Author Topic: (AAN) Effect of [vitamin D analog] alfacalcidol on fatigue in MS...  (Read 294 times)

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Offline agate

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Presented at the annual AAN conference in Philadelphia, April 29, 2014:

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[S23.004] Effect of Alfacalcidol on Fatigue in MS Patients: A Randomized, Double-Blind Study


Yoram Barak,1David Magalashvili,2Mark Dolev Dolgopiat,3David Ladkani,4Dalia Nitzani,1Zeev Mazor,5Anat Achiron2

1Ramat-Gann, Israel, 2Ramat Gann, Israel, 3Ramt-Gann, Israel, 4Jerusalem, Israel, 5Petah-Tiqva, Israel

OBJECTIVE:

To evaluate the effect of vitamin D analogue, alfacalcidol, on multiple sclerosis (MS)-related fatigue.

BACKGROUND:

Fatigue is one of the most common and disabling symptoms of multiple sclerosis (MS), not efficiently responsive to current therapeutic agents.

DESIGN/METHODS:

A single site randomized double-blind placebo-controlled study. Patients suffering from significant fatigue were enrolled and randomized to parallel treatment arms: alfacalcidol (1 mcg) or placebo once daily for 6 months. The effect of treatment on fatigue and quality of life was evaluated using the fatigue impact scale (FIS) and RAYS quality of life (QOL) scale.

RESULTS:

One-hundred and fifty-eight MS patients (mean age 41.1+9.2 years, mean disease duration 6.2+5.5 years, 92% with relapsing-remitting disease) suffering from significant fatigue were included in the study. The baseline mean FIS score was 77.0+25.9 and the mean Expanded Disability Status Scale was 2.6+2.6. There was no difference in baseline FIS total score between the placebo and the (N=78) and the alfacalcidol (N=80) treatment arms.

At study completion, there was a significant decrease in FIS total score within each treatment arm (p<0.001); however the mean relative decrease from baseline was statistically significantly greater in the alfacalcidol treatment arm compared with the placebo arm (-41.6%±39.0 versus -27.4%±45.6, p=0.007). QOL improved significantly with alfacalcidol treatment in the psychological sub-scale (p=0.033) and in the social sub-scale (p=0.043). Alfacalcidol-treated patients had a reduced number of relapses (p<0.001) and no serious adverse events were recorded.

CONCLUSIONS:

Alfacalcidol is a safe and effective treatment strategy for treating fatigue in MS.
 _______________
Study Supported by: This study was supported by a research grant from Teva Ltd., Israel.

Category - MS and CNS Inflammatory Disease: Clinical Science



S23: Platform Session: MS and CNS Inflammatory Disease: Novel Therapeutics (3:15 PM-5:00 PM)
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Offline agate

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More on this in MedPage Today, May 1, 2014:

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Vitamin D Analog Fights MS Fatigue


By Michael Smith, North American Correspondent, MedPage Today

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.


PHILADELPHIA -- A synthetic analog of vitamin D reduces fatigue in patients with multiple sclerosis, a researcher said here.

In a randomized, placebo-controlled trial, the compound -- 1a-hydroxyvitamin D3 or alfacalcidol -- significantly reduced fatigue scores, according to Anat Achiron, MD, PhD, of the Sheba Medical Center in Tel-Hashomer, Israel.

The substance also was associated with improvements in quality of life and number of relapses, Achiron reported at the annual meeting here of the American Academy of Neurology.

The investigators saw no serious adverse events, Achiron told an oral session, and there was no significant difference between treatment and placebo arms in the number of adverse events.

In particular, calcium levels remained within normal limits in 91.4% of the alfacalcidol patients and 90.2% of those on placebo, she reported.

The compound is a "safe and effective strategy" for treating fatigue in MS patients, Achiron concluded.

The synthetic compound "does look to have activity in MS," commented Robert Fox, MD, of the Cleveland Clinic, who was not part of the study but who moderated a session at which it was presented.

"What's not clear," he told MedPage Today, "is whether there would be similar activity with regular vitamin D."

He said trials with standard vitamin D are now underway and should help settle that question.

Fatigue, Achiron noted, is a daily event for MS patients and is not directly related to depression or the degree of neurological disability. It doesn't respond to current therapies and there is no drug approved specifically for MS-related fatigue.

She and colleagues enrolled 158 MS patients who reported that fatigue interferes with their work, family, or social life, and randomly assigned them to alfacalcidol or placebo for 6 months.

The primary outcome measure was change on the multi-dimensional Fatigue Impact Scale (FIS), with improvement defined as a 30% decrease in the score, Achiron said. Secondary outcomes were improvement in neurological disability, quality of life, and number of relapses.

