Archive for the ‘Autonomic Nervous System Dysfunction (Dysautonimia)’ Category

In 2012, I began to come very close to passing out several times a day. I had no idea why. My pulse and blood pressure were all over the place. I also had horrible chest pain, but just ignored the symptoms.

Then this happened during physical therapy for my ongoing sacroiliac joint issues. EMS was called. They hospitalized me for 5 days. A neurologist diagnosed me with “dysautonomia,” and explained that my autonomic nervous system wasn’t functioning properly for some unknown reason. During discharge, he recommended that I “go buy an abdominal binder,” a device would provide constant pressure on my abdomen to help keep my blood circulating and prevent sudden drops in BP, tachycardia, weakness and fainting – all hallmarks of dysautonomia.

Abdominal BINDER? What?

I asked Google, and was horrified at what I was shown: latex tubes with multiple rows of bra-like hooks (like those popularized by Kardashian wanna-be crowd), and contraptions made from beige, scratchy material with a confusing array of laces and buckles – like a straight jacket without the “hug yourself” arms. Noooo thanks. I’ll take my beta blockers and do more Pilates to “zip up” my abs.

Well, that approach lasted about a year. Every time I left my house, it was guaranteed that I would end up sitting on the floor of retail establishments and/or propping myself on random cars in parking lots. The unpredictable BP changes, combined with excruciating back and leg pain (exacerbated by repeated sit-down-on-the-ground-stand-up-again episodes) were draining and embarrassing. I dreaded leaving the house, and refused to go anywhere alone. I stopped teaching jewelry classes, and would only spend an hour or so in my jewelry studio a few times weekly.

Then, serendipity!

Two years ago (3 years after my dysautonomia diagnosis), I was comparing symptoms with an acquaintance – she also had an SI joint anomaly similar to mine (excruciating point-specific pain, joint laxity, hip/leg pain). Her physical therapist had recommended that she try a corset to help stabilize her low back and hips.

Wait…What? A CORSET??

My first thoughts were probably the same as yours:  “Corsets are for…strippers, porn stars, hookers, BDSM fetishists, Playboy bunnies and…and…and people with body dysmorphia that want to squeeze their ribs into unnatural shapes…and…and…NO FRIGGIN’ WAY would I wear one of THOSE!!!! Eewww.”

Then – I had a flashback to what that neurologist had told me in 2012 – “…abdominal binder.” Hmmm…..

So, I did some research. And, I learned that corsets aren’t just for Renaissance faires, fantasy wear and adult sexual play.  Corsets have a long, rich history, full of controversy, with over 3 centuries of documented drama and discourse about the good and bad. Used for centuries to support the fatigued torsos and backs of women (and men!), address a variety of health issues, and of course, fashion challenges. Corsets have actually played quite an important role in both fashion and medical history. (If you’d like more details, Google can help you delve into the blathering of doctors, designers and devotees on both sides of the debate…from the 1700’s until today. Enjoy!)

So, I bought an honest-to-goodness corset, underbust style (just the hips and torso – no boob support involved), with steel bones and lacing. Not a latex tube. Not a “waist-shaper” from Amazon with multiple rows of hooks-and-eyes. And, certainly NOT one promoted or sold by any reality TV star.

After about 2 weeks of “seasoning” (breaking it in…getting it used to my body, and my body to it) –  VOILA!

  • It helped maintain my blood pressure!
  • It stabilized my loosey-goosey and wickedly painful sacroiliac joints. My body wasn’t feeling as weak as it had before after a couple of hours of activity,  as if it was held together by overstretched rubber bands. [I have stretchy connective tissues from Ehlers Danlos Syndrome, which, contrary to other articles addressing EDS and corsetry, is NOT an autoimmune disorder, but a genetic one].
  • I was able to work at my jewelry bench longer than an hour.
  • I could drive my car more than 10 minutes without back, neck and shoulder pain.
  • I was sitting up straighter, walking much more gracefully, and I had a waist again!
  • My boobs and stomach no longer appeared as one amorphous blob, and I didn’t have to wear an XL shirt over my size M body just to hide my shape. With the corset, clothes looked great on me again! I could wear things I had put in the “I’ll never fit into THOSE” pile.
  • Looking better improved my self esteem (in spite of my ongoing, complicated and not-properly-diagnosed/treated health issues). These improvements in my life were worth far more than the $60 I had paid for that first corset.

