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  1. Article ; Online: An update on the safety of long-acting beta-agonists in asthma patients using inhaled corticosteroids.

    Salpeter, Shelley R

    Expert opinion on drug safety

    2010  Volume 9, Issue 3, Page(s) 407–419

    Abstract: Importance of the field: Pooled trial data have shown that long-acting beta-agonists increase the risk for asthma hospitalizations and deaths by two to fourfold compared with placebo. Until recently, it was unclear whether concomitant inhaled ... ...

    Abstract Importance of the field: Pooled trial data have shown that long-acting beta-agonists increase the risk for asthma hospitalizations and deaths by two to fourfold compared with placebo. Until recently, it was unclear whether concomitant inhaled corticosteroids (ICSs) could eliminate this risk.
    Areas covered in this review: This review summarizes the available data on the safety of long-acting beta-agonist use in asthma, with and without concomitant ICSs. The results from an updated meta-analysis are presented, with data through December 2008.
    What the reader will gain: In pooled trial data, catastrophic asthma events (defined as asthma-related intubation or death) were increased fourfold for concomitant treatment with long-acting beta-agonists and ICSs compared with corticosteroids alone (odds ratio 3.7; 95% CI 1.4 - 9.6). It is estimated that the addition of long-acting beta-agonists to ICS therapy is associated with an absolute increase of one catastrophic event per 1500 patient-years.
    Take home message: When the available trial data are pooled together, it is clear that long-acting beta-agonists significantly increase the risk for asthma-related intubations and deaths, even when used in a controlled fashion with concomitant ICSs. Clinical guidelines should readdress the role long-acting beta-agonists have in the management of asthma.
    MeSH term(s) Administration, Inhalation ; Adrenal Cortex Hormones/administration & dosage ; Adrenal Cortex Hormones/adverse effects ; Adrenergic beta-Agonists/administration & dosage ; Adrenergic beta-Agonists/adverse effects ; Animals ; Anti-Asthmatic Agents/administration & dosage ; Anti-Asthmatic Agents/adverse effects ; Asthma/drug therapy ; Asthma/mortality ; Clinical Trials as Topic/trends ; Delayed-Action Preparations ; Humans
    Chemical Substances Adrenal Cortex Hormones ; Adrenergic beta-Agonists ; Anti-Asthmatic Agents ; Delayed-Action Preparations
    Language English
    Publishing date 2010-05
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2088728-0
    ISSN 1744-764X ; 1474-0338
    ISSN (online) 1744-764X
    ISSN 1474-0338
    DOI 10.1517/14740330903535852
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  2. Article ; Online: A Risk-Benefit Assessment of Dementia Medications: Systematic Review of the Evidence.

    Buckley, Jacob S / Salpeter, Shelley R

    Drugs & aging

    2015  Volume 32, Issue 6, Page(s) 453–467

    Abstract: Background: There is no cure for dementia, and no treatments exist to halt or reverse the course of the disease. Treatments are aimed at improving cognitive and functional outcomes.: Objective: Our objective was to review the basis of pharmacological ...

