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Managing Acute Post-operative Pain In Hospital
Health professionals caring for patients with acute post-operative pain can improve pain management with a new drug use evaluation toolkit developed by the National Prescribing Service Ltd (NPS).

Obama, Pope Focus On Abortion, 'Life' Issues In First Meeting
In their first meeting, President Obama and Pope Benedict XVI on Friday discussed their views on abortion, embryonic stem cell research and the rights of health care workers to object to procedures and services that go against their beliefs, the Los Angeles Times reports. During a 30-minute discussion, the pope expressed to Obama his beliefs about "the defense and promotion of life and the right to abide by one"s conscience," according to the Vatican. The Times reports that the statement was a "clear reference" to debates over abortion rights, embryonic stem cell research and "conscience" protections for health care providers who refuse care on moral or religious grounds (Chu, Los Angeles Times, 7/11).According to Time, Benedict showed "no intention of papering over differences on what the Vatican calls "life" issues," including abortion rights. Vatican spokesperson the Rev. Federico Lombardi said that the pope told him how Obama "explicitly expressed his commitment to reducing the number of abortions and to listen to the Church"s concerns on moral issues" (Israely, Time, 7/10). According to White House deputy national security aide Denis McDonough, Obama was "eager to find common ground on these issues and to work aggressively to do that" (Simpson/Feller, AP/Boston Globe, 7/11). However, "[I]t may just be that there"s issues that you can"t come to agreement on," McDonough added, noting that Obama believes that "you can disagree without being disagreeable" (Los Angeles Times, 7/11).Montsignor Georg Ganswein, the pope"s personal secretary, said that Obama was given a copy of "Dignitas Personae," or "The Dignity of a Person," a Vatican document released in December detailing the Roman Catholic Church"s most recent stance on bioethics issues (Time, 7/10). The document "hardened" the Church"s opposition to embryonic stem cell research, cloning and in vitro fertilization (AP/Boston Globe, 7/11). Obama assured the pope he would read the document that day on his flight from Italy to Ghana. Ganswein said that the document "can help the president better understand the position of the Catholic Church." Lombardi noted that it "would be ambiguous to hide or minimize what we believe," adding, "It"s not meant to be divisive or polemical" (Time, 7/10).
News of the day
RNs Praise House Vote To Permit State Single-Payer Laws
The nation"s largest union and professional association of registered nurses hailed passage of a key amendment in the House Education and Labor Committee to the national healthcare reform bill this morning that would enable individual states to go a step farther and adopt single-payer, Medicare-for-All style reforms.
Nutrition

Orencia(R) (Abatacept) Demonstrates Consistent Safety And Effectiveness Over 7 Years