After purchasing three more off-the-rack corsets, and so much more research, I learned that a “bespoke” corset – one made to fit MY body and address MY specific medical issues, would probably be more beneficial.  With the guidance of an experienced and educated member of the corset community, I found a designer to help me.

Carlos, of Innova Corsetry, designed and constructed an exquisite corset for me, with architectural precision and attention to detail. Most important was the inclusion of “cupped ribs” (no compression at all on the ribs, the waist being the focus of any reshaping desired, or in my case, compression to control my BP). He shaped the hips to fit quite snugly to stabilize my troublesome sacroiliac areas and gluteus muscles that in turn, support the hips. Genius!!

With this beauty hidden stealthily under my clothes, I can move about with good posture, drive without slouching, and spend several hours at my jewelry studio. It actually extend my tolerance to “do stuff” to 4 – 6 hours (sometimes much more!), far longer than the brief periods I could endure before corseting. I now go on errands without fear that I will randomly pass out in public places as before. I can make plans and participate in life again. And, I feel much more confident because I know I look better that I did before I began my corset journey.

Ok. Stop right three. I know what you are thinking.

YES, I CAN breathe freely and completely in my corset. As mentioned above, the cupped ribs are designed to support, not compress.

NO, it doesn’t hurt.  I drive, do errands and housework, work easily in my jewelry studio and do my photography with ease. I forget it’s there.

And, NO, my muscles are not weakening because I wear a corset – the opposite is true!  All the years of physical therapy, gait training, Pilates and core stabilization finally make sense. I am able to maintain the correct position of my pelvis and low back with ease. My corset provides “feedback” throughout the day, reminding me to use all of my core muscles for stabilization. Now, my torso musculature is much stronger and more supportive when I am not wearing the corset. Without it, I am able to continue moving about for another hour or so without the familiar stabs and spasms I had endured for almost 20 years.

A corset should never be painful. If it is, it isn’t on correctly, or it is the wrong type of corset for your body. NOTE: All corsets are NOT the the same. Different styles influence the body in different ways. It is not a “one size fits all” solution. Many less expensive corsets are incorrectly shaped and are painful to wear. Before you consider corseting, do lots of research and talk to people that corset regularly to learn how to find the right corset. There are plenty of resources on the interwebs and in social media that are very helpful! There are many, like me, that started corseting for medical reasons are happy to share their knowledge.

Oh – my doctors – how do THEY feel about my decision to corset? Well, most don’t have the knowledge of what a corset really is – some seem pleased and intrigued I have found a way to address some of my medical issues that has been largely ignored by medical research. Those that are openly critical of the practice seem get their information from the sensationalized (and not very accurate) comments of Dr. Oz and his ilk. Luckily, I have physical therapists that applaud my investigation and use of the corsets, and understand their benefits.

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REMEMBER THIS:

Don'tUnderestimateMe

Radical acceptance isn’t supposed to be bitter. It is supposed to bring peace.

So, I will now continue along my path, knowing, thinking, and noticing.

I don’t know what else to call this set of emotions that have lead me to say, “I’m done.”

I am just frustrated beyond words over  being marginalized by my healthcare providers, and really, just people in general.

I’m tired of the fight getting me nowhere.

I recently read something by Australian historian and author. Tim Flannery (The Eternal Frontier) that made me take serious pause: one person cannot change mass behavior that they believe to be inappropriate or immoral. By bringing such things to the attention of the majority, it creates hostility against the person. So, in other words, accept the bad/poor/inappropriate behavior and keep quiet. Accept it. That’s just the way it is. Morality never wins – the mob wins. (this is a paraphrase, not quote)

I have been unsuccessful at creating or joining a mob that can truly make a difference.

So, I am DONE.

Done doing my due diligence just to be ridiculed and then, ignored- not treated – told that I should “get used to getting older.”

Done doing this – what ever  you want to call “this.” Trying to gain acceptance as a human being, trying to get someone to care enough to try and help me, trying to teach people to advocate for themselves as I have tried to do… Maybe not forever, but for now, I am DONE.

WHY?

