What Should Work, What Might: Migraine Meds Reassessed

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New Studies Re-assesses Migraine Drug Efficacies (1)

Efficacy of migraine drugs was under another new review from researchers who have examined all of the scientific literature available on the treatment as well as followed up on migraine patients and the scientists have come up with what in their view prove effective in acute cases of migraine. Besides these 2 criteria the study was also based on the depth of the published research done on the medications as well as the quantum of studies on them.

The conclusions of the new study at a glance are:

DEEMED EFFECTIVE (LEVEL A) PROBABLY EFFECTIVE (LEVEL B)
TRIPTANS – Sumatriptan, Zolmitriptan, Rizatriptan, Frovatriptan, Almotriptan, Naratriptan, Eletriptan, Avitriptan OPIOID – Codeine+Acetaminophen, Tramadaol+Acetaminophen
Dihydroergotamins
NSAID – Aspirin, Ibuprofen, Naproxen
OPIOID – Butorphanol Nasal Spray
Caffeine with NSAIDS

Findings of the study were published in the January 2015 issue of the medical journal Headache. As per Dr. Stephen Silberstein , professor of neurology and director of the Jefferson Headache Center of Thomas Jefferson University in Philadelphia, “We hope that this assessment of the efficacy of currently available migraine therapies helps patients and their physicians utilize treatments that are the most appropriate for them.” (2)

Based on the study criteria, drugs were thus rated as deemed effective (Level A), probably effective (Level B), possibly effective (Level C). For such medications where the proof was found either inadequate or gave such results which refutes the use of that medicine, was classified as Level U. For a drug to be classified as deemed effective or a Level A drug, the studies done on the drug must be supported by at least well-designed, double-blind, randomized, placebo-controlled clinical trials.  (3)

The American Headache Society will soon be translating the research findings that will aid in providing evidence-based guidelines to clinical practice. In any case, doctors treating migraine patients must consider the individuals on a case to case basis keeping in view the drug side-effects, patient history, costs and drug efficacy.

SOURCES

  1. Image credit: Pills and Capsules – Stock Photo; freedigitalphotos.net; Web February 2015; http://www.freedigitalphotos.net/images/pills-and-capsules-photo-p308698
  2. Study Rates Migraine Medications; WebMD.com; Web February 2015; http://www.webmd.com/migraines-headaches/news/20150120/study-rates-migraine-medications
  3. American Headache Society Provides Updated Assessment of Medications to Treat Acute Migraine; Newswise.com; Web February 2015; http://www.newswise.com/articles/american-headache-society-provides-updated-assessment-of-medications-to-treat-acute-migraine

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Drug Effectiveness & Power of Suggestion: Migraine Study

Role of Self Suggestions In Migraine

Doctor’s Words Affect Migraineurs’ Response To Drug (1)

A recent study conducted by researchers from Harvard Medical School and Beth Israel Deaconess Medical Center in Boston on migraineurs has shown that the type of labeling on the drug affects the body’s response to pain, nausea, photo-sensitivity, sound-sensitivity as well as vomiting (symptoms associated with a typical migraine attack).

According to Dr. Andrew Charles professor and director of the headache research and treatment program in the department of neurology at University of California School of Medicine, Los Angeles, who was not involved in the research, “When migraine patients were told by their doctor that a pill would help ease their headaches, this advice seemed to produce results whether or not the pill was a real migraine medication or a dummy placebo. Relief was still higher with the actual medicine, so drugs do work beyond the placebo effect, but the researchers say that the placebo effect may still account for half of the therapeutic value of a drug.” (2)

The research studied over 450 migraine attacks in total of 66 migraineurs over a period of their seven attacks.

  • The first attack was to go untreated but the migraineurs were expected to self-rate their pain and migraine-associated symptoms on a scale.
  • From the second attack up to the seventh attack the migraineurs were given medication (pills) in packets that were labelled.
  • The packets were labelled ‘Maxalt’ (Rizatriptan) – positive suggestion ( a drug that will help); ‘Placebo’ – a negative suggestion (drug with no effect on pain); ‘Maxalt or placebo’ – neutral suggestion (unknown if the drug will help or not).
  • But for two situations, one of the “Maxalt” envelopes actually held a placebo and one of the “placebo” envelopes contained Maxalt.
  • The migraineurs were to record the level of pain and discomfort 30 minutes from the onset of the migraine attack (for each of episode 2 through 7th episode)
  • Then they were to take the pills in the labelled packets.
  • Then they were to record their pain and discomfort two our thence ( A total of 2.5 hours after the commencement of a migraine attack)
  • In addition, they were also given a rescue medication in the event that the study medicines did not provide them with any relief. This rescue medication consisted of 1 Maxalt and 2 Naproxen tablets.
  • But for two situations, one of the “Maxalt” envelopes actually held a placebo and one of the “placebo” envelopes contained Maxalt.

