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  1. I sent a note to Shire and the FDA BUT another thread posted a response from Shire that said they were going to discontinue the drug in September 2010 for business reasons. The generic companies would also have to cease manufacturing. So I'm wondering how much good lobbying the FDA is going to do if the drug company is saying they don't want to continue manufacturing the drug?! I remember Dr. Grubb told me there is no $$$ in low blood pressure, hence the lack of research and meds. I'm super bummed. I was on Midodrine for a few years and now I take cymbalta and only use midodrne "as needed" which is about 1x a month for periods of extended standing. It has been a security blanket for me.
  2. Soooo frustrating. Wonder how long we have to stockpile before they pull it??!!
  3. I recall it taking only a couple of days, less than a week. What dose did they start you at. I started at 20mg and have found that works best for me -- I tried 40mg and 30 mg but I had side effects. I vaguely recall dr. grubb saying that I might not feel anything at 20mg but I definitely had pretty immediate results.
  4. I have had excellent results with cymbalta as prescribed by dr.grubb. It really stabalized my POTS symptoms and got me functioning pretty close to normal. I still have some orthostatic intolerance issues but I really am much better than I was 2 years ago!
  5. Dr. Grubb prescribed a low dose of 20mg of Cymbalta for POTS symptoms about 2 years ago. It has worked miracles for me, and some others who I know who also see him. He said it improves neurotransmission, he equated it to a diabetic taking insulin or with Parkinson = dopamine. I am nearly symptom free on Cymbalta + exercise + fluids/salt, vitamin D (by prescription). He seems to favor Cymbalta where as my other Cardiologist who treats POTS was slower to catch on to it but now she also reports good success with it at low dose. I think it is a drug that less is more for POTS.
  6. Hi, So sorry to hear about your daughter! I would imagine having POTS as a young person would pose its own set of issues. As far as the walking and standing goes, that was my biggest problem when I was fist "struck down" with POTS. Though I didn't know that's what I had until I saw Dr. Grubb in 2006. I remember having trouble walking from the couch to the door every morning to go to work. Before seeing Dr. Grubb my local cardiologist had me on too much florinef and Midodrine and I actually think that made walking worse. I no longer take either and am only using cymbalta as prescribed by Dr. Grubb. So one thing to look at is how the meds are helping her or possibly causing new problems? I have heard from other people that florinef can cause trouble with walking. Also are they checking her potassium on the florinef? Even a low normal can be a problem from what I was told. One of the many many tips I got from Dr. Grubb about life/POTS/walking was: "In order to improve a person with POTS needs to do what their body wants to do least" He was referring to standing and walking. I tell myself that every time I want to avoid walking. After 3 years I have improved a lot but I am only about 70-75% of what I once was in terms of orthostatic tolerance. Good luck!!!!
  7. I have been reading about Droxidopa -- it targets norepinephrine...sounds like same idea as the SSNRIs... I will be curious to ask my cardiologist if she knows about it! http://money.cnn.com/news/newsfeeds/articl...wire/127219.htm
  8. Dr. Grubb told me that any of the gastrointestinal autoimmune discorders such as celiac/gluten intolerance are a principal trigger for POTS in some people. He believe this was definitley the case in my abrupt onset of POTS. I did not have all the classic gastro symptoms associated with celiac and I am blood/gene negative but biopsy positive. Once I went gluten free most of my gastro symptoms improved and my autonomic dysfunction/orthostatic intolerance got much worse. He said that's typical with the autoimmune stuff. Now cymbalta the cymbalta he put me on is helping me a lot!
  9. They told me at the hospital my test was inconclusive, but my cardio who ordered the test said I had orthostatic hypotension and the Tachycardia was compensatory. Dr. Grubb read it as POTS. I said to him "but I thought there was no blood pressure drop with POTS?" even though in my gut/heart I knew it was POTS from all my reading. Dr. Grubb said I definitely had POTS and it is seen with or without a BP drop. Don't worry too much about the original tilt because he will do a very detailed exam and ask you a lot of questions and take you BP/HR in all posititons and then he'll make his own diagnosis.
