bad news. They dont want to prove Afrezza the blockbuster many of us here believe it could be , obsoleting many other diabetic and cholesterol lowering drugs. So this limbo status continues for 2, 3 or how many years. This clinical trial does nothing to justify to insurers to improve their coverage, nor to does it suggest to doctors a new protocol where nothing other than Afrezza and metformin is all most T2s needs (as do probably most pre-diabetics as that will nix their CVD risk too) Come on folks, this is a study for Alirocumab, not Afrezza. I agree that more Afrezza specific trials are in order (and I am sure forthcoming). Yes, there will be all kinds of spin on the protocol and the results, but SNY is sponsoring this trial on behalf of Alirocumab, period.
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Post by jpg on Oct 27, 2015 11:25:28 GMT -5
Afrezza will be blamed? What are you talking about again? This seems like another attempt to diffuse a good news story? You seem to have a glass empty type of view of all things Afrezza... Its a good news, bad news story. Let me try and thread that needle, and I admit I'm in a bit of a dark mood this morning. Good news. SNY runs a long trial with Afrezza , so wont drop it. Bad news. They dont want to prove Afrezza the blockbuster many of us here believe it could be , obsoleting many other diabetic and cholesterol lowering drugs. So this limbo status continues for 2, 3 or how many years. This clinical trial does nothing to justify to insurers to improve their coverage, nor to does it suggest to doctors a new protocol where nothing other than Afrezza and metformin is all most T2s needs (as do probably most pre-diabetics as that will nix their CVD risk too) There is no reason whatsoever to believe Afrezza will obsolete any lipid lowering drug. Good post prandial glycemic control could theoretically and anectodately help with 'metabolic syndrome' but that is by far a magic bullet for all things lipid. I will again state that this type of study is a big deal for Afrezza and forward seeing. I do not see your or accept your bad news scenario.
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Post by rrtzmd on Oct 27, 2015 11:31:36 GMT -5
I cannot agree given the objectives: "To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in patients with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy. To evaluate the safety and tolerability of alirocumab in patients with diabetes treated with insulin." Whatever the results, praluent will get the limelight for anything positive. Sanofi may even resort to blaming afrezza for any bad results. I believe the reason they chose afrezza is because praluent itself is injected and they likely don't want any skin reactions that might arise from injected insulin to be blamed on praluent: "The most common side effects of Praluent include itching, swelling, pain, or bruising where injection is given..." Afrezza will be blamed? What are you talking about again? This seems like another attempt to diffuse a good news story? You seem to have a glass empty type of view of all things Afrezza... No, I'm merely assessing the possibilities. Praluent is already approved, so Sanofi, with this study, is most likely looking for justification to move up the "tier" ladder in order to improve reimbursement from third party payors. In that aspect, this trial is similar to the large "real life" trial they are doing for toujeo. Like I said, SNY likely wanted to avoid injected insulin in order to prevent praluent getting the blame for any skin reactions caused by insulin injections, hence avoiding "adverse reactions" that insurance companies can hold against the drug. Now, the thing is, if the trial is successful and praluent works, it will be given all the credit since it is a "big ticket" item with all of the profit going to SNY. On the other hand, if it doesn't work out in praluent's favor, it wouldn't surprise me if SNY went looking for something to blame it on -- that happens frequently after failed trials -- hence the possibility that afrezza may find itself being the one getting blamed.
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Post by rrtzmd on Oct 27, 2015 11:44:07 GMT -5
I believe the reason they chose afrezza is because praluent itself is injected and they likely don't want any skin reactions that might arise from injected insulin to be blamed on praluent: "The most common side effects of Praluent include itching, swelling, pain, or bruising where injection is given..." Furthermore, you seem to have a knack for completely disregarding positive or possibly positive factors that might not suit your personal interpretation of the story. ...and, if I might add, a faulty logic, as your statement and quotation clearly demonstrate. I'm afraid I don't see where the logic is faulty. In a trial, all adverse events are recorded under a single heading such as "skin and subcutaneous tissue disorders." The etiology of the adverse event is not assessed nor recorded, just the numbers that occur. Adverse events can affect payor reimbursement decisions. Hence, SNY wants to avoid as many as they can. Praluent itself is already known to produce skin reactions. Insulin injections are also know to produce skin reactions. Eliminating injected insulin from the protocol eliminates one source of skin reactions -- simple as that.
