Valdecoxib

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Kenneth M. Verburg - One of the best experts on this subject based on the ideXlab platform.

  • Analgesic efficacy of Valdecoxib for acute postoperative pain after bunionectomy.
    Journal of the American Podiatric Medical Association, 2006
    Co-Authors: Richard Pollak, Mark T. Brown, Gary A Raymond, Richard M Jay, Howard J. Hillstrom, Kieran T Mahan, Dennis Riff, Ellis L Jacobs, Kenneth M. Verburg
    Abstract:

    Two randomized, double-blind, placebo-controlled studies assessed the analgesic efficacy of Valdecoxib in patients with moderate-to-severe pain after bunionectomy. Study 1 (N = 374) assessed the efficacy of two regimens of Valdecoxib on the day after surgery (Valdecoxib, 40 mg, with a 20-mg redose [n = 127]; Valdecoxib, 40 mg, with a placebo redose [n = 122]; and placebo/placebo [n = 125]), and study 2 (N = 478) examined the efficacy of two different multiple-dose regimens on postoperative days 2 through 5 (Valdecoxib, 20 mg, twice daily [n = 160]; Valdecoxib, 20 mg, once daily [n = 159]; and placebo [n = 159]). Valdecoxib provided significant pain relief and reduced the use of opioid rescue medication. This efficacy was accompanied by improved global scores, decreased pain interference with function, and increased patient satisfaction.

  • complications of the cox 2 inhibitors parecoxib and Valdecoxib after cardiac surgery
    The New England Journal of Medicine, 2005
    Co-Authors: Nancy A Nussmeier, Mark T. Brown, Andrew Whelton, R M Langford, Andreas Hoeft, Joel L Parlow, Steven W Boyce, Kenneth M. Verburg
    Abstract:

    background Valdecoxib and its intravenous prodrug parecoxib are used to treat postoperative pain but may involve risk after coronary-artery bypass grafting (CABG). We conducted a randomized trial to assess the safety of these drugs after CABG. methods In this randomized, double-blind study involving 10 days of treatment and 30 days of follow-up, 1671 patients were randomly assigned to receive intravenous parecoxib for at least 3 days, followed by oral Valdecoxib through day 10; intravenous placebo followed by oral Valdecoxib; or placebo for 10 days. All patients had access to standard opioid medications. The primary end point was the frequency of predefined adverse events, including cardiovascular events, renal failure or dysfunction, gastroduodenal ulceration, and wound-healing complications. results As compared with the group given placebo alone, both the group given parecoxib and Valdecoxib and the group given placebo and Valdecoxib had a higher proportion of patients with at least one confirmed adverse event (7.4 percent in each of these two groups vs. 4.0 percent in the placebo group; risk ratio for each comparison, 1.9; 95 percent confidence interval, 1.1 to 3.2; P=0.02 for each comparison with the placebo group). In particular, cardiovascular events (including myocardial infarction, cardiac arrest, stroke, and pulmonary embolism) were more frequent among the patients given parecoxib and Valdecoxib than among those given placebo (2.0 percent vs. 0.5 percent; risk ratio, 3.7; 95 percent confidence interval, 1.0 to 13.5; P=0.03). conclusions The use of parecoxib and Valdecoxib after CABG was associated with an increased incidence of cardiovascular events, arousing serious concern about the use of these drugs in such circumstances.

  • reduced incidence of upper gastrointestinal ulcer complications with the cox 2 selective inhibitor Valdecoxib
    Alimentary Pharmacology & Therapeutics, 2004
    Co-Authors: Jay L Goldstein, Naurang M Agrawal, Glenn M Eisen, William F Stenson, J D Kent, Kenneth M. Verburg
    Abstract:

    Summary Aim : In a predefined analysis, data were pooled from eight blinded, randomized, controlled trials, and separately from three long-term, open-label trials to determine the rate of upper gastrointestinal ulcer complications with the cyclo-oxygenase-2 selective inhibitor, Valdecoxib, vs. non-selective non-steroidal anti-inflammatory drugs. Methods : In randomized, controlled trials, 7434 osteoarthritis and rheumatoid arthritis patients received placebo (n = 973), Valdecoxib 5–80 mg daily (n =4362), or a non-selective non-steroidal anti-inflammatory drug (naproxen, ibuprofen or diclofenac; n =2099) for 12–26 weeks. In long-term, open-label trials, 2871 patients received Valdecoxib 10–80 mg daily for up to 1 year. All potential events were reviewed by a blinded, independent review committee based on a priori definitions of ulcer complications (perforations, obstructions, bleeds). Results : In randomized, controlled trials, 19 of 955 potential events were adjudicated to be ulcer complications. Valdecoxib was associated with a significantly lower ulcer complication rate than non-selective non-steroidal anti-inflammatory drugs (0.68% vs. 1.96%, all patients; 0.29% vs. 2.08%, non-aspirin users; P < 0.05). In long-term, open-label trials, seven of 310 potential events were adjudicated to be ulcer complications; the annualized incidence for Valdecoxib was 0.39% (seven of 1791 patient-years) for all patients and 0.2% (three of 1472 patient-years) for non-aspirin users. Conclusions : Valdecoxib, including above recommended doses, is associated with a significantly lower rate of upper gastrointestinal ulcer complications than therapeutic doses of non-selective non-steroidal anti-inflammatory drugs.