Participants reported baseline scores of about 80 on the 160-point fatigue scale, where higher scores indicate worse fatigue, she said. But after 6 months, patients in both arms had improvements that were significant at P<0.001.

However, those taking alfacalcidol had a greater relative decrease, on average, than those in the placebo arm -- drops of 41.6% and 27.4%, respectively -- and the difference was significant at P=0.007, she said.

The difference between treatment and placebo was more marked on the cognitive subscale of the FIS, Achiron said, but was still significant for the physical and social subscales.

There was no change in the degree of neurological disability, she reported, but quality of life improved on the psychological and social subscale, although not on the physical subscale.

In the alfacalcidol group, there were eight relapses during the study, compared with 25 in the placebo group (P=0.006).
_________________________

Achiron disclosed commercial relationships with Teva Pharmaceuticals, Novartis, Bayer-Schering Pharma, Biogen Idec, and Merck Serono.

Fox disclosed commercial relationships with Allozine, Avanir Pharmaceuticals, Biogen Idec, Novartis, Questcor, Teva Neuroscience, and Xenoport.


The article can be seen here.
MS Speaks--online for 17 years

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Offline agate

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An article on alfacalcidol is in the latest issue of Neurology Now, August -September 2014:

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POSSIBLE TREATMENT FOR FATIGUE IN MULTIPLE SCLEROSIS

In another study presented at the AAN Annual Meeting, alfacalcidol—a synthetic form of vitamin D—was found to significantly improve fatigue among people with multiple sclerosis (MS).Fatigue related to MS can occur daily, often gets worse as the day goes on, and is intensified by heat and humidity. MS-related fatigue is not directly correlated with either depression or the degree of neurologic disability. In addition, no medication has been approved specifically for fatigue caused by MS.The study—presented by Anat Achiron, MD, PhD, director of the Multiple Sclerosis Center at Sheba Medical Center in Israel and sponsored by drug-maker Teva Pharmaceuticals—involved 158 MS patients reporting that fatigue impacts their lives and who had poor scores on scales, including the Fatigue Severity Scale and Fatigue Impact Scale (FIS), in which patients answer questions about how fatigue is affecting their lives. Eighty were randomized to receive alfacalcidol, and 78 were randomized to get a placebo over eight months.Those in the alfacalcidol group improved by 41.6 percent, while those in the placebo group improved by 27.4 percent.“Alfacalcidol is a safe and effective treatment strategy for treating fatigue in MS,” Dr. Achiron says.John R. Corboy, MD, Fellow of the AAN, professor of neurology at the University of Colorado, and co-director of the Rocky Mountain MS Center at Anschutz Medical Campus, says the study was interesting but that he isn't ready to fully embrace the results. The placebo effect was large, he notes, with a decrease of 27 percent in FIS scores in the placebo group.Nonetheless, if the study could be repeated with better controls and analysis, “this would be an additional compelling argument to use vitamin D regularly in all relapsing MS patients,” Dr. Corboy says.
MS Speaks--online for 17 years

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Offline agate

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The MS International Federation has weighed in on this (November 18, 2014):

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New Treatment for Fatigue

Background

Fatigue is one of the most common and disabling symptoms of multiple sclerosis (MS), occurring in up to 90 per cent of people with MS.

MS-related fatigue occurs on a daily basis and gets worse during the day. Heat and humidity make it worse.

Fatigue is not directly linked to depression or degree of neurological disability, and may occur first thing in the morning even if the patient has slept well.

There is no medication approved specifically to treat MS-related fatigue.

Amantadine was the first medication used to treat fatigue, although most studies have not shown evidence of benefit. Modafinil was studied recently, also showing inconsistent results.

Several non-drug interventions have also been proposed including aquatic exercise training, occupational therapy, and internet-based programs.

Combating MS-related fatigue is of importance to those affected by MS, as it interferes with daily living, work, family life and socialising.

Study findings

The Multiple Sclerosis Journal recently published the results of a study by researchers from Israel who measured the effect of vitamin D analogue, Alfacalcidol, on MS-related fatigue. In this study, 158 MS patients with significant fatigue received Alfacalcidol or a placebo.

The researchers found that Alfacalcidol is a safe and effective treatment for fatigue among patients with MS.

These findings suggest that Alfacalcidol, a drug similar to vitamin D, should be considered a safe treatment option for MS-related fatigue.

- See more at: http://www.msif.org/news/2014/11/17/new-treatment-fatigue/#sthash.VU5TUnHE.dpuf
MS Speaks--online for 17 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.