Study to Investigate the Efficacy and Safety of Ferric Carboxymaltose in Iron-Deficient Patients with Fibromyalgia, 2017, Boomershine et al

Andy

Andy

Retired committee member
A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ferric Carboxymaltose in Iron-Deficient Patients with Fibromyalgia.

Abstract

INTRODUCTION:
This study sought to compare efficacy and safety of ferric carboxymaltose vs. placebo in iron-deficient patients with fibromyalgia.

METHODS:
This blinded, placebo-controlled, phase 2 study randomized adults with fibromyalgia and Revised Fibromyalgia Impact Questionnaire (FIQR) scores ≥ 60, ferritin levels < 0.05 µg/ml, and transferrin saturation < 20% (1:1) to receive ferric carboxymaltose [15 mg/kg (up to 750 mg)], or placebo (15 cc normal saline) intravenously on study days 0 and 5. Patients visited the clinic on days 14, 28, and 42 for efficacy and safety assessments. The primary efficacy endpoint was proportion of patients with a ≥ 13-point improvement from baseline to day 42 in FIQR scale score. Secondary endpoints included changes from baseline in FIQR scale, Brief Pain Inventory (BPI) total score, Medical Outcomes Study (MOS) Sleep scale, Fatigue Visual Numeric Scale (VNS), iron indices (transferrin saturation and ferritin), and safety.

RESULTS:
The efficacy analysis group comprised 80 patients, and the safety analysis group comprised 81. More ferric carboxymaltose patients (77%) vs. placebo patients (67%) achieved the primary endpoint, but the difference was not significant. Greater improvements from baseline to day 42 were observed for ferric carboxymaltose vs. placebo in FIQR total score, BPI total score, Fatigue VNS score, and iron indices. Mean changes in MOS Sleep scale scores were similar between groups. Ferric carboxymaltose was safe and well tolerated.

CONCLUSIONS:
Compared with placebo, ferric carboxymaltose improved measures of fibromyalgia severity and was well tolerated. The current results suggest that ferric carboxymaltose shows benefit in iron-deficient patients with concurrent fibromyalgia.

FUNDING:
Luitpold Pharmaceuticals, Inc.
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Open access at https://link.springer.com/article/10.1007/s40744-017-0088-9
 
This study sought to compare efficacy and safety of ferric carboxymaltose vs. placebo in iron-deficient patients with fibromyalgia.
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Since they're comparing it to nothing at all, apparently they already know it's no more effective than a cheap iron supplement. And since they're studying it specifically in fibromyalgia, they're probably looking to create a market for something people don't need. And since they're studying a deficiency, shouldn't blood levels be the primary outcome, not "how do you feel"?

I'm also not sure how they could be diagnosed with any form of anemia when hemoglobin was normal at baseline. They also seem to be using an artificially high threshold for determining that there was a deficiency of transferrin (20% instead of 12%) and ferritin (50ng instead of 18ng) at baseline.
 
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My Ferritin Iron levels are low while my overall iron is high which is very abnormal but not unheard of.

Low Ferritin has been associated with RLS which I have. This was the only iron measured initially by a sleep doctor and he mentioned iron infusion and had me take Ferritin supplements. I didn't take them for more than a few months as I received no benefits for sleep or my Fibromyalgia. But about a year later I went to a cancer center where they give iron infusions and told them what my sleep doctor said and they measured my Ferritin and other iron levels and that is when they found my overall iron to be too high and an iron infusion was out. This is when I really emotionally, for the first time, hit a wall realizing there just is nothing that can be done for me. Not for my Fibro or CFS.

And I also found that cancer centers treat their patients remarkably well. They were always kind and smiled caringly. So different from what I normally experience.
 
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