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Stuart H Ralston - One of the best experts on this subject based on the ideXlab platform.

  • randomized trial of switching from prescribed non selective non steroidal anti inflammatory drugs to prescribed Celecoxib the standard care vs Celecoxib outcome trial scot
    European Heart Journal, 2016
    Co-Authors: Thomas M Macdonald, C J Hawkey, Ian Ford, John J V Mcmurray, James M Scheiman, Jesper Hallas, Evelyn Findlay, Diederick E Grobbee, F Richard D Hobbs, Stuart H Ralston
    Abstract:

    Background: Selective cyclooxygenase-2 inhibitors and conventional non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) have been associated with adverse cardiovascular (CV) effects. We compared the CV safety of switching to Celecoxib vs. continuing nsNSAID therapy in a European setting. Method: Patients aged 60 years and over with osteoarthritis or rheumatoid arthritis, free from established CV disease and taking chronic prescribed nsNSAIDs, were randomized to switch to Celecoxib or to continue their previous nsNSAID. The primary endpoint was hospitalization for non-fatal myocardial infarction or other biomarker positive acute coronary syndrome, non-fatal stroke or CV death analysed using a Cox model with a pre-specified non-inferiority limit of 1.4 for the hazard ratio (HR). Results: In total, 7297 participants were randomized. During a median 3-year follow-up, fewer subjects than expected developed an on-treatment (OT) primary CV event and the rate was similar for Celecoxib, 0.95 per 100 patient-years, and nsNSAIDs, 0.86 per 100 patient-years (HR = 1.12, 95% confidence interval, 0.81-1.55; P = 0.50). Comparable intention-to-treat (ITT) rates were 1.14 per 100 patient-years with Celecoxib and 1.10 per 100 patient-years with nsNSAIDs (HR = 1.04; 95% confidence interval, 0.81-1.33; P = 0.75). Pre-specified non-inferiority was achieved in the ITT analysis. The upper bound of the 95% confidence limit for the absolute increase in OT risk associated with Celecoxib treatment was two primary events per 1000 patient-years exposure. There were only 15 adjudicated secondary upper gastrointestinal complication endpoints (0.078/100 patient-years on Celecoxib vs. 0.053 on nsNSAIDs OT, 0.078 vs. 0.053 ITT). More gastrointestinal serious adverse reactions and haematological adverse reactions were reported on nsNSAIDs than Celecoxib, but more patients withdrew from Celecoxib than nsNSAIDs (50.9% patients vs. 30.2%; P < 0.0001). Interpretation: In subjects 60 years and over, free from CV disease and taking prescribed chronic nsNSAIDs, CV events were infrequent and similar on Celecoxib and nsNSAIDs. There was no advantage of a strategy of switching prescribed nsNSAIDs to prescribed Celecoxib. This study excluded an increased risk of the primary endpoint of more than two events per 1000 patient-years associated with switching to prescribed Celecoxib. Clinical Trial Registration: https://clinicaltrials.gov/show/NCT00447759; Unique identifier: NCT00447759.

  • randomized trial of switching from prescribed non selective non steroidal anti inflammatory drugs to prescribed Celecoxib the standard care vs Celecoxib outcome trial scot
    European Heart Journal, 2016
    Co-Authors: Thomas M Macdonald, C J Hawkey, Ian Ford, John J V Mcmurray, James M Scheiman, Jesper Hallas, Evelyn Findlay, Diederick E Grobbee, F Richard D Hobbs, Stuart H Ralston
    Abstract:

