PDA

View Full Version : Boehringer wins first US OK in blood-thinner race



Islander
10-20-10, 12:40 PM
Tue Oct 19, 2010

LOS ANGELES (Reuters) - German drugmaker Boehringer Ingelheim won the first U.S. approval for a new stroke-fighting medicine that will compete in an estimated $10 billion market for drugs to replace the 65-year-old blood thinner warfarin.
The Food and Drug Administration cleared Boehringer's drug, Pradaxa, for preventing strokes in patients with a type of irregular heart beat.

The approval gives Boehringer a head start over several other drugmakers, including partners Bayer and Johnson & Johnson, and Bristol-Myers Squibb Co and Pfizer, that are working on competing drugs. Pradaxa and potential rivals are alternatives to warfarin, a problematic medicine originally developed as rat poison.

Warfarin is the treatment of choice for people at high risk of stroke due to atrial fibrillation, a common form of irregular heart beat. But the drug interacts badly with food and other medicines, carries a high risk of bleeding and requires regular blood tests.
In September, an FDA advisory panel voted 9-0 to recommend approval of Pradaxa, which also carries a risk of serious bleeding.
The warfarin replacement market is expected to be worth more than $10 billion a year and possibly as much as $20 billion. Bayer Chief Executive Werner Wenning recently put the opportunity at $12 billion to $15 billion.

At least eight potential warfarin replacements are currently being tested by major drugmakers. An estimated 2.3 million Americans have atrial fibrillation, and the prevalence is expected to grow to 5.6 million by 2050 as the population ages, Boehringer said.

Boehringer, now controlled by great-grandchildren of the company's founder, suffered a setback in June when U.S. advisers rejected the company's experimental sex pill for women. The company recently halted development of that drug.
(Reporting by Lisa Richwine (http://blogs.reuters.com/search/journalist.php?edition=us&n=lisa.richwine&) and Deena Beasley; Editing by Steve Orlofsky)

http://tinyurl.com/3xj8qq7

mellowsong
10-21-10, 08:31 PM
Proteolytic enzymes such as NATTOKINASE or LUMBROKINASE are the answer. Of course, they can't be patented so are completely overlooked and discredited by the pharmaceutical and medical industries.

These work on fibrinogen and actually DISSOLVE clots, not just help prevent. They have been proven to REVERSE coronary artery blockage in 2 years. They are also potent anti-inflammatory agents. These enzymes carry very little risk of excess bleeding compared to warfarin.

Islander
10-21-10, 09:32 PM
You know, I could swear I made that very comment, Mello. Maybe I forgot to hit the POST button? We old folks have these memory lapses, y'know?

One does have to be careful with the kinases, though. I was taking Nattokinase 3x/day for a while and then, twice in a row, I knocked my hand and my knee and noticed a lot of sub-cue bleeding that spread and took a very long time to resorb. At that point I cut out the supplementation completely. Don't think I really need it anyway. Any potential clots I might have had are long gone!

LabDoc
10-22-10, 02:16 AM
Have to take exception to the use of the word 'preventing'. The implication here is that if you take Pradaxa you 'will not' have a stroke - like warfarin, this is simply incorrect. Anticoagulants acting on the Extrinsic coagulation Factors II, V, VII, and X, have been proven to REDUCE the risk of stroke, pulmonary embolism, deep vein thrombosis, NOT prevent them happening.
Use of kinases should be reserved for hospitalized patients because of their potency and require more blood tests to regulate the dosage than warfarin. If bleeding occurs when on kinases it is a Medical Emergency and pro coagulants need to be administered, merely stopping the medication is not enough. I have personally seen several patients literally bleed to death due to kinases.

Reesacat
10-22-10, 11:26 AM
LabDoc-were the patients on Nattokinase? I am curious since in the USA it is sold as an OTC supplement, recommended by many alternate health practitioners since 1990's. I haven't heard of any deaths due to Nattokinase as far as I can recall. (Nattokinase made from fermented nattocheese/soybeans).

mellowsong
10-22-10, 11:44 AM
LabDoc, come off it. I am not talking about urokinase etc, I'm talking about natto and lumbro kinase. I don't believe you've had anyone bleed to death from taking these. These are over the counter. When I used "prevent" I am well aware that they don't prevent these events but lessen the risk...should have been more explicit I guess.

