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Harry A Guess - One of the best experts on this subject based on the ideXlab platform.
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lower risk of thromboembolic cardiovascular events with Naproxen among patients with rheumatoid arthritis
JAMA Internal Medicine, 2002Co-Authors: Douglas J Watson, Thomas Rhodes, Harry A GuessAbstract:Background Naproxen strongly inhibits platelet aggregation. Objective To examine the risk of acute thromboembolic cardiovascular events (TCEs) (myocardial infarction, sudden death, and stroke) with current Naproxen use among patients with rheumatoid arthritis. Methods We studied patients aged 40 to 79 years with rheumatoid arthritis in the British General Practice Research Database, excluding those with a prior TCE and potentially confounding conditions. We matched up to 4 controls by sex, age, and site of medical practice to cases with first incident TCEs. The case diagnosis date was designated as the index date for each case and his or her controls. We categorized Naproxen according to the most recent prescription prior to the index date as being current (≤30 days), past (>30 days but Results We identified 809 cases. Current Naproxen use was more common among controls (5.7%) than cases (3.2%). Adjusting for calendar year of treatment start, systemic corticosteroid use, diabetes, and comorbidity, we found that the odds ratio (95% confidence interval) for current Naproxen use was 0.61 (0.39-0.94) while that for past use was 0.87 (0.65-1.16). Secondary and sensitivity analyses supported these results. Conclusions In this case-control study, patients with rheumatoid arthritis and a current prescription for Naproxen had a reduced risk of acute major TCEs relative to those with no Naproxen prescription in the past year. These results are consistent with the ability of Naproxen to inhibit platelet aggregation.
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lower risk of thromboembolic cardiovascular events with Naproxen among patients with rheumatoid arthritis
American College of Rheumatology Annual Scientific Meeting, 2002Co-Authors: Douglas J Watson, Thomas Rhodes, Harry A GuessAbstract:Background: Naproxen strongly inhibits platelet aggregation. Objective: To examine the risk of acute thromboembolic cardiovascular events (TCEs) (myocardial infarction, sudden death, and stroke) with current Naproxen use among patients with rheumatoid arthritis. Methods: We studied patients aged 40 to 79 years with rheumatoid arthritis in the British General Practice Research Database, excluding those with a prior TCE and potentially confounding conditions. We matched up to 4 controls by sex, age, and site of medical practice to cases with first incident TCEs. The case diagnosis date was designated as the index date for each case and his or her controls. We categorized Naproxen according to the most recent prescription prior to the index date as being current (≤30 days), past (>30 days but <365 days), or none (≥365 days before index date). Using founders, conditional logistic regression, we conducted a matched case-control analysis with adjustment for potential con Results: We identified 809 cases. Current Naproxen use was more common among controls (5.7%) than cases (3.2%). Adjusting for calendar year of treatment start, systemic corticosteroid use, diabetes, and comorbidity, we found that the odds ratio (95% confidence interval) for current Naproxen use was 0.61 (0.39-0.94) while that for past use was 0.87 (0.65-1.16). Secondary and sensitivity analyses supported these results. Conclusions: In this case-control study, patients with rheumatoid arthritis and a current prescription for Naproxen had a reduced risk of acute major TCEs relative to those with no Naproxen prescription in the past year. These results are consistent with the ability of Naproxen to inhibit platelet aggregation.
Douglas J Watson - One of the best experts on this subject based on the ideXlab platform.