    Abstract Background: There is no cure for dementia, and no treatments exist to halt or reverse the course of the disease. Treatments are aimed at improving cognitive and functional outcomes.
    Objective: Our objective was to review the basis of pharmacological treatments for dementia and to summarize the benefits and risks of dementia treatments.
    Methods: We performed a systematic literature search of MEDLINE through November 2014, for English-language trials and observational studies on treatment of dementia and mild cognitive impairment. Additional references were identified by searching bibliographies of relevant publications. Whenever possible, pooled data from meta-analyses or systematic reviews were obtained. Studies were included for review if they were randomized trials or observational studies on dementia or mild cognitive impairment that evaluated efficacy outcomes or adverse outcomes associated with treatment. Studies were excluded if they evaluated non-FDA approved treatments, or if they evaluated treatment in disorders other than dementia and mild cognitive impairment.
    Results: The literature search found 540 potentially relevant studies, of which 257 were included in the systematic review. In pooled trial data, cholinesterase inhibitors (ChEIs) produce small improvements in cognitive, functional, and global benefits in patients with mild to moderate Alzheimer's and Lewy body dementia, but the clinical significance of these effects are unclear. There is no significant benefit seen for vascular dementia. The efficacy of ChEI treatment appears to wane over time, with minimal benefit seen after 1 year. There is no evidence for benefit for those with advanced disease or those aged over 85 years. Adverse effects are significantly increased with ChEIs, in a dose-dependent manner. A two- to fivefold increased risk for gastrointestinal, neurological, and cardiovascular side effects is related to cholinergic stimulation, the most serious being weight loss, debility, and syncope. Those aged over 85 years have double the risk of adverse events compared with younger patients. Memantine monotherapy may provide some cognitive benefit for patients with moderate to severe Alzheimer's and vascular dementia, but the benefit is small and may wane over the course of several months. Memantine exhibits no significant benefit in mild dementia or Lewy body dementia or as an add-on treatment with ChEIs. Memantine has a relatively favorable side-effect profile, at least under controlled trial conditions.
    Conclusions: ChEIs produce small, short-lived improvements in cognitive function in mild to moderate dementia, which may not translate into clinically meaningful effects. Marginal benefits are seen with severe disease, long-term treatment, and advanced age. Cholinergic side effects, including weight loss, debility, and syncope, are clinically significant and could be especially detrimental in the frail elderly population, in which the risks of treatment outweigh the benefits. Memantine monotherapy may have minimal benefits in moderate to severe dementia, balanced by minimal adverse effects.
    MeSH term(s) Aged ; Aged, 80 and over ; Cholinesterase Inhibitors/adverse effects ; Cholinesterase Inhibitors/therapeutic use ; Dementia/drug therapy ; Female ; Humans ; Male ; Memantine/adverse effects ; Memantine/therapeutic use ; Middle Aged ; Observational Studies as Topic ; Randomized Controlled Trials as Topic ; Risk Assessment
    Chemical Substances Cholinesterase Inhibitors ; Memantine (W8O17SJF3T)
    Language English
    Publishing date 2015-06
    Publishing country New Zealand
    Document type Journal Article ; Review
    ZDB-ID 1075770-3
    ISSN 1179-1969 ; 1170-229X
    ISSN (online) 1179-1969
    ISSN 1170-229X
    DOI 10.1007/s40266-015-0266-9
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  3. Article ; Online: Do inhaled anticholinergics increase or decrease the risk of major cardiovascular events?: a synthesis of the available evidence.

    Salpeter, Shelley R

    Drugs

    2009  Volume 69, Issue 15, Page(s) 2025–2033

    Abstract: There has been recent uncertainty about whether the inhaled anticholinergic agents ipratropium bromide and tiotropium bromide increase or decrease cardiovascular risk in the treatment of patients with chronic obstructive pulmonary disease (COPD). This ... ...

