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Aimovig - New Migraine Treatment approved by FDA (Read 3825 times)
neuropath
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Aimovig - New Migraine Treatment approved by FDA
May 18th, 2018 at 5:26am
 
Potentially one of us is also is a migraine sufferer and can update us on whether this has any effect on CH.

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Re: Aimovig - New Migraine Treatment approved by FDA
Reply #1 - May 19th, 2018 at 1:14am
 
This was actually trialed as a treatment for CH. It's interesting it is being trotted out as a migraine medication -- probably because it's a bigger market. I was to be a part of the trial, but didn't qualify because of Vit D3 and 5 MeO DALT having me under control. I'm not sure of the results of the trial, and really haven't kept up on it since.

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Re: Aimovig - New Migraine Treatment approved by FDA
Reply #2 - May 19th, 2018 at 3:49am
 
There have been several discussions of CGRP over the last few months and the new drugs going through trials for CH / migraine. Using the google search at the top of the screen will find them.

Given the success of D3 and the relative price, I suspect that D3 or similar will possible be a better option for most, but having another option available will always be good as CH seems to have a habit of getting around / not working for many of the preventives, i.e. what works one cycle might not for another.
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Re: Aimovig - New Migraine Treatment approved by FDA
Reply #3 - May 20th, 2018 at 9:56am
 
I am really eager to know the effect of this new medicine I heard also it is expensive
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Re: Aimovig - New Migraine Treatment approved by FDA
Reply #4 - May 20th, 2018 at 11:42am
 
    Seattle times ran a front page article a few days ago...stated it would run $6900 a year. I would imagine health insurance providers will be loath to approve it's use.
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Re: Aimovig - New Migraine Treatment approved by FDA
Reply #5 - May 21st, 2018 at 12:58am
 
It's important to understand the efficacy of CH and Migraine preventatives.  In other words, what's the real Bang for the Buck?  or Cost per reduction in migraine days per month or cost per reduction in the frequency of CH/day or a complete cessation of both.

For example, the RCT for the monoclonal antibody (mAb) Aimovig (erenumab) concluded "Between months four and six of treatment, the number of migraine days decreased by 3.2 and 3.7 in the 70-mg Aimovig and 140-mg Aimovig groups, respectively. Between the start of the study and four to six months of treatment, in the 70-mg group, 43.3 percent of patients experienced at least a 50 percent reduction in the number of migraine days."

Doing the math... 6 months at $575/Month ($6900/year/12 months) = $3,450 for 43.3% of Migraineurs taking Amovig to achieve at least a 50% reduction in the number of migraine days.  It appears Aimovig was not effective for 56.7% of episodic Migraineurs taking it.

Assuming there was no reduction in migraine days among the placebo group (I know better... There was...), that means the absolute efficacy was a 50% reduction in migraine days for 43.3% of the migraineurs who took Aimovig monthly for six months.  To compute the Number Needed to Treat in order to achieve a 50% reduction in migraine days for one migraineur, we divide 100 by 43.3 = 2.3, then round up to the nearest whole migraineur we get 3 as the NNT after 4 to 6 months of treatment.  Again this figure is too high and not realistic....

Digging a little deeper for the actual study results, we find "this RCT had a total of 577 patients enrolled in ARISE that were randomized to receive either placebo or AMG 334 (erenumab) at 70mg subcutaneously, once monthly. Patients experienced between four and 14 migraine days each month, with an average of eight migraine days per month at baseline. Those receiving AMG 334 experienced a statistically significant 2.9-day reduction from baseline in monthly migraine days, as compared to a 1.8-day reduction in the placebo arm."

A reduction of 2.9 migraine days a month is the relative effectiveness... We need to subtract 1.8-Migrain day reduction (22.5%) for the placebo from 2.9-Migraine day reduction (36.3%) for Aimovig in order to get the absolute reduction in migraine days of 1.1 (13.75%) at four to six months. 

In order to determine the Number Needed to Treat (NNT) to have one migraineur experience a 13.75% reduction in migraine days we divide 100 by the absolute reduction of 13.75% and round up to the nearest whole person.  100/13.75 = a NNT of 7.27 -> 8 migraineurs as the number needed to be treated with Aimovig monthly to get one migraineur to experience a 50% reduction in migraine days/month in 4 to 6 months.  An NNT of 8 is more realistic.