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lower risk of thromboembolic cardiovascular events with Naproxen among patients with rheumatoid arthritis
JAMA Internal Medicine, 2002Co-Authors: Douglas J Watson, Thomas Rhodes, Harry A GuessAbstract:Background Naproxen strongly inhibits platelet aggregation. Objective To examine the risk of acute thromboembolic cardiovascular events (TCEs) (myocardial infarction, sudden death, and stroke) with current Naproxen use among patients with rheumatoid arthritis. Methods We studied patients aged 40 to 79 years with rheumatoid arthritis in the British General Practice Research Database, excluding those with a prior TCE and potentially confounding conditions. We matched up to 4 controls by sex, age, and site of medical practice to cases with first incident TCEs. The case diagnosis date was designated as the index date for each case and his or her controls. We categorized Naproxen according to the most recent prescription prior to the index date as being current (≤30 days), past (>30 days but Results We identified 809 cases. Current Naproxen use was more common among controls (5.7%) than cases (3.2%). Adjusting for calendar year of treatment start, systemic corticosteroid use, diabetes, and comorbidity, we found that the odds ratio (95% confidence interval) for current Naproxen use was 0.61 (0.39-0.94) while that for past use was 0.87 (0.65-1.16). Secondary and sensitivity analyses supported these results. Conclusions In this case-control study, patients with rheumatoid arthritis and a current prescription for Naproxen had a reduced risk of acute major TCEs relative to those with no Naproxen prescription in the past year. These results are consistent with the ability of Naproxen to inhibit platelet aggregation.
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lower risk of thromboembolic cardiovascular events with Naproxen among patients with rheumatoid arthritis
American College of Rheumatology Annual Scientific Meeting, 2002Co-Authors: Douglas J Watson, Thomas Rhodes, Harry A GuessAbstract:Background: Naproxen strongly inhibits platelet aggregation. Objective: To examine the risk of acute thromboembolic cardiovascular events (TCEs) (myocardial infarction, sudden death, and stroke) with current Naproxen use among patients with rheumatoid arthritis. Methods: We studied patients aged 40 to 79 years with rheumatoid arthritis in the British General Practice Research Database, excluding those with a prior TCE and potentially confounding conditions. We matched up to 4 controls by sex, age, and site of medical practice to cases with first incident TCEs. The case diagnosis date was designated as the index date for each case and his or her controls. We categorized Naproxen according to the most recent prescription prior to the index date as being current (≤30 days), past (>30 days but <365 days), or none (≥365 days before index date). Using founders, conditional logistic regression, we conducted a matched case-control analysis with adjustment for potential con Results: We identified 809 cases. Current Naproxen use was more common among controls (5.7%) than cases (3.2%). Adjusting for calendar year of treatment start, systemic corticosteroid use, diabetes, and comorbidity, we found that the odds ratio (95% confidence interval) for current Naproxen use was 0.61 (0.39-0.94) while that for past use was 0.87 (0.65-1.16). Secondary and sensitivity analyses supported these results. Conclusions: In this case-control study, patients with rheumatoid arthritis and a current prescription for Naproxen had a reduced risk of acute major TCEs relative to those with no Naproxen prescription in the past year. These results are consistent with the ability of Naproxen to inhibit platelet aggregation.
James W Alexander - One of the best experts on this subject based on the ideXlab platform.
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sumatriptan Naproxen for acute treatment of migraine a randomized trial
JAMA, 2007Co-Authors: Jan Lewis Brandes, Stuart R Stark, Susan E Spruill, James W Alexander, David Kudrow, Phillip C Ocarroll, James U Adelman, Francis J Odonnell, Pamela S Barrett, Shelly E LenerAbstract:ContextMultiple pathogenic mechanisms may be involved in generating the migraine symptom complex, and multimechanism-targeted therapy may confer advantages over monotherapy.ObjectiveTo evaluate the efficacy and safety of a fixed-dose tablet containing sumatriptan succinate and Naproxen sodium relative to efficacy and safety of each monotherapy and placebo for the acute treatment of migraine.Design, Setting, and ParticipantsTwo replicate, randomized, double-blind, single-attack, parallel-group studies conducted among 1461 (study 1) and 1495 (study 2) patients at 118 US clinical centers who were diagnosed as having migraine and received study treatment for a moderate or severe migraine attack.InterventionsPatients were randomized in a 1:1:1:1 ratio to receive a single tablet containing sumatriptan, 85 mg, and Naproxen sodium, 500 mg; sumatriptan, 85 mg (monotherapy); Naproxen sodium, 500 mg (monotherapy); or placebo, to be used after onset of a migraine with moderate to severe pain.Main Outcome MeasuresPrimary outcome measures included the percentages of patients with headache relief 2 hours after dosing, absence of photophobia, absence of phonophobia, and