Discoveries & Stats

13 October 2009

New Migraine Drug Telcagepant – Not Dead Yet

James Discoveries & Stats, Medications, News 4

The pharmaceutical company Merck & Co., Inc was at the 14th International Headache Congress in September, talking again about the migraine drug Telcagepant. And hopes that Telcagepant will see the light of day aren’t dead yet.

After concerns about using Telcagepant as a migraine preventative, Merck has moved ahead with trials using the new drug as an abortive. Researchers were originally concerned when some patients developed high levels of liver enzymes (transaminases). (more on the background of Telcagepant here)

In one of the new trials, none of the patients had high levels of liver enzymes apparently caused by the drug (you caught that, right? Some did have the problem, but investigators felt it was not drug related.).

Two trials were reported on. First, compared with rizatriptan (Maxalt, Rizaliv, Rizalt), how many "adverse events" would patients experience?

Investigators didn’t look for any side effect here, they only measured events from a predetermined list. The adverse events were not too serious with either group, and there tended to be fewer with Telcagepant.

The problems more common with Telcagepant included nasopharyngitis, upper abdominal pain, and nausea and vomiting. In the other study, patients on telcagepant were more likely to feel sleepy (than those on a placebo). In an earlier study, Telcagepant was less likely to cause nausea than zolmitriptan, so we’ll see how it continues to compare with the triptans on this one.

But did Telcagepant fight symptoms of migraine? Yes, the results still look positive. In a large trial of 1,677 patients, researchers used doses of 140mg or 280mg and measured symptoms after 2 hours. They were interested in pain freedom or pain relief (reduction to mild or none). These charts show the percentage of patients helped at either dose, compared to a placebo:

Merck is preparing to have some major discussions regarding Telcagepant later this year with regulatory agencies. It remains to be seen if this drug will be the next big one for Merck and migraine, though it’s still showing promise.

The bad news is that Merck has shelved MK-3207, it’s other possible oral calcitonin gene-related peptide (CGRP) receptor antagonist for migraine treatment. So research on this type of drug continues to be stop and go for Merck.

However, Dr. David Michelson, vice president of clinical neurosciences, said Merck is still committed to this type of research: "Merck believes that the blocking of CGRP receptors remains an exciting pathway to address the underlying pathophysiology of migraine. We are continuing our efforts to offer patients a new treatment approach."

via: Merck Updates Status of Clinical Development Programs for Investigational CGRP Receptor Antagonist Treatments for Acute Migraine; MK-3207 Clinical Development Discontinued

9 October 2009

How to avoid that Altitude Headache

James Discoveries & Stats, Tips 3

Whether you’re going hiking for the weekend, or just visiting Uncle Frank who lives at a high altitude, mountain sickness – and so an altitude headache – could be a risk for you. You may not have thought about it, but it’s actually quite common, and headache is a common symptom.

Most often, acute mountain sickness is going to be a factor for you if you experience a major change in altitude. Though this could happen travelling from city to city, more likely it’s the case when you’re actually hiking in the mountains, especially if you’re not used to it.

PopocatÃ©petl Volcano Mountain in Mexico - 5,426 m (17,802 ft)

Besides headache, you could experience trouble sleeping, light headedness, nausea, shortness of breath, rapid heart rate, dizziness, and a loss of appetite.

If you get more severe mountain sickness, you could find you’re having trouble walking a straight line, your skin gets bluish, gray or pale, you get confused, your chest gets tight and you can’t even catch your breath while you’re resting, and you start coughing and may even cough up blood. This is very serious, and can even lead to death if not treated.

A recent study in the Eastern Alps reminded me that a little education can prevent a lot of problems here. Researchers found that water intake was a factor, for example. Make sure you’re well hydrated, especially when you’re up in higher altitudes.

Also, exertion seemed to play a big role. Often people are hiking hard when they’re simply not experienced – take it slow, and you can avoid a lot of problems.

A history of migraine was also a risk factor. Those of us with migraine do need to be more careful when climbing to higher altitudes. Drink lots and take it slow, and headache symptoms can be minimized.

If you’re travelling up above 6300 feet / 1900 meters you do have a chance of experiencing mild symptoms. Over 14,000ft / 4,200m, and you can almost bet on it. But a little caution, awareness and preparation can hopefully make your trip much more enjoyable.

More on acute mountain sickness

7 October 2009

New Botox Trials – Encouraging News on the bumpy road to acceptance

James Discoveries & Stats, Treatments 5

If you want your insurance to pay for Botox treatment for migraine, you should be encouraged by the report at last month’s International Headache Congress. Botox migraine treatment is continuing on the road to acceptance, but there’s no doubt it’s still a bumpy road.

The President-elect of the American Headache Society, Dr. David Dodick, gave the report on two trials of onabotulinumtoxinA (Botox), and there’s a lot for proponents of Botox treatment to celebrate.

First, these trials were very professionally done, a serious step toward Botox’ acceptance by the USA’s FDA. They were randomized, placebo-controlled, well balanced trials, the kind of trials that we need more of.

Botox trials for Botox migraine treatment

As you may guess, the results were positive. Patients that received Botox had fewer headache and migraine days, fewer attacks, and significantly fewer actual hours of headache and migraine attacks. Overall, those taking Botox had less disability and functioned better than the placebo group.

