good news oniron infusion (from medscape)
Posted: Thu Jun 18, 2009 12:03 pm
From Medscape Medical News
SLEEP 2009: Intravenous Iron is Effective in Restless-Legs Syndrome
Jim Kling
Authors and Disclosures
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Dr. Daniel Mikol discusses the findings from the multicenter REGARD study.Click here. June 16, 2009 (Seattle, Washington) — A double-blind, placebo-controlled study shows that intravenous (IV) iron, specifically ferric carboxymaltose (FCM), is a safe and effective treatment for moderate to severe restless-legs syndrome (RLS).
Previous open-label trials of IV treatment with iron dextran have demonstrated greatly reduced RLS symptoms, but a controlled trial of IV iron sucrose showed little improvement. One reason for these differences may be that different iron formulations can have dramatic differences in uptake and half-life in tissues.
FCM is a formulation that can be given in a single dose by IV infusion. It has little risk of anaphylaxis, which can be a problem with other iron formulations, and its half-life is 16 hours, with tissue availability up to 4 weeks following treatment. The researchers performed a controlled study to evaluate the efficacy of IV FCM in RLS patients.
"We got dramatic responses," Richard Allen, PhD, a research associate in neurology at Johns Hopkins Medicine, in Baltimore, Maryland, said during his presentation here at SLEEP 2009: 23rd Annual Meeting of the Associated Professional Sleep Societies.
Positive Results
The team recruited only patients with primary moderate to severe RLS who were free of RLS medications and randomly assigned them to IV FCM treatment (24 patients), with an initial 500-mg dose followed by 1000 mg on day 5, or a placebo group (21 patients).
They evaluated patients at baseline using the International Restless Legs Syndrome Study Group Scale (IRLS), Medical Outcomes Study Sleep Scale (MOS sleep), and RLS Quality of Life (RLS-QoL) measurements and then carried out repeated IRLS and MOS sleep assessments on days 14 and 28 and RLS-QoL on day 28. They also obtained the clinician's global impression of improvement (CGI-I) at days 14 and 28.
The day-28 evaluation revealed several positive results. Treated patients had a significant decrease in the IRLS scale vs controls. The number of remitters, defined as an IRLS ≤10, was higher among treated patients than those on placebo, and 4 of these achieved scores less than 5, vs none among the placebo patients.
Improvements in MOS sleep scores and the RLS-QoL scale were also seen. Significantly more treated patients had an improved or very much improved CGI-I vs those on placebo.
Change in Study End Points with IV FCM Treatment vs Placebo in RLS Patients from Baseline to Day 28 End Point IV FCM Treatment Placebo P
IRLS score -8.9 -4.0 .04
Remitters (IRLS < 10), n (%) 7 (29) 1 (4. .051
IRLS scores < 5, n (%) 4 (17) 0 (0) .11
Improvement on MOS Sleep Score (points) 24 19 .09
Improvement on RLS-QoL (points) 23 18 .024
Improvement in CGI-I (% of patients) 58 14 .005
The results were also lasting. After 1 month, 75% of treated patients did not require additional medication. This number dropped to 38% at 3 months and 25% at 5.5 months.
In earlier studies, Dr. Allen's team used magnetic resonance imaging to demonstrate a deficit in iron concentration in the brains of RLS patients. "It suggests that we might need to start working on how we can (best) deliver iron to the brain," he told Medscape Neurology.
Reorienting RLS Research?
Michael Silber, MBchB, professor of neurology at the Mayo Clinic College of Medicine, in Rochester, Minnesota, who attended the conference, agreed that the study should reorient research.
"It suggests we're looking at the wrong thing — that we need to be looking at iron in the brain [in RLS]," he told Medscape Neurology. Clinically, Dr. Silber said that IV FCM is a useful option for patients who are iron-deficient and cannot absorb iron supplements orally. "It's an encouraging report," he said.
The study received support from Luitpold Pharmaceuticals. Dr. Silber disclosed no relevant financial relationships.
SLEEP 2009: 23rd Annual Meeting of the Associated Professional Sleep Societies: Abstract 0902. Presented June 10, 2009.
Corrie
SLEEP 2009: Intravenous Iron is Effective in Restless-Legs Syndrome
Jim Kling
Authors and Disclosures
Print This Email this
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[ Close Window ]Email This
Your email has been sent .
