Archive for June, 2008

Discovery of protein that helps predict prostate cancer survival

Monday, June 16th, 2008

Men’s Health News
An Oregon Health & Science University Cancer Institute researcher has identified a protein that is a strong indicator of survival for men with advanced prostate cancer. The C-reactive protein, also known as CRP, is a special type of protein produced by the liver that is elevated in the presence of inflammation.
"This could mean that a simple blood test that is already available could help in clinical decision making and patient counseling. Patients and doctors would know better what to expect from the prostate cancer they are facing," said Tomasz Beer, M.D., director of the Prostate Cancer Research Program at the OHSU Cancer Institute, associate professor of medicine (hematology/medical oncology), OHSU School of Medicine.
Beer’s research will be published online in the journal Cancer on Monday, April 21.
Past research has shown that cancer causes an inflammatory response. This research also suggests that inflammation may play an important role in driving prostate cancer progression and resistance to therapy. Inflammatory cells are attracted to cancer sites and this local inflammation can lead to a release of inflammatory markers, like CRP.
"While inflammation may sometimes slow the progression of the cancer, an increasing body of evidence suggests that cancer can actually take advantage of the inflammatory response, and the reaction of the immune system may fuel cancer progression. To the extent that our hypothesis proves true, C-reactive protein may be reflecting the overall intensity of the inflammation," Beer said.
Buy generic lasix The finding that higher CRP is associated with shorter survival and a lower probability of response to chemotherapy is a result of a secondary analysis of inflammatory markers in patients enrolled in the ASCENT study, a large Phase 2 clinical trial that evaluated treatment with docetaxel and DN-101, a high dose formulation of calcitriol or docetaxel with placebo. This analysis included patients from both groups. The analyses were supported by Novacea Inc., the sponsor of the ASCENT study. This new finding was in collaboration with Novacea.
Because this is the first time CRP has been linked with both response and survival in study subjects with advanced prostate cancer receiving chemotherapy, it will be important to confirm this finding in an independent data set before this can become a routine blood test for men with advanced prostate cancer, Beer explained.
"If confirmed, besides providing useful information for the patient, this finding could also provide us with vital insight into the fundamental role of inflammation in the progression of advanced prostate cancer. A better understanding of this process could provide us with novel therapeutic interventions for control of this disease and its symptoms," Beer said.

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Wyeth’s Pristiq, A New Treatment For Major Depressive Disorder