Maybe this is the straw that broke this camel’s back: I don’t think that the things that are going on with me now (like a sudden 10 lb weight gain; almost daily, debilitating migraines; hair loss; very easy bruising) are something I should just “get used to.” (Thanks for that sage advice, Doc.)  Just because simple blood tests show me as “normal” – isn’t it quite obvious things are far from normal? Example: I have had a bone infection for at least 4 months – it was discovered on a routine dental X-ray 2 weeks ago – but – it HAD been noted on an MRI in April. But, did ANYONE bother to address it – NO. I asked about the radiologists comment and was told not to worry. Who’s worrying? I just want such weirdness to addressed. Or should I just “radically accept” my conditions? (no, I’m not leaning towards the “church” of Mary Baker Eddy!)

Now, I am working on radically accepting that I am not going to get the care, attention, treatment, testing, concern and compassion others may be fortunate enough to get.

[If you are reading this, and are getting these things I listed in the previous sentence, please be joyous. Seriously.]

I am also trying to radically accept that my absence from the fight will not make one bit of difference on this overcrowded, selfish planet.

Now…I am DONE.

InvisDisability

My current medical symptoms would send the average person to the ER…crushing chest pain, blurred vision, difficult breathing, unrelenting migraine headaches, inability to eat normally, tachycardia or bradycardia, high or low blood pressures, insomnia – oh, and the back pain I can’t find any specialist to address because I have already had 6 surgeries, and now, the shoulder that already has been repaired twice is painfully shredding its way out of its socket…I really haven’t had a “good day” in about 12 years. But I don’t LOOK like I’m sick so people think I am a malingerer, just looking for attention, or faking my symptoms.

I guarantee I haven’t developed the magical ability to manipulate my blood tests, MRIs and various other medical tests so they come back abnormal.

I have had a difficult time learning to accept my medical issues. I have many symptoms in many systems that cannot be classified into any particular category. I have most recently been dumped into the category Ehlers-Danlos Syndrome (but not any particular type, of course) as this seems to at least catch-all the symptoms I display in some way. All of my official diagnoses have the letters “NOS” after them – “not otherwise specified.”

It really stings when people are just plain callous about my health issues – and it is the worst when these people are the doctors that are supposed to help me. I have had to had to do a lot of my own research within professional resources (Medscape, PubMed, etc.) and advocate strongly for myself. This has meant seeing many doctors in an attempt to find one willing to take on my complex issues and try to piece together the puzzle that I am. I have been treated quite harshly by many health professionals due to my complexity. I understand that they may to want to take on a patient they cannot easily figure out. It would just be nice if they could not be so abrasive in their dismissal of my symptoms and test results.

Because of the unpredictable nature of my symptoms, I have lost what few social connections I had. I spend much of my time alone, at home. I used to find solace in online forums, but I have found many of these are similar to real-life support groups that tend towards a circular discussion of hardships – and never achieve any growth or change. What would be helpful is a directed, online resource or app that provides guidance and education in the management of chronic illnesses and the psychological challenges people like me experience. Can such a thing become a reality?

I have always had to be a survivor – my Type A personality and perfectionist tendencies helped me through the cPTSD (complex PTSD) from 14 years of sexual abuse, rapes, and general cruelty from classmates. I found ways to cope – all on my own. I never really had much of a support system. Now, to be sidelined from so many activities that used to define “me,” was – and IS – quite distorting to my thoughts and feelings about life in general.

Anxiety has replaced what used to be stoic resolve.

Anger and resentment that I was formerly able to tap into as energy to push through rough situations – to make myself physically stronger in the gym, or mentally tougher in the workplace – now comes to the surface in staccato bursts, and those closest to me (my husband, primarily) suffer the consequences.

It took me about 6 yrs to be able to say the words “I can’t.” This is NOT pessimism. It is pure, unadulterated realism. And with the myriad of undiagnosable conditions I live with, I HAVE TO be realistic. To think any other way is deleterious.

I know this goes against the “rainbows, unicorns and fluffy bunnies” mentality that most self-help resources (and professionals) seem to think is THE ONLY WAY is the way to overcome hard times. But, with the help of a therapist that specializes in treating people with multiple medical issues, and, a good PCP that is a realist, I learned that I HAVE TO say the words, “I can’t.” It’s really a no-brainer – but 99% of people just don’t have the comprehension of how their body actually works to really understand. Simply, it protects me – and others – from injury. An example of this would be not getting behind the wheel of my car when I am having certain symptoms.