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Post by jpg on Oct 27, 2015 11:49:08 GMT -5
Afrezza will be blamed? What are you talking about again? This seems like another attempt to diffuse a good news story? You seem to have a glass empty type of view of all things Afrezza... No, I'm merely assessing the possibilities. Praluent is already approved, so Sanofi, with this study, is most likely looking for justification to move up the "tier" ladder in order to improve reimbursement from third party payors. In that aspect, this trial is similar to the large "real life" trial they are doing for toujeo. Like I said, SNY likely wanted to avoid injected insulin in order to prevent praluent getting the blame for any skin reactions caused by insulin injections, hence avoiding "adverse reactions" that insurance companies can hold against the drug. Now, the thing is, if the trial is successful and praluent works, it will be given all the credit since it is a "big ticket" item with all of the profit going to SNY. On the other hand, if it doesn't work out in praluent's favor, it wouldn't surprise me if SNY went looking for something to blame it on -- that happens frequently after failed trials -- hence the possibility that afrezza may find itself being the one getting blamed. You are simply repeating the same FUD. And I will simply repeat that I find your point ill thought out and uninformed. I will go one step furthur and state you seem to have little understanding of how 'companion drugs' are chossen and why. What you are saying (the skin thing:what??) shows a deep knowledge discomect to how companion drugs are picked or is simply more FUD. The study is not directly about Afrezza but a very big deal that Afrezza is used. You don't use a drug that won't be around or that you think will be a minor players. Sanofi is directly linking Afrezza with the new best lipid thing around.
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Post by mnholdem on Oct 27, 2015 12:11:14 GMT -5
PRALUENT is an injectable prescription medicine called a PCSK9 inhibitor. PRALUENT is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL cholesterol) or atherosclerotic heart problems, who need additional lowering of LDL cholesterol.
That (above) is the label description, although it seems clear from the website that Sanofi/Regeneron are targeting more that just patients with Heterozygous FH:
"Some people need extra help managing their bad cholesterol (LDL-C). Along with your statin, PRALUENT is a new medicine that can help lower your bad cholesterol. PRALUENT works differently than statins to lower your LDL-C. It works by increasing the body’s natural ability to remove cholesterol from the blood stream." www.praluent.com/what-is-praluent
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At first blush, I wondered if this trial were some kind of precursor of a future multi-drug treatment related to high cholesterol and diabetes, but in the sites that I have perused which provide a description of Praluent and what it treats, there is no mention of diabetes. Of course, that just may be the FDA not permitting certain statements.
People with diabetes are more prone to having unhealthy cholesterol levels, which contributes to cardiovascular disease. By taking steps to manage cholesterol, individuals can reduce their chance of cardiovascular disease and premature death.
www.heart.org/HEARTORG/Conditions/Diabetes/WhyDiabetesMatters/Cholesterol-Abnormalities-Diabetes_UCM_313868_Article.jsp#.Vi-yE2eFO70
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NOTE: Below is a brief description of the disorder for which Praluent is used as a treatment, according to its label: Familial hypercholesterolemia (FH) is an autosomal dominant disorder that causes severe elevations in total cholesterol and low-density lipoprotein cholesterol (LDLc).
Heterozygous Familial Hypercholesterolemia
The following are used in the management of heterozygous FH:
• Lifestyle modification, including diet (limited saturated fats, trans fats, and cholesterol); weight management; aerobic/toning exercises • HMG-CoA reductase inhibitors (statins) (eg, simvastatin, atorvastatin, or rosuvastatin), and one or more other LDL lowering medications, or • Bile acid sequestrants, or • Ezetimibe, or • Niacin • Estrogen replacement therapy in postmenopausal women
emedicine.medscape.com/article/121298-overview
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Post by peppy on Oct 27, 2015 12:31:59 GMT -5
I wondered if this trial were some kind of precursor of a multi-drug treatment related to high cholesterol and diabetes, but in the sites that I perused that provide a description of Praluent and what it treats, there is no mention of diabetes.
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PRALUENT is an injectable prescription medicine called a PCSK9 inhibitor. PRALUENT is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL cholesterol) or atherosclerotic heart problems, who need additional lowering of LDL cholesterol.
www.praluent.com/what-is-praluent
Familial hypercholesterolemia (FH) is an autosomal dominant disorder that causes severe elevations in total cholesterol and low-density lipoprotein cholesterol (LDLc).
