ESA use decreases in pre-dialysis patients, study says

EXTON, Pa.—Safety concerns regarding anemia drugs have led to a decrease in the use of erythropoiesis-stimulating agents in predialysis patients, according to a recent report.

The use of ESAs in CKD stage 4 patients decreased from 54 percent in the first quarter of 2007 to 42 percent in the first quarter of 2008, according to a report by the market research company BioTrends Research Group.

The recent BioTrends reports looked into anemia management and bone and mineral metabolism management in CKD and dialysis patients. Data were collected in March through an online survey that had responses from 105 nephrologists and 195 renal dietitians.

Last year, the U.S. Food and Drug Administration placed a black-box warning—its most severe warning—on ESAs after clinical studies raised safety concerns about the class of drugs.

Despite the decreased use of ESAs, these drugs are still likely to be the first renal-related product to be given to CKD patients, according to the study. In addition, the report found that nephrologists see Amgen’s Aranesp and Ortho Biotech’s Procrit as similar. However, the surveyed nephrologists saw a safety and reimbursement advantage with Procrit. On the other hand, they saw a dosing advantage with Aranesp.

Iron Trends

The use of IV iron did not change significantly in the last year, despite the decreased use of ESAs, according to the BioTrends report. IV iron is often used in conjunction with ESAs to treat anemia in renal patients.

The majority of dialysis patients are treated with IV iron, but far fewer pre-dialysis patients are given the therapy, according to the report. Only 15 percent of CKD stage 4 patient are given IV iron, and 9 percent of CKD stage 3 patients receive the therapy.

However, the survey found that a majority of nephrologists see a significant increase in the use of IV iron in these patients in the next three months.

As for the drugs themselves, the survey found that the majority of nephrologists saw American Regent's Venofer and Watson’s Ferrlecit as interchangeable.

Phosphate Binders

Concerns about calcium absorption are growing in dialysis, which has led to the increased use of non-calcium based bingers such as Genzyme’s Renagel and Shire’s Fosrenol, according to the BioTrends report.

Renagel continues to be the market leader in phosphate binder treatment, according to the report. However, the survey predicts that Fosrenol is expected to be used significantly more in the future.

In CKD care, the report said calcium-based binders are preferred with Fresenius’ PhosLo being the market leader with a 43 percent share.

Genzyme released its new phosphate binder Renvela in March, but a majority of nephrologists and renal dietitians surveyed said they feel Renvela offers moderate clinical advantages over Renagel. However, the surveyed participants see Renvela increasing its market share by cannibalizing Renagel’s share.

Secondary Hyperparathyroidism Management

Approximately half of the nephrologists and 40 percent of the renal dietitians surveyed by BioTrends said Abbott’s Zemplar and Genzyme’s Hectorol are interchangeable. However, according to the report, Zemplar has an advantage over Hectorol in three PTH modifier attributes nephrologists felt were important: “supported by clinical data,” “effectively lowers PTH,” and “improves mortality.”

In addition, Zemplar dominates the dialysis market with a 72 percent share, and nephrologists see Zemplar becoming the market leader in CKD, overtaking Calcitriol in the next three months, according to the report.

As for Amgen’s Sensipar, nephrologists and renal dietitians reported that the main reason behind Sensipar’s use is to lower calcium, phosphorus and PTH. Sensipar scored better than all vitamin D products on efficacy, but it is seen to have a disadvantage in reimbursement and tolerability, according to the report. As a result, Sensipar is seen as a second-line therapy for dialysis patients with extremely elevated PTH, but the survey found that its use will increase in the future.

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