  10. Good job on getting the referral! But you had to agree to get counseling?!! OH BOY THAT MAKES MY BLOOD BOIL. Here's the thing -- when you read some of the interviews Dr. Grubb had given he says by the time he sees a patient they have already gone to about 11 doctors. Because autonomic dysfunction is not well understood you can't expect to get much understanding from most doctors. The first doctor I saw (my PCP) after my first episode immediately went for the "you're going to need to learn to manage stress" lecture. I switched drs. Even my cardiologist had reached the end of the line with me, all she kept doing was upping the florinef & midodrine until I told her point blank I think should I go out of network and she was relieved I think and said "yes, you need t find a doctor who has "written the book" on your problem" That's when I decided to see Grubb. After I saw him he sent a very detailed summary of his diagnosis and I must say it was SWEET to know the doctors who thought I was crazy would have to read this! Have you had a tilt or seen a cardiologist? You really need to get all the testing done so Dr. Grubb will have something to work with, these results will really influence what he decides to treat you with... I see you are on Midodrine and Florinef, are the helping? Are you boosting the sodium to get the benefit of the florinef. I did not get much better until after I saw Dr. grubb and started cymbalta. After that I was able to get off the florinef and Midodrine completely, though my other cardiologist (the one Grubb referred me to) says keep the Midodrine in my medicine cabinet and I can use it as needed, though I haven't needed it in almost 2 years!
  11. The way the referral thing was explained to me by Grubb's office is that they just want to be sure that they will get your records. They said with all the patient privacy issues now they had problems getting records. I told my first Cardio who had reached the end of her rope with me that I had ggod news, found an expert who could help me and I needed a referral stating she would get him my records. It wasn't an option for her to say no, and I was paying out of my own pocket so why would she not give me a referral. Don't look at the referral as something your doctor has contol over, just state to your current dr./his office "this is what I want to do next, and this is what I need from you to help me"...
  12. Honestly after all the mixed reviews I've read here on Mayo I decided I didn't even want to apply there. I had my tilt done at my local hospital and I was so discouraged by the lack of help I got and the way I was blown off by drs. because it was not "life threatening" I was devistated too. After being "rejected" at UCLA, actually they offered me an appointment in the resident clinic NOT with the doctor I requested... I had ENOUGH. So I just called Dr. Grubb's office and made an appointment. It took a year to see him but it was 110% worth the wait. He diagnosed POTS from the test results I brought with and got me treated. The best part of going to see him was that he was able to refer me to a cardiologist in California who I never would have found on my own. She is awesome too and she has spent a lot of time at Vanderbilt. I feel like between her and Dr. Grubb I now have access to what I need. Maybe if you start by seeing someone else they might be able to get you in to someplace like Vanderbilt if you need that?
  13. Helen, You are not alone, My POTS sysmptoms got worse too once I started the GF diet. When I asked Dr. Grubb about this he explained it as part of the autoimmune process, he said removing gluten likely stopped the autoimmune process in my small intestine but then the autoimmune cells fought back by attacking and damaging my autonomic nervous system. Reserach has show that gluten intolerance/celiac DOES cause autonomic neuropothy in some people but unfortunately the gluten free diet does NOT reverse the autonomic neuropathy. BUT the bright side is that Dr. Grubb put my situation in the "abrupt onset" category of POTS which he said improved the odds of a reasonable recovery over time, and I have. Good luck to you!
  14. Has any one heard about this drug? It is supposed to be an alternatice to Midodrine and currently in use in Japan? Sounds like it is in Phase IIT trials FDA Grants Chelsea Therapeutics Orphan Drug Designation for Droxidopa Multi-Center Pivotal Phase III Trial Planned for Second Half 2007 CHARLOTTE, N.C., Jan. 22, 2007 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to its drug candidate Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with Primary Autonomic Failure, a group of diseases that includes Parkinson's Disease, Pure Autonomic Failure (PAF) and Multiple Systems Atrophy (MSA). The Orphan Drug Act provides for economic incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the United States. Orphan Drug designation will entitle Chelsea to seven years of market exclusivity for Droxidopa in the treatment of symptomatic NOH. Additional benefits include tax credits related to clinical trial expenses, a possible exemption from the FDA-user fee, and assistance in clinical trial protocol design. "Because of the U.S. Orphan Drug Act, there are incentives for companies like Chelsea to bring desperately needed drug therapies like Droxidopa to underserved patients who suffer from neurogenic orthostatic hypotension," said Dr. Horacio Kaufmann, the Alex and Shirley Aidekman Professor of Neurology, Mount Sinai School of Medicine and Director, Autonomic Disorders Research and Treatment Program. "Given its clearly delineated mechanism of action, extensive body of efficacy data and favorable safety reputation in the Japanese market, Droxidopa will help improve the health and quality of life for many patients with neurogenic orthostatic hypotension." Chelsea plans to initiate a double-blind pivotal Phase III trial comparing Droxidopa to placebo at multiple sites in the U.S. and Europe during the second half of 2007. The trial is intended to assess the safety and efficacy of Droxidopa in patients suffering from symptomatic NOH associated with Parkinson's Disease, Pure Autonomic Failure and Multiple Systems Atrophy with the primary efficacy endpoint being defined as improvement in