    Abstract There has been recent uncertainty about whether the inhaled anticholinergic agents ipratropium bromide and tiotropium bromide increase or decrease cardiovascular risk in the treatment of patients with chronic obstructive pulmonary disease (COPD). This article synthesizes the available data in order to understand the controversy. COPD is a common cause of hospitalizations and is a rapidly increasing cause of mortality worldwide. Despite the heavy burden of COPD-related illness, the leading cause of hospitalization in COPD patients is cardiovascular disease. This link between COPD and cardiovascular disease is in part due to the fact that both diseases share common risk factors, such as tobacco smoking and advanced age. It is also hypothesized that systemic inflammation in COPD increases the risk for cardiac events such as myocardial infarction. Inhaled anticholinergics reduce COPD-related hospitalizations and respiratory deaths compared with placebo, and tiotropium bromide is more effective than ipratropium bromide. In randomized trials, patients receiving tiotropium bromide have lower discontinuation rates than those receiving placebo and, therefore, contribute more person-years to the analyses. In a recent large 4-year tiotropium bromide trial, the proportion of patients who died was similar in the tiotropium bromide and placebo groups, whereas the death rate per person-years was lower with tiotropium bromide, indicating longer overall survival. There has been conflicting evidence concerning cardiovascular risk associated with inhaled anticholinergics. One meta-analysis found that the risk for major cardiovascular events was higher with anticholinergics compared with placebo or active comparator controls, whereas two subsequent meta-analyses that included new trial data found no difference in risk. In a recent pooled safety analysis, when incidence rates of events over time were evaluated, tiotropium bromide was associated with a lower rate of major cardiovascular events and cardiovascular deaths compared with placebo. This risk reduction was mainly because of a reduction in serious cardiac events such as myocardial infarction and congestive heart failure. In conclusion, inhaled anticholinergics, especially tiotropium bromide, reduce COPD-related hospitalizations and deaths, and may improve total survival over time. Many COPD patients have concomitant cardiovascular disease processes. Thus, trials may observe more cardiovascular events associated with anticholinergics than with placebo, but this differential is eliminated when evaluating the rate of events per person-years of exposure. New evidence indicates that tiotropium bromide may actually reduce the incidence of cardiovascular events and deaths over time. It is possible that the reduction in respiratory morbidity could improve functional status and reduce adverse cardiac outcomes over time. Further studies are needed to address this important issue.
    MeSH term(s) Administration, Inhalation ; Bronchodilator Agents/adverse effects ; Cardiovascular Diseases/chemically induced ; Cholinergic Antagonists/adverse effects ; Humans ; Ipratropium/adverse effects ; Pulmonary Disease, Chronic Obstructive/chemically induced ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Pulmonary Disease, Chronic Obstructive/mortality ; Risk ; Scopolamine Derivatives/adverse effects ; Tiotropium Bromide
    Chemical Substances Bronchodilator Agents ; Cholinergic Antagonists ; Scopolamine Derivatives ; Ipratropium (GR88G0I6UL) ; Tiotropium Bromide (XX112XZP0J)
    Language English
    Publishing date 2009-10-01
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 120316-2
    ISSN 1179-1950 ; 0012-6667
    ISSN (online) 1179-1950
    ISSN 0012-6667
    DOI 10.2165/11318580-000000000-00000
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  4. Article ; Online: Rebuttal: should we avoid beta-agonists for moderate and severe chronic obstructive pulmonary disease? Yes.

    Salpeter, Shelley R

    Canadian family physician Médecin de famille canadien

    2007  Volume 53, Issue 9, Page(s) 1429–30, 1432–3

    MeSH term(s) Adrenergic beta-Agonists/contraindications ; Albuterol/analogs & derivatives ; Albuterol/therapeutic use ; Bronchodilator Agents/therapeutic use ; Cholinergic Antagonists/therapeutic use ; Drug Evaluation ; Humans ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Salmeterol Xinafoate
    Chemical Substances Adrenergic beta-Agonists ; Bronchodilator Agents ; Cholinergic Antagonists ; Salmeterol Xinafoate (6EW8Q962A5) ; Albuterol (QF8SVZ843E)
    Language French
    Publishing date 2007-09
    Publishing country Canada
    Document type Journal Article
    ISSN 1715-5258
    ISSN (online) 1715-5258
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  5. Article ; Online: Should we avoid beta-agonists for moderate and severe chronic obstructive pulmonary disease? YES.

    Salpeter, Shelley R

    Canadian family physician Médecin de famille canadien

    2007  Volume 53, Issue 8, Page(s) 1290–1297

    MeSH term(s) Adrenergic beta-Agonists/contraindications ; Bronchodilator Agents/therapeutic use ; Cholinergic Antagonists/therapeutic use ; Conflict of Interest ; Drug Evaluation ; Humans ; Practice Guidelines as Topic ; Pulmonary Disease, Chronic Obstructive/drug therapy
    Chemical Substances Adrenergic beta-Agonists ; Bronchodilator Agents ; Cholinergic Antagonists
    Language French
    Publishing date 2007-08
    Publishing country Canada
    Document type Journal Article
    ISSN 1715-5258
    ISSN (online) 1715-5258
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  6. Article: Bronchodilators in COPD: impact of beta-agonists and anticholinergics on severe exacerbations and mortality.

    Salpeter, Shelley R

    International journal of chronic obstructive pulmonary disease

    2007  Volume 2, Issue 1, Page(s) 11–18

    Abstract: This review summarizes the long-term clinical outcomes associated with beta-agonist and anticholinergic bronchodilator use in patients with chronic obstructive pulmonary disease (COPD). Pooled data from randomized placebo-controlled trials of at least ... ...

