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  1. Article: Trials are short, disease long: measuring drug utility beyond clinical trials.

    Luggen, Michael L

    The Journal of rheumatology

    2004  Volume 31, Issue 2, Page(s) 205–206

    MeSH term(s) Antirheumatic Agents/therapeutic use ; Clinical Trials as Topic/methods ; Humans ; Rheumatic Diseases/drug therapy
    Chemical Substances Antirheumatic Agents
    Language English
    Publishing date 2004-02
    Publishing country Canada
    Document type Comment ; Editorial ; Review
    ZDB-ID 194928-7
    ISSN 1499-2752 ; 0315-162X
    ISSN (online) 1499-2752
    ISSN 0315-162X
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1168: Show issues Location:
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    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 135: Show issues

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  2. Article: Monitoring methotrexate toxicity in juvenile idiopathic arthritis.

    Kocharla, Lakshmi / Taylor, Janalee / Weiler, Tracey / Ting, Tracy V / Luggen, Michael / Brunner, Hermine I

    The Journal of rheumatology

    2009  Volume 36, Issue 12, Page(s) 2813–2818

    Abstract: Objective: To determine the frequency of laboratory abnormalities with methotrexate (MTX) use in patients with juvenile idiopathic arthritis (JIA); to identify potential risk factors for MTX toxicity requiring medical interventions; and to compare the ... ...

    Abstract Objective: To determine the frequency of laboratory abnormalities with methotrexate (MTX) use in patients with juvenile idiopathic arthritis (JIA); to identify potential risk factors for MTX toxicity requiring medical interventions; and to compare the frequency of liver function abnormalities in patients treated with MTX to those not treated with MTX.
    Methods: Results of MTX surveillance laboratory testing (SLT) available in clinical databases were reviewed for 588 children with JIA. Information on demographics, JIA features, and factors previously associated with increased frequency of SLT abnormalities was obtained.
    Results: Results of SLT performed in at least 4-month intervals were available for 138 JIA patients whose JIA was not treated with MTX, and for 198 JIA patients treated with MTX plus folic acid. On SLT of the MTX-treated patients, there were 44 of 2650 (1.7%) AST tests and 90 of 2647 (3.4%) ALT tests that exceeded 2 times the upper limit of normal (> 2 ULN) in 30 children (15%). AST or ALT tests at > 2 ULN occurred more often with systemic JIA (p = 0.04), macrophage activation syndrome, during infections, in systemic antibiotic use, and after intensifying JIA drug regimens. AST or ALT results at > 2 ULN were as frequent among MTX-treated children as those not treated with MTX. Renal and hematological abnormalities with MTX were uncommon.
    Conclusion: Liver enzyme abnormalities > 2 ULN are rare in JIA, irrespective of MTX exposure. These data suggest that the adult standard of SLT every 4-8 weeks may not be necessary in children treated with MTX, especially if certain risk factors are absent.
    MeSH term(s) Adolescent ; Adult ; Antirheumatic Agents/therapeutic use ; Antirheumatic Agents/toxicity ; Arthritis, Juvenile/drug therapy ; Chemical and Drug Induced Liver Injury/physiopathology ; Child ; Databases, Factual ; Drug Monitoring ; Female ; Humans ; Liver/drug effects ; Liver/enzymology ; Male ; Methotrexate/therapeutic use ; Methotrexate/toxicity ; Risk Factors
    Chemical Substances Antirheumatic Agents ; Methotrexate (YL5FZ2Y5U1)
    Language English
    Publishing date 2009-11-16
    Publishing country Canada
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 194928-7
    ISSN 1499-2752 ; 0315-162X
    ISSN (online) 1499-2752
    ISSN 0315-162X
    DOI 10.3899/jrheum.090482
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1168: Show issues Location:
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    Zs.MO 135: Show issues

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  3. Article: Hypertrophic pachymeningitis in rheumatoid arthritis after adalimumab administration.