However, the OTC kinases are safe, even in high doses. I replaced coumadin with nattokinase 3 years ago (have a genetic clotting disorder and had spontaneous multiple bilateral pulmonary emboli in 1998). I can eat whatever I want, no blood tests required ...sorry but I take extreme exception to your fear tactics when you don't know what you are talking about.

LabDoc
10-23-10, 11:54 AM
Mellow, sorry if I have upset you. I was speaking of Streptokinase without realizing you were referring to OTC kinases. I was not objecting to your use of the word 'preventing', but in Islanders quoted article, was not having a go at you at all. Just in relation to Streptokinase, these are not fear tactics, they are facts, for the record, I ran a Coagulation Laboratory in a major hospital for several years in my previous life, so think I do know what I am talking about. Please pardon me for my misinterpretation, think I read what I wanted to read instead of what was written on your post. Mea Culpa

Reesacat
10-23-10, 11:59 AM
Thank you, LabDoc. Streptokinase is scary stuff-in USA only available by prescription as is urokinase. Anyone on those drugs needs constant monitoring by MD.

mellowsong
10-23-10, 12:28 PM
Mellow, sorry if I have upset you. I was speaking of Streptokinase without realizing you were referring to OTC kinases. I was not objecting to your use of the word 'preventing', but in Islanders quoted article, was not having a go at you at all. Just in relation to Streptokinase, these are not fear tactics, they are facts, for the record, I ran a Coagulation Laboratory in a major hospital for several years in my previous life, so think I do know what I am talking about. Please pardon me for my misinterpretation, think I read what I wanted to read instead of what was written on your post. Mea Culpa

Apology accepted. I guess I got a little upset. I felt insulted and that people would see the "doc" in your name and immediately assume you were right :) So, therefore, I also apologize for over reacting :)

I have had such remarkable results from nattokinase as far as pain, inflammation and anti coagulation that I am a huge believer in it. For example, my hsCRP came down fro 7 to 0.3, ESR from >99 to 15. Pain is manageable with fish oil, natto and a occasional naproxen, vs almost 300mg of morphine/day.

I was an RN before I was injured and believe me, yes, I have seen people bleed to death from strepto and urokinase (as well as the miraculous turn arounds during stroke) It can happen even when used appropriately and I would never advise anyone to mess around with these :) So, I do understand where you were coming from also.

http://www.clipartguide.com/_named_clipart_images/0511-0808-2818-3535_Hippy_Giving_the_Peace_Sign_Clip_Art_clipart_ image.jpg

LabDoc
10-23-10, 12:48 PM
WoW Mellow! Fantastic results with the natto, you must be so pleased. Wish some of us 'trained conservatives' could get through to the 'old school' types.

mellowsong
10-23-10, 01:08 PM
WoW Mellow! Fantastic results with the natto, you must be so pleased. Wish some of us 'trained conservatives' could get through to the 'old school' types.

Yeah that's for sure :) I forgot to say that I replaced 9 years of Coumadin with nattokinase (and fish oil) with excellent results. Since I'm a klutz in the kitchen...I do my own bleeding times, lol. I got off Coumadin because once I changed my diet to unprocessed, whole foods, they absolutely could not get my INR therapeutic. At one point I was up to 12mg of Coumadin/day and the side effects were horrendous. I did a ton of research and took myself off much to their dismay. All I heard from docs and pharmacists was that I was going to die. 3 years later, with no blood clots, nobody bugs me anymore.

Of the myriad of docs I've had to see the last year, one has paid attention and tried to learn from what I'm telling him about my supplements. I figure that's a start considering he is an infectious disease specialist, Assistant Medical Director of the VA and medical school, Chief of Education and a professor. He subspecializes in CFIDS and VA recently started a Chronic Fatigue clinic which is how I met him. So he is a great person to be interested in what I've learned, lol.

Islander
10-23-10, 01:23 PM
Doesn't it feel wonderful to have a qualified professional take you seriously? I mean I dunno, it rarely happens, but it must feel great!

mellowsong
10-23-10, 04:40 PM
Doesn't it feel wonderful to have a qualified professional take you seriously? I mean I dunno, it rarely happens, but it must feel great!