Don’t misunderstand me, it doesn’t ever feel comfortable to say “I can’t” – and many people don’t “get” this way of thinking at all, nor do they even bother trying. This leaves me feeling isolated and rejected by society. I might as well be some alien life form. And, if I had a dime for every time I have ben offered advice about supplements, yoga, qi gong, tai chi, Reiki, acupuncture and whatever new “complimentary therapy that Dr. Oz has been touting of late, I’d be one a rich gal.

People need to learn that not all disabilities are visible ones. Not all of us that have difficulty getting about are in wheelchairs. And, not everyone with life-altering conditions look or acts “sick.”

Abandoned...like a polar bear on an ice floe

This is me.

I’ve literally been abandoned by my last remaining health care providers.

This is exactly how I feel as another boot strikes the edge of my ice floe. I float out farther into the icy waters, towards a slow and certain demise.

Each of those boots belong to a health care provider – a staff member of a hospital – even a “Patient Advocate” at a world-famous hospital in Boston. Names will follow. I will not go silently into that good night. They will be decloaked. Stay tuned.

Who put me on the floe?  I was forced there by the medical “professionals” that refuse to be proactive. They can’t be bothered to pick up a phone and call a colleague to see if they can help me or even ask, perhaps, if they know someone who might.

They can’t be bothered to do a simple internet search to find out how to treat someone with my rare and complex conditions.

(I’ll even tell them where to look…Medscape, Mayo Clinic, NCBI, Vanderbilt University, Google Scholar.)

It takes seconds.

If I do that, I will be labeled and ostracized (remember the “Seinfeld” episode where that happened to Elaine Bennis?) and my fade-out into black be hastened by their turned backs.

They forget I’m intelligent. They forget I have medical background and medical training and decades of experience advocating for myself and my mother.

[How tragically sad it is when I think about how poorly she was treated. I am being treated just like she was, so she ended her suffering. She too was shoved onto an ice floe. And suffered for 9 years despite of everything i tried to do to help get her some “care.”]

These so-called experts don’t and won’t even pay attention to any of the recent FDA approvals for treatments that could help me.

They won’t pick up the phone and reach out to specialists in the area to dee if they are interested in helping me.

They mindlessly throw out referrals to random places that I have already been (they don’t bother to read my record – to learn about ME), They tell me to “learn to meditate” or “do yoga.”

I have. I did. I am unable to do so.

Then, they insult my counselor. They tell me to talk to her – or that I need to find a new one.

Read my file. (Oh no – that would take time! Doctors are far too important and busy to read a patient’s file. “Only 5 minutes” – “only 2 questions” – “what ONE condition do I want to talk about today?”

Learn about my medical conditions. Read my file. Care about me. Please. Someone just CARE.

Don’t treat me as if don’t matter, as if I am a waste product – isn’t the first line of that all important oath that you take, “First, do no harm?”

Well, your acts and omissions ARE doing harm. Wake up. Pay attention. Realize what you are doing.

Every time your shove me further out into the icy waters, away from you so you won’t have to deal with me, you hurt me. You hurt my husband.  You hurt human beings.

As in the excellent movie, “Gattaca,” I am reduced to the status of being an “in-valid.” One that is not worth the time to help; to waste resources on; to listen to; to treat. A lesser part of society. Disposable.

Shove my floe again. Go ahead. Perhaps you will get lucky and YOU will be the one to cause me to wither and die sooner and the you will not have to be bothered with another patients like me. You can spend your time treating sniffles and GERD and Type 2 Diabetics. Tell them to meditate their problems away and be mindful to help their conditions improve.

But one day, your inattention to patients like me will catch up to you. I promise.

I intend to be on that list of those that YOU ignored and let languish on our ice floes.

Any talents and contributions I had the ability to make to the world will vanish as my floe heads farther out to the horizon – out of sight, out of mind. Good riddance.

I will expose you for your acts and omissions –  that will be my last act. That will be my legacy.

TOO harsh?  Well, that is too bad. This is how I feel.

I have been kicked out of the human race, shoved out into the cold, icy world alone to slowly die. All the boots that have shoved my ice floe farther into the icy waters – my former PCPs, my PCP’s practice, my former orthopaedic surgeon, my anesthesiologist, my former autoimmune doctor, my former cardiologist – all have turned their backs on me and returned to their warm and spacious mansions and forgotten about me. I am just an insignificant blip in the world. After all, there are 7 billion others (and counting – God help us…) Why care about just one?  Especially another one over 50. The world belongs to GenX and the Millenials. Those of us that are Boomers, well, we are just wasting the resources that should be reserved for THEM. the sooner we perish, the better.

