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Low vitamin D levels in early multiple sclerosis predict increased disease activity progression 

MD-FM Thursday January 23rd, 2014



SARAH:

MD FM — Medical News from around the world with Peter Goodwin.

SEGMENT 1: MULTIPLE SCLEROSIS: Low vitamin D levels in early stages predict worsening long-term prognosis

 

PETER:

Hello, and with me is Sarah Maxwell. To begin with, in patients with early signs of multiple sclerosis, vitamin-D levels are an early predictor of MS disease activity and progression. That’s according to a longitudinal trial published in JAMA Neurology…

 

SARAH:

Yes, patients with clinically isolated syndrome and low vitamin-D serum levels, that is below 50 nmol/L, had twice the level of disease activity and double the rate of new brain lesions at five years, compared to patients with levels above 50 nmol/L…

 

PETER:

Interesting because previous studies had already shown a link between low vitamin-D levels and worse MS outcomes hadn’t they? But the experts couldn’t tell whether low vitamin-D levels were just a consequence of MS…

 

SARAH:

That’s right but these latest results shed some light on this. Lead study author Dr. Alberto Ascherio:

 

ASCHERIO:

This shows that vitamin D deficiency precedes and contributes to predict the course of MS. This is strongly suggestive that there is a causal association but we cannot really prove it. So my recommendation would be to screen the vitamin D levels in all patients who present with first symptoms of MS, definitely give supplements to all patients below 50 nmol/L and, to be safe, I would suggest to give supplements to all the patients below 70 nmol/L to elevate the level to a physiological range, which I would place between 70 and 120 nmol/L. So people argue that going even higher could be better, but for that we do need a trial and experiments. 

 

SARAH:

That was Alberto Ascherio, from Harvard University, in Boston.

 

 

SEGMENT 2: Alzheimer’s disease: therapeutic antibodies used might delay the progression of dementia

 

PETER:

Therapeutic antibodies used during the early stages of Alzheimer’s disease might delay the progression of dementia, according to findings published in the New England Journal of Medicine...

 

SARAH:

Yes, these data come from the first two large studies looking at the use of monoclonal antibodies directed against amyloid, the protein that builds up the plaques in Alzheimer’s disease. One study looked at bapineuzumab, and the other, solanezumab, in patients with mild to moderate dementia, so patients who are pretty far along in the course of their disease. Unfortunately, neither agent was associated with a clear delay in cognitive decline, however, scan imaging and biomarker tests suggested that the agents were nonetheless hitting their target:

 

SALLOWAY:

The consensus among dementia researchers is that the role of amyloid is strongest earlier in the disease, in pre-clinical and early-clinical phases, and we think that this type of treatment is probably going to have a bigger effect if given earlier rather than in the dementia phase. 

 

SARAH:

That was lead author, Dr. Stephen Salloway, from Butler Hospital in Providence, Rhode Island, who added that solanezumab actually did show some slight clinical improvements in patients with mild dementia.

 

PETER:

So what next? Will there be further investigation?

 

SARAH:

Well, looking at both drugs here, the teams actually discovered that more than 20 per cent of people in the study didn’t have signs for Alzheimer’s, so this obviously limits the results!

 

SALLOWAY:

More than likely we’ve been testing an anti-amyloid drug with a large number of people who don’t have Alzheimer’s. So in future studies, we’re going to be using an amyloid PET-scan or a CSF test for amyloid to make sure we’ll only treat the people that are building amyloid and have Alzheimer’s disease.

 

SARAH:

Dr. Solloway, who told MDFM that trials were now underway to test solanezumab in carefully selected patients with milder Alzheimer’s disease. And John Hardy, who wrote an editorial on the study, sounded pretty encouraged about this:

 

HARDY:

You know they came very close to getting statistical significance with their primary outcome measure so I, actually, for the first time in about 4 or 5 years, feel cautiously optimistic. 

 

SARAH:

Professor John Hardy, from University College in London.

