RxPG News : Anaemia

Anemia linked with higher death risk in heart patients

Thu, 18 Jun 2009 15:42:04 PST

( from http://www.rxpgnews.com ) The presence of anaemia in patients with chronic heart failure is linked to a significantly higher risk of death.

Heart failure is a common and serious chronic illness. A large number of patients with heart failure also have anaemia, which is most likely a complication from poor heart function.

The aim of this study was to assess the impact of anaemia on the clinical outcomes of chronic heart failure - by a meta-analysis and systemic review of published literature.

A total of 97,699 patients with CHF were identified from the published studies. From a collective analysis, researchers found that when anaemia occurs, it worsens patient prognosis, making them more likely to be hospitalized or die from heart failure.

'Health professionals may need to improve current practices to better treat anaemia in patients with chronic heart failure,' said Lexin Wang, study co-author and head of the cardiovascular group at Charles Sturt University -, in Australia.

Even with contemporary medical treatment, the mortality rate from CHF is still high, reaching 40 percent in very sick patients, said a CSU release.

Given the clear association between anaemia, mortality rate and hospitalization rate, optimal treatment of anaemia, on top of other heart-failure-specific therapies, may reduce the rate of mortality and further improve patient's prognosis.

These findings will appear in Congestive Heart Failure journal.

Deferasirox may revolutionize the way chronic iron overload is treated

Sun, 23 Apr 2006 18:22:37 PST

( from http://www.rxpgnews.com ) Those with severe chronic anemias need frequent blood transfusions to remain healthy, but such frequent transfusions can cause a potentially deadly buildup of iron in the body, leading to heart and liver failure. The traditional treatment to remove excess iron is so onerous that many patients choose to forgo it, putting their own lives at risk. The results of an international study on deferasirox, a new drug that may revolutionize the way chronic iron overload is treated, will be published in the May 1, 2006, issue of Blood, the official journal of the American Society of Hematology.

The current standard therapy to rid the body of excess iron is deferoxamine, administered for as long as the patient continues to receive blood transfusions, which, for many patients, can be for the rest of their lives. Although its effectiveness and safety are well-established, the necessity for the drug to be delivered by slow subcutaneous or intravenous infusion for eight to 12 hours a night over a period of five to seven days makes it an inconvenient and painful choice for patients. Unlike deferoxamine, deferasirox is available in a once-daily, drinkable format, providing a promising alternative.

"The ease and convenience of deferasirox means that more patients needing frequent blood transfusions, especially young children, will be able to be successfully treated and lead normal, healthy lives," said Maria Domenica Cappellini, MD, of the University of Milan, Italy, and lead study author.

To compare the efficacy and safety of the two drugs, a multicenter trial of both children (some as young as two years old) and adults diagnosed with chronic iron overload was conducted in a dozen countries worldwide. People with beta-thalassemia, an inherited blood disorder, were selected for this study because complications of chronic iron overload have been best studied in those with this disease. All participants continued receiving regular blood transfusions to treat beta-thalassemia throughout the year-long study.

Participants were randomized into two groups: 290 received deferoxamine infusions five days a week; 296 drank deferasirox dissolved in water each day before breakfast. Drug dosages were determined by each patient's liver iron concentration (LIC) level; those with higher levels received increased doses. Since LIC values above 7 mg Fe/g dw are associated with increased morbidity and mortality, the primary goal of the trial was to reduce LIC levels in those with high values and maintain LIC levels in those with low values. At the beginning of the study, more than two-thirds of the participants had at-risk LIC levels.

Deferasirox proved to be equally as effective as deferoxamine in patients receiving the highest doses of the drug. A majority of these patients (nearly 60 percent), demonstrated sustained or reduced LIC levels during the study. For those receiving the lowest drug doses, the amount of deferasirox was found to be insufficient in these regularly transfused thalassemia patients.

Deferasirox was generally well-tolerated. The most common side effects were skin rash (affecting approximately 11 percent of patients) and gastrointestional problems, which occurred in 15 percent of the group and included abdominal pain, vomiting, diarrhea, and constipation. Most patients (92 percent) were able to complete the study, though a small number in each treatment arm discontinued because of safety reasons. Four deaths, determined to be unrelated to the study drugs, also occurred during the trial.

FDA approves extended dosing of Aranesp

Tue, 28 Mar 2006 19:58:37 PST

( from http://www.rxpgnews.com ) Amgen (NASDAQ: AMGN), the world's largest biotechnology company, today announced the U.S. Food and Drug Administration (FDA) has approved every-three-week dosing of Aranesp® (darbepoetin alfa) for the treatment of chemotherapy-induced anemia (low red blood cell count) in patients with non-myeloid malignancies. Aranesp is the only erythropoiesis-stimulating agent approved by the FDA for every-three-week administration.