  • a comparison of the upper gastrointestinal mucosal effects of Valdecoxib naproxen and placebo in healthy elderly subjects
    Alimentary Pharmacology & Therapeutics, 2003
    Co-Authors: Jay L Goldstein, Kenneth M. Verburg, David P Recker, A J Kivitz, R C Palmer, Jeffrey D Kent
    Abstract:

    Summary Background : In long-term outcomes studies, cyclooxygenase COX-2 specific inhibitors spare COX-1 at supratherapeutic doses and therefore demonstrate improved gastrointestinal safety over nonspecific nonsteroidal anti-inflammatory drugs (NSAIDs). However, in clinical practice, anti-inflammatory drugs are often used for short-term treatment of pain. Aim : To compare the short-term upper gastrointestinal mucosal effects of naproxen with the new COX-2 specific inhibitor, Valdecoxib, or placebo, in elderly subjects. Methods : In this multicentre, double-blind, randomized, study, elderly subjects (65–76 years old), with a normal baseline esophagogastroduodenoscopy (EGD), received oral Valdecoxib (a supratherapeutic 40 mg b.d. dosage, n = 62), naproxen (500 mg b.d., n = 62), or placebo (n = 62) for 6.5 days. Upper gastrointestinal mucosal injury was evaluated post-treatment by EGD (day 7). Results : Subjects receiving naproxen (11/60, 18%) had significantly more gastroduodenal ulcers post-treatment than those receiving placebo (2/61, 3%; P < 0.01) or Valdecoxib (0/60, 0%; P < 0.001). A similar significant finding was observed for gastric ulcer rates. All treatments had similar adverse event rates and clinical laboratory findings. Conclusions : Valdecoxib, even at supratherapeutic doses, was associated with an ulcer rate significantly lower than naproxen but similar to placebo in healthy elderly subjects, despite the short duration of therapy (6.5 days). Naproxen and Valdecoxib were as well tolerated as placebo.

  • the cox 2 specific inhibitor Valdecoxib is an effective opioid sparing analgesic in patients undergoing total knee arthroplasty
    Journal of Pain and Symptom Management, 2003
    Co-Authors: Lowell Reynolds, David P Recker, Robert K Hoo, Robert J Brill, Janine North, Kenneth M. Verburg
    Abstract:

    This multicenter, randomized, double-blind, placebo-controlled study evaluated the analgesic efficacy and opioid-sparing effects of Valdecoxib, a potent COX-2 specific inhibitor, in patients undergoing knee replacement. Patients received morphine by patient-controlled analgesia (PCA), and Valdecoxib 40 mg or 80 mg daily, or placebo, for up to two days. Efficacy was assessed by the cumulative amount of morphine administered over 48 hours, pain intensity and patient's evaluation of medication. Morphine consumption over 48 hours by patients receiving Valdecoxib 40 mg or 80 mg daily plus morphine was 83.7% and 75.8% (P < 0.05) of the total amount consumed by patients receiving morphine alone. Patients receiving Valdecoxib 40 mg and 80 mg daily experienced significantly lower maximum pain intensity on Day 2 (P < 0.05), and rated their study medication significantly higher than patients receiving morphine alone. Valdecoxib plus morphine was well tolerated. Thus, Valdecoxib in combination with morphine provides multi-modal analgesia that reduces pain and opioid use and increases patient satisfaction following knee replacement surgery.

David P Recker - One of the best experts on this subject based on the ideXlab platform.

  • a comparison of the upper gastrointestinal mucosal effects of Valdecoxib naproxen and placebo in healthy elderly subjects
    Alimentary Pharmacology & Therapeutics, 2003
    Co-Authors: Jay L Goldstein, Kenneth M. Verburg, David P Recker, A J Kivitz, R C Palmer, Jeffrey D Kent
    Abstract:

    Summary Background : In long-term outcomes studies, cyclooxygenase COX-2 specific inhibitors spare COX-1 at supratherapeutic doses and therefore demonstrate improved gastrointestinal safety over nonspecific nonsteroidal anti-inflammatory drugs (NSAIDs). However, in clinical practice, anti-inflammatory drugs are often used for short-term treatment of pain. Aim : To compare the short-term upper gastrointestinal mucosal effects of naproxen with the new COX-2 specific inhibitor, Valdecoxib, or placebo, in elderly subjects. Methods : In this multicentre, double-blind, randomized, study, elderly subjects (65–76 years old), with a normal baseline esophagogastroduodenoscopy (EGD), received oral Valdecoxib (a supratherapeutic 40 mg b.d. dosage, n = 62), naproxen (500 mg b.d., n = 62), or placebo (n = 62) for 6.5 days. Upper gastrointestinal mucosal injury was evaluated post-treatment by EGD (day 7). Results : Subjects receiving naproxen (11/60, 18%) had significantly more gastroduodenal ulcers post-treatment than those receiving placebo (2/61, 3%; P < 0.01) or Valdecoxib (0/60, 0%; P < 0.001). A similar significant finding was observed for gastric ulcer rates. All treatments had similar adverse event rates and clinical laboratory findings. Conclusions : Valdecoxib, even at supratherapeutic doses, was associated with an ulcer rate significantly lower than naproxen but similar to placebo in healthy elderly subjects, despite the short duration of therapy (6.5 days). Naproxen and Valdecoxib were as well tolerated as placebo.

