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Aranesp

Erythropoietin (EPO) is a glycoprotein hormone that is a growth factor for erythrocyte (red blood cell) precursors in the bone marrow. It increases the number of red blood cells in the blood. Synthetic erythropoietin is available as a therapeutic agent produced by recombinant DNA technology. It is used in treating anemia resulting from chronic renal failure or from chemotherapy for the treatment of cancer. Its use is also believed to be common as a blood doping agent in endurance sports such as bicycle racing, triathlons and marathon running. more...

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Discovery and Biological Role

The existence of a humoral factor regulating red blood cell production was first postulated in 1906 based on transfusion experiments in rabbits. In 1950, the still unidentified erythropoietic factor was found to be stimulated in rats breathing a low-oxygen atmosphere, thus establishing the elements of its biological regulation. In the 1960s its source was identified as the kidneys. The human hormone was first purified in 1977 from human urine and a small amount was used experimentally to treat patients with anemia.

EPO has now been identified as a glycoprotein with a molecular mass of about 30,000 Daltons. It has a 165 amino acid chain with four oligosaccharide side chains and circulates in the blood plasma at a very low concentration (about 5 pmol/L).

In adult humans, EPO is produced primarily by peritubular cells in the kidneys, where its production is stimulated by low oxygen levels in the blood. Some EPO is also produced by the liver, which is the primary source in the fetus.

EPO acts by binding to a specific erythropoietin receptor (EpoR) on the surface of red cell precursors in the bone marrow, stimulating them to transform into mature red blood cells. As a result the oxygen level in blood reaching the kidney rises and the amount of EPO produced decreases.

Because the kidneys are the primary source of erythropoietin, chronic kidney disease often results in a systemic deficiency of EPO and consequent anemia. Anemia can also occur in cancer patients, sometimes as a direct result of the malignancy but usually as a side effect of chemotherapy.

Also, in patients who may require a blood transfusion or undergo surgery where blood loss is expected, EPO is given in advance as a precaution. The bone marrow produces more red blood cells, and if blood is lost during the operation, there is still enough to sustain the patient.

EPO as a Therapeutic Agent

A portion of the human EPO isolated from urine in 1977 was acquired by Amgen, Inc., an American biotechnology company. In 1983, the gene coding for it was identified at Amgen just weeks ahead of a corporate rival, allowing the company to establish a dominant patent position in the field after an epic legal battle. Recombinant DNA technology was used to express the protein in Chinese hamster ovary cells, which allowed a synthetic form of EPO (rEPO) to be produced in commercial quantities for the first time.

Recombinant EPO was launched as a pharmaceutical product by Amgen for treatment of anemia resulting from chronic kidney disease in 1989 under the brand name Epogen. In 1991 it was also approved for treating anemia resulting from cancer chemotherapy. Johnson & Johnson (J&J), an American pharmaceutical company, markets EPO under license from Amgen for cancer chemotherapy under the brand name Procrit. Amgen’s patents have so far prevented other companies from entering the US market. Even though the patents are all based on work done in the early 1980s, the last of them will not expire until 2015, thirty-two years after the date of the original application.

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New & approved: Aranesp & Foradil & Entocort EC - Primary Care
From OB/GYN News, 11/15/01 by Elizabeth Mechcatie

Aranesp

(darbepoetin alfa, Amgen)

A recombinant erythropoiesis-stimulating protein for treating anemia associated with chronic renal failure (CRF), in people on dialysis and those not on dialysis. Like epoietin alfa (Procrit and Epogen), Aranesp acts like endogenous erythropoietin, stimulating red blood cell production, but has a longer half-life and can be administered less frequently.

* Dosage: Start at 0.45 [micro]g/kg IV or subcutaneously once a week; adjust dose to maintain target hemoglobin level between 11 and 12 g/dL. Some CRF patients can be maintained with one subcutaneous dose every 2 weeks; dose may need to be altered every few weeks. Patients can switch from Epogen or Procrit to Aranesp. Better pharmacokinetics make subcutaneous administration preferable, said Dr. Ravi Thadhani, staff nephrologist at Massachusetts General Hospital, Boston.

* Special Considerations: The most important side effect is an increase in blood pressure, which requires dose alterations; contraindicated in uncontrolled hypertension. This is a class effect. Other side effects include hypotension, myalgias, headache, and diarrhea.

* Comment: Trials of Aranesp in CRF patients included a study of predialysis patients; 93% of those on Aranesp once a week and 92% of those on epoetin alfa three times a week reached target hemoglobin levels after 24 weeks. Aranesp will have the greatest impact on predialysis patients with kidney disease, said Dr. Thadhani, one of the investigators. Most of these patients have hypertension and/or diabetes and take several medications; a single subcutaneous injection administered at home every week or two "would not compete" with other medications and should significantly help with compliance.

Patients with CRF typically develop asymptomatic anemia well before they need dialysis; if untreated they gradually develop left ventricular hypertrophy, heart failure, and death, noted Dr. Thadhani, who is on Amgen's speakers bureau.

Foradil

(formoterol fumarate, Novartis)

A long-acting [[beta].sub.2]-agonist for long-term maintenance treatment of bronchoconstriction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

* Dosage: 12 [micro]g inhaled twice a day in the morning and evening.

* Special Considerations: Use with extreme caution when taken with MAO inhibitors, tricyclic antidepressants, and drugs known to prolong the QTc interval.

* Comment: In a Novartis-supported study of 780 patients with COPD, Foradil was better than placebo and ipratropium bromide in improving lung function over 12 weeks. Compared with ipratropium--considered first-line therapy for long-term treatment of stable COPD--Foradil "significantly reduced symptoms, the frequency of 'bad days,' and the need for short-acting bronchodilators on demand," and it improved quality of life. Both drugs had similar safety and tolerability profiles (Am .J. Respir. Grit. Care Med. 164[5]:778-84, 2001). Foradil has not been directly compared with Serevent (salmeterol xinafoate inhalation aerosol).

Entocort EC

(budesonide, AstraZeneca)

An oral corticosteroid for mild to moderate active Crohn's disease involving the ileum and/or ascending colon; formulated so that budesonide is released in the intestine to decrease inflammation, according to the Food and Drug Administration.

* Dosage: 9 mg once each morning for up to 8 weeks; taper to 6 mg a day for last 2 weeks; repeat course for recurring episodes.

* Special Considerations: In trials, two hypocorticism symptoms (moon face, acne) occurred less often with Entocort than with a 40-mg tapered dose of prednisolone.

* Comment: In patients with mild to moderate active Crohn's of the ileum and/or ascending colon, 48%-69% improved with Entocort in five studies, vs. 20%-33% with placebo in two of the studies and 60%-65% with prednisolone in two other studies. Entocort is expected to challenge aminosalicylates for treating mild disease and systemic steroids for moderate disease, said Dr. Stephen Hanauer, chief of the section of gastroenterology, University of Chicago. Entocort is for acute treatment and is not a maintenance therapy like azathioprine (Imuran), noted Dr. Hanauer, an investigator and consultant to AstraZeneca.

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