    Ahmed, Mansoor / Luggen, Michael / Herman, Jerome H / Weiss, Kenneth L / Decourten-Myers, Gabrielle / Quinlan, John G / Khanna, Dinesh

    The Journal of rheumatology

    2006  Volume 33, Issue 11, Page(s) 2344–2346

    Abstract: Tumor necrosis factor-a (TNF-a) inhibition, used in the treatment of rheumatoid arthritis (RA), is associated with central nervous system (CNS) events including new onset and/or exacerbations of pre-existing demyelinating neurological diseases. We ... ...

    Abstract Tumor necrosis factor-a (TNF-a) inhibition, used in the treatment of rheumatoid arthritis (RA), is associated with central nervous system (CNS) events including new onset and/or exacerbations of pre-existing demyelinating neurological diseases. We describe a patient with refractory RA where adalimumab, a fully humanized IgG1 monoclonal antibody against TNF-a, may have contributed to the development of meningoencephalitis, with brain biopsy suggestive of hypertrophic pachymeningitis, a rare complication of this disease. The patient had recurrence of neurological symptoms upon repeated administration of adalimumab, and resolution of symptoms after withdrawal.
    MeSH term(s) Adalimumab ; Aged ; Anti-Inflammatory Agents/administration & dosage ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal, Humanized ; Antirheumatic Agents/adverse effects ; Arthritis, Rheumatoid/drug therapy ; Histocytochemistry ; Humans ; Magnetic Resonance Imaging ; Male ; Meningitis/chemically induced ; Meningitis/diagnosis ; Meningitis/drug therapy ; Prednisone/administration & dosage
    Chemical Substances Anti-Inflammatory Agents ; Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Antirheumatic Agents ; Adalimumab (FYS6T7F842) ; Prednisone (VB0R961HZT)
    Language English
    Publishing date 2006-11
    Publishing country Canada
    Document type Case Reports ; Journal Article
    ZDB-ID 194928-7
    ISSN 1499-2752 ; 0315-162X
    ISSN (online) 1499-2752
    ISSN 0315-162X
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1168: Show issues Location:
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    Zs.MO 135: Show issues

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  4. Article ; Online: Concomitant leflunomide therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate. A randomized, double-blind, placebo-controlled trial.

    Kremer, Joel M / Genovese, Mark C / Cannon, Grant W / Caldwell, Jacques R / Cush, John J / Furst, Daniel E / Luggen, Michael E / Keystone, Ed / Weisman, Michael H / Bensen, William M / Kaine, Jeffrey L / Ruderman, Eric M / Coleman, Patricia / Curtis, David L / Kopp, Elliot J / Kantor, Seth M / Waltuck, Jonathan / Lindsley, Herbert B / Markenson, Joseph A /
    Strand, Vibeke / Crawford, Bruce / Fernando, Indra / Simpson, Karen / Bathon, Joan M

    Annals of internal medicine

    2002  Volume 137, Issue 9, Page(s) 726–733

    Abstract: Background: Disease-modifying antirheumatic drugs may confer greater benefits when combined with the antimetabolite methotrexate.: Objective: To evaluate the efficacy and safety of leflunomide versus placebo when added to ongoing, stable-dose ... ...