    Background Selective cyclooxygenase-2 inhibitors and conventional non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) have been associated with adverse cardiovascular (CV) effects. We compared the CV safety of switching to Celecoxib vs. continuing nsNSAID therapy in a European setting. Method Patients aged 60 years and over with osteoarthritis or rheumatoid arthritis, free from established CV disease and taking chronic prescribed nsNSAIDs, were randomized to switch to Celecoxib or to continue their previous nsNSAID. The primary endpoint was hospitalization for non-fatal myocardial infarction or other biomarker positive acute coronary syndrome, non-fatal stroke or CV death analysed using a Cox model with a pre-specified non-inferiority limit of 1.4 for the hazard ratio (HR). Results In total, 7297 participants were randomized. During a median 3-year follow-up, fewer subjects than expected developed an on-treatment (OT) primary CV event and the rate was similar for Celecoxib, 0.95 per 100 patient-years, and nsNSAIDs, 0.86 per 100 patient-years (HR = 1.12, 95% confidence interval, 0.81–1.55; P = 0.50). Comparable intention-to-treat (ITT) rates were 1.14 per 100 patient-years with Celecoxib and 1.10 per 100 patient-years with nsNSAIDs (HR = 1.04; 95% confidence interval, 0.81–1.33; P  = 0.75). Pre-specified non-inferiority was achieved in the ITT analysis. The upper bound of the 95% confidence limit for the absolute increase in OT risk associated with Celecoxib treatment was two primary events per 1000 patient-years exposure. There were only 15 adjudicated secondary upper gastrointestinal complication endpoints (0.078/100 patient-years on Celecoxib vs. 0.053 on nsNSAIDs OT, 0.078 vs. 0.053 ITT). More gastrointestinal serious adverse reactions and haematological adverse reactions were reported on nsNSAIDs than Celecoxib, but more patients withdrew from Celecoxib than nsNSAIDs (50.9% patients vs. 30.2%; P  < 0.0001). Interpretation In subjects 60 years and over, free from CV disease and taking prescribed chronic nsNSAIDs, CV events were infrequent and similar on Celecoxib and nsNSAIDs. There was no advantage of a strategy of switching prescribed nsNSAIDs to prescribed Celecoxib. This study excluded an increased risk of the primary endpoint of more than two events per 1000 patient-years associated with switching to prescribed Celecoxib.

Thomas M Macdonald - One of the best experts on this subject based on the ideXlab platform.

  • randomized trial of switching from prescribed non selective non steroidal anti inflammatory drugs to prescribed Celecoxib the standard care vs Celecoxib outcome trial scot
    European Heart Journal, 2016
    Co-Authors: Thomas M Macdonald, C J Hawkey, Ian Ford, John J V Mcmurray, James M Scheiman, Jesper Hallas, Evelyn Findlay, Diederick E Grobbee, F Richard D Hobbs, Stuart H Ralston
    Abstract:

    Background: Selective cyclooxygenase-2 inhibitors and conventional non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) have been associated with adverse cardiovascular (CV) effects. We compared the CV safety of switching to Celecoxib vs. continuing nsNSAID therapy in a European setting. Method: Patients aged 60 years and over with osteoarthritis or rheumatoid arthritis, free from established CV disease and taking chronic prescribed nsNSAIDs, were randomized to switch to Celecoxib or to continue their previous nsNSAID. The primary endpoint was hospitalization for non-fatal myocardial infarction or other biomarker positive acute coronary syndrome, non-fatal stroke or CV death analysed using a Cox model with a pre-specified non-inferiority limit of 1.4 for the hazard ratio (HR). Results: In total, 7297 participants were randomized. During a median 3-year follow-up, fewer subjects than expected developed an on-treatment (OT) primary CV event and the rate was similar for Celecoxib, 0.95 per 100 patient-years, and nsNSAIDs, 0.86 per 100 patient-years (HR = 1.12, 95% confidence interval, 0.81-1.55; P = 0.50). Comparable intention-to-treat (ITT) rates were 1.14 per 100 patient-years with Celecoxib and 1.10 per 100 patient-years with nsNSAIDs (HR = 1.04; 95% confidence interval, 0.81-1.33; P = 0.75). Pre-specified non-inferiority was achieved in the ITT analysis. The upper bound of the 95% confidence limit for the absolute increase in OT risk associated with Celecoxib treatment was two primary events per 1000 patient-years exposure. There were only 15 adjudicated secondary upper gastrointestinal complication endpoints (0.078/100 patient-years on Celecoxib vs. 0.053 on nsNSAIDs OT, 0.078 vs. 0.053 ITT). More gastrointestinal serious adverse reactions and haematological adverse reactions were reported on nsNSAIDs than Celecoxib, but more patients withdrew from Celecoxib than nsNSAIDs (50.9% patients vs. 30.2%; P < 0.0001). Interpretation: In subjects 60 years and over, free from CV disease and taking prescribed chronic nsNSAIDs, CV events were infrequent and similar on Celecoxib and nsNSAIDs. There was no advantage of a strategy of switching prescribed nsNSAIDs to prescribed Celecoxib. This study excluded an increased risk of the primary endpoint of more than two events per 1000 patient-years associated with switching to prescribed Celecoxib. Clinical Trial Registration: https://clinicaltrials.gov/show/NCT00447759; Unique identifier: NCT00447759.