  • the cox 2 selective inhibitor Valdecoxib does not impair platelet function in the elderly results of a randomized controlled trial
    The Journal of Clinical Pharmacology, 2003
    Co-Authors: Philip T Leese, David P Recker, Jeffrey D Kent
    Abstract:

    The effects of the new cyclooxygenase (COX)-2 selective inhibitor, Valdecoxib (40 mg bid; n = 17), on platelet function were evaluated, along with ibuprofen (800 mg tid; n = 15) and placebo (n = 15), in healthy elderly subjects (65-85 years) in this 7.5-day, randomized, single-center, double-blind study. Platelet aggregation (to sodium arachidonate, collagen, and adenosine diphosphate), bleeding time, and serum thromboxane B2 (TxB2) concentrations were measured up to 8 hours postdose on Days 1 and 8. Valdecoxib had no platelet effects, while ibuprofen significantly decreased platelet aggregation, significantly increased bleeding time (2-4 h postdose on each day), and significantly decreased TxB2 levels at all time points. In conclusion, unlike ibuprofen, Valdecoxib 40 mg bid spares platelet COX-1 function in healthy elderly subjects. Valdecoxib's lack of effect on platelet aggregation and bleeding time suggests that it will have an improved clinical profile over nonselective NSAIDs, particularly in patients for whom bleeding complications are a concern.

  • the cox 2 specific inhibitor Valdecoxib is an effective opioid sparing analgesic in patients undergoing total knee arthroplasty
    Journal of Pain and Symptom Management, 2003
    Co-Authors: Lowell Reynolds, David P Recker, Robert K Hoo, Robert J Brill, Janine North, Kenneth M. Verburg
    Abstract:

    This multicenter, randomized, double-blind, placebo-controlled study evaluated the analgesic efficacy and opioid-sparing effects of Valdecoxib, a potent COX-2 specific inhibitor, in patients undergoing knee replacement. Patients received morphine by patient-controlled analgesia (PCA), and Valdecoxib 40 mg or 80 mg daily, or placebo, for up to two days. Efficacy was assessed by the cumulative amount of morphine administered over 48 hours, pain intensity and patient's evaluation of medication. Morphine consumption over 48 hours by patients receiving Valdecoxib 40 mg or 80 mg daily plus morphine was 83.7% and 75.8% (P < 0.05) of the total amount consumed by patients receiving morphine alone. Patients receiving Valdecoxib 40 mg and 80 mg daily experienced significantly lower maximum pain intensity on Day 2 (P < 0.05), and rated their study medication significantly higher than patients receiving morphine alone. Valdecoxib plus morphine was well tolerated. Thus, Valdecoxib in combination with morphine provides multi-modal analgesia that reduces pain and opioid use and increases patient satisfaction following knee replacement surgery.

  • incidence of gastroduodenal ulcers associated with Valdecoxib compared with that of ibuprofen and diclofenac in patients with osteoarthritis
    European Journal of Gastroenterology & Hepatology, 2002
    Co-Authors: David H Sikes, David P Recker, William W Zhao, Naurang M Agrawal, Jeffrey D Kent, Kenneth M. Verburg
    Abstract:

    OBJECTIVE: To determine whether Valdecoxib, at chronic arthritis doses, has the characteristics of a cyclo-oxygenase 2 (COX-2) specific inhibitor, as measured by a reduced incidence of upper-gastrointestinal ulceration compared with conventional nonsteroidal anti-inflammatory drugs (NSAIDs). METHODS: This double-blind, multicentre, placebo-controlled, parallel-group study compared the incidence of gastroduodenal ulcers associated with Valdecoxib 10 mg daily (q.d.) and 20 mg q.d. with that of ibuprofen 800 mg three times daily (t.i.d.) or diclofenac 75 mg twice daily (b.i.d.) when administered over a 12-week period. The incidence of gastroduodenal ulcers was assessed by upper-gastrointestinal endoscopy, performed at baseline and again at the end of week 12 (or at early study termination). Efficacy assessments were performed at baseline and at weeks 2, 6 and 12 using Patient's and Physician's Global Assessments of Arthritis. RESULTS: A total of 1052 osteoarthritis patients were enrolled into the trial. The incidence of gastroduodenal ulcers over 12 weeks was 5% in patients receiving Valdecoxib 10 mg q.d., 4% in patients receiving Valdecoxib 20 mg q.d., 7% in patients receiving placebo, 16% in patients receiving ibuprofen 800 mg t.i.d. (P <0.05 v. placebo), and 17% in patients receiving diclofenac 75 mg b.i.d. (P <0.05 v. placebo). The incidence of gastroduodenal ulcers at week 12 seen in the ibuprofen 800 mg t.i.d. and diclofenac 75 mg b.i.d. groups was significantly higher than that in the Valdecoxib 10 mg q.d. and Valdecoxib 20 mg q.d. groups (P <0.05). The incidence rates of gastroduodenal ulcers were not significantly different between the Valdecoxib treatment groups or between Valdecoxib- and placebo-treated patients. Efficacy responses to Valdecoxib 10 mg and 20 mg q.d. were significantly greater than placebo and comparable with both ibuprofen 800 mg t.i.d. and diclofenac 75 mg b.i.d. CONCLUSIONS: The results of the study demonstrate that Valdecoxib has an upper-gastrointestinal safety profile typical of a COX-2 specific inhibitor. Overall, the data indicate that administration of Valdecoxib offers similar efficacy for the treatment of osteoarthritis but improved upper-gastrointestinal safety compared with the conventional NSAIDs, ibuprofen and diclofenac, based on the significantly lower incidence of gastroduodenal ulcers detected by endoscopy.