Heterozygous FH
The following are used in the management of heterozygous FH:
• Lifestyle modification, including diet (limited saturated fats, trans fats, and cholesterol); weight management; aerobic/toning exercises • HMG-CoA reductase inhibitors (statins) (eg, simvastatin, atorvastatin, or rosuvastatin), and one or more other LDL lowering medications, or • Bile acid sequestrants, or • Ezetimibe, or • Niacin • Estrogen replacement therapy in postmenopausal women
emedicine.medscape.com/article/121298-overview
interesting. the blood laboratory results of some require both cholesterol lowering as well as better blood glucose control. The drug is interesting as well. Take a look. The recommended starting dose of PRALUENT is 75 mg administered subcutaneously once every 2 weeks, Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. 7
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Post by mnholdem on Oct 27, 2015 12:42:24 GMT -5
Can you write that in a "dumb swede" translation? I didn't understand a single thing you wrote...except "Chinese Hamster" (chuckle).
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Post by jpg on Oct 27, 2015 13:07:31 GMT -5
PCSK9 is THE in lipid loweri target. It is the future of cholesterol management. Anything Sanofi does around this space is big news.
We should all be excited that Afrezza is used in any 500 patient study incolving this class of drug. If and when the lipid profiles and primary outcomes do well it will be in the context of using Afrezza. Look up the recent outcome studies with PCSK9 inhibitors to see how powerful linking Afrezza to this group can and will be. Sanofi is trying to redefine optimal cardiovascular care in diabetes. Afrezza seems to be inimately related to this aim.
Don'tl listen to the FUD (or uninformed guessing to be more generous as to intent) being spread to minimize this latest news. This to me us the big news of the month.
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Post by peppy on Oct 27, 2015 13:45:14 GMT -5
Can you write that in a "dumb swede" translation? I didn't understand a single thing you wrote...except "Chinese Hamster" (chuckle). Thank you for asking.
I may have it all wrong. I image an antibody "the drug" that reacts to something on the surface of lipids, attaches to the lipid with that as the "antigen", then being able to call in macrophage and neutrophils to EAT the lipid.
Wow. There is film now in presentations using electron microscopes magnified at least 30,000 times, showing neutrophils and macrophage/neutrophils "eating things they recognize". I know where to find some good ones. A neutrophil going after a bacteria screencast.com/t/PKnookF6cuz2 the bacteria engulfed screencast.com/t/RTdlREj4A the video is sped up.
Anyway, the thought, (perhaps wrong) of lipid eating macrophage, weehaw. with afrezza, this is an exciting study screencast.com/t/hG6fYq1Jr
www.youtube.com/watch?v=gKkvTXLvbhs I'll snap a picture of it. it is a long video.
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Post by tripoley on Oct 27, 2015 14:15:27 GMT -5
"Why is Afrezza included?" Estimated enrollment is 500. To double script numbers? LOL. Could also be a cheap way for SNY to get more safety data on Afrezza.
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Post by goyocafe on Oct 27, 2015 14:30:08 GMT -5
I wondered if this trial were some kind of precursor of a multi-drug treatment related to high cholesterol and diabetes, but in the sites that I perused that provide a description of Praluent and what it treats, there is no mention of diabetes.
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PRALUENT is an injectable prescription medicine called a PCSK9 inhibitor. PRALUENT is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL cholesterol) or atherosclerotic heart problems, who need additional lowering of LDL cholesterol.
www.praluent.com/what-is-praluent
Familial hypercholesterolemia (FH) is an autosomal dominant disorder that causes severe elevations in total cholesterol and low-density lipoprotein cholesterol (LDLc).
Heterozygous FH
The following are used in the management of heterozygous FH:
• Lifestyle modification, including diet (limited saturated fats, trans fats, and cholesterol); weight management; aerobic/toning exercises • HMG-CoA reductase inhibitors (statins) (eg, simvastatin, atorvastatin, or rosuvastatin), and one or more other LDL lowering medications, or • Bile acid sequestrants, or • Ezetimibe, or • Niacin • Estrogen replacement therapy in postmenopausal women
emedicine.medscape.com/article/121298-overview
interesting. the blood laboratory results of some require both cholesterol lowering as well as better blood glucose control. The drug is interesting as well. Take a look. The recommended starting dose of PRALUENT is 75 mg administered subcutaneously once every 2 weeks, Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. 7
Maybe they already have evidence that Afrezza (through an internal study) has a direct effect on metabolic syndrome, but are using Afrezza as "just another diabetes drug" for now since there is nothing known to the FDA about this benefit. As such, they're piggy backing on Afrezza to show better results of Praluent. Long shot, I know.
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Post by Deleted on Oct 27, 2015 14:40:35 GMT -5
dem sneaky bas**ards..lol
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