That makes the cost for one migraineur to achieve a 13.75% reduction in migraine days per month at four to six months is 8 X 5 months X $575 = $27,600.  That's how public health experts and insurance company actuaries look at cost and efficacy.

I don't have enough data from migraineurs taking the anti-inflammatory regimen to compute a reliable NNT but I do for CHers.  Data from the online survey of 257 CHers taking the anti-inflammatory regimen indicate 80% of the CHers who start this regimen achieve ≥ 70% reduction in the frequency of their CH from an average of 4 CH/Day down to 4 CH/week and 50% of CHers taking this regimen experience a complete cessation of CH symptoms in the first 30 days.   

If we use Dr. Goadsby's figures for placebo effect for CH obtained from from multiple CH preventative studies at 14% to 43% with the 14% figure representing a complete cessation of headache attacks, we get an absolute efficacy of (80 - 43) = 37% of CHers achieving ≥70% reduction and (50 - 14) =  34% of CHers achieving a complete cessation of CH symptoms all in the first 30 days.  That works out to an NNT for ≥ 70% reduction of 100/37 = 2.7 then rounding up to 3 as the number of CHers needed to treat to get one CHer a  ≥70% reduction in the frequency of CH and an NNT for one CHer to achieve a complete cessation of CH symptoms of 100/34 = 2.9 rounding up to an NNT of 3 CHers treated for one CHer to experience a pain free response.

Computing the cost at 55 cents/day for 30 days for one CHer to experience either ≥ 70% reduction in CH in one month or 3 X 30 days X .55 = $50 plus (0.50 cents/day X 12 days = $6) to cover the additional vitamin D3 taken during 12-day loading schedule we get $56 as the cost to treat for one CHer to achieve a favorable response in 30 days.  The cost to treat for one CHer to experience a  pain free response is the same $56.

Again, we're talking apples and oranges comparing migraine prevention with a mAb and cluster headache prevention with the vitamin D3 regimen.  That said, I estimate the migraineur response to this vitamin D3 regimen very close to that of CHers with a few additional supplements and a maintenance dose of 15,000 IU/day.  My wife was a 20 year episodic migraineur with attacks hitting for 3 to 5 days a month like clockwork.   She started the anti-inflammatory regimen at 15,000 IU/day vitamin D3 in December of 2010.  She hasn't had a single migraine since.  I've 10 other migraineurs with similar results...

Other than mAbs like Aimovig costing $575/month for life... I see the frequency of adverse side effects being the real discriminator in choosing between a mAb like Aimovig and the vitamin D3 regimen...  mAbs tend to insult and weaken the immune system making colds, flu and other infections more frequent than normal where vitamin D3 and the cofactors make them less frequent as it helps build a T-Rex immune system.   For a complete list of possible adverse side effects due to mAbs, watch a Humira (Adalimumab) commercial.  Some of these adverse effects can be onerous...

In case you'd like to know what Big Pharma wants to have you take for the rest of your life to prevent your cluster or migraine headaches, look over the following graphic carefully.  If you've been on one of the mAbs and your nose twitches or you have a craving for cheese or you're afraid of cats... this may be the answer.

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Finally, as the mAbs are man-made and have no genetic source in the human physiology, they must be replaced monthly for $575.  I'll stick with a far more natural preventative by taking the anti-inflammatory regimen at $220 to $250 per year.

Having said that... even an expensive preventative like erenumab might be a good deal and worth the expense for CHers who are unresponsive to other prevents... if it works.   Clinicaltrials.gov lists three RCTs either in progress, recruiting or enrolling by invitation using mAbs to prevent CH.

Take care,

V/R, Batch

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« Last Edit: May 21st, 2018 at 3:27pm by Batch »  

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Re: Aimovig - New Migraine Treatment approved by FDA
Reply #6 - May 21st, 2018 at 3:02am
 
A great analysis Batch. Thank you for writing this up for us.

Batch wrote on May 21st, 2018 at 12:58am:
I estimate the migraineur response to this vitamin D3 regimen very close to that of CHers with a few additional supplements and a maintenance dose of 15,000 IU/day.  My wife was a 20 year episodic migraineur with attacks hitting for 3 to 5 days a month like clockwork.   She started the anti-inflammatory regimen at 15,000 IU/day vitamin D3 in December of 2010.  She hasn't had a single migraine since.  I've 10 other migraineurs with similar results...
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Having said that... even an expensive preventative like erenumab might be a good deal and worth the expense for CHers who are unresponsive to other prevents... if it works.   Clinicaltrials.gov lists three RCTs either in progress, recruiting or enrolling by invitation using mAbs to prevent CH.