Bristol-Myers Squibb Company (NYSE: BMY) announced results of two ORENCIA® (abatacept) studies at the 2009 Annual European Congress of Rheumatology (EULAR) currently being held in Copenhagen, Denmark. I. Phase IIb 100 trial (7 years)[1] The first, a long-term extension (LTE) study, analysed ORENCIA"s safety and efficacy profile over 7 years of treatment in rheumatoid arthritis (RA) patients who have had an inadequate response to methotrexate (MTX). Study design During the 1 year randomised, double-blind (DB) placebo controlled period of this Phase IIb study, 339 patients with active RA and an inadequate response to MTX were randomised to receive either ORENCIA plus MTX or placebo plus MTX. On completion of the DB period, 219 patients entered the open-label LTE, receiving a fixed dose of ORENCIA 10 mg/kg (according to weight range) plus MTX every 4 weeks. During the LTE, safety assessments were performed once a month, and efficacy assessments quarterly. Outcomes During the LTE, treatment with ORENCIA and MTX in combination was generally well tolerated, with no increase in the frequency of safety events over time. The cumulative incidence of adverse events (AEs) was 366.1 per 100 patient years, serious AEs was 17.4 per 100 patient years and serious infections was 3.18 per 100 patient years. These data are consistent with previous data on ORENCIA in combination with MTX. After 7 years, over half (52.1%) of ORENCIA patients (n=85) entering the LTE period remained on treatment. Over this 7 year period, discontinuations due to lack of efficacy and AEs were 11.0% and 19.2%, respectively. While the LTE was principally designed to examine the long-term safety of ORENCIA, efficacy data were also collected (as observed) in those patients who remained in the LTE. At 7 years, of those patients still on ORENCIA (n=85): - 69.7% achieved a low disease activity score (LDAS) - 51.5% achieved remission (DAS28-CRP defined) - 51.4% achieved an ACR 70 score "The relevance of these long-term data should not be underestimated for a chronic and progressive disease such as rheumatoid arthritis," commented Professor Renç© Westhovens, University Hospital Leuven, Belgium. "These patients have to live with the disease, and in many cases, undergo treatment, for the rest of their lives. For both patients and clinicians therefore, it is important that a treatment has a proven long-term safety and efficacy profile. As part of a comprehensive clinical trial programme, ORENCIA"s safety profile has already been studied through more than 10,000 patient years of exposure. These new data further reinforce ORENCIA, in combination with MTX, as a proven treatment option for moderate to severe active RA in adult patients who have had an insufficient response or intolerance to other disease-modifying anti-rheumatic drugs, including at least one tumour necrosis factor (TNF) inhibitor.[2] II. AIM trial (5 years)[3] The second study, also presented in Copenhagen this week is the AIM (Abatacept in Inadequate responders to Methotrexate) study LTE, which reinforces the long-term safety and efficacy profile of ORENCIA. Study design Of the 433 ORENCIA and 219 placebo treated patients who completed the 1 year, randomised DB, placebo controlled AIM trial, 378 ORENCIA and 161 placebo treated patients entered the open-label LTE period, receiving ORENCIA [~10 mg/kg] plus MTX. Outcomes: efficacy & safety ORENCIA patient retention rates remained high in the AIM LTE, with 70.4% of patients (n=266/378) remaining on treatment with ORENCIA plus MTX at year 5. Of these, 33.7% achieved clinical remission (DAS28 defined), and ACR 20, 50 and 70 response rates were 83.6%, 61.1% and 39.6%, respectively, at 5 years. The types and incidence of AEs and serious AEs were similar between the DB and cumulative (combined DB + LTE) phases. During the DB phase, incidence rates of AEs were 303.4 per 100 patient years and serious AEs, 17.7 per 100 patient years. During the cumulative phase, incidence rates of AEs were 242.3 per 100 patient years and serious AEs, 13.9 per 100 patient years. Incidence rates of serious infections were 4.2 per 100 patient years in the DB period and 2.8 per 100 patient years in the cumulative phase. Outcomes: inhibition of structural damage progression[4] X-ray data from the AIM LTE, also presented at EULAR this week, demonstrated that over 5 years, ORENCIA inhibited structural damage progression in the majority of patients on treatment. 45.1% of patients (n=120) assessed at year 5 continued to show no progression in structural damage. 98% of patients who were non-progressors during years 1-4 remained non-progressors at year 5. About ORENCIA ORENCIA is a selective co-stimulation modulator of T-cell activation. ORENCIA is designed to prevent full T-cell activation and inhibit the release of chemicals leading to joint inflammation and destruction as observed in RA.[5] ORENCIA is the first biologic discovered and developed in Bristol-Myers Squibb research centres and was approved in May 2007 by the European Commission. ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease-modifying anti-rheumatic drugs including at least one tumour necrosis factor (TNF) inhibitor. A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with ORENCIA and methotrexate. The safety profile of ORENCIA has been studied through more than 10,000 patient-years of exposure and has demonstrated a consistent safety profile to 7 years.[2] Medicinal products, including ORENCIA, which affect the immune system, may affect host defences against infections and malignancies. Serious infections, at least possibly related to treatment, were reported in 1.8% of patients with ORENCIA and in 1.0% of patients not treated by ORENCIA (receiving placebo). There is a need to evaluate and monitor patients regarding the risk of infection prior to and during treatment. In the placebo-controlled clinical trials, the frequency of malignancies with ORENCIA was 1.4% and with placebo 1.1%. These rates are similar to that observed in the general RA population.[6] ORENCIA, like other biologics, is contraindicated in patients with severe and uncontrolled infections such as sepsis and opportunistic infections and in patients with hypersensitivity to the active substance or to any of the excipients. Allergic reactions have been reported uncommonly with ORENCIA in clinical trials, where patients were not required to be pretreated to prevent allergic reactions. In the case of any serious allergic/anaphylactic reaction, ORENCIA should be discontinued. About Rheumatoid Arthritis RA is a systemic, chronic, autoimmune disease characterised by inflammation in the lining of joints (or synovium), causing joint damage with chronic pain, stiffness and swelling. RA causes limited range of motion and decreased function as a result of affected joints losing their shape and alignment. RA may affect up to 7 million people in Europe.[7],[8] References: [1] Westhovens, R et al. Consistent Safety and Sustained Improvement in Disease Activity and Treatment Response Over 7 Years of Abatacept Treatment in Biologic-Naç¯ve Patients with RA. EULAR 2009, abstract no. FRI0108. [2] Smitten, A et al. Descriptive Analysis of Serious Infections, Hospitalized Infections and Malignancies Over Time in the Abatacept Clinical Development Program: A Safety Update with >10,000 Person-Years of Exposure. EULAR 2008, abstract no. 1065. [3] Kremer JM et al. Abatacept Demonstrates Consistent Safety and Sustained Improvements in Efficacy Through 5 Years of Treatment in Biologic-Naç¯ve Patients with RA. EULAR 2009, abstract no. FRI0263. [4] Genant, HK el al. Abatacept Increases the Proportion of Patients who Remain Free From Structural Damage Progression Through 5 Years in Methotrexate Inadequate Responders with RA.EULAR 2009, abstract no. FRI0253. [5] Kremer, JM et al. Treatment of Rheumatoid Arthritis by Selective Inhibition of T-Cell Activation with Fusion Protein CTLA4Ig. N. Engl. J. Med. 2003;349:1907-1915. [6] Simon, T et al. Ann Rheum Dis 2006;65(Suppl II):489. [7] United Nations. 2008 Revision Population Database. http://esa.un.org/unpp/ Accessed 14-05-09. [8] Symons, D et al. The Global Burden of Rheumatoid Arthritis in the Year 2000. See here. Accessed 14-05-09. Bristol-Myers Squibb


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