    Abstract This review summarizes the long-term clinical outcomes associated with beta-agonist and anticholinergic bronchodilator use in patients with chronic obstructive pulmonary disease (COPD). Pooled data from randomized placebo-controlled trials of at least three months duration were used to evaluate the risk for COPD hospitalizations, respiratory mortality, and total mortality. The results show that anticholinergic use is associated with a 30% reduction in COPD hospitalizations, a 70% reduction in respiratory mortality, and without a significant effect on total mortality. In contrast, beta-agonist use had no effect on COPD hospitalizations and was associated with a two-fold increased risk for respiratory death compared with placebo. When the two bronchodilators were directly compared with each other, beta-agonists were associated with a two-fold increased risk for COPD hospitalization and a five-fold increased risk for total mortality compared with anticholinergics. When beta-agonists were added to either anticholinergic use or inhaled corticosteroid use alone, there was no significant improvement in any long-term clinical outcome. These results indicate that anticholinergics should be the bronchodilator of choice in COPD, while beta-agonists may be associated with poorer disease control.
    MeSH term(s) Administration, Inhalation ; Adrenal Cortex Hormones/administration & dosage ; Adrenal Cortex Hormones/therapeutic use ; Adrenergic beta-Agonists/therapeutic use ; Bronchodilator Agents/therapeutic use ; Cholinergic Antagonists/therapeutic use ; Humans ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Pulmonary Disease, Chronic Obstructive/physiopathology ; Severity of Illness Index
    Chemical Substances Adrenal Cortex Hormones ; Adrenergic beta-Agonists ; Bronchodilator Agents ; Cholinergic Antagonists
    Language English
    Publishing date 2007-11-28
    Publishing country New Zealand
    Document type Journal Article ; Review
    ZDB-ID 2212419-6
    ISSN 1178-2005 ; 1176-9106
    ISSN (online) 1178-2005
    ISSN 1176-9106
    DOI 10.2147/copd.2007.2.1.11
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  7. Article: Cardiovascular safety of beta(2)-adrenoceptor agonist use in patients with obstructive airway disease: a systematic review.

    Salpeter, Shelley R

    Drugs & aging

    2004  Volume 21, Issue 6, Page(s) 405–414

    Abstract: Background: beta(2)-Adrenoceptor agonists have been used as bronchodilators in the management of asthma and chronic obstructive pulmonary disease (COPD); however, there is evidence suggesting that beta(2)-adrenoceptor agonist use may increase morbidity ... ...

    Abstract Background: beta(2)-Adrenoceptor agonists have been used as bronchodilators in the management of asthma and chronic obstructive pulmonary disease (COPD); however, there is evidence suggesting that beta(2)-adrenoceptor agonist use may increase morbidity and mortality.
    Methods: A systematic review of case-control studies and randomised controlled trials was performed to evaluate the cardiovascular safety of beta(2)-adrenoceptor agonist use in patients with obstructive airway disease, defined as asthma or COPD.
    Results: Case-control studies have shown that beta(2)-adrenoceptor agonist use is associated with an increased risk of myocardial infarction, congestive heart failure, cardiac arrest and sudden cardiac death. The degree of risk appears to be dose-dependent, and may be highest for new users and those with concomitant cardiac conditions. Pooled data from randomised placebo-controlled trials indicate that beta(2)-adrenoceptor agonist use increases the risk of adverse cardiovascular events by more than 2-fold compared with placebo, thus providing evidence that the association seen in case-control studies is a causal one. Single doses of beta(2)-adrenoceptor agonists significantly increase heart rate and decrease potassium concentrations compared with placebo.
    Conclusions: Initiation of beta(2)-adrenoceptor agonist treatment increases heart rate and decreases potassium concentrations, while continued use may increase the risk of adverse cardiovascular events. It could be through these effects of beta-adrenergic stimulation that beta(2)-adrenoceptor agonists may induce ischaemia, congestive heart failure, arrhythmias and sudden cardiac death. In addition to increasing adverse cardiovascular events, beta(2)-adrenoceptor agonist use may induce respiratory tolerance and increase the risk of asthma attacks. It is not clear whether beta(2)-adrenoceptor agonists should be used regularly in the treatment of obstructive airway disease, with or without concomitant cardiovascular disease.
    MeSH term(s) Adrenergic alpha-2 Receptor Agonists ; Adrenergic beta-Agonists/adverse effects ; Adrenergic beta-Agonists/therapeutic use ; Animals ; Asthma/complications ; Asthma/drug therapy ; Cardiovascular Diseases/chemically induced ; Case-Control Studies ; Humans ; Pulmonary Disease, Chronic Obstructive/complications ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Randomized Controlled Trials as Topic
    Chemical Substances Adrenergic alpha-2 Receptor Agonists ; Adrenergic beta-Agonists
    Language English
    Publishing date 2004-04-08
    Publishing country New Zealand
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 1075770-3
    ISSN 1179-1969 ; 1170-229X
    ISSN (online) 1179-1969
    ISSN 1170-229X
    DOI 10.2165/00002512-200421060-00005
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    Zs.A 3481: Show issues Location:
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  8. Article ; Online: Very-low-dose methadone: authors' response.