I am disposable and useless.

At no time in my life have I felt this hopeless and alone.

I have been forced to return to scouring the web to find any information about my chronic conditions and any doctors that may be interested in seeing a 51 yr old with 4 chronic issues and multiple drug resistance genes. No one is interested. Not a single doctor in the Boston area.

You would think I live in Antarctica. No. I live in Boston. Great medical care?  Cutting edge medical care? Bullshit. Not when I actually have to explain to a physician what an :Autonomic Nervous System dysfunction is, and I watch them blink-blink-blink with wide doe-like eyes during my explanation. Are they even listening to me? Or are they just thinking about buying another Berkin bag or the color of their next Bentley.

Angry, arrogant doctors not interested in listening to a patient with tangible and complex conditions? Yes. Boston is their Mecca.  Don’t believe the hype. Listen to the patients that suffer because of their omissions and arrogance.

I am a compliant patient  – but there reaches a point at which it should be (SHOULD be) apparent these “conservative” (seems to be the latest buzz word) treatments aren’t working. I think 17 years should be good enough. No matter how many times I repeat these “conservative” treatments, costing me thousands of dollars, I get no better. In fact, I often get worse. . But that doesn’t matter. The quicker  I get out of their office – out of their sight – the doctors feel as if they can justify their actions – they have done their job. (Yes, I see you looking at the clock and glancing at your watch every few moments. Thanks for the disrespect. If you would take the time to read my file, I wouldn’t have tor repeat myself very single time I see you. If you would communicate with specialists before you refer me, I wouldn’t be wasting their time, boring them with a life story they don’t want to hear.) HOW RUDE.

Thank you, dear physicians,  for hastening the arrival of another cadaver for the next entitled overachiever to pick apart and insult in their gross anatomy classes. 

 

Made by me on someecards.com

Made by me on someecards.com

I recently posted that received a course of TMS (transcranial magnetic stimulation) to knock back a major depressive episode.

However, I failed to mention that I experienced several other changes in symptoms  – symptoms other than the “F5 tornado.”

There HAS to be a connection between whatever the TMS does and the symptoms from which I experienced relief…which leads me to believe that the doctors are missing a serious connection between all my weird symptoms that make me the zebra I am.

So, what changed during treatment?

1.  Much fewer migraines….

2.  My odd and unexplained breast regrowth ceased – along with the pain that went along with the growth. (I had a reduction Nov 2013 due to the major and PAINFUL increase in size of my breasts from a 34DDD to a 34I in 4 yrs). My reduction was “supposed” to bring me to a 34C. HA. I quickly (and PAINFULLY) grew from that alleged size to a 34DDD in 4 months post-reduction. NOTE: all hormonal and endocrine levels always test “normal” – even though any bachelor’s level bio student knows endocrine levels can change on a moment-to-moment basis, the doctors that order these tests seem to stand firm that everything is “normal. Yeah…right. As the Ghostbusters always said – “we are ready to believe you.” NOT.

3. An increase in dreams. Some good – some bad – but all were vivid and memorable.

4. Longer periods of deep and restful sleep (I wear 2 “life trackers” that monitor sleep because of my weird sleep history (See my prior post on DSPS  – delayed sleep phase disorder).

5. A marked increase in sensitivity to medications: Clonidine (a BP medication), and MSIR (morphine sulfate immediate-release).I had to completely STOP the Clonidine as the effects that it caused during the TMS were debilitating – I literally would be unable to wake-up for 14+ hours if I took even half the smallest dose.) I take the MSIR for chronic back and leg pain I have had for 16+ years  – and the 6 surgeries I have had have failed to completely resolve the pain. During the TMS sessions, I required a lower dose of the MSIR to get pain relief, and, for the first time, I experienced side effects (a bit of nausea and extreme sleepiness) from my usual dose and had to reduce it by half.

6.  I had far less incidents of low blood pressure (associated with my Autonomic System Disorder – I have many posts and links to others’ posts about this condition on my blog.

What has happened with these symptoms since I ceased treatment one month ago?

1.  I am once again being awakened by migraines – with nausea, photophobia and positional increase in pain. I am getting 2-3 migraines per week.