Yep, it is...gives me hope and a light in the darkness of allopathy :)

Samurai
10-23-10, 07:17 PM
However, the OTC kinases are safe, even in high doses. I replaced coumadin with nattokinase 3 years ago (have a genetic clotting disorder and had spontaneous multiple bilateral pulmonary emboli in 1998). I can eat whatever I want, no blood tests required .

Mellow,
You don't have to watch your INR numbers with kinases?

Reesacat
10-23-10, 07:49 PM
Mellow,
You don't have to watch your INR numbers with kinases?

I think the INR measures different clotting factors (like the ones the drug Coumadin affects) than what the nattokinase affects, which is fibrinogen. LabDoc and Mellow would know more.

mellowsong
10-23-10, 09:05 PM
Nope, PT/INR strictly looks at prothrombin, which is a precursor of thrombin. Kinases work on fibrinogen. Fibrinogen can be measured and increased fibrinogen is usually a sign of severe inflammation and high fibrinogen does put you at increased risk of blood clots. Anyone on natto or lumbro or any of the other OCT proteolytic enzymes should make sure a doc knows what they are taking and gets fibrinogen measured before a surgical procedure. It is difficult to convince a doc to measure fibrinogen though.

Kinases: Break down fibrinogen
Coumadin and other coumarin derivatives: Antagonizes Vitamin K which is needed for the liver to synthesize clotting factors.
Heparin: Upregulates a natural anticoagulant produced by the body
Anti-platelets: (aspirin, Plavix etc) Decrease the stickiness of blood platelets which, clumped together, are part of blood clots.

There are a myriad of clotting factors in the blood and interfering anywhere in the clotting cascade can lessen the risk of a blood clot. However, all of the prescription anticoagulants and even aspirin carry quite a risk of hemorrhage. While I won't say this can't occur with the OTC proteolytic enzymes, the likelihood is much less.

Reesacat
10-23-10, 09:28 PM
Mellow, you rock!

LabDoc
10-23-10, 10:46 PM
mellow, go to top of the class for Coagulation 101 !
The Prothrombin Time is the actual test performed to measure the effectiveness of the Vitamin K dependant 'Extrinsic' clotting Factors II V VII and X and indirectly gives an indication of fibrinogen and fibrin formation as these are the endpoint of the test. The result obtained in the test is a time in seconds taken for the plasma to 'clot' usually around 12, 13, 14 seconds.
The INR - International Normalised Ratio - is not a test, it is a method of expressing the result of the prothrombin time and is obtained by dividing the test result by the accepted 'normal' time. Hence a prothrombin result of 13 seconds would be expressed as an INR of 1.0. PT of 26 seconds - INR 2.0 etc.
It is common these days to use the term PT/INR interchangeably and less confusion for patients. Different clinical reasons for taking Warfarin have different therapeutic INR ranges so you should never compare your results with someone else even if they are taking it for the same reason as you.
Hope this helps.

Reesacat
10-23-10, 10:56 PM
LabDoc, you rock also! Thank you-Sam had a good question, too.

LabDoc
10-23-10, 11:02 PM
Slightly off the point, I have to wear a wristband stating my allergy to ASPIRIN. I get bradycardic and then arrest!! It's not nice waking up to be told you have just been jump started! So even simple medications can be dangerous, you may or may not be surprised at the number of pharmaceuticals and foodstuffs which contain salicylates (aspirin). Don't get me started on headaches again!

LabDoc
10-23-10, 11:04 PM
reesacat, thanks, glad I can get my rocks off from you ??!!??

Reesacat
10-23-10, 11:13 PM
reesacat, thanks, glad I can get my rocks off from you ??!!??

Naughty LabDoc! ROTFL!!
http://www.addemoticons.com/emoticon/cat/AddEmoticons00948.gif

BryanPerret
07-10-12, 08:04 AM
Earlier this year, a study conducted by researchers Ken Uchino from Cleveland Clinic and MD Adrian V. Hernandez, involving seven clinics and 30,514 patients revealed that patients who are taking the anticoagulant drug Pradaxa may present a 33% higher risk of heart attack or heart disease than patients who were taking other drugs such as warfarin.

Source: "http://www.pradaxainjury.com/"

Islander
07-10-12, 08:21 AM
Welcome, Bryan. Start a thread in New Members forum and introduce yourself, please!