Monday, June 16th, 2008

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced that PRISTIQTM (desvenlafaxine), a new serotonin-norepinephrine reuptake inhibitor (SNRI) approved to treat adult patients with major depressive disorder (MDD), is now available in U.S. retail pharmacies nationwide. The recommended dose of PRISTIQ is 50 milligrams (mg) once daily. The Company begins full-scale selling and educational efforts regarding PRISTIQ for physicians this week.
"We are proud to make PRISTIQ available as a new treatment option for the millions of American adults who struggle with depression," comments Philip Ninan, M.D., Vice President, Wyeth Medical Affairs, Neuroscience. "The recommended therapeutic dose of PRISTIQ is 50 mg once daily. Titration is not required to reach the recommended therapeutic dose." Dosage adjustment (50 mg every other day) is necessary, however, in patients with severe renal impairment or end-stage renal disease.
About PRISTIQ
PRISTIQ, an SNRI approved by the U.S. Food and Drug Administration on February 29, 2008, is an important new treatment option for the millions of adults in the United States who have MDD. Discovered and developed by Wyeth, PRISTIQ demonstrates the Company’s significant and continued commitment to developing new therapies in the field of neuroscience.
At the recommended dose of 50 mg, the discontinuation rate due to an adverse experience for PRISTIQ (4.1 percent) was similar to the rate for placebo (3.8 percent) in clinical studies. The most commonly observed adverse reactions in patients taking PRISTIQ for MDD in short-term, fixed-dose studies (incidence > 5 percent and at least twice the rate of placebo in the 50 mg dose groups) were nausea, dizziness, hyperhidrosis, constipation and decreased appetite.
About Major Depressive Disorder
Major depressive disorder (MDD) is a common mental disorder, affecting about 121 million people worldwide. In the United States, MDD affects approximately 15 million adults, or 6.7 percent of the U.S. population age 18 and older in a given year. In fact, depression is among the leading causes of disability and the fourth leading contributor to the global burden of disease. Further, a research study estimated that the total economic burden of depression was $83.1 billion in 2000, including direct treatment costs and suicide- and work-related costs.
Important Treatment Considerations
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders.
– Anyone considering the use of PRISTIQ or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.
– Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.
Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.
– Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
– PRISTIQ is not approved for use in pediatric patients.
Contraindications
– PRISTIQ is contraindicated in patients with a known hypersensitivity to PRISTIQ or venlafaxine.
– PRISTIQ must not be used concomitantly with an MAOI or within 14 days of stopping an MAOI. Allow 7 days after stopping PRISTIQ before starting an MAOI.
Warnings and Precautions
– All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when changing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient??s presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients.
– Development of a potentially life-threatening serotonin syndrome may occur with SNRIs and SSRIs, including PRISTIQ, particularly with concomitant use of serotonergic drugs, including triptans, and with drugs that impair the metabolism of serotonin (including MAOIs). If concomitant use is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Buy propecia pills Concomitant use of PRISTIQ with serotonin precursors is not recommended.
– Patients receiving PRISTIQ should have regular monitoring of blood pressure since sustained increases in blood pressure were observed in clinical studies. Pre-existing hypertension should be controlled before starting PRISTIQ. Caution should be exercised in treating patients with pre-existing hypertension or other underlying conditions that might be compromised by increases in blood pressure. Cases of elevated blood pressure requiring immediate treatment have been reported. For patients who experience a sustained increase in blood pressure, either dose reduction or discontinuation should be considered.
– SSRIs and SNRIs, including PRISTIQ, may increase the risk of bleeding events. Concomitant use of aspirin, NSAIDs, warfarin, and other anticoagulants may add to this risk.
– Mydriasis has been reported in association with PRISTIQ; therefore, patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored.
– PRISTIQ is not approved for use in bipolar depression. Prior to initiating treatment with an antidepressant, patients should be adequately screened to determine the risk of bipolar disorder.
– As with all antidepressants, PRISTIQ should be used cautiously in patients with a history or family history of mania or hypomania, or with a history of seizure disorder.
– Caution is advised in administering PRISTIQ to patients with cardiovascular, cerebrovascular, or lipid metabolism disorders. Increases in blood pressure and small increases in heart rate were observed in clinical studies with PRISTIQ. PRISTIQ has not been evaluated systematically in patients with a recent history of myocardial infarction, unstable heart disease, uncontrolled hypertension, or cerebrovascular disease.
– Dose-related elevations in fasting serum total cholesterol, LDL (low density lipoprotein) cholesterol, and triglycerides were observed in clinical studies. Measurement of serum lipids should be considered during PRISTIQ treatment.
– On discontinuation, adverse events, some of which may be serious, have been reported with PRISTIQ and other SSRIs and SNRIs. Abrupt discontinuation of PRISTIQ has been associated with the appearance of new symptoms. Patients should be monitored for symptoms when discontinuing treatment. A gradual reduction in dose (by giving 50 mg of PRISTIQ less frequently) rather than abrupt cessation is recommended whenever possible.
– Dosage adjustment (50 mg every other day) is necessary in patients with severe renal impairment or end-stage renal disease (ESRD). The dose should not be escalated in patients with moderate or severe renal impairment or ESRD.
– Products containing desvenlafaxine and products containing venlafaxine should not be used concomitantly with PRISTIQ.
– Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including PRISTIQ. Discontinuation of PRISTIQ should be considered in patients with symptomatic hyponatremia.
– Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine (the parent drug of PRISTIQ) therapy have been rarely reported.
Adverse Reactions
The most commonly observed adverse reactions in patients taking PRISTIQ vs placebo for MDD in short-term fixed-dose premarketing studies (incidence ?