D3 has made me CH pain free for over 6 years and I was just a few weeks short of qualifying for the chronic label. I've not tried stopping to see if the CHs return.

For migraine, can you confirm what the "few additional supplements" are? I want to make it 11 other migraineurs.

And the last paragraph sums it up perfectly. If it works for someone for whom nothing else has worked then it is vital for them to get something that does work.
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« Last Edit: May 21st, 2018 at 3:03am by Mike NZ »  
 
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Re: Aimovig - New Migraine Treatment approved by FDA
Reply #7 - May 21st, 2018 at 12:59pm
 
Hey Mike,

Gladly... Modifications and additions to the anti-inflammatory regimen for Migraineurs include the following:  (Note:  These modifications and additions will become part of the next version of the anti-inflammatory regimen in a new section for migraineurs that I'll post in a month or so on the VitaminDWiki website.)

Vitamin D3:  Migraineurs need a higher 25(OH)D target serum concentration around 95 ng/mL (238 nmol/L).  Some migraineurs may need an even higher 25(OH)D serum concentration up to 140 ng/mL, but should only do this under a physician's supervision with frequent lab tests for serum 25(OH)D, calcium and PTH.

This also means Migraineurs need a longer vitamin D3 loading schedule of 14 days at 50,000 IU/day and a higher maintenance dose of 15,000 to 20,000 IU/day.  (Note: The latest harvest of the online survey from Feb 2018 indicates Chronic CHers need this higher target 25(OH)D serum concentration.)

Additions for Migraineurs:
1.  CoQ10 (Pick one and take as directed on label)

2.  Vitamin B 100 Complex* (Take as directed on label)

3.  Alpha Lipoic Acid*:  600 mg/day

4.  Carnitine*:  1,000 to 1,500 mg/day

5.  Vitamin C: 4,000 to 8,000 mg/day

6.  Turmeric (Curcumin):  1000 mg/day.  (Take with a heaping teaspoon of coconut oil to improve absorption.) 

7.  Benadryl (Diphenhydramine):  25 to 150 mg/day taken at 25 mg every four hours.  (Any first-generation antihistamine will work - As this may be needed daily, start at 100 mg/day then taper to the lowest effective dose. Alternative - Children's Liquid Benadryl Antihistamine at 12.5 mg (5 mL in measuring cap) every four hours.)

8.  Probiotic:  Pick one with 12 to 15 or more probiotic strains and at least 25 Billion colony forming units (CFUs) then take as directed on the label.

9.  Diet:  Diet is very important for migraineurs. No sugars, artificial sweeteners or soda pop. No wheat or grain products.  This includes grain oils like Canola and corn oils.  Good fats include organic butter, olive oil, avocado oil and coconut oil. Eat organic NON GMO produce (green and yellow veggies), free range meats and poultry including eggs, wild caught fish and crab.  Avoid shrimp and prawns as they're mostly farmed so likely contain antibiotics and glyphosate from GMO grain feed. Eat one serving of organic NON GMO fresh fruit/day.

10.  Reduce exposure to allergens as much as possible.  Simple things like using a saline nasal spray to rinse the nasal passages before going to bed can help. Dust mites have been with humans since they started sleeping in the same bedding.  That means it's prudent to use hypoallergenic pillow and mattress covers and to wash the bed sheets, pillow cases and synthetic blankets twice a week in the hottest water possible.

11.  Migraine Headaches associated with metal excess/deficiencies (likely CH as well)

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If migraine headaches continue for more than a month, it may be prudent to have a hair sample analyzed for heavy metals.  These lab tests are available on amazon.com.

12. Hydration:  Drink 2.5 liters of water a day.

Comments:  The latest monoclonal antibody (mAb) RCT results for Migraineurs taking Aimovig (erenumab) provided some important information.  As all of the mAbs are too large to pass through the blood brain barrier (BBB), that erenumab was able to reduce the number of migraine days/month tells me it is working primarily in the periphery (outside the CNS) where CGRP is also expressed in nearly all cell types. 