absence of nausea for the comparison between sumatriptan–Naproxen sodium and placebo, and the percentages of patients with sustained pain-free response for the comparison between sumatriptan–Naproxen sodium and each monotherapy.ResultsSumatriptan–Naproxen sodium was more effective than placebo for headache relief at 2 hours after dosing (study 1, 65% vs 28%; P<.001 and study 2, 57% vs 29%; P<.001), absence of photophobia at 2 hours (58% vs 26%; P<.001 and 50% vs 32%; P<.001), and absence of phonophobia at 2 hours (61% vs 38%; P<.001 and 56% vs 34%; P<.001). The absence of nausea 2 hours after dosing was higher with sumatriptan–Naproxen sodium than placebo in study 1 (71% vs 65%; P = .007), but in study 2 rates of absence of nausea did not differ between sumatriptan–Naproxen sodium and placebo (65% vs 64%; P = .71). For 2- to 24-hour sustained pain-free response, sumatriptan–Naproxen sodium was superior at P<.01 (25% and 23% in studies 1 and 2, respectively) to sumatriptan monotherapy (16% and 14% in studies 1 and 2), Naproxen sodium monotherapy (10% and 10% in studies 1 and 2), and placebo (8% and 7% in studies 1 and 2). The incidence of adverse events was similar between sumatriptan–Naproxen sodium and sumatriptan monotherapy.ConclusionSumatriptan, 85 mg, plus Naproxen sodium, 500 mg, as a single tablet for acute treatment of migraine resulted in more favorable clinical benefits compared with either monotherapy, with an acceptable and well-tolerated adverse effect profile.Trial Registrationclinicaltrials.gov Identifiers: NCT00434083 (study 1); NCT00433732 (study 2)
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sumatriptan and Naproxen sodium for the acute treatment of migraine
Headache, 2005Co-Authors: Timothy R Smith, Abraham Sunshine, Stuart R Stark, Diane E Littlefield, Susan E Spruill, James W AlexanderAbstract:Objective.—To evaluate the efficacy and tolerability of treatment with a combination of sumatriptan 50 mg (encapsulated) and Naproxen sodium 500 mg administered concurrently in the acute treatment of migraine. Background.—The pathogenesis of migraine involves multiple peripheral and central neural mechanisms that individually have been successful targets for acute (abortive) and preventive treatment. This suggests that multimechanism therapy, which acts on multiple target sites, may confer improved efficacy and symptom relief for patients with migraine. Design and Methods.—This was a multicenter, randomized, double-blind, double-dummy, placebo-controlled, four-arm study. Participants (n = 972) treated a single moderate or severe migraine attack with placebo, Naproxen sodium 500 mg, sumatriptan 50 mg, or a combination of sumatriptan 50 mg and Naproxen sodium 500 mg. In the latter two treatment arms, the sumatriptan tablets were encapsulated in order to achieve blinding of the study. Results.—In the sumatriptan plus Naproxen sodium group, 46% of subjects achieved 24-hour pain relief response (primary endpoint), which was significantly more effective than sumatriptan alone (29%), Naproxen sodium alone (25%), or placebo (17%) (P < .001). Two-hour headache response also significantly favored the sumatriptan 50 mg plus Naproxen sodium 500 mg therapy (65%) versus sumatriptan (49%), Naproxen sodium (46%), or placebo (27%) (P < .001). A similar pattern of between-group differences was observed for 2-hour pain-free response and sustained pain-free response (P < .001). The incidence of headache recurrence up to 24 hours after treatment was lowest in the sumatriptan plus Naproxen sodium group (29%) versus sumatriptan alone (41%; P = .048), versus Naproxen sodium alone (47%; P = .0035), and versus placebo (38%; P = .08). The incidences of the associated symptoms of migraine were significantly lower at 2 hours following sumatriptan 50 mg plus Naproxen sodium 500 mg treatment versus placebo (P < .001). The frequencies and types of adverse events reported did not differ between treatment groups, with dizziness and somnolence being the most common. Conclusions.—This is among the first prospective studies to demonstrate that multimechanism acute therapy for migraine, combining a triptan and an analgesic, is well tolerated and offers improved clinical benefits over monotherapy with these selected standard antimigraine treatments. Specifically, sumatriptan 50 mg (encapsulated) and Naproxen sodium 500 mg resulted in significantly superior pain relief as compared to monotherapy with either sumatriptan 50 mg (encapsulated) or Naproxen sodium 500 mg for the acute treatment of migraine. Because encapsulation of the sumatriptan for blinding purposes may have altered its pharmacokinetic profile and thereby decreased the efficacy responses, additional studies are warranted that do not involve encapsulation of the active treatments and assess the true onset of action of multimechanism therapy in migraine. This study did show that the combination of sumatriptan and Naproxen sodium was well tolerated and that there was no significant increase in the incidence of adverse events compared to monotherapy. Ke yw ords: migraine, sumatriptan, acute treatment, NSAIDs, Naproxen sodium, clinical trial Abbreviations: NSAIDs nonsteroidal anti-inflammatory drugs, CGRP calcitonin gene-related peptide, IHS
Hermann J. Girschick - One of the best experts on this subject based on the ideXlab platform.