Morria Biopharmaceuticals Plc Announces Regulatory Approval To Commence Phase II Clinical Study Of MRX-4 In Allergic Rhinitis

Monday, June 16th, 2008

Morria Biopharmaceuticals Plc, a
biopharmaceutical company focused on the development of novel
anti-inflammatory drugs, announced that it has obtained regulatory
approval from the South African Medicines Control Council (MCC) to initiate
a Phase II study of MRX-4 in 105 patients suffering from allergic rhinitis
(AR). The two-arm, randomized, multi-dose, double-blind, placebo-controlled
study includes a steroid comparator arm.
The study will evaluate the safety, tolerability, and preliminary
efficacy of intranasal MRX-4 in AR patients outside of allergy season as
compared with both placebo and an intranasal steroid. An experimental
multi-functional anti-inflammatory drug (MFAID), MRX-4 is a non-steroidal
potential treatment for AR that was shown to be safe and well tolerated in
a Phase I equivalent trial completed in Israel earlier this year.
"This study will provide valuable data regarding its potential in
allergic rhinitis, including efficacy, tolerability and pharmacokinetic
data," said Buy diflucan without prescription Dr. Yuval Cohen, president of Morria. "We are excited to be
taking this significant step toward testing a potentially safer, more
effective, and more affordable treatment option for the significant
commercial opportunity in the multi-billion dollar allergic rhinitis
market".
ABOUT ALLERGIC RHINITIS
Allergic rhinitis is a common condition that affects nearly 59 million
people in the United States (nearly 20 percent of the population) with a
market of close to $4 billion. Allergic rhinitis is characterized by
inflammation of the nasal membranes accompanied by symptoms that may
include sneezing, nasal congestion, nasal itching and rhinorrhea.
ABOUT MORRIA BIOPHARMACEUTICALS Plc
Morria Biopharmaceuticals Plc is a biopharmaceutical company focused on
the development of novel anti-inflammatory pharmaceuticals termed
multi-functional anti-inflammatory drugs (MFAIDs). This class of drugs
uniquely combines two promising approaches to preventing and reversing
inflammation: first, they control the phospholipase A2 (PLA2) enzyme
family, a known, but previously elusive anti-inflammatory drug target. At
the same time, they also protect cells and tissues against inflammatory
damage. Morria is determined to become a pivotal player in the $20 billion
anti-inflammatory drug market by developing and commercializing novel drugs
for acute pulmonary and gastro-intestinal inflammatory diseases. For more
information, please visit
This is not an invitation nor is it an offer to purchase or subscribe
for shares. This release is only intended for persons falling within the
exception set out in regulation 47 of the Financial Promotion order -
Persons in the business of disseminating information.
Morria Biopharmaceuticals Plc

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Heart Failure Patients May Suffer Similarly To Advanced Cancer Patients