 

 

SEGMENT 3: Rotavirus vaccines recommended despite slight increased risk of intussusception

 

PETER:

The two vaccines against rotavirus, the most common cause of severe childhood diarrhea, caused   a small but significant increase in the risk of the intestinal complication intussusception that caused the withdrawal of an earlier vaccine. That’s according to new evidence from the United States …

 

SARAH:

Yes, the risk occurs in the first seven days after the first dose of either vaccines, and is in the order of one to five cases per 10,000 infants…

 

PETER:

The pre-licensing studies, published in 2006, had suggested that these recent generations of rotavirus-vaccines did not raise the risk. But then, post-marketing surveillance had been recommended…

 

SARAH:

That’s right, and that’s what these two independent studies did, published in the New England Journal of Medicine, and they provide the most comprehensive description of the associations so far.

 

PETER:

So what are the recommendations now coming out of this then?

 

SARAH:

Well, given the low risk, the recommendations aren’t going to change. Rotavirus vaccination is recommended by the World Health Organization, and these vaccines have had a big impact on hospitalizations and emergency department visits, which have decreased by more than 80% in the USA. Now there’ll be investigations into whether there’s a subgroup of children who might still be at a marked increased risk of intussusception, who haven’t yet been identified by research so far.

SEGMENT 4: Combination of newer-generation antivirals safe and very effective for patients with hepatitis C infection, irrespective of subtype

 

PETER:

For patients with hepatitis C, whether it be genotype one, two or three, a combination of newer generation, direct acting antivirals, taken orally once a day, was extremely effective and safe. These very encouraging results came from a study published in the New England Journal of Medicine…

 

SARAH:

Yes, 91 per cent of patients infected with genotype two or three Hep-C and almost all: 98 per cent of patients with genotype-1 disease, including those who didn’t respond to treatments with first generation antivirals, telaprevir and boceprevir, had sustained virologic responses 12 weeks after they were treated with daclatasvir + sofosbuvir.

 

PETER:

Well that sounds good because the first generation antivirals don’t work on all genotypes, the regimens can be complicated and you can induce drug resistance…

 

SARAH:

Exactly. So it’s pretty exciting to find powerful new agents. And this new combination worked as well with or without ribavirin, so you don’t need to include ribavirin.

 

PETER:

Well that’s a relief because ribavirin is teratogenic. But how long do you need to continue these new treatments?

 

SARAH:

A 12-week regimen worked as well as 24-weeks in patients with treatment-naïve genotype-1 disease. The next step will be to test this shorter regimen in the other groups. Stanislas Pol, who did not participate in the study:

 

POL:

Times are very rapidly changing and it is now a new done with a therapeutic revolution, which will be mainly based on the combination of different direct-acting antivirals (DAAs) but clearly the daclatasvir + sofosbuvir combination will be, in the next future, probably the best combination to treat all the patients who need to be treated.

 

SARAH:

That was Professor Stanislas Pol, from Hopital Cochin in Paris, who said that sofosbuvir should be approved this week, and daclatasvir in May.

 

IN BRIEF 1: Novel long-acting recombinant factor VIII reduces frequency of injections for patients with severe hemophilia A

 

PETER:

Finally, in brief: For patients with severe hemophilia-A, a novel recombinant factor-VIII, with a prolonged half-life compared to currently available treatment, resulted in low bleeding rates and was well tolerated. This factor-VIII was given prophylactically, once or twice a week (that’s less frequently than standard treatments) in a phase-III pivotal study  published in the journal Blood looking at 165 men.
 

 

In BRIEF 2: Mediterranean diet associated with lower risk of peripheral artery disease

 

PETER:

A Mediterranean diet was associated with a lower risk of peripheral artery disease, in the first randomized trial to investigate this relationship. It was published in JAMA. It looked at over 7,400 people with either diabetes or at least three cardiovascular risk factors. This study followed previous data showing that the Mediterranean diet can also reduce the incidence of heart attacks and stroke.



PETER:

That's all from MDFM for now. Sarah Maxwell and I will be back with more next week, so until then from me Peter Goodwin, goodbye!

 

 

 

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