2. My breasts are sore, lumpy and swollen. Gads, I hope they are not growing again. I just bought new bras because I though the growth had ceased.)

3. I am still dreaming, but less frequently. And they “loop” – much like they did before the TMS.

4. Problems getting to sleep AND staying asleep. (And, I cannot take any sleep aids due to the side effects I have from any meds used to sleep since this odd Autonomic Disorder I have kicked in back in 2012.

5. I have had to increase my MSIR dose back to pre-TMS Levels. I seem to have more pain in my back as well.

6. My BP and heart rate are becoming much more labile (variable) again. I have had to take additional beta-blockers recently to address the increase heart rate and chest pain.

Sooo….what is the connection? So far, none of my doctors have tried to solve this mystery. Why not?  A simple Google search can provide clues….

Which is what I did. It didn’t take long at all. I am an experienced researcher with decades of research experience so I know how to word my searches to get the best results. I am sure that diagnostic research was covered at some point in medical school.

What did I find out?  All of these things are connected in some way to DOPAMINE levels, and are things that are effected by what is known as the HPA (Hypothalamic-Pituitary-Adrenal) Axis. (Check out the link for hundreds of images from sources that could provide clues to my doctors….note the 3 words I used for the search…real rough, huh?)

HELLO? Can someone PLEASE tell me why a single medical professional cannot take this information and try to help me?  Doesn’t anyone care about me and the quality of my life???

Just recieved this update from Chelsea Therapeutics and had to share!!!!! (Yes, I did include the Legal mumbo jumbo from their email announcement to protect and preserve CT’s rights and responsibilities).


NORTHERA Clinical Trial Data
Published in Neurology:

Data Supported FDA-Label for Patients with Symptomatic Neurogenic Orthostatic Hypotension

CHARLOTTE, N.C., June 19, 2014 — Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) today announced the publication in Neurology of its pivotal, Phase 3 study 301, a multicenter, multinational, double-blind, randomized, placebo-controlled, parallel-group study of NORTHERA (droxidopa) that details how NORTHERA demonstrated a statistically significant difference in efficacy compared to placebo for improving the symptoms of neurogenic orthostatic hypotension (NOH).

NORTHERA was approved by the U.S. Food and Drug Administration on February 18, 2014, for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson’s disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been demonstrated. The continued effectiveness of NORTHERA should be assessed periodically.

Data from pivotal study 301, published online today ahead of print in Neurology, was used to support the safety and efficacy of NORTHERA as part of its new drug application.

“Droxidopa, a norepinephrine prodrug, is the first treatment approved in 20 years for symptomatic neurogenic orthostatic hypotension, a syndrome characterized by blunted noradrenergic response to standing,” said lead author Horacio Kaufmann, M.D., Professor of Neurology and Medicine at New York University and Director of the Dysautonomia Center at NYU Langone Medical Center. “In a double-blind randomized trial, 7-day treatment with droxidopa was superior to placebo in relieving symptoms and was associated with an increase in standing systolic blood pressure.”

“Neurogenic orthostatic hypotension is a rare and debilitating condition associated with neurogenic disorders such as Parkinson’s Disease and multiple system atrophy, that is often overlooked and underdiagnosed,” said Joseph G. Oliveto, President and CEO of Chelsea. “The publication of our 301 study in Neurology, a highly respected medical journal, adds to the peer-reviewed literature on NOH and will help increase understanding of NOH among physicians.”

The trial examined the efficacy and safety of droxidopa versus placebo. The primary endpoint was the relative improvement in mean Orthostatic Hypotension Questionnaire (OHQ) composite score following 1 week of treatment. The OHQ is a validated, NOH-specific tool assessing symptom severity and symptom impact on daily activities as reported by patients. When evaluating the OHQ composite, it was found that droxidopa-treated patients improved by 0.90 units (p=0.003), compared to placebo.