    Salpeter, Shelley R / Buckley, Jacob S / Bruera, Eduardo

    Journal of palliative medicine

    2013  Volume 16, Issue 10, Page(s) 1174

    MeSH term(s) Analgesics, Opioid/administration & dosage ; Dose-Response Relationship, Drug ; Female ; Hospice Care ; Humans ; Hyperalgesia/prevention & control ; Male ; Methadone/administration & dosage ; Pain Management/methods
    Chemical Substances Analgesics, Opioid ; Methadone (UC6VBE7V1Z)
    Language English
    Publishing date 2013-10
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 1427361-5
    ISSN 1557-7740 ; 1096-6218
    ISSN (online) 1557-7740
    ISSN 1096-6218
    DOI 10.1089/jpm.2013.9476
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  9. Article ; Online: Impact of more restrictive blood transfusion strategies on clinical outcomes: a meta-analysis and systematic review.

    Salpeter, Shelley R / Buckley, Jacob S / Chatterjee, Saurav

    The American journal of medicine

    2014  Volume 127, Issue 2, Page(s) 124–131.e3

    Abstract: Background: There is accumulating evidence that restricting blood transfusions improves outcomes, with newer trials showing greater benefit from more restrictive strategies. We systematically evaluated the impact of various transfusion triggers on ... ...

    Abstract Background: There is accumulating evidence that restricting blood transfusions improves outcomes, with newer trials showing greater benefit from more restrictive strategies. We systematically evaluated the impact of various transfusion triggers on clinical outcomes.
    Methods: The MEDLINE database was searched from 1966 to April 2013 to find randomized trials evaluating a restrictive hemoglobin transfusion trigger of <7 g/dL, compared with a more liberal trigger. Two investigators independently extracted data from the trials. Outcomes evaluated included mortality, acute coronary syndrome, pulmonary edema, infections, rebleeding, number of patients transfused, and units of blood transfused per patient. Extracted data also included information on study setting, design, participant characteristics, and risk for bias of the included trials. A secondary analysis evaluated trials using less restrictive transfusion triggers, and a systematic review of observational studies evaluated more restrictive triggers.
    Results: In the primary analysis, pooled results from 3 trials with 2364 participants showed that a restrictive hemoglobin transfusion trigger of <7 g/dL resulted in reduced in-hospital mortality (risk ratio [RR], 0.74; confidence interval [CI], 0.60-0.92), total mortality (RR, 0.80; CI, 0.65-0.98), rebleeding (RR, 0.64; CI, 0.45-0.90), acute coronary syndrome (RR, 0.44; CI, 0.22-0.89), pulmonary edema (RR, 0.48; CI, 0.33-0.72), and bacterial infections (RR, 0.86; CI, 0.73-1.00), compared with a more liberal strategy. The number needed to treat with a restrictive strategy to prevent 1 death was 33. Pooled data from randomized trials with less restrictive transfusion strategies showed no significant effect on outcomes.
    Conclusions: In patients with critical illness or bleed, restricting blood transfusions by using a hemoglobin trigger of <7 g/dL significantly reduces cardiac events, rebleeding, bacterial infections, and total mortality. A less restrictive transfusion strategy was not effective.
    MeSH term(s) Acute Coronary Syndrome/epidemiology ; Acute Coronary Syndrome/prevention & control ; Bacterial Infections/etiology ; Bacterial Infections/prevention & control ; Blood Transfusion/mortality ; Blood Transfusion/standards ; Blood Transfusion/utilization ; Confounding Factors (Epidemiology) ; Critical Illness ; Evidence-Based Medicine ; Hemoglobins/analysis ; Hemoglobins/metabolism ; Hemorrhage/epidemiology ; Hemorrhage/prevention & control ; Hospital Mortality ; Humans ; Odds Ratio ; Pulmonary Edema/epidemiology ; Pulmonary Edema/prevention & control ; Randomized Controlled Trials as Topic
    Chemical Substances Hemoglobins
    Language English
    Publishing date 2014-02
    Publishing country United States
    Document type Journal Article ; Meta-Analysis ; Review
    ZDB-ID 80015-6
    ISSN 1555-7162 ; 1873-2178 ; 0002-9343 ; 1548-2766
    ISSN (online) 1555-7162 ; 1873-2178
    ISSN 0002-9343 ; 1548-2766
    DOI 10.1016/j.amjmed.2013.09.017
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  10. Article ; Online: The use of very-low-dose methadone and haloperidol for pain control in the hospital setting: a preliminary report.