  • randomized trial of switching from prescribed non selective non steroidal anti inflammatory drugs to prescribed Celecoxib the standard care vs Celecoxib outcome trial scot
    European Heart Journal, 2016
    Co-Authors: Thomas M Macdonald, C J Hawkey, Ian Ford, John J V Mcmurray, James M Scheiman, Jesper Hallas, Evelyn Findlay, Diederick E Grobbee, F Richard D Hobbs, Stuart H Ralston
    Abstract:

    Background Selective cyclooxygenase-2 inhibitors and conventional non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) have been associated with adverse cardiovascular (CV) effects. We compared the CV safety of switching to Celecoxib vs. continuing nsNSAID therapy in a European setting. Method Patients aged 60 years and over with osteoarthritis or rheumatoid arthritis, free from established CV disease and taking chronic prescribed nsNSAIDs, were randomized to switch to Celecoxib or to continue their previous nsNSAID. The primary endpoint was hospitalization for non-fatal myocardial infarction or other biomarker positive acute coronary syndrome, non-fatal stroke or CV death analysed using a Cox model with a pre-specified non-inferiority limit of 1.4 for the hazard ratio (HR). Results In total, 7297 participants were randomized. During a median 3-year follow-up, fewer subjects than expected developed an on-treatment (OT) primary CV event and the rate was similar for Celecoxib, 0.95 per 100 patient-years, and nsNSAIDs, 0.86 per 100 patient-years (HR = 1.12, 95% confidence interval, 0.81–1.55; P = 0.50). Comparable intention-to-treat (ITT) rates were 1.14 per 100 patient-years with Celecoxib and 1.10 per 100 patient-years with nsNSAIDs (HR = 1.04; 95% confidence interval, 0.81–1.33; P  = 0.75). Pre-specified non-inferiority was achieved in the ITT analysis. The upper bound of the 95% confidence limit for the absolute increase in OT risk associated with Celecoxib treatment was two primary events per 1000 patient-years exposure. There were only 15 adjudicated secondary upper gastrointestinal complication endpoints (0.078/100 patient-years on Celecoxib vs. 0.053 on nsNSAIDs OT, 0.078 vs. 0.053 ITT). More gastrointestinal serious adverse reactions and haematological adverse reactions were reported on nsNSAIDs than Celecoxib, but more patients withdrew from Celecoxib than nsNSAIDs (50.9% patients vs. 30.2%; P  < 0.0001). Interpretation In subjects 60 years and over, free from CV disease and taking prescribed chronic nsNSAIDs, CV events were infrequent and similar on Celecoxib and nsNSAIDs. There was no advantage of a strategy of switching prescribed nsNSAIDs to prescribed Celecoxib. This study excluded an increased risk of the primary endpoint of more than two events per 1000 patient-years associated with switching to prescribed Celecoxib.

Alireza Homayouni - One of the best experts on this subject based on the ideXlab platform.

  • anomalous dissolution behavior of Celecoxib in pvp isomalt solid dispersions prepared using spray drier
    Materials Science and Engineering: C, 2017
    Co-Authors: Roya Ghanavati, Azade Taheri, Alireza Homayouni
    Abstract:

    Celecoxib is a COX II inhibitor NSAID which is used for joint pains, rheumatoid arthritis and osteoarthritis, however due to its poor water solubility it shows very low oral bioavailability. Using solid dispersion formulations is one of the most promising strategies to increase solubility of poorly water soluble drugs. The purpose of this study is dissolution enhancement of Celecoxib by preparation of solid dispersions via spray drying technique using PVP and Isomalt as hydrophilic carriers. Different ratios of Celecoxib, Isomalt and PVP K30 (7:3:0, 5:5:0, 3:7:0, 1:9:0 and 3:5:2, 3:2:5) were prepared from 2% hydroalcoholic solutions (70:30 ethanol:water) using spray drier. Particle size analyzing, saturation solubility, SEM, DSC, FT-IR, XRPD and dissolution studies in 0.25% SDS and 0.04M Na3HPO4 mediums were performed. Stability of samples was also studied after a week and a month storage at 75% humidity condition. The results showed that the saturation solubility of Celecoxib in solid dispersion samples is 20-30 folds higher than raw Celecoxib. Similar results have been shown for dissolution studies. Solid state analyses showed glass solution state of Celecoxib in PVP/Isomalt matrixes. FTIR studies exhibited the formation of hydrogen bonding between Celecoxib and PVP in these samples. Spray dried Celecoxib (amorphous Celecoxib) without usage of carrier showed lower dissolution rate compare to its crystalline state (in 0.25% SDS dissolution medium) whilst these results is vise versa in Na3PO4 dissolution medium. Interestingly almost all samples exhibited higher dissolution rate (in 0.25% SDS) after storage in 75% humidity. XRPD analysis demonstrated the crystallization of amorphous Celecoxib after 1month storage. In general using PVP K30 and Isomalt as hydrophilic carriers could increase solubility and dissolution rate of Celecoxib in solid dispersion formulations.

  • Anomalous dissolution behavior of Celecoxib in PVP/Isomalt solid dispersions prepared using spray drier
    Materials Science and Engineering: C, 2016
    Co-Authors: Roya Ghanavati, Azade Taheri, Alireza Homayouni
    Abstract:

    Celecoxib is a COX II inhibitor NSAID which is used for joint pains, rheumatoid arthritis and osteoarthritis, however due to its poor water solubility it shows very low oral bioavailability. Using solid dispersion formulations is one of the most promising strategies to increase solubility of poorly water soluble drugs. The purpose of this study is dissolution enhancement of Celecoxib by preparation of solid dispersions via spray drying technique using PVP and Isomalt as hydrophilic carriers. Different ratios of Celecoxib, Isomalt and PVP K30 (7:3:0, 5:5:0, 3:7:0, 1:9:0 and 3:5:2, 3:2:5) were prepared from 2% hydroalcoholic solutions (70:30 ethanol:water) using spray drier. Particle size analyzing, saturation solubility, SEM, DSC, FT-IR, XRPD and dissolution studies in 0.25% SDS and 0.04M Na3HPO4 mediums were performed. Stability of samples was also studied after a week and a month storage at 75% humidity condition. The results showed that the saturation solubility of Celecoxib in solid dispersion samples is 20-30 folds higher than raw Celecoxib. Similar results have been shown for dissolution studies. Solid state analyses showed glass solution state of Celecoxib in PVP/Isomalt matrixes. FTIR studies exhibited the formation of hydrogen bonding between Celecoxib and PVP in these samples. Spray dried Celecoxib (amorphous Celecoxib) without usage of carrier showed lower dissolution rate compare to its crystalline state (in 0.25% SDS dissolution medium) whilst these results is vise versa in Na3PO4 dissolution medium. Interestingly almost all samples exhibited higher dissolution rate (in 0.25% SDS) after storage in 75% humidity. XRPD analysis demonstrated the crystallization of amorphous Celecoxib after 1month storage. In general using PVP K30 and Isomalt as hydrophilic carriers could increase solubility and dissolution rate of Celecoxib in solid dispersion formulations.