Your Name:
Send me a copy(jjalgera@xs4all.nl)
Recipient's Email:
Separate multiple email addresses with commas (Limit is 10).
Subject:
Optional Message: Ha Joke, positief nieuws m.b.t. iron infusions Corrie
sending...
Information from Industry
Find out about a head-to-head comparison of MS treatment options
Dr. Daniel Mikol discusses the findings from the multicenter REGARD study.Click here. June 16, 2009 (Seattle, Washington) — A double-blind, placebo-controlled study shows that intravenous (IV) iron, specifically ferric carboxymaltose (FCM), is a safe and effective treatment for moderate to severe restless-legs syndrome (RLS).
Previous open-label trials of IV treatment with iron dextran have demonstrated greatly reduced RLS symptoms, but a controlled trial of IV iron sucrose showed little improvement. One reason for these differences may be that different iron formulations can have dramatic differences in uptake and half-life in tissues.
FCM is a formulation that can be given in a single dose by IV infusion. It has little risk of anaphylaxis, which can be a problem with other iron formulations, and its half-life is 16 hours, with tissue availability up to 4 weeks following treatment. The researchers performed a controlled study to evaluate the efficacy of IV FCM in RLS patients.
"We got dramatic responses," Richard Allen, PhD, a research associate in neurology at Johns Hopkins Medicine, in Baltimore, Maryland, said during his presentation here at SLEEP 2009: 23rd Annual Meeting of the Associated Professional Sleep Societies.
Positive Results
The team recruited only patients with primary moderate to severe RLS who were free of RLS medications and randomly assigned them to IV FCM treatment (24 patients), with an initial 500-mg dose followed by 1000 mg on day 5, or a placebo group (21 patients).
They evaluated patients at baseline using the International Restless Legs Syndrome Study Group Scale (IRLS), Medical Outcomes Study Sleep Scale (MOS sleep), and RLS Quality of Life (RLS-QoL) measurements and then carried out repeated IRLS and MOS sleep assessments on days 14 and 28 and RLS-QoL on day 28. They also obtained the clinician's global impression of improvement (CGI-I) at days 14 and 28.
The day-28 evaluation revealed several positive results. Treated patients had a significant decrease in the IRLS scale vs controls. The number of remitters, defined as an IRLS ≤10, was higher among treated patients than those on placebo, and 4 of these achieved scores less than 5, vs none among the placebo patients.
Improvements in MOS sleep scores and the RLS-QoL scale were also seen. Significantly more treated patients had an improved or very much improved CGI-I vs those on placebo.
Change in Study End Points with IV FCM Treatment vs Placebo in RLS Patients from Baseline to Day 28 End Point IV FCM Treatment Placebo P
IRLS score -8.9 -4.0 .04
Remitters (IRLS < 10), n (%) 7 (29) 1 (4. .051
IRLS scores < 5, n (%) 4 (17) 0 (0) .11
Improvement on MOS Sleep Score (points) 24 19 .09
Improvement on RLS-QoL (points) 23 18 .024
Improvement in CGI-I (% of patients) 58 14 .005
The results were also lasting. After 1 month, 75% of treated patients did not require additional medication. This number dropped to 38% at 3 months and 25% at 5.5 months.
In earlier studies, Dr. Allen's team used magnetic resonance imaging to demonstrate a deficit in iron concentration in the brains of RLS patients. "It suggests that we might need to start working on how we can (best) deliver iron to the brain," he told Medscape Neurology.
Reorienting RLS Research?
Michael Silber, MBchB, professor of neurology at the Mayo Clinic College of Medicine, in Rochester, Minnesota, who attended the conference, agreed that the study should reorient research.
"It suggests we're looking at the wrong thing — that we need to be looking at iron in the brain [in RLS]," he told Medscape Neurology. Clinically, Dr. Silber said that IV FCM is a useful option for patients who are iron-deficient and cannot absorb iron supplements orally. "It's an encouraging report," he said.
The study received support from Luitpold Pharmaceuticals. Dr. Silber disclosed no relevant financial relationships.
SLEEP 2009: 23rd Annual Meeting of the Associated Professional Sleep Societies: Abstract 0902. Presented June 10, 2009.
Corrie