In other words, erenumab is reducing the effects of CGRP produced outside the CNS by blocking CGRP receptors in the periphery.  In doing this, it's possible erenumab is also lowering serum concentrations of histamine which can pass through the BBB to trigger both migraine and cluster headache.  This also tells me by inference, it's very likely that vitamin D3 is also working to reduce the expression and effects of CGRP in the periphery.

Histamine is a spoiler for both CHers and migraineurs.  If CH and migraine headaches continue with a 25(OH)D serum concentration ≥150 ng/mL (375 nmol/L), histamine is the likely culprit followed by an infection or any source of inflamation including some Rx medications.  If headaches persist at 25(OH)D serum concentrations ≥150 ng/mL (375 nmol/L) it may be prudent to see an Allergyst for skin tests of common allergens.  If that's not possible, you can order a hair sample allergy test for $60 to $76.50 USD from Multimedia File Viewing and Clickable Links are available for Registered Members only!!  You need to Login or Register These lab tests also include the heavy metals as well as food and non-food allergens.  Their test labs are located world-wide.

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Hope this helps.

Take care and please keep me posted.  I'm trying to collect as much response data as possible from migraineurs taking the anti-inflammatory regimen to control their migraines.

V/R, Batch
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« Last Edit: May 21st, 2018 at 1:06pm by Batch »  

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Re: Aimovig - New Migraine Treatment approved by FDA
Reply #8 - Aug 5th, 2018 at 10:37pm
 
I am on Aimovig and cluster free for two months since starting.  I have stopped verapamil.  I also have migraines and no migraines either.  Happy to answer any questions.  BTW my insurance covers Aimovig for the migraines but they do not compare to the clusters in frequency or severity by any means.
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Re: Aimovig - New Migraine Treatment approved by FDA
Reply #9 - Sep 29th, 2018 at 7:26pm
 
FYI: It has been ~8 weeks since my prior post on this topic. Aimovig is working. My usual frequency in a cluster phase is up to 7/24 hrs. I now have one cluster every 7-10 days and 8/10 pain instead of 10/10 pain level. A few minor shadows sprinkled in. I have had zero migraines rather than 1-2 per month. I am not afraid to go to sleep.  I am not afraid to have a glass of wine or a beer, which I would previously NEVER do in a cluster phase. I will try going off when I am completely cluster free for one month. I have no side effects from Aimovig.

JMHO: If you have tried everything else (as I have) then tell your doctor you have 'cluster migraines' and give Aimovig a try. I still take Vitamin D and Turmeric supplement.

GC
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Re: Aimovig - New Migraine Treatment approved by FDA
Reply #10 - Nov 2nd, 2018 at 2:37am
 
I wanted to share the latest update. I have had chronic cluster headaches for 20 years.
1 to 8 a day. Making my life come to a stand still. I lost my partner, my friends, my job and pretty much my life. I was a single mom and my poor children had to raise themselves.  I  have tried everything and I mean everything.

The last 3 years I started the d3 regiment w o2, Imitrex and Verapamil 960mg. My symptoms decreased 50% and for me this just wasn't enough. PATCH  was great always making suggestions how to adjust or add a supplement. Benadryl, melatonin are a few examples. The last year I did a study at Stanford University which involved: Fremanezumab,a monoclonal antibody for Calcitonin Gene Related Peptide subcutaneous injection once a month. Although there were some minor side effects; body aches, nausea and tight throat for a few days, The beast disappeared 100% for 3 weeks. The 4 th week I got very minor traces of CH. I got off all medications and supplements. A true miracle. Unfortunately the study ended. I have just started Amiovig 70mg injection. They have a program and I pay $20 copay on their website. Its month 2 and no headaches  I haven't had to use a shot and its fall. I still cant believe it. I Have added back d3 5000,  multivitamins magnesium 500mg.
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My life is amazing I Have a new job, a partner and friends. I celebrate each day headache free.
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Re: Aimovig - New Migraine Treatment approved by FDA
Reply #11 - Aug 17th, 2019 at 11:43pm
 
WSNurse

Would you care to please update us after all this time what is your experience with Aimovig?  Is it still working? Whatever you can share would be great.

I am epsiodic and Aimovig started working fine but I am just in my second month.

Thanks

Rick
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« Last Edit: Aug 17th, 2019 at 11:44pm by RickJim »  

Thanks

Rick
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