This is the kind of evidence we’re looking for – proof that Botox is helping some people enough to be considered a valid migraine treatment.

But these trials are not telling us Botox is the miracle treatment we’ve all been waiting for – there are issues remaining. First, though there was a general improvement, Botox was certainly a long way from drastically cutting down on everyone’s symptoms. Of course, we wouldn’t expect that with most treatments – we know that few work with everyone. The Cochair at the session, Dr. Elizabeth Loder, pointed out one of the big issues with Botox – there’s still no easy way to predict who it will work with.

There’s still a lot of work to be done with Botox. How should it be administered? How much? When? Who does it work best with? Considering how far we still need to go answering these questions, we should be encouraged that we’re already seeing such good results in trials.

Another issue with these trials was that those taking Botox did not end up taking fewer other medications. This confirms what earlier studies have told us, and it will continue to be a concern to researchers – and to insurance companies. Can we get the overall cost down, while still improving people’s quality of life?

That being said, we did see that those on Botox took fewer triptan medications. So there are some interesting questions on this front that still need to be answered.

But let’s end on an encouraging note. This study did focus on a group that has a high need. These weren’t people who have an attack a year, but people who are disabled by moderate or severe attacks on average every week or more. They’re losing many hours a month to migraine. Many of them were, by typically accepted standards, taking too much medication (though they were off it at the time of the study).

There is hope then that Botox may give back many hours of life to people who are losing the most to migraine. And if doctors and insurance companies want proof that it works, well designed trials like this are giving them what they need. Doctors already using Botox treatment are convinced that it is significantly helping many.

The researchers hope to have approval of Botox treatment from the FDA for chronic migraine by the end of next year.

References:
Humanistic, utilization, and cost outcomes associated with the use of botulinum toxin for treatment of refractory migraine headaches in a managed care organization.
Botulinum Neurotoxin Reduces Headache Frequency and Disability in Chronic Migraine by Dr. Daniel M. Keller (report on this study) 16 Sep 2009
Botox is proven to help chronic migraine

2 October 2009

Deeper into Migraine, Glucose and Insulin…

James Discoveries & Stats 33

There’s a lot of talk about migraine and sugar levels. At one time or another, it seems everyone suspects there’s a strong relationship. So it really is surprising how little we talk about it, and how little research has come out to explain it.

One little study coming out of Austria published this month in the journal Cephalalgia is getting the conversation going again. The study set out to investigate things like glucose, insulin, and something known as "nitric oxide stress" in migraineurs.

Now there’s a lot to explain here, so stay with me and I’ll try to give you a simple overview.

All three of these things – glucose, insulin, and nitric oxide, are interrelated. It’s common for people with diabetes, for example, to have impaired nitric oxide (NO) pathways. Too much or too little NO in your body can cause problems.

Now NO has an amazing influence on all kinds of things in your body. It has to do with regulating blood flow in your blood vessels (through smooth muscle function). It plays a role in inflammation. Proper levels in your body may help prevent heart disease, influence how you feel pain, and even impact your memory. You can already see how a migraineur may be interested in research related to nitric oxide.

But when there are problems with NO production or elimination, this can lead to too much insulin in the body (hyperinsulinemia). Hyperinsulinemia may actually have no symptoms on its own, but it could lead to things like low blood sugar, and may lead to the development of insulin resistance and type 2 diabetes. And this brings us back to questions of carbohydrates and glucose and the glycaemic index and all those things that have to do with blood sugar levels, diabetes and hypoglycemia.

Back to our study. Using various parameters and tests on 48 migraineurs and 72 non-migraineurs, the researchers found that migraineurs were significantly more likely to have hyperinsulinaemia (hyperinsulinemia), and so showed signs of increased nitric oxide stress.

I hope you’ve followed me so far, and see the value of the study. What we’re looking for is evidence that can be tested that migraine patients do have insulin related problems. This gives us a glimpse into a web of related functions in the body – nitric oxide pathways, insulin production, glucose, and so on, and how these things may not be functioning properly in the person with migraine disease.

Not only is it a step into a new world of treatment, it’s also another confirmation of what we already knew – there is a relation between migraine and blood sugar levels.

Because of this, two things. First, the way we eat and the way we exercise can make a difference in our symptoms, and this gives us a clue of how to think about it. Second, just eating differently and exercising may not be enough for many of us. The research needs to continue to see why the body is not functioning the way it should be.

Summary of the study: Hyperinsulinaemia in migraineurs is associated with nitric oxide stress.
Another study currently in process related to nitric oxide stress and insulin

28 August 2009

Migraine: Does your face hurt?

James Discoveries & Stats 75

A small study published in June suggested that almost 9% of migraineurs have facial pain during an attack. Now this is of course another of those chicken-and-egg questions, because some of those patients likely have jaw issues that are triggering migraine attacks. But others simply have migraine attacks that cause the facial pain. Read about the study from Germany, Prevalence of facial pain in migraine: a population-based study.

In fact, in rare cases, there is something rare called isolated facial migraine, where the pain in the face is the main feature of the migraine.

Sometimes treatment for the jaw is needed, such as an NTI-tss device. In other cases, when the pain is coming from the migraine attack, simply treating migraine as a whole will solve the facial pain issue as well.

What about you? Do you have facial pain during an attack? What’s it like?