  • A single preoperative oral dose of Valdecoxib, a new cyclooxygenase-2 specific inhibitor, relieves post-oral surgery or bunionectomy pain.
    Anesthesiology, 2002
    Co-Authors: Paul J Desjardins, Kenneth M. Verburg, David P Recker, Vincent S. Shu, Clifford J. Woolf
    Abstract:

    Background: The trend toward day-case surgery, with discharge on oral medication, has highlighted the need for effective and safe analgesics that facilitate a rapid recovery and discharge time. This study evaluated the analgesic efficacy, dose dependency, duration of action, and safety of the cyclooxygenase-2 specific inhibitor, Valdecoxib, administered before oral or orthopedic surgery. Methods: Eligible healthy adult patients were scheduled to undergo either extraction of two impacted third molar teeth (n = 284) or bunionectomy surgery (n = 223) with local anesthesia in two randomized, double-blind, placebo-controlled studies conducted at three centers in the United States. Patients received a single, preoperatively administered oral dose of placebo or 10 (oral surgery only), 20, 40, or 80 mg Valdecoxib. Analgesic efficacy was assessed postoperatively, over a 24-h treatment period, or until the patient required rescue medication. Efficacy measures included time to rescue medication, proportion of patients requiring such rescue, pain intensity, and the Patient's Global Evaluation of Study Medication. Results: In both studies, all doses of Valdecoxib produced analgesia with a duration (time to rescue analgesia) and magnitude (Pain Intensity, Patient's Global Evaluation) significantly greater than placebo. A dose-dependent effect was observed up to 40 mg Valdecoxib, with an 80-mg dose providing no additional analgesic benefit. In both models, all doses of Valdecoxib were well tolerated, with no clinically significant treatment-related gastrointestinal, renal, or platelet-derived adverse events, and no evidence of a dose-related increase in adverse events. Conclusions: Preoperative orally administered Valdecoxib provides well-tolerated and effective analgesia for mild to moderate postoperative pain.

Sharon Pan - One of the best experts on this subject based on the ideXlab platform.

  • cardiovascular safety of the cyclooxygenase 2 selective inhibitors parecoxib and Valdecoxib in the postoperative setting an analysis of integrated data
    Anesthesia & Analgesia, 2009
    Co-Authors: Stephan A Schug, Girish P Joshi, Frederic Camu, Sharon Pan, Raymond Cheung
    Abstract:

    BACKGROUND:Studies of parecoxib, the inactive prodrug of the cyclooxygenase-2 selective inhibitor Valdecoxib, and Valdecoxib for postoperative pain relief in patients undergoing coronary artery bypass graft surgery revealed an increased risk of cardiovascular (CV) adverse events compared with placeb

  • utility and sensitivity of the sore throat pain model results of a randomized controlled trial on the cox 2 selective inhibitor Valdecoxib
    The Journal of Clinical Pharmacology, 2007
    Co-Authors: Bernard P Schachtel, Sharon Pan, Joseph D Kohles, K Sanner, E Schachtel, Mary Bey
    Abstract:

    The sore throat pain model was employed in this randomized, placebo-controlled trial to examine the sensitivity of the model in testing the efficacy of Valdecoxib as an acute analgesic drug. Changes were made to the study design by employing a different diagnostic index for tonsillo-pharyngitis, a different rating scale (derived from Lasagna's pain thermometer), and alternative analyses, individual responder rates. Under double-blind conditions, 197 patients with painful pharyngitis were randomly allocated to Valdecoxib 20 mg bid (n = 65), Valdecoxib 40 mg qd (n = 66), or placebo (n = 66) for 24 hours. The expanded Tonsillo-Pharyngitis Assessment and the Lasagna Pain Scale were validated as sensitive study instruments. Both dosage regimens provided significantly greater pain relief compared with placebo on standard efficacy measures over the 24-hour study (all P < .05). Tests for individual response (eg, percentage of patients with at least moderate relief) confirmed these results, and other response rates identified the high sensitivity of the model itself (eg, only 5% of placebo-treated patients achieved ≥50% of maximum total pain relief over 6 hours). These findings indicate that sore throat is a sensitive model to assess analgesic efficacy.

  • efficacy and tolerability of Valdecoxib in treating the signs and symptoms of severe rheumatoid arthritis a 12 week multicenter randomized double blind placebo controlled study
    Clinical Therapeutics, 2007
    Co-Authors: Allan Gibofsky, Justus J Fiechtner, Manuela F Berger, Jude Rodrigues, Sharon Pan
    Abstract:

    Abstract Objective: This study compared the efficacy and tolerability of the cyclooxygenase-2-selective inhibitor Valdecoxib with the nonselective NSAID naproxen and with placebo in treating severe rheumatoid arthritis (RA). Methods: This 12-week, multicenter, randomized, double-blind, placebo-controlled study compared the efficacy and tolerability of Valdecoxib 10 mg QD (n = 170) or naproxen 500 mg BID (n = 167) with placebo (n = 171) in treating the signs and symptoms of severe RA. Study patients were aged ≥18 years and were diagnosed as having RA for ≥6 months that was stable due to a treatment regimen. Severe RA was defined as a physician's and patient's global assessment of disease activity of fair, poor, or very poor at baseline; ≥6 tender or painful joints; ≥3 swollen joints; ≥45 minutes of morning stiffness; a visual analog scale pain rating of ≥40 mm; or increases since baseline in these measures. Efficacy outcome measures included the percentage of patients achieving an American College of Rheumatology Responder Index 20% (ACR-20) at weeks 1, 6 and 12. Adverse events (AEs) were graded by the investigator as mild, moderate, or severe at weeks 1, 6, and 12. Results: Of the 508 patients randomized, 340 completed the study. The study groups were comparable for age, ethnic origin, weight, height, and concomitant medications, but the naproxen group had significantly more men (29% [49/167]) than the Valdecoxib (18% [31/170]) and placebo (16% [27/171]) groups. The percentage of patients achieving an ACR-20 response was significantly greater in the Valdecoxib and naproxen treatment groups (58.8% [100/170] and 60.8% [101/166], respectively) than in the placebo group (39.6% [67/169]) at week 12 (both, P P = 0.003) and week 6 (64.5% [107/166] vs 46.7% [79/169]; P = 0.001), and in the Valdecoxib group compared with placebo at week 1 (52.9% [90/170]; P = 0.008) but not at week 6. Patients in the Valdecoxib and naproxen groups had significantly improved efficacy compared with placebo in most of the other secondary assessments of inflammation, pain, and function. The incidence of AEs was similar in all groups (Valdecoxib, 54.1% [92/170]; naproxen, 55.4% [92/166]; and placebo, 52.9% [90/170]). Conclusion: Valdecoxib 10 mg QD administered over 12 weeks was significantly better than placebo and similar to naproxen 500 mg BID in treating the signs and symptoms of severe RA in these patients.

  • a multicenter randomized double blind active comparator placebo controlled parallel group comparison of the incidence of endoscopic gastric and duodenal ulcer rates with Valdecoxib or naproxen in healthy subjects aged 65 to 75 years
    Clinical Therapeutics, 2006
    Co-Authors: Jay L Goldstein, Manuela F Berger, James Aisenberg, Frank L Lanza, Howard Schwartz, Sands George Harry, Sharon Pan
    Abstract:

    Abstract Background: Compared with nonselective NSAIDs, cyclooxygenase (COX)-2-selective inhibitors have been associated with a lower incidence of gastroduodenal ulcers (in short-term endoscopic studies) and ulcer complications (in long-term trials). Objective: The aim of this study was to comparethe effects of Valdecoxib 20 mg BID and naproxen 500 mg BID, administered for 6.5 days, on the upper gastrointestinal (UGI) mucosa of healthy older subjects (aged 65–75 years) as assessed by UGI endoscopy. Methods: In this multicenter, double-blind, active-comparator, placebo-controlled, parallel-group study, eligible subjects who were free of NSAID or COX-2-selective inhibitor use for 2 weeks and who had normal UGI mucosa (mucosal grading score of 0, based on endoscopic evaluation of both the stomach and duodenum) were randomized. Serologic testing for Helicobacter pylori antibodies was conducted at baseline. No antiulcer medications were permitted. The primary end point was the incidence of gastroduodenal ulcers (gastric or duodenal mucosal grading score of 7, as indicated by any lesion with unequivocal depth ≥3 mm in diameter) after 6.5 days of blinded treatment with Valdecoxib, naproxen, or placebo. Secondary end points were incidence of gastric ulcers, duodenal ulcers, and gastroduodenal erosions/ulcers, and the incidence of ≥11 gastroduodenal erosions/ulcers. All documented adverse events were self-reported by subjects or were observed by investigators. Results: Sixty-one patients were randomized to receive Valdecoxib, 60 to naproxen, and 60 to placebo. Mean (SD) subject age was 68.8 (3.25) years in the Valdecoxib group, 68.6 (2.76) years in the naproxen group, and 68.6 (3.14) years in the placebo group ( P = NS). In the Valdecoxib and naproxen groups, 47.5% and 58.3% of subjects were female, respectively, compared with 56.7% of the placebo group ( P = NS). Valdecoxib and placebo were associated with significantly lower incidences of gastroduodenal ulcers than naproxen (1.6% [1 gastroduodenal ulcer/61 patients] and 1.7% [1/59], respectively, vs 22.0% [13/59]; P P P H pylori status. The number of adverse events was low in each group. Conclusion: In these healthy older subjects (aged65–75 years), Valdecoxib 20 mg BID was associated with a significantly lower rate of gastroduodenal, gastric, and duodenal ulcers than naproxen 500 mg BID, even after 6.5 days of therapy.

Manuela F Berger - One of the best experts on this subject based on the ideXlab platform.