    Abstract Background: Disease-modifying antirheumatic drugs may confer greater benefits when combined with the antimetabolite methotrexate.
    Objective: To evaluate the efficacy and safety of leflunomide versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis.
    Design: 24-week, multicenter, randomized, double-blind, placebo-controlled trial.
    Setting: 20 centers in the United States and Canada.
    Patients: Patients with persistent rheumatoid arthritis, as defined by American College of Rheumatology (ACR) criteria, despite receiving methotrexate for at least 6 months.
    Intervention: Leflunomide or matching placebo added to existing methotrexate therapy.
    Measurements: The primary efficacy variable was the rate of achievement of 20% improvement in ACR criteria (ACR20) at the end of the study. The Health Assessment Questionnaire Disability Index was assessed at each visit, and the Medical Outcomes Study 36-Item Short Form was completed as an end point analysis.
    Results: In the leflunomide and placebo groups, 46.2% and 19.5% of patients, respectively, met ACR20 criteria at 24 weeks (P < 0.001). Clinical improvement was demonstrated by statistically significant mean changes in individual components of the ACR20 response criteria. Discontinuation rates were similar in both treatment groups (23.1% in the leflunomide group and 24.8% in the placebo group), as were the overall incidences of adverse events (89.2% vs. 89.5%, respectively). Adverse events were predominantly mild or moderate.
    Conclusions: Combination therapy with leflunomide and methotrexate provides statistically significant clinical benefit in patients with active rheumatoid arthritis who are receiving methotrexate therapy. Leflunomide plus methotrexate is generally well tolerated and can be used safely with appropriate liver enzyme and hematologic monitoring.
    MeSH term(s) Adult ; Aged ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Antimetabolites/adverse effects ; Antimetabolites/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; Diarrhea/chemically induced ; Disability Evaluation ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Humans ; Isoxazoles/therapeutic use ; Leflunomide ; Liver Function Tests ; Male ; Methotrexate/adverse effects ; Methotrexate/therapeutic use ; Middle Aged ; Placebos ; Quality of Life ; Surveys and Questionnaires ; Treatment Outcome
    Chemical Substances Anti-Inflammatory Agents, Non-Steroidal ; Antimetabolites ; Isoxazoles ; Placebos ; Leflunomide (G162GK9U4W) ; Methotrexate (YL5FZ2Y5U1)
    Language English
    Publishing date 2002-11-05
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 336-0
    ISSN 1539-3704 ; 0003-4819
    ISSN (online) 1539-3704
    ISSN 0003-4819
    DOI 10.7326/0003-4819-137-9-200211050-00007
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Ua VI Zs.178/2: Show issues Location:
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  5. Article: A controlled trial comparing sulfasalazine, gold sodium thiomalate, and placebo in rheumatoid arthritis.

    Williams, H J / Ward, J R / Dahl, S L / Clegg, D O / Willkens, R F / Oglesby, T / Weisman, M H / Schlegel, S / Michaels, R M / Luggen, M E

    Arthritis and rheumatism

    1988  Volume 31, Issue 6, Page(s) 702–713

    Abstract: One hundred eight-six patients with active rheumatoid arthritis were evaluated in a double-blind, randomized study that compared treatment with sulfasalazine (SSZ) (2 mg/day), gold sodium thiomalate (GST) (50 mg/week), and placebo (PBO). The 37-week ... ...

    Abstract One hundred eight-six patients with active rheumatoid arthritis were evaluated in a double-blind, randomized study that compared treatment with sulfasalazine (SSZ) (2 mg/day), gold sodium thiomalate (GST) (50 mg/week), and placebo (PBO). The 37-week course of therapy was completed by 109 patients. While marked improvement was seen in all 3 treatment groups, the only statistically significant differences between SSZ or GST and PBO were in a decreased erythrocyte sedimentation rate and increased grip strength in the right hand. GST is known to be superior to PBO, and the response of the GST-treated group was similar to that seen in other trials. The response of the PBO group, however, was much greater than in other placebo groups we have studied. SSZ was similar in efficacy to injectable gold, but was better tolerated. Because of adverse drug reactions (most commonly, rash, stomatitis, and proteinuria), 41% of patients were withdrawn from the GST treatment. Untoward drug effects (most frequently, rash and gastrointestinal distress) caused 16% of patients to be withdrawn from SSZ therapy.
    MeSH term(s) Adolescent ; Adult ; Arthritis, Rheumatoid/blood ; Arthritis, Rheumatoid/drug therapy ; Arthritis, Rheumatoid/physiopathology ; Blood Sedimentation ; Clinical Trials as Topic ; Gold Sodium Thiomalate/adverse effects ; Gold Sodium Thiomalate/therapeutic use ; Humans ; Joints/physiopathology ; Pain ; Patient Compliance ; Patient Dropouts ; Sulfasalazine/adverse effects ; Sulfasalazine/therapeutic use ; Time Factors
    Chemical Substances Gold Sodium Thiomalate (12244-57-4) ; Sulfasalazine (3XC8GUZ6CB)
    Language English
    Publishing date 1988-06
    Publishing country United States
    Document type Clinical Trial ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 127294-9
    ISSN 1529-0131 ; 0004-3591 ; 2326-5191
    ISSN (online) 1529-0131
    ISSN 0004-3591 ; 2326-5191
    DOI 10.1002/art.1780310602
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 24: Show issues Location:
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    Zs.MO 523: Show issues

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