Here is a chart depiction of the study methodology: (3)

Migraine Placebo Effect

As per Dr. Ted Kaptchuk, a senior author of the study, director of the Program in Placebo Studies, Beth Israel Deaconess Medical Center, and a professor of medicine at the Harvard Medical School, “We found that under each of the three messages, the placebo effect accounted for at least 50 percent of the subjects’ overall pain relief. When Maxalt was labelled “Maxalt,” the patients’ reports of pain relief more than doubled compared to when Maxalt was labeled “placebo.This tells us that the effectiveness of a good pharmaceutical may be doubled by enhancing the placebo effect.”

The authors were surprised to find that even when patients were given a placebo labeled as “placebo,” they reported pain relief, compared with no treatment. They had no idea why this occurred.

However, the findings of the study are best used for indicative purposes only and more research will be needed to be done to find out these results could be applied to clinical care and how placebos might help boost drug treatment care. As per Kaptchuk it is possible that simply hearing the words of medicine can have a healing effect, he noted.

SOURCES:

  1. Image Credit: Help Yourself Key Shows Self Improvement Online; Image by Stuart Miles; Freedigitalphotos.net; Web January 2014; http://www.freedigitalphotos.net/images/help-yourself-key-shows-self-improvement-online-photo-p211446
  2. Power of Suggestion Shown in Study of Migraine Drug; WebMD.com; January 2014; http://www.webmd.com/migraines-headaches/news/20140108/power-of-suggestion-revealed-in-study-of-migraine-drug
  3. Table Credit: Placebo effects are not the “power of positive thinking”; Science-Based Medicine; Web January 2014; http://www.sciencebasedmedicine.org/ted-kaptchuk-versus-placebo-effects-again/

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Migraining Women Likely To Develop Dementia: Study

Dementia Risk For Migraineurs

 

Migraineurs With Aura Are 48% More Likely To Develop Dementia In Later Life (1)

As if the sustained pounding, debilitating pain, the flurry of traumatic symptoms and ineffective medicines were not enough for migraineurs, studies are now showing that persons who suffer migraines with visual and other aura are 48% more likely to develop dementia as they begin to age than their healthier counterparts! (2)

In part this could be explained by the presence of white matter lesions that the brains of migraineurs are often seemed to have when scanned using an MRI (Magnetic Resonance Imaging).

We know that white matter of the brain consists of nerve fibres (axons) and are surrounded by fat called myelin (3). The main function of the white matter is to transmit signals from one region of the cerebrum to another and between the cerebrum and lower brain centres. Lesions in the white matter interfere with signal transmissions. Damage to this white matter is a common significant factor observed in all those suffering from dementia.

Earlier control tests and those conducted at the Changhua Christian Hospital, Taiwan has already shown that migraineurs are at an exponential risk of diabetes and of developing hypertension, depression and cardiovascular diseases.

However, other studies have shown that the mental status of women with a history of migraine was no different from other women’s, so more research is needed.

SOURCES

  1. Image Credits: Dementia Disease And A Loss Of Brain Function And Memories As Al by David Castillo Dominici: FreeDigitalPhotos.net; Web November 2013; http://www.freedigitalphotos.net/images/dementia-disease-and-a-loss-of-brain-function-and-memories-as-al-photo-p173821
  2. Migraine may be linked to dementia; IOL Lifestyle; Web November 2013; http://www.iol.co.za/lifestyle/migraine-may-be-linked-to-dementia-1.1608597#.UoowF9JmiSo
  3. White matter of the brain; MedlinePlus; Web November 2013; http://www.nlm.nih.gov/medlineplus/ency/article/002344.htm

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FDA Grants Approval To Rizatriptan Benzoate ODT For Acute Migraine Treatment

Migraine Blog Rizatriptan ODT

Rizatriptan Benzoate ODT approved by FDA and launched in the market.  Image is not of said drug (1)

Pharmaceutical company Breckenridge’s drug Rizatriptan Benzoate has been given the green flag for immediate launch by the U.S Food and Drug Administration. The drug comes in the form of orally disintegrating tablet (ODT). It is available commercially in packs of potency/dosage 5 mg and 10 mg.