"Amgen developed Aranesp to provide cancer patients with a long-acting and effective means to treat chemotherapy-induced anemia, a common side effect of chemotherapy," said Willard Dere, M.D., chief medical officer and senior vice president of Global Development at Amgen. "The approval of an extended dosing protocol for Aranesp is an important milestone allowing anemia treatment to be synchronized with both weekly and every-three-week chemotherapy, which are the most commonly used treatment regimens. This offers improved convenience for patients and less injection-related burden for patients and healthcare professionals compared to weekly anemia treatment."

Anemia can negatively affect patients and impact their daily activities. This can often manifest as fatigue, trouble breathing or rapid heartbeat, chest pain, dizziness or lightheadedness, inability to concentrate, headache, inability to stay warm, loss of sex drive, and pale skin. Frequent visits to the clinic for anemia treatment can result in significant time spent by patients, caregivers and healthcare providers. Reducing the number of visits required for anemia treatment with less frequent dosing and trying to synchronize anemia treatment with other naturally occurring visits could reduce the amount of patient and caregiver time required for anemia treatment.

"In clinical studies, Aranesp has proven effective in reducing the incidence of red blood cell transfusions and boosting and maintaining target hemoglobin levels when administered every three weeks," said Ralph Boccia, M.D., director of clinical research, Center for Cancer and Blood Disorders, Bethesda, MD. "Now, this less frequent dosing means patients can visit the doctor less frequently, which can result in less time away from loved ones and daily activities."

The update to the Aranesp label now includes a recommended starting dose of 500 mcg once every three weeks in addition to the recommended starting dose of 2.25 mcg/kg once weekly. The new dosing recommendations are based on a randomized, double-blind, phase 3 study that evaluated the safety and effectiveness of every-three-week administration of Aranesp. Patients with chemotherapy-induced anemia were randomized to receive 500 mcg of Aranesp every three weeks (n=353) or 2.25 mcg/kg (n=352) administered weekly for up to 15 weeks. In both groups, the starting dose was reduced by 40 percent if hemoglobin levels increased by more than 1 g/dL in a 14-day period, and Aranesp was withheld if hemoglobin levels exceeded 13 g/dL. More than 70 percent of patients in the every-three-week group required dose reductions, resulting in an average weekly dose of 125 mcg for the patients in this group.

Study Suggests Drug For Chemotherapy-Induced Anemia Can Be Effectively Administered Tri-Weekly

Wed, 15 Feb 2006 20:00:37 PST

( from http://www.rxpgnews.com ) Parallel administration of chemotherapy and an anti-anemia drug called darbepoetin alfa every 3 weeks is safe and effective, according to a new study.

Chemotherapy can reduce the bone marrow's ability to produce red blood cells leading to anemia. Anemia is a common side effect among cancer patients receiving chemotherapy. There are drugs available that are often given in conjunction with chemotherapy to counteract anemia. In the United States, one such drug, called darbepoetin, is often given to cancer patients once every week or every other week. In Europe, some anemic cancer patients receive darbepoetin every third week, synchronizing the treatment with chemotherapy administration. However, past studies have not investigated whether dual administration of chemotherapy and darbepoetin every 3 weeks is as safe and effective as the established weekly regimen.

Jean-Luc Canon, M.D., at the Centre Hospitalier Notre Dame et Reine Fabiola in Charleroi, Belgium, and colleagues performed a phase III clinical trial in which 705 anemic cancer patients were randomly assigned to receive darbepoetin treatment every week or every third week at 110 European medical centers.

Compared with patients who received weekly treatment, a fewer number of patients who received treatment every 3 weeks required blood transfusions from week 5 of treatment onwards. Patients taking darbepoetin every third week, synchronized with chemotherapy, had similar hemoglobin levels, and experienced equivalent side effects as patients taking darbepoetin weekly.

The authors conclude that patients with anemia can effectively be treated with darbepoetin every third week with no additional health risks.