  • efficacy and tolerability of Valdecoxib in treating the signs and symptoms of severe rheumatoid arthritis a 12 week multicenter randomized double blind placebo controlled study
    Clinical Therapeutics, 2007
    Co-Authors: Allan Gibofsky, Justus J Fiechtner, Manuela F Berger, Jude Rodrigues, Sharon Pan
    Abstract:

    Abstract Objective: This study compared the efficacy and tolerability of the cyclooxygenase-2-selective inhibitor Valdecoxib with the nonselective NSAID naproxen and with placebo in treating severe rheumatoid arthritis (RA). Methods: This 12-week, multicenter, randomized, double-blind, placebo-controlled study compared the efficacy and tolerability of Valdecoxib 10 mg QD (n = 170) or naproxen 500 mg BID (n = 167) with placebo (n = 171) in treating the signs and symptoms of severe RA. Study patients were aged ≥18 years and were diagnosed as having RA for ≥6 months that was stable due to a treatment regimen. Severe RA was defined as a physician's and patient's global assessment of disease activity of fair, poor, or very poor at baseline; ≥6 tender or painful joints; ≥3 swollen joints; ≥45 minutes of morning stiffness; a visual analog scale pain rating of ≥40 mm; or increases since baseline in these measures. Efficacy outcome measures included the percentage of patients achieving an American College of Rheumatology Responder Index 20% (ACR-20) at weeks 1, 6 and 12. Adverse events (AEs) were graded by the investigator as mild, moderate, or severe at weeks 1, 6, and 12. Results: Of the 508 patients randomized, 340 completed the study. The study groups were comparable for age, ethnic origin, weight, height, and concomitant medications, but the naproxen group had significantly more men (29% [49/167]) than the Valdecoxib (18% [31/170]) and placebo (16% [27/171]) groups. The percentage of patients achieving an ACR-20 response was significantly greater in the Valdecoxib and naproxen treatment groups (58.8% [100/170] and 60.8% [101/166], respectively) than in the placebo group (39.6% [67/169]) at week 12 (both, P P = 0.003) and week 6 (64.5% [107/166] vs 46.7% [79/169]; P = 0.001), and in the Valdecoxib group compared with placebo at week 1 (52.9% [90/170]; P = 0.008) but not at week 6. Patients in the Valdecoxib and naproxen groups had significantly improved efficacy compared with placebo in most of the other secondary assessments of inflammation, pain, and function. The incidence of AEs was similar in all groups (Valdecoxib, 54.1% [92/170]; naproxen, 55.4% [92/166]; and placebo, 52.9% [90/170]). Conclusion: Valdecoxib 10 mg QD administered over 12 weeks was significantly better than placebo and similar to naproxen 500 mg BID in treating the signs and symptoms of severe RA in these patients.

  • the cox 2 specific inhibitor Valdecoxib versus tramadol in acute ankle sprain a multicenter randomized controlled trial
    American Journal of Sports Medicine, 2006
    Co-Authors: Evan F Ekman, Gary E Ruoff, Kerry S Kuehl, Lee Ralph, Philip Hormbrey, Justus J Fiechtner, Manuela F Berger
    Abstract:

    BackgroundThe cyclooxygenase-2 specific inhibitor Valdecoxib has not been approved in the United States for treatment of acute pain.HypothesisValdecoxib 20 mg twice daily or once daily (both with a 40-mg loading dose) is not clinically inferior to tramadol for treating the signs and symptoms of acute ankle pain.Study DesignRandomized, controlled clinical trial; Level of evidence, 1.MethodsPatients (N = 829) with acute firstor second-degree ankle sprain received 7 days’ treatment with Valdecoxib 20 mg either twice daily or once daily (both with 40-mg loading dose), tramadol 50 mg 4 times daily, or placebo. The primary end point was Patient's Assessment of Ankle Pain visual analog scale on day 4; a test of noninferiority compared Valdecoxib with tramadol.ResultsOn day 4, both Valdecoxib doses were significantly better versus placebo and were comparable with tramadol in relieving ankle pain. On day 7, Valdecoxib, but not tramadol, significantly reduced pain versus placebo. On days 4 and 7, more patients resu...

  • a multicenter randomized double blind active comparator placebo controlled parallel group comparison of the incidence of endoscopic gastric and duodenal ulcer rates with Valdecoxib or naproxen in healthy subjects aged 65 to 75 years
    Clinical Therapeutics, 2006
    Co-Authors: Jay L Goldstein, Manuela F Berger, James Aisenberg, Frank L Lanza, Howard Schwartz, Sands George Harry, Sharon Pan
    Abstract:

    Abstract Background: Compared with nonselective NSAIDs, cyclooxygenase (COX)-2-selective inhibitors have been associated with a lower incidence of gastroduodenal ulcers (in short-term endoscopic studies) and ulcer complications (in long-term trials). Objective: The aim of this study was to comparethe effects of Valdecoxib 20 mg BID and naproxen 500 mg BID, administered for 6.5 days, on the upper gastrointestinal (UGI) mucosa of healthy older subjects (aged 65–75 years) as assessed by UGI endoscopy. Methods: In this multicenter, double-blind, active-comparator, placebo-controlled, parallel-group study, eligible subjects who were free of NSAID or COX-2-selective inhibitor use for 2 weeks and who had normal UGI mucosa (mucosal grading score of 0, based on endoscopic evaluation of both the stomach and duodenum) were randomized. Serologic testing for Helicobacter pylori antibodies was conducted at baseline. No antiulcer medications were permitted. The primary end point was the incidence of gastroduodenal ulcers (gastric or duodenal mucosal grading score of 7, as indicated by any lesion with unequivocal depth ≥3 mm in diameter) after 6.5 days of blinded treatment with Valdecoxib, naproxen, or placebo. Secondary end points were incidence of gastric ulcers, duodenal ulcers, and gastroduodenal erosions/ulcers, and the incidence of ≥11 gastroduodenal erosions/ulcers. All documented adverse events were self-reported by subjects or were observed by investigators. Results: Sixty-one patients were randomized to receive Valdecoxib, 60 to naproxen, and 60 to placebo. Mean (SD) subject age was 68.8 (3.25) years in the Valdecoxib group, 68.6 (2.76) years in the naproxen group, and 68.6 (3.14) years in the placebo group ( P = NS). In the Valdecoxib and naproxen groups, 47.5% and 58.3% of subjects were female, respectively, compared with 56.7% of the placebo group ( P = NS). Valdecoxib and placebo were associated with significantly lower incidences of gastroduodenal ulcers than naproxen (1.6% [1 gastroduodenal ulcer/61 patients] and 1.7% [1/59], respectively, vs 22.0% [13/59]; P P P H pylori status. The number of adverse events was low in each group. Conclusion: In these healthy older subjects (aged65–75 years), Valdecoxib 20 mg BID was associated with a significantly lower rate of gastroduodenal, gastric, and duodenal ulcers than naproxen 500 mg BID, even after 6.5 days of therapy.

Jay L Goldstein - One of the best experts on this subject based on the ideXlab platform.

  • a multicenter randomized double blind active comparator placebo controlled parallel group comparison of the incidence of endoscopic gastric and duodenal ulcer rates with Valdecoxib or naproxen in healthy subjects aged 65 to 75 years
    Clinical Therapeutics, 2006
    Co-Authors: Jay L Goldstein, Manuela F Berger, James Aisenberg, Frank L Lanza, Howard Schwartz, Sands George Harry, Sharon Pan
    Abstract:

    Abstract Background: Compared with nonselective NSAIDs, cyclooxygenase (COX)-2-selective inhibitors have been associated with a lower incidence of gastroduodenal ulcers (in short-term endoscopic studies) and ulcer complications (in long-term trials). Objective: The aim of this study was to comparethe effects of Valdecoxib 20 mg BID and naproxen 500 mg BID, administered for 6.5 days, on the upper gastrointestinal (UGI) mucosa of healthy older subjects (aged 65–75 years) as assessed by UGI endoscopy. Methods: In this multicenter, double-blind, active-comparator, placebo-controlled, parallel-group study, eligible subjects who were free of NSAID or COX-2-selective inhibitor use for 2 weeks and who had normal UGI mucosa (mucosal grading score of 0, based on endoscopic evaluation of both the stomach and duodenum) were randomized. Serologic testing for Helicobacter pylori antibodies was conducted at baseline. No antiulcer medications were permitted. The primary end point was the incidence of gastroduodenal ulcers (gastric or duodenal mucosal grading score of 7, as indicated by any lesion with unequivocal depth ≥3 mm in diameter) after 6.5 days of blinded treatment with Valdecoxib, naproxen, or placebo. Secondary end points were incidence of gastric ulcers, duodenal ulcers, and gastroduodenal erosions/ulcers, and the incidence of ≥11 gastroduodenal erosions/ulcers. All documented adverse events were self-reported by subjects or were observed by investigators. Results: Sixty-one patients were randomized to receive Valdecoxib, 60 to naproxen, and 60 to placebo. Mean (SD) subject age was 68.8 (3.25) years in the Valdecoxib group, 68.6 (2.76) years in the naproxen group, and 68.6 (3.14) years in the placebo group ( P = NS). In the Valdecoxib and naproxen groups, 47.5% and 58.3% of subjects were female, respectively, compared with 56.7% of the placebo group ( P = NS). Valdecoxib and placebo were associated with significantly lower incidences of gastroduodenal ulcers than naproxen (1.6% [1 gastroduodenal ulcer/61 patients] and 1.7% [1/59], respectively, vs 22.0% [13/59]; P P P H pylori status. The number of adverse events was low in each group. Conclusion: In these healthy older subjects (aged65–75 years), Valdecoxib 20 mg BID was associated with a significantly lower rate of gastroduodenal, gastric, and duodenal ulcers than naproxen 500 mg BID, even after 6.5 days of therapy.

  • Valdecoxib is associated with improved dyspepsia related health compared with nonspecific nsaids in patients with osteoarthritis or rheumatoid arthritis
    The American Journal of Gastroenterology, 2005
    Co-Authors: Linda Rabeneck, Jay L Goldstein, Tracy J Mayne, Dale Rublee
    Abstract:

    Valdecoxib Is Associated with Improved Dyspepsia-Related Health Compared with Nonspecific NSAIDs in Patients with Osteoarthritis or Rheumatoid Arthritis

  • meta analysis upper gastrointestinal tolerability of Valdecoxib a cyclooxygenase 2 specific inhibitor compared with nonspecific nonsteroidal anti inflammatory drugs among patients with osteoarthritis and rheumatoid arthritis
    Alimentary Pharmacology & Therapeutics, 2005
    Co-Authors: Glenn M Eisen, D B Hanna, Jay L Goldstein, Dale Rublee
    Abstract:

    Summary Aim : To compare the incidence of abdominal pain, dyspepsia and/or nausea associated with Valdecoxib, nonspecific nonsteroidal anti-inflammatory drugs and placebo in patients with rheumatoid arthritis and osteoarthritis. Methods : Data from five randomized, double-blind 12-week trials were pooled. Independent risk factors for abdominal pain, dyspepsia and/or nausea were also determined. Results : The final analysis consisted of 4394 patients. Nonspecific nonsteroidal anti-inflammatory drug users (n = 1185) received naproxen 1000 mg/day (n = 766), ibuprofen 2400 mg/day (n = 207) or diclofenac sodium 150 mg/day (n = 212). Valdecoxib users received 10 mg/day (n = 955), 20 mg/day (n = 851) or 40 mg/day (n = 430). A total of 973 patients received placebo. The nonspecific nonsteroidal anti-inflammatory drug group was most likely to report abdominal pain or dyspepsia, while the placebo group reported the highest incidence of nausea. The most important risk factors for abdominal pain, dyspepsia and/or nausea were nonspecific nonsteroidal anti-inflammatory drug use, gastrointestinal history of nonspecific nonsteroidal anti-inflammatory drug-related intolerance or gastroduodenal ulcers, osteoarthritis diagnosis, female gender and age <65 years. Conclusion : This pooled analysis demonstrates a clear decrease in dyspepsia and an improvement in upper gastrointestinal tolerability for patients with osteoarthritis and rheumatoid arthritis taking Valdecoxib, even at supratherapeutic doses, compared with those taking nonspecific nonsteroidal anti-inflammatory drugs over 12 weeks.

  • reduced incidence of upper gastrointestinal ulcer complications with the cox 2 selective inhibitor Valdecoxib
    Alimentary Pharmacology & Therapeutics, 2004
    Co-Authors: Jay L Goldstein, Naurang M Agrawal, Glenn M Eisen, William F Stenson, J D Kent, Kenneth M. Verburg
    Abstract:

    Summary Aim : In a predefined analysis, data were pooled from eight blinded, randomized, controlled trials, and separately from three long-term, open-label trials to determine the rate of upper gastrointestinal ulcer complications with the cyclo-oxygenase-2 selective inhibitor, Valdecoxib, vs. non-selective non-steroidal anti-inflammatory drugs. Methods : In randomized, controlled trials, 7434 osteoarthritis and rheumatoid arthritis patients received placebo (n = 973), Valdecoxib 5–80 mg daily (n =4362), or a non-selective non-steroidal anti-inflammatory drug (naproxen, ibuprofen or diclofenac; n =2099) for 12–26 weeks. In long-term, open-label trials, 2871 patients received Valdecoxib 10–80 mg daily for up to 1 year. All potential events were reviewed by a blinded, independent review committee based on a priori definitions of ulcer complications (perforations, obstructions, bleeds). Results : In randomized, controlled trials, 19 of 955 potential events were adjudicated to be ulcer complications. Valdecoxib was associated with a significantly lower ulcer complication rate than non-selective non-steroidal anti-inflammatory drugs (0.68% vs. 1.96%, all patients; 0.29% vs. 2.08%, non-aspirin users; P < 0.05). In long-term, open-label trials, seven of 310 potential events were adjudicated to be ulcer complications; the annualized incidence for Valdecoxib was 0.39% (seven of 1791 patient-years) for all patients and 0.2% (three of 1472 patient-years) for non-aspirin users. Conclusions : Valdecoxib, including above recommended doses, is associated with a significantly lower rate of upper gastrointestinal ulcer complications than therapeutic doses of non-selective non-steroidal anti-inflammatory drugs.

  • a comparison of the upper gastrointestinal mucosal effects of Valdecoxib naproxen and placebo in healthy elderly subjects
    Alimentary Pharmacology & Therapeutics, 2003
    Co-Authors: Jay L Goldstein, Kenneth M. Verburg, David P Recker, A J Kivitz, R C Palmer, Jeffrey D Kent
    Abstract:

    Summary Background : In long-term outcomes studies, cyclooxygenase COX-2 specific inhibitors spare COX-1 at supratherapeutic doses and therefore demonstrate improved gastrointestinal safety over nonspecific nonsteroidal anti-inflammatory drugs (NSAIDs). However, in clinical practice, anti-inflammatory drugs are often used for short-term treatment of pain. Aim : To compare the short-term upper gastrointestinal mucosal effects of naproxen with the new COX-2 specific inhibitor, Valdecoxib, or placebo, in elderly subjects. Methods : In this multicentre, double-blind, randomized, study, elderly subjects (65–76 years old), with a normal baseline esophagogastroduodenoscopy (EGD), received oral Valdecoxib (a supratherapeutic 40 mg b.d. dosage, n = 62), naproxen (500 mg b.d., n = 62), or placebo (n = 62) for 6.5 days. Upper gastrointestinal mucosal injury was evaluated post-treatment by EGD (day 7). Results : Subjects receiving naproxen (11/60, 18%) had significantly more gastroduodenal ulcers post-treatment than those receiving placebo (2/61, 3%; P < 0.01) or Valdecoxib (0/60, 0%; P < 0.001). A similar significant finding was observed for gastric ulcer rates. All treatments had similar adverse event rates and clinical laboratory findings. Conclusions : Valdecoxib, even at supratherapeutic doses, was associated with an ulcer rate significantly lower than naproxen but similar to placebo in healthy elderly subjects, despite the short duration of therapy (6.5 days). Naproxen and Valdecoxib were as well tolerated as placebo.

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