Breckenridge’s drug Rizatriptan Benzoate ODT is manufactured and supplied by Natco Pharma Limited. Just like Merck & Co. Inc’s Maxalt MLT, Rizatriptan Benzoate ODT is a prescription drug used in the management and treatment of acute migraine.

The FDA granted final ‘go ahead’ for the Abbreviated New Drug Application (ANDA) for Rizatriptan Benzoate ODT some nine months prior to expiration of the pediatric-exclusivity period for the challenged Orange Book patent (April 1, 2014).

‘Breckenridge’s patent challenge regarding Rizatriptan Benzoate Orally Disintegrating Tablets is a continuing part of its larger aggressive Paragraph IV strategy commenced a few years ago. Since the beginning of 2011, Breckenridge has filed twelve (12) Paragraph IV patent challenges and intends to continue that trend in the next several years, focusing on niche Paragraph IV opportunities with certain barriers to entry.’ (2)

SOURCES:

  1. Image Credit: FreeDigitalPhotos.net; Yellow Tablet; Image by rakratchada torsap; Web July 2013; http://www.freedigitalphotos.net/images/agree-terms.php?id=10096441
  2. Breckenridge Pharmaceutical, Inc. Announces Approval of Rizatriptan Benzoate ODT (Orally Disintegrating Tablets): BioSpace.com; Web July 2013;  http://www.biospace.com/news_story.aspx?StoryID=301892&full=1

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CGRP Blockers & SRAs – The New Faces In Research For Migraine Management

CGRP stands for Calcitonin Gene-Related Peptide. It is a calcitonin group compound made up of polymers of amino acid monomers. CGRP is manufactured in the human body in the nerve cells (neurons) of the central nervous system and the peripheral nervous system.

Research – New Migraine drugs In The Pipeline (1)

So what is the function of CGRP? Of the many functions, CGRP is a powerful vasodilator and it contributes significantly in the transmission of pain message through the body. It is also believed to play a critical role in cardiovascular homeostasis as well as in processing noxious stimuli that has the potential to damage the tissues of the heart.

The development of drugs which are essentially CGRP receptor antagonist is in the pipeline aimed at helping migraineurs the world over cull the pain of their migraine episodes. How does the CGRP receptor antagonist do this? It has been observed that during the onset of a migraine attack, CGRP binds to CGRP receptors and activates these receptors which then transmit pain signals. CGRP receptor antagonist prevents the CGRP from binding on to CGRP receptors thus circumventing the transmission of pain signals causing migraine pain.

Telecagepant was such a CGRP receptor antagonist drug developed by Merck & Co. and was undergoing Phase III clinical trials but the trials were abandoned after identification of two patients with significant elevations in serum transaminases indicating liver damage. However, similar drugs without such side-effects are now being designed. CGRP receptor blockers also significantly reduce nausea and are more desirable in total benefit than triptans. As per Peter Goadsby, MD, PhD, director of UCSF’s Headache Center, “So this is a way for it to be effective and adds a safety bonus to the patients and it seems to be better tolerated.” (2)

There is another approach to drug design and development aimed at reducing the misery of migraineurs and it comes from the side of serotonin activity. In this class, one investigational drug of note is Lasmiditan thought of by Eli Lilly & Co and being designed to treat acute migraine by CoLucid Pharmaceuticals. These drugs are technically serotonin receptor agonists and selectively bind to the 5-HT1F receptor subtype. Unlike triptans these drugs do not constrict the heart vessels and have lesser side-effects. Trials have shown that administration of this drug reduced migraines to almost nothing within a two-hour period in almost 60% of the patients also tackling nausea and photophobia beautifully. The drug is expected to be ready by 2014. As per Dr. Goadsby, “Lasmiditan is now that finished its phase two studies and clearly works. It does not have the same sort of liver effects as its predecessors and will move on into phase three. That is again for acute migraine treatment. So it is a safe and totally different action than what we currently have.” (2)

 

SOURCES:

  1. Image by Ponsulak; Freedigitalphotos.net; March 2012; http://www.freedigitalphotos.net/images/view_photog.php?photogid=1983
  2. Cutting Edge Treatments For Migraines: More Than Just A Headache; Ivanhoe.com; March 2012; http://www.ivanhoe.com/channels/p_channelstory.cfm?storyid=29106&channelid=CHAN-100018

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