Aranesp treatment achieved and maintained target hemoglobin levels and reduced incidence of red blood cell transfusions

Wed, 14 Dec 2005 20:08:38 PST

( from http://www.rxpgnews.com ) Amgen (NASDAQ: AMGN), the world's largest biotechnology company, today announced interim results from the first multi-center, randomized, double-blind, placebo-controlled, Phase 3 trial of Aranesp® (darbepoetin alfa) administered every three weeks in cancer patients with chemotherapy-induced anemia. The study revealed that Aranesp increased and maintained patient hemoglobin levels to the target level of greater than or equal to 11 grams per deciliter (g/dL) and reduced the need for red blood cell transfusions by almost half compared to placebo. The data were presented at the American Society of Hematology (ASH) 47th Annual Meeting and Exposition. (Abstract #3556)

"These results on every-three-week dosing of Aranesp are encouraging," said Kerry Taylor, MD, Mater Hospital, South Brisbane, Queensland, Australia. "If approved, this extended dosing of Aranesp may allow physicians to treat anemia on the same schedule as chemotherapy, which is frequently administered every three weeks. This may reduce the number of visits patients and their caregivers need to make to the clinic."

Researchers reported results for 386 patients (n=193 per arm) treated for up to 16 weeks and found that 77 percent of patients achieved target hemoglobin levels in the Aranesp-treated group versus 55 percent in the placebo group. Additionally, from week five to the end of treatment phase, the incidence of red blood cell transfusions was significantly lower for the Aranesp-treated group (24 percent) than for the placebo group (41 percent). The number and type of adverse events were consistent with the adverse event profile for this population of anemic cancer chemotherapy patients receiving Aranesp. Cardiovascular and thromboembolic adverse events were reported in few patients in either treatment group, and were not associated with increases in hemoglobin levels.

In May 2005, Amgen announced the submission of a supplemental biologics license application to the U.S. Food and Drug Administration (FDA) for every-three-week dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.

Interim Aranesp data suggest major response in anemic patients with MDS

Tue, 13 Dec 2005 20:05:38 PST

( from http://www.rxpgnews.com ) Amgen (NASDAQ: AMGN), the world's largest biotechnology company, today announced updated interim data from a Phase 2 study evaluating the use of 500 mcg of Aranesp darbepoetin alfa) administered every three weeks to treat anemia in patients with a bone marrow disorder known as myelodysplastic syndrome (MDS). Low-risk MDS patients receiving Aranesp every three weeks, who had no prior erythropoietic therapy, exhibited an overall response of 70 percent, increased hemoglobin levels and improvements in patient-reported fatigue. The data were presented at the American Society of Hematology (ASH) 47th Annual Meeting in Atlanta. (Abstract #2541)

"During the course of their disease, the majority of MDS patients develop clinically significant anemia, which can lead to fatigue and the need for red blood cell transfusions," said Janice Gabrilove, MD, professor of medicine, hematology and medical oncology at Mount Sinai School of Medicine, New York and the study's lead investigator. "Currently, there are no recombinant erythropoietic products approved for the treatment of anemia in MDS patients. These results are encouraging."

Results for the 13-week test period were presented for 189 of 209 patients enrolled and included erythroid response, achievement of target hemoglobin, incidence of transfusion and patient reported fatigue. Sixty-nine percent of these patients (n=130) had no prior erythropoietic agent use.

In the group that had no previous treatment with an erythropoietic agent, 70 percent of patients had an erythroid response, with 49 percent classified as major response (defined as greater than or equal to 2 grams per deciliter [g/dL] increase from baseline hemoglobin or transfusion independence). Sixty-seven percent of patients achieved the target hemoglobin level of 11 g/dL. Nineteen percent in the erythropoietin-naive group had at least one transfusion during the 13-week observation period.

In the group previously treated with an erythropoietic agent (n= 59), 44 percent experienced an erythroid response, with 24 percent classified as major. Forty-five percent of patients achieved the target hemoglobin level of 11 g/dL, and 29 percent had at least one transfusion.

During the 13-week test period, 78 percent of patients experienced at least one adverse event. Seventeen percent (n= 33) of patients experienced a serious adverse event, with fatigue, asthenia, and diarrhea as the most common. Six percent (n=12) had treatment-related adverse events, with injection-site pain and diarrhea the most common (n=2 for each). No thrombotic events have been reported to date in this study.

Interim data suggest major response with Aranesp(R) in anemic patients with MDS

Sun, 10 Jul 2005 20:16:38 PST

( from http://www.rxpgnews.com ) Amgen Inc. (NASDAQ:AMGN), the world's largest biotechnology company, today announced new interim data from a Phase 2 study evaluating the use of 500 mcg of Aranesp(R) (darbepoetin alfa) every three weeks to treat anemia in patients with a bone marrow disorder known as myelodysplastic syndromes (MDS). The data were presented at the 17th International Symposium of the Multinational Association of Supportive Care in Cancer (MASCC) in Geneva. (Abstract #02-007)

"The majority of MDS patients develop clinically significant anemia during the course of their disease, which often leads to fatigue and increased red blood cell transfusions," said Janice Gabrilove, M.D., professor of medicine, hematology and medical oncology at Mount Sinai School of Medicine, New York and the study's lead investigator. "In this study, low risk MDS patients receiving Aranesp every three weeks, who had no prior erythropoietic therapy, exhibited an overall response of 77 percent, increased hemoglobin levels and improvements in patient reported fatigue."