G. S. Geis - One of the best experts on this subject based on the ideXlab platform.

  • Celecoxib versus diclofenac in the management of osteoarthritis of the knee
    Scandinavian journal of rheumatology, 2001
    Co-Authors: F. Mckenna, David G. Borenstein, H. Wendt, C. Wallemark, J. B. Lefkowith, G. S. Geis
    Abstract:

    Objective: A clinical trial was conducted in 600 patients with OA of the knee to test the hypothesis that the specific COX-2 inhibitor, Celecoxib, has equivalent efficacy and a superior tolerability/safety profile when compared to diclofenac, the current worldwide standard of care. Methods: Patients were administered Celecoxib 100 mg BID, diclofenac 50 mg TID or placebo for 6 weeks in a multicentre, double-blind, placebo-controlled trial. Results: Primary efficacy measures (index joint pain by VAS, WOMAC index) indicated statistically significant improvement versus placebo for both Celecoxib and diclofenac and no statistically significant differences between Celecoxib and diclofenac. American Pain Society (APS) measures to assess the rapidity of onset of action showed statistically significant and comparable pain relief versus placebo within 24 h for both Celecoxib and diclofenac. More diclofenac patients reported GI side effects than patients treated with either placebo or Celecoxib. Diclofenac-treated p...

C. Wallemark - One of the best experts on this subject based on the ideXlab platform.

  • Celecoxib versus naproxen and diclofenac in osteoarthritis patients success i study
    The American Journal of Medicine, 2006
    Co-Authors: Gurkirpal Singh, C. Wallemark, John G Fort, Jay L Goldstein, Roger A Levy, Patrick S Hanrahan, Alfonso E Bello, Lilia Andradeortega, Naurang M Agrawal, Glenn M Eisen
    Abstract:

    PURPOSE: To evaluate the efficacy and upper gastrointestinal (UGI) safety of Celecoxib, compared with nonspecific nonsteroidal anti-inflammatory drugs (NSAIDs), among patients with osteoarthritis. METHODS: A total of 13274 osteoarthritis patients from 39 countries were randomly assigned to double-blind treatment with either Celecoxib 100 mg twice daily (BID), Celecoxib 200 mg BID, or nonselective NSAID therapy (diclofenac 50 mg BID or naproxen 500 mg BID) for 12 weeks. Standard validated measures were used to assess osteoarthritis efficacy. Serious UGI events were evaluated by 2 blinded, independent, gastrointestinal events committees. RESULTS: Results from all primary efficacy assessments showed that both dosages of Celecoxib were as effective as NSAIDs in treating osteoarthritis. Significantly more ulcer complications occurred within the nonselective NSAID group (0.8/100 patient-years) compared with the Celecoxib group (0.1/100 patient-years) (odds ratio 7.02; 95% confidence interval [CI], 1.46 to 33.80; P .008). There were fewer ulcer complications in the Celecoxib group compared with the NSAID group, both in patients taking concomitant aspirin and those not taking aspirin, but the difference reached statistical significance only in the latter comparison. The number of cardiovascular thromboembolic events was low and not statistically different between the groups (eg, myocardial infarction rates: Celecoxib 10 events [0.55/100 patient-years] vs NSAIDs 1 event [0.11/100 patientyears], (P .11), but the study was not powered to detect such differences. CONCLUSIONS: In the treatment of osteoarthritis, Celecoxib is as effective as the nonspecific NSAIDs naproxen and diclofenac, but has significantly fewer serious upper gastrointestinal events. © 2006 Elsevier Inc. All rights reserved.

  • Celecoxib versus diclofenac in the management of osteoarthritis of the knee
    Scandinavian journal of rheumatology, 2001
    Co-Authors: F. Mckenna, David G. Borenstein, H. Wendt, C. Wallemark, J. B. Lefkowith, G. S. Geis
    Abstract:

    Objective: A clinical trial was conducted in 600 patients with OA of the knee to test the hypothesis that the specific COX-2 inhibitor, Celecoxib, has equivalent efficacy and a superior tolerability/safety profile when compared to diclofenac, the current worldwide standard of care. Methods: Patients were administered Celecoxib 100 mg BID, diclofenac 50 mg TID or placebo for 6 weeks in a multicentre, double-blind, placebo-controlled trial. Results: Primary efficacy measures (index joint pain by VAS, WOMAC index) indicated statistically significant improvement versus placebo for both Celecoxib and diclofenac and no statistically significant differences between Celecoxib and diclofenac. American Pain Society (APS) measures to assess the rapidity of onset of action showed statistically significant and comparable pain relief versus placebo within 24 h for both Celecoxib and diclofenac. More diclofenac patients reported GI side effects than patients treated with either placebo or Celecoxib. Diclofenac-treated p...