The OHQ may be divided into two independently validated composite sub scores. The orthostatic hypotension symptom assessment composite (OHSA), which examines a variety of symptoms, and the orthostatic hypotension daily activities assessment composite (OHDAS), which examines a variety of symptom impacts. Improvement in the OHSA composite score favored droxidopa by 0.73 units (p=0.010). The largest improvement in an individual symptom item was recorded for item 1 (dizziness/lightheadedness) which favored droxidopa by 1.30 units (p<0.001). Improvement in OHDAS composite favored droxidopa by 1.06 units (p=0.003), with the largest individual item change recorded for "ability to conduct activities that require standing a long time" which favored droxidopa by 1.30 units (p=0.001)

A biologically relevant correlate for efficacy, the mean change in standing systolic blood pressure (BP) increased by 11.2 vs 3.9 mmHg (p<0.001). An important safety observation was the change in the mean supine systolic BP by 7.6 vs 0.8 mmHg (p<0.001) study. There were relatively few patients who experienced BP increases above180 mmHg: 4.9 percent of droxidopa and 2.5 percent of placebo recipients.

Overall, this short-term multicenter trial showed that droxidopa treatment was associated with significant improvement in multiple symptoms of NOH and of NOH impact on activities requiring standing or walking as well as an associated increase in standing systolic BP. Furthermore, these benefits were associated with an acceptable safety profile.

About Symptomatic Neurogenic Orthostatic Hypotension (NOH)

It is estimated that 80,000 to 150,000 patients suffer from symptomatic NOH in the U.S. Symptomatic NOH is a chronic disorder that is caused by an underlying neurogenic disorder, such as Parkinson's disease, multiple system atrophy or pure autonomic failure. Symptoms of NOH may include dizziness, lightheadedness, blurred vision, fatigue, poor concentration, and fainting episodes when a person assumes a standing position. These symptoms can severely limit a person's ability to perform routine daily activities that require standing or walking for both short and long periods of time.

About NORTHERATM (droxidopa)

NORTHERA is the first and only therapy approved by the FDA that demonstrates symptomatic benefit in adult patients with NOH caused by primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. NORTHERA is expected to be launched in the second half of 2014.

NORTHERA carries a boxed warning for supine hypertension. The most common adverse events experienced in controlled studies were headache, dizziness, nausea, hypertension and fatigue. Please see NORTHERA full Prescribing Information at http://www.chelseatherapeutics.com, and Important Safety Information below.

The NORTHERA approval was granted under the FDA's accelerated approval program, which allows for conditional approval of a medicine that fills a serious unmet medical need, provided additional confirmatory studies are conducted. The package insert indicates that effectiveness beyond two weeks of treatment has not yet been demonstrated; therefore the continued effectiveness of NORTHERA in patients should be assessed periodically. A multi-center, placebo-controlled, randomized study, which is designed with the goal of definitively establishing the durability of the clinical benefits of NORTHERA, has been preliminarily agreed to with the FDA.

IMPORTANT SAFETY INFORMATION

WARNING: SUPINE HYPERTENSION
See full prescribing information for complete boxed warning. Monitor supine blood pressure prior to and during treatment and more frequently when increasing doses. Elevating the head of the bed lessens the risk of supine hypertension, and blood pressure should be measured in this position. If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue NORTHERA.

CONTRAINDICATIONS
None

WARNINGS AND PRECAUTIONS
Supine Hypertension: NORTHERA therapy may cause or exacerbate supine hypertension in patients with NOH, which may increase cardiovascular risk if not well-managed.

Hyperpyrexia and Confusion: Postmarketing cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been reported in Japan with NORTHERA use. Observe patients carefully when the dosage of NORTHERA is changed or when concomitant levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia, muscle rigidity, involuntary movements, altered consciousness, and mental status changes. The early diagnosis of this condition is important for the appropriate management of these patients.

Ischemic Heart Disease, Arrhythmias, and Congestive Heart Failure: NORTHERA therapy may exacerbate symptoms in patients with existing ischemic heart disease, arrhythmias, and congestive heart failure.

Allergic Reactions: This product contains FD+C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD+C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

ADVERSE REACTIONS
The most common adverse reactions (greater than 5 percent) were headache, dizziness, nausea, hypertension, and fatigue.

DRUG INTERACTIONS
Administering NORTHERA in combination with other agents that increase blood pressure (e.g., norepinephrine, ephedrine, midodrine, and triptans) would be expected to increase the risk for supine hypertension; Dopa-decarboxylase inhibitors may require dose adjustments for NORTHERA.