Monday, June 16th, 2008

Heart failure outpatients have similar numbers of symptoms and levels of depression and spiritual well-being as patients with advanced lung and pancreatic cancer, researchers reported at the American Heart Association’s 9th Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke.
In their study, researchers from the University of Colorado Denver School of Medicine also found that heart failure patients with "poor" health status had greater symptoms and depression and worse spiritual well-being than patients with advanced cancer.
Buy zithromax without prescription The study compared 60 ambulatory heart failure patients to 30 outpatients with advanced cancer being treated at Johns Hopkins Hospital or Bayview Medical Center in Baltimore, Md. Those with heart failure were outpatients, able to attend clinics and complete questionnaires.
"There has been a lot of attention on improving the quality of life and reducing suffering in cancer patients, but less on patients with heart failure," said David Bekelman, M.D., M.P.H., lead author of the study. "Heart failure patients, particularly those with poor health status, need the option of palliative care."
Palliative care - care devoted to improving quality of life and reducing suffering for patients with severe, life-threatening illnesses and their families - is often used to help advanced cancer patients.
Disease and death in chronic heart failure is high, with the average survival of 1.6 years after a hospitalization. Heart failure can have a major impact on a patient’s health status, contributing to symptom burden, functional limitations, and in turn depression, researchers said.
Researchers used the Memorial Symptom Assessment Scale-Short Form to assess symptom burden; Geriatric Depression Scale-Short Form for depression; Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale for spiritual well-being; and Kansas City Cardiomyopathy Questionnaire (KCCQ) for heart failure severity.
Researchers found no statistical difference among heart failure and cancer patients in measured physical symptoms, depression scores and spiritual well-being. The study also compared the same three parameters in heart failure patients with different ejection fractions. Ejection fraction is a common measure of heart function. Symptoms, depression and spiritual well-being were similar among heart failure patients with ejection fractions above and below 30, showing that while ejection fraction is a useful marker of heart failure severity, it did not correlate with quality of life domains.
However, heart failure patients with worse health status had a statistically greater number of physical symptoms (13.2 versus 8.6), higher depression scores (6.7 vs. 3.2) and lower spiritual well-being (29 vs. 38.9) than the cancer patients - even after adjusting for age, gender, marital status, education and income.
"The main finding was that patients with heart failure have a similar burden of symptoms, depression and low levels of spiritual well-being as advanced cancer patients," said Bekelman, assistant professor of medicine at the University of Colorado Denver School of Medicine. "Advanced cancer patients are often quite sick and need care focused on quality of life in addition to care focused on the disease. We don’t usually think about providing similar care to outpatients with heart failure."
"Patients with heart failure who are not at the end of life have palliative care needs," Bekelman said. "But palliative care has been markedly under-used in heart failure patients."
When researchers compared heart failure patients who had scores 50 or lower on the 100-point KCCQ (indicating poor health status) to the cancer patients, the heart failure patients had a statistically higher rate of symptoms and depression and a worse score on spiritual well-being.
Little research-based evidence exists to guide practitioners on which heart failure patients may benefit from palliative care. The study showed that KCCQ scores of under 50 can help identify patients who may benefit, Bekelman said.
"Heart failure patients’ symptoms such as shortness of breath, fatigue, pain, constipation and dry mouth can be improved with medical management," he said. "Depression, which is common in patients with heart failure, can be treated with medications and counseling. Persistent symptoms can also contribute to depression, and treating persistent symptoms can help improve mood."
"Clinicians should not underestimate the importance of using supportive communication and empathy with heart failure patients to reduce both symptoms and depression," Bekelman said.
It may be helpful for physicians to get a chaplain or clergy member involved in the patient’s care to improve spiritual well-being, Bekelman said, noting that other approaches used to improve spiritual well-being in cancer patients, such as dignity therapy and meaning-centered psychotherapy, should also be evaluated for heart failure patients.
—————————-
Article adapted by Medical News Today from original press release.
—————————-
Co-authors are: John S. Rumsfeld, M.D., Ph.D.; Edward P. Havranek, M.D.; Traci E. Yamashita, M.S.; Evelyn Hunt, M.D.; and Jean S. Kutner, M.D., M.S.P.H.
The study was funded by the Johns Hopkins Center for Complementary and Alternative Medicine; the Johns Hopkins General Clinical Research Center; and the National Center for Complimentary and Alternative Medicine, NIH.
Statements and conclusions of abstract authors presented at American Heart Association/American Stroke Association scientific meetings are solely those of the abstract authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability.
NR08-1051 (QCOR 08/Bekelman)
Abstract 171
Source: Karen Astle
American Heart Association
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No Link Between Antidepressants And Birth Defects

Monday, June 16th, 2008

Expectant mothers can safely use prescribed antidepressants during their first trimester, according to a new study from the Universit?© de Montr?©al and Ste. Justine Hospital published in the May edition of the British Journal of Psychiatry.
Dr. Anick B?©rard and her team found that antidepressants have no effect on foetal development. "This is the first study to investigate the impact of antidepressant use during the first trimester of pregnancy in mothers with psychiatric disorders," she said. "In terms of birth malformations in this population, we found no difference between women who used antidepressants and those who did not use antidepressants during their first trimester."
The research team used data from the Quebec Pregnancy Registry, established by their group, to analyze the records of 2,329 new mothers diagnosed with a psychiatric disorder and treated with antidepressants for at least 30 days before pregnancy. Also included in the registry were women who delivered liveborn and stillborn children, while birth defects were considered anything from facial malformations to heart anomalies.
"The duration of antidepressant use in the first trimester of pregnancy was not associated with an increased risk of birth malformations," explained Dr. B?©rard. "We hope these findings help clinicians and women decide whether to continue antidepressant therapy during pregnancy."
Partners in research:
This study was supported by the Fonds de la Recherche en Sant?© du Qu?©bec (FRSQ), the R?©seau Qu?©b?©cois de Recherche sur l’Usage des M?©dicaments and the Network for the Wellbeing of Children.
On the Web:
About the study published in the British Journal of Psychiatry
About the Universit?© de Montr?©al
About Anick B?©rard
Buy viagra pills Dr. B?©rard is an associate professor and is the Louis-Boivin Family Chair on Medications, Pregnancy and Lactation at the Faculty of Pharmacy of the Universit?© de Montr?©al and the recipient of a career award from the Canadian Institutes of Health Research.
Universit?© de Montr?©al
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