    Salpeter, Shelley R / Buckley, Jacob S / Buckley, Nicholas S / Bruera, Eduardo

    Journal of palliative medicine

    2015  Volume 18, Issue 2, Page(s) 114–119

    Abstract: Objective: Our aim was to evaluate the use of very-low-dose methadone with haloperidol in the acute-care setting.: Methods: We reviewed the records of 735 hospitalized patients receiving a palliative care consultation between 2011 and 2014. All ... ...

    Abstract Objective: Our aim was to evaluate the use of very-low-dose methadone with haloperidol in the acute-care setting.
    Methods: We reviewed the records of 735 hospitalized patients receiving a palliative care consultation between 2011 and 2014. All patients with pain on opiates were offered conversion to methadone, 2.5 mg/day to 15 mg/day, in conjunction with scheduled haloperidol. Additional doses of haloperidol or short-acting opiates were given as needed for pain. Patients receiving an opiate at a morphine-equivalent daily dose (MEDD) of ≥40 mg had pain scores assessed daily, before and after conversion. Descriptive statistics were used to summarize the results.
    Results: Forty-three patients underwent conversion from another opiate (median MEDD, 78.5 mg) to methadone (median daily dose, 5 mg) and haloperidol (median daily dose, 1.5 mg). The median pain score was 5 in the week prior to conversion, 1 in week 1 after conversion (p<0.001 for difference), and zero in week 2. Similar results were seen for patients with cancer and noncancer diagnoses and for those with the highest and lowest initial opiate doses.
    Conclusion: The use of very-low-dose methadone in conjunction with haloperidol in the acute-care setting resulted in improved pain control after conversion from typical opiates.
    MeSH term(s) Administration, Oral ; Aged ; Aged, 80 and over ; Analgesics, Opioid/administration & dosage ; California ; Dose-Response Relationship, Drug ; Female ; Haloperidol/administration & dosage ; Humans ; Male ; Methadone/administration & dosage ; Middle Aged ; Morphine/therapeutic use ; Pain/drug therapy ; Pain Management/methods ; Palliative Care/methods ; Retrospective Studies
    Chemical Substances Analgesics, Opioid ; Morphine (76I7G6D29C) ; Haloperidol (J6292F8L3D) ; Methadone (UC6VBE7V1Z)
    Language English
    Publishing date 2015-02
    Publishing country United States
    Document type Evaluation Studies ; Journal Article
    ZDB-ID 1427361-5
    ISSN 1557-7740 ; 1096-6218
    ISSN (online) 1557-7740
    ISSN 1096-6218
    DOI 10.1089/jpm.2014.0266
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