USE IN SPECIAL POPULATIONS
Clinical experience with NORTHERA in patients with severe renal function impairment (GFR less than 30 mL/min) is limited; There are no adequate and well controlled trials of NORTHERA in pregnant women; Women who are nursing should choose nursing or NORTHERA; The safety and effectiveness of NORTHERA in pediatric patients have not been established; No overall differences in safety or effectiveness were observed between subjects aged 75 years and older, and younger subjects in clinical trials, but greater sensitivity of some older individuals cannot be ruled out.

About Chelsea Therapeutics

Chelsea Therapeutics (Nasdaq: CHTP) is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases, including central nervous system disorders. Chelsea acquired global development and commercialization rights to droxidopa (L-DOPS), or NORTHERA, from Dainippon Sumitomo Pharma Co., Ltd. in 2006, excluding Japan, Korea, China and Taiwan. For more information about the Company, visit http://www.chelseatherapeutics.com.

As previously announced, pursuant to the Agreement and Plan of Merger, dated as of May 7, 2014 (Merger Agreement), by and among Chelsea, H. Lundbeck A/S (Lundbeck), and Charlie Acquisition Corp., an indirect wholly owned subsidiary of Lundbeck (Acquisition Sub), Lundbeck has commenced a tender offer (Offer) to purchase all of the outstanding shares of Chelsea. Lundbeck and Acquisition Sub have filed a tender offer statement on Schedule TO (as amended, the Schedule TO), including an offer to purchase, a letter of transmittal and related documents, with the Securities and Exchange Commission (SEC), and Chelsea has filed a Solicitation/Recommendation Statement on Schedule 14D-9 (as amended, the Statement) with respect to the Offer. The Offer will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. Subject to Acquisition Sub's irrevocable acceptance for payment in the Offer of at least a majority of Chelsea's common stock outstanding on a fully diluted basis and to the satisfaction or waiver of certain other customary conditions, Acquisition Sub will merge with and into Chelsea (Merger) and, subject to certain exceptions, each Chelsea share not tendered in the Offer will be cancelled and converted into the right to receive in the Merger the same consideration per share paid in the Offer.

Safe Harbor/Forward-Looking Statements

The above information contains forward-looking statements, including without limitation statements regarding the planned completion of the Offer and the Merger.

Some of these forward-looking statements may contain words like "believe," "may," "could," "would," "might," "possible," "will," "should," "expect," "intend," "plan," "anticipate," or "continue," the negative of these words, or other terms of similar meaning or they may use future dates. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the timing of the transaction; diversion of the attention of Chelsea's management away from Chelsea's day-to-day business operations; the percentage of Chelsea's stockholders tendering their shares in the Offer; the possibility that competing offers will be made and the effects of provisions in the Merger Agreement that could discourage or make it difficult for competing offers to be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of disruption caused by the transaction making it more difficult to maintain relationships with employees, collaborators, vendors and other business partners; stockholder litigation in connection with the transaction resulting in significant costs of defense, indemnification and liability; and other risks and uncertainties discussed in Chelsea's filings with the SEC, including the "Risk Factors" sections of Chelsea's Annual Report on Form 10-K for the year ended December 31, 2013 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2014, as well as the Statement and the tender offer documents filed by Lundbeck and Acquisition Sub. Chelsea undertakes no obligation to update any forward-looking statements as a result of new information, future developments or otherwise, except as expressly required by law. All forward-looking statements in this document are qualified in their entirety by this cautionary statement.

CONTACTS:
Media:
David Connolly
LaVoieHealthScience
617.374.8800 ext 108
dconnolly@lavoiehealthscience.com
Investors:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com

Here’s some info- albeit not empirical – a good posting that describes a DYSAUTONOMIC’s experience (not just POTs patients). This was posted on another bloggers blog and I’m re-posting here. ..and, oddly, contains passages that I, (myself..me) had written in response to a posting on someone else’s blog months ago.
So I learned a lesson…always make sure you post your musings on your own blog to preserve ownership.
Regarding this “article” – It describes FAR more than POTS-which, is but a small percentage of those that have the symptoms described in this re-posting and apply to most folks with dysautonomia. (Disagree? I’ll let my dysautonomic specialists know.)
I often ponder why it is that most POTS folks seem to claim ownership of the dysautonomia diagnosis ….it’s as if the rest of us that have another, and often untreatable, form of the disorder just don’t matter at all….
A note to those that fit into this category (the non-POTS group) – you are not fighting this invisible illness alone. Medscape has a fantastic educational page on Autonomic Disorders in their education/diagnostic section. We do exist.