Results of an interim analysis were presented from the first 100 patients of an approximately 200 patient, Phase 2, single arm study of low risk MDS patients (those with a low risk of progressing to acute myeloid leukemia) with anemia and treated with Aranesp 500 mcg administered every three weeks. Of the 100 patients evaluated, 63 percent had no prior erythropoietic agent use. The primary endpoint of the study was the proportion of patients achieving an erythroid response (defined in accordance with the International Working Group Response Criteria) during the 13-week test period. Secondary endpoints included changes in hemoglobin level from baseline, incidence of transfusions and impact on patient reported fatigue.

Results were presented for all 100 patients for incidence of transfusion and patient reported fatigue and 90 patients were evaluated for erythroid response and target hemoglobin. In the group who had no previous treatment with an erythropoietin (n=57), 77 percent of patients had an erythroid response with 47 percent classified as major (greater than or equal to 2 g/dL increase from baseline hemoglobin or transfusion independence). In the previously erythropoietin treated group (n=33), 36 percent experienced an erythroid response with 21 percent classified as major. Two-thirds of patients achieved hemoglobin levels above 11 g/dL, the target range for patients with chemotherapy-induced anemia. Eighteen percent in the erythropoietin-naive group had a least one transfusion during the 13-week observation period.

"In these interim results MDS patients who have never been treated for their anemia responded to Aranesp and those who had prior erythropoietic therapy continued to respond," added Gabrilove. "There are currently no recombinant erythropoietic products approved by the FDA for the treatment of anemia in MDS patients. These interim data are encouraging and we look forward to the final results."

During the 13-week test period, 74 percent of patients experienced at least one adverse event. Sixteen percent (n=16) of patients experienced a serious adverse event, with anemia, neutropenia and chest pain as the most common. Five percent (n=5) had treatment-related adverse events, with injection-site pain as the most common. No thrombotic events have been reported to date in this study.

Aranesp dosed every three weeks achieved and maintained target hemoglobin levels

Mon, 16 May 2005 20:26:38 PST

( from http://www.rxpgnews.com ) Amgen Inc., (NASDAQ: AMGN) the world's largest biotechnology company, today announced that new interim data from a single-arm, open label study of 1,225 cancer patients receiving chemotherapy demonstrated that Aranesp® (darbepoetin alfa) administered every three weeks was effective in increasing and maintaining patient hemoglobin levels to the recommended target of greater than or equal to 11 g/dL. Further, treatment with Aranesp reduced the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia. The results of the study were presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). [Abstract #8129]

"Chemotherapy is most often administered every three weeks. Our results suggest that every-three-week dosing of Aranesp at 300 mcg may allow physicians to effectively combine anemia treatment on the same schedule as chemotherapy," said Ralph Boccia, M.D., clinical associate professor of medicine, Georgetown University Medical Center. "This may improve patient convenience without sacrificing efficacy."

In the interim analysis of 1,225 cancer patients receiving 300 mcg of Aranesp every three weeks, 91 percent of patients achieved a target hemoglobin of greater than or equal to 11 g/dL, and 72 percent of patients maintained the target hemoglobin level. The mean hemoglobin was 11.5 g/dL after achieving target hemoglobin. From week five to the end of the study (week 16), only 20 percent of patients required red blood cell transfusion. The number and type of adverse events were consistent with the adverse event profile for this population of anemic cancer patients receiving Aranesp.

In May, Amgen announced submission of a supplemental biologics license application to the U.S. Food and Drug Administration (FDA) for every-three-week dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.

Final results from a Phase 3 head-to-head study of Aranesp 200 mcg administered every two weeks and Epoetin alfa dosed once a week were also presented during the ASCO Annual Meeting. [Abstract #8125]

Final results demonstrate Aranesp dosed every two weeks is comparable to Epoetin alfa dosed weekly

Mon, 16 May 2005 20:22:38 PST

( from http://www.rxpgnews.com ) Amgen Inc., (NASDAQ: AMGN) the world's largest biotechnology company, today announced that final results of a Phase 3 randomized, head-to-head study demonstrated that 200 mcg of Aranesp® (darbepoetin alfa) administered every two weeks is as effective as 40,000 U of Epoetin alfa dosed once a week in boosting hemoglobin levels and reducing the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia. The data were presented today at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). [Abstract #8125]

"This is the largest, randomized head-to-head comparison of darbepoetin alfa dosed every two weeks to Epoetin alfa dosed weekly, as they are most often used in current oncology practice," said John Glaspy, MD, professor, David Geffen School of Medicine, University of California at Los Angeles. "Less frequent dosing provides anemia management with less frequent injections, and for patients receiving chemotherapy every two or three weeks, less frequent office visits. Our data demonstrate that less frequent injections can be accomplished without a compromise in efficacy in terms of decreased transfusion risk or improved quality of life."