orthostatic blood pressure over time. "Receiving this designation is an important step in both our clinical development and planned commercialization of Droxidopa, providing Chelsea with considerable strategic advantages by providing market exclusivity, reducing clinical development costs and facilitating future regulatory filings," said Dr. Simon Pedder, President and Chief Executive Officer of Chelsea. "With 7-years of exclusivity in place in the U.S. and 10-years in the EU, either under Orphan designation or as a new chemical entity, we have secured the necessary exclusivity to move aggressively ahead in our planned development of Droxidopa. We are pleased to have reached this critical milestone and look forward to working with the FDA to finalize our trial design and initiate our pivotal Phase III study later this year." As part of its Orphan Drug strategy for Droxidopa, Chelsea also filed an application for Orphan designation for the treatment of symptomatic NOH in patients with Primary Autonomic Failure with the EMEA. Based on the timing of this filing, Chelsea expects to receive a determination regarding EU Orphan status late in the first quarter 2007. About Droxidopa and Symptomatic Neurogenic Orthostatic Hypotension Symptomatic NOH is a neurogenic disorder resulting from a deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart. This deficiency results in decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, blurred vision and syncope. Droxidopa, an orally active synthetic precursor of norepinephrine, increases the supply of norepinephrine available for delivery to its receptors to improve orthostatic blood pressure and alleviate symptoms of orthostatic hypotension. Chelsea estimates that nearly 300,000 patients suffer from chronic symptomatic neurogenic orthostatic hypotension (NOH) in the U.S. and EU combined. In the U.S. alone, there is a defined population of approximately 72,000 patients that experience chronic, symptomatic NOH associated with Primary Autonomic Failure, a group of diseases that includes Parkinson's Disease, Pure Autonomic Failure and Multiple Systems Atrophy. In addition to creating significant health care costs, symptomatic NOH has a dramatic impact on the quality of life for those patients suffering from Primary Autonomic Failure. Midodrine, currently the only FDA approved treatment for orthostatic hypotension, not only fails to treat the underlying cause of symptomatic NOH but is limited in its use by a pronounced side-effect profile and black box warning for supine hypertension. Given the chronic nature of symptomatic NOH and the proven safety and tolerability of Droxidopa, Chelsea expects that daily oral treatment with Droxidopa should provide a significant improvement in the long-term treatment of symptomatic NOH. Droxidopa, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd. (DSP), initially received Japanese approval in 1989 for the treatment of frozen gait and dizziness on standing associated with Parkinson's Disease and for the treatment of orthostatic hypotension, syncope or dizziness on standing associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy. In 2000, Droxidopa received expanded marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients. Droxidopa has historically generated annual revenues of approximately $50 million in Japan. About Chelsea Therapeutics Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea's lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea's antifolate program is complemented by a strategic partnership with Active Biotech AB for the joint development of a portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is pursing an Orphan Drug strategy for the development of Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan. This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate CH-1504, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.
  15. This was a recent study that supports the link between gastrointestinal autoimmune disorders/autonomic neuropathy. Asymptomatic neuropathy seen early in Crohn's disease Source: Reuters Author: Will Boggs, MD Date: Fri, 7 September 2007 Subclinical sympathetic neuropathy develops early in the course of Crohn's disease, investigators in Sweden report. "We think that the sympathetic neuropathy may be evidence that inflammatory bowel disease is a general disease involving a great part of the body, and not only the bowel," Dr. Bodil Ohlsson from Lund University, Malmo, told Reuters Health. Dr. Ohlsson and associates compared autonomic nerve function in controls and patients with short-duration Crohn's disease at baseline and seven years later to determine whether neuropathy is a concomitant manifestation of the disease or a complication that develops many years later. Resting blood pressure did not differ between controls and patients with Crohn's disease, but systolic blood pressure was significantly lower eight minutes into the baseline orthostatic tilt table test in patients than in controls, the authors report in the August 14 issue of BMC Gastroenterology. At the seven-year assessment, the systolic blood pressure one minute into the orthostatic tilt table test tended to be lower in patients than in controls and after eight minutes the difference remained significant. These orthostatic blood pressure changes were not associated with frequent relapses, severe disease, or use of aggressive immune modulating drugs. There were no differences between Crohn's disease patients and controls in the deep breathing test and laser Doppler perfusion imaging at baseline or at the second assessment seven years later, the investigators report. "We should be aware that patients with Crohn's disease for many years may have clinical signs of autonomic neuropathy," Dr. Ohlsson said. "Further, we should be aware that these patients may have changes in the enteric nervous system explaining dysmotility in the absence of inflammatory relapse of the mucosa." "Not all attacks of constipation or diarrhea are signs of inflammatory relapses, but can be signs of autonomic or enteric neuropathy," Dr. Ohlsson explained. "Thus, these changes ought not be treated by anti-inflammatory drugs." BMC Gastroenterology 2007;7:33.
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