Better Than Oral Iron for Preop Anemia? IV Iron, Maybe

Nancy A. Melville

June 24, 2015

VIENNA — Not all iron is equal for improving preoperative anemia, a new study suggests.

Intravenous (IV) ferric carboxymaltose administered prior to surgery is associated with improvements in preoperative hemoglobin and ferritin levels, compared with oral iron, according to researchers. In addition, hospital stays were shorter and quality of life after surgery was better with IV ferric carboxymaltose.

"There are various scenarios in which IV ferric carboxymaltose is recommended," said lead study author Alhossain Khalafallah, MD, from the Launceston General Hospital at the University of Tasmania in Australia.

"Our findings show the potential to reduce the requirement for blood transfusions and possibly also reduce the length of the stay in the hospital," Dr Khalafallah said here at the 20th Congress of the European Hematology Association.

However, a study critic said that larger trials are needed before clinicians should embrace the approach.

Preoperative anemia is linked to a host of adverse outcomes, including the need for a blood transfusion and increased morbidity and mortality.

But the standard therapy of oral iron has limitations of its own. In fact, issues with noncompliance typically caused by gastrointestinal discomfort can occur in more than 30% of patients.

In their prospective open-label study, Dr Khalafallah and colleagues randomized 125 patients scheduled to undergo elective surgery from January 2012 to August 2014 to one of two treatments 2 to 4 weeks before surgery: a single IV ferric carboxymaltose 1000 mg infusion; or daily oral iron sulfate 325 mg (equivalent to 105 mg of elemental iron) until the day of surgery.

Of these patients, 70 underwent major orthopedic surgery, 23 underwent abdominal surgery, 27 underwent genitourinary surgery, and five underwent general surgery.

Hemoglobin and ferritin levels improved with the IV therapy.

Table. Average Hemoglobin Levels

Timepoint IV Therapy, g/L Oral Therapy, g/L
Baseline 113 120
At surgery 122 124
3 months after surgery 126 123

 

The increase in median ferritin level from baseline to surgery was significantly greater with the IV therapy (32 µg/L to 544 µg/L) than with the oral therapy (76 µg/L to 107 µg/L; P < .001). And at 3 months, ferritin levels were significantly higher in the IV group than in the oral group (176 µg/L vs 90 µg/L; P < .001).

Average hospital stay was 1 day shorter in the IV group than in the oral group. In addition, "we observed improvement in physical function, well-being, and general health in favor of the ferric carboxymaltose patients," Dr Khalafallah reported.

There were no serious adverse events in the IV group, and the IV formulation was well tolerated.

"In terms of durability, patients reacted very well," he said.

In a separate trial presented as a poster, Dr Khalafallah's team evaluated the IV formulation for the treatment of iron deficiency in 246 pregnant women.

Patients were randomized to one of three treatment groups: a single dose of IV ferric carboxymaltose; a single dose of IV iron polymaltose 100 mg administered over 60 minutes; or oral iron 325 mg daily for 4 weeks.

Hemoglobin and ferritin levels improved in the IV ferric carboxymaltose group, and the improvement in ferritin was maintained until delivery.

"Our data indicate that ferric carboxymaltose application during pregnancy is safe and leads to improved efficacy and improvement of iron stores, compared with oral iron, in pregnancy-related iron deficiency anemia," Dr Khalafallah and his colleagues report.

There were no differences between the two IV groups, but "ferric carboxymaltose is considered cost-effective and more convenient for patients," they add.

Study Critic Voices Concerns

Studies such as this are useful in demonstrating safety and tolerability, but larger trials are needed, said Toby Richards, MD, a vascular surgeon from University College Hospital in London, United Kingdom, who is involved in IV iron research.

"The study wasn't blinded, and it's not entirely clear what the end point was," he told Medscape Medical News.

"There also seemed to be differences in the baselines of the groups, but these early data are in line with the thought process that IV iron has an important role," he explained, adding that "larger trials are necessary to determine of it truly is effective."

Dr Richards is at the helm of one such trial — the Preoperative Intravenous Iron to Treat Anaemia in Major Surgery (PREVENTT) Trial (NCT01692418) — that is comparing preoperative anemia, postoperative complications, recovery, and the need for transfusion in patients treated with IV ferric carboxymaltose or placebo. Of the targeted 500 patients, 155 scheduled to undergo major surgery are currently enrolled.

"Oral iron tablets will take you 6 to 9 months to replenish your iron stores, whereas with an injection, it takes approximately 15 minutes, and you should feel better within 5 days," Dr Richards explained. "So the societal impact of something like this is potentially huge."

Dr Khalafallah has disclosed no relevant financial relationships. Dr Richards runs a research program called Intravenous Iron Therapy and has received educational grants from ferric carboxymaltose maker Ferinject and PharmaCosmos A/S, which makes an injectable IV product. The PREVENTT trial has received no industry funding.

20th Congress of the European Hematology Association (EHA): Abstract LB2073. Presented June 14, 2015.

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