In the Phase 3 head-to-head study, a total of 1,220 patients with chemotherapy-induced anemia were randomized to receive either Aranesp 200 mcg every two weeks (n=613) or Epoetin alfa 40,000 U once a week (n=607). The majority of patients in both groups achieved the target hemoglobin of greater than or equal to 11 g/dL. Both groups of patients had similar blood transfusion rates, patient reported outcomes, and safety endpoints.

In this study, at least 90 percent of patients in both arms of the study achieved target hemoglobin of greater than or equal to 11 g/dL. Seventy-four percent of patients in the Aranesp group remained in the target range compared to 80 percent in the Epoetin alfa group. The study's primary endpoint was designed to evaluate non-inferiority with respect to transfusion rate. Transfusions were similar in the two treatment groups (21 percent in the Aranesp group and 16 percent in the Epoetin alfa group) demonstrating non-inferiority of Aranesp and Epoetin alfa with respect to transfusion requirements.

The number and type of adverse events were similar between the two groups and were consistent with the adverse event profile for this population of anemic cancer patients receiving Aranesp.

New interim data from a study of Aranesp administered every three weeks were also presented during the ASCO Annual Meeting [Abstract #8129]. In May, Amgen announced submission of a supplemental biologics license application to the U.S. Food and Drug Administration (FDA) for every-three-week dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.

Anemia drug reduces transfusions and chemotherapy-related fatigue

Wed, 28 Aug 2002 20:14:38 PST

( from http://www.rxpgnews.com ) Patients treated with darbepoetin alfa (AranespTM) for chemotherapy-induced anemia may require fewer blood transfusions and feel less fatigued than patients receiving a placebo, concludes a new study in the August 21 issue of the Journal of the National Cancer Institute.

Chemotherapy-related anemia often results from decreased production of the hormone erythropoietin, a hormone that stimulates the formation of red blood cells. Anemia can be treated with red blood cell transfusions, but risks associated with this procedure include adverse reactions and infection.

A newer approach to treating anemia has been the use of recombinant human erythropoietin (rHuEPO). However, to sufficiently increase levels of hemoglobin (the oxygen-carrying component of red blood cells) and reduce the number of blood transfusions, a patient must receive treatment three times a week. The erythropoietic protein darbepoetin alfa, an analogue of rHuEPO, stays in the blood for longer periods of time and can be given less frequently.

In randomized, placebo-controlled phase III trial of the safety and efficacy of darbepoetin alfa, Johan Vansteenkiste, M.D., Ph.D., of the University Hospital Gasthuisberg in Belgium, and his colleagues from the Aranesp 980297 Study Group, treated 321 anemic patients receiving chemotherapy for lung cancer with either weekly injections of darbepoetin alfa or a placebo.

By 12 weeks, patients receiving darbepoetin alfa required about half as many blood transfusions, nearly a third fewer units of blood, had elevated hemoglobin levels, and experienced significantly less fatigue than patients given the placebo. Adverse events were similar to those in cancer patients receiving chemotherapy, and were similar in both groups. Overall survival rates were not statistically significantly different between the two treatment groups.

The dosing advantage of darbepoetin alfa could allow patients to miss less time from work and potentially increase compliance, the researchers say. They add that further studies are under way to examine the possibility to administering darbepoetin alfa at an even lower frequency, such as every two to three weeks.

In an accompanying editorial, Claudette G. Varricchio, DSN, RN, FAAN, of the National Institute of Nursing Research in Bethesda, Md., and Jeff A. Sloan, Ph.D., of the Mayo Clinic in Rochester, Minn., note that researchers now recognize cancer as a chronic disease. The editorialists point to the increasing need to incorporate the management of treatment-related symptoms into clinical trials, and they praise the current study as a successful effort to do just that.

"Clinical trials of various approaches to the management of symptoms related to cancer or its treatment are needed to promote the well-being of persons with cancer, especially in the context of cancer as a chronic condition," they write. "These clinical trials must be as rigorous as those that evaluate cancer treatments."