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Early onset pauciarticular arthritis is the major risk factor for Naproxen-induced pseudoporphyria in juvenile idiopathic arthritis
Arthritis Research & Therapy, 2007Co-Authors: Susanne G Schäd, Andrea Kraus, Imme Haubitz, Jiri Trcka, Henning Hamm, Hermann J. GirschickAbstract:Pseudoporphyria (PP) is characterized by skin fragility, blistering and scarring in sun-exposed skin areas without abnormalities in porphyrin metabolism. The phenylpropionic acid derivative group of nonsteroidal anti-inflammatory drugs, especially Naproxen, is known to cause PP. Naproxen is currently one of the most prescribed drugs in the therapy of juvenile idiopathic arthritis (JIA). The prevalence of PP was determined in a 9-year retrospective study of children with JIA and associated diseases. In addition, we prospectively studied the incidence of PP in 196 patients (127 girls and 69 boys) with JIA and associated diseases treated with Naproxen from July 2001 to March 2002. We compared these data with those from a matched control group with JIA and associated diseases not treated with Naproxen in order to identify risk factors for development of PP. The incidence of PP in the group of children taking Naproxen was 11.4%. PP was particularly frequent in children with the early-onset pauciarticular subtype of JIA (mean age 4.5 years). PP was associated with signs of disease activity, such as reduced haemoglobin (10,400/μl) and erythocyte sedimentation rate (>26 mm/hour). Comedications, especially chloroquine intake, appeared to be additional risk factors. The mean duration of Naproxen therapy before the onset of PP was 18.1 months, and most children with PP developed their lesions within the first 2 years of Naproxen treatment. JIA disease activity seems to be a confounding factor for PP. In particular, patients with early-onset pauciarticular JIA patients who have significant inflammation appear to be prone to developing PP upon treatment with Naproxen.
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Naproxen induced pseudoporphyria appearance of new skin lesions after discontinuation of treatment
Scandinavian Journal of Rheumatology, 1995Co-Authors: Hermann J. Girschick, H Hamm, Gerd Ganser, Hans-iko HuppertzAbstract:Non-steroidal antiinflammatory drugs (NSAIDs) are routinely used in the therapy of chronic inflammatory joint diseases in childhood. Recently the NSAID Naproxen was recognized to induce pseudoporphyria. This rare photodermatitis is characterized by skin fragility and vesiculation, resulting in shallow scarring. We report 4 children with juvenile rheumatoid arthritis who developed Naproxen-induced pseudoporphyria. All children had received Naproxen for more than 5 months when pseudoporphyria occurred. A disorder of porphyrin metabolism was excluded by analysis of the urine, serum and erythrocytes.Previous reports on Naproxen-induced pseudoporphyria described a rapid disappearance of blisters after discontinuation of treatment. However, in our patients, new lesions appeared for up to 5 weeks after discontinuation of the therapy and skin fragility was apparent for up to 6 months after cessation of treatment.Since Naproxen is a widely used drug in the treatment of children with juvenile rheumatoid arthritis p...
Henry J Mcquay - One of the best experts on this subject based on the ideXlab platform.
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The Cochrane Library - Single dose oral Naproxen and Naproxen sodium for acute postoperative pain in adults.
Cochrane Database of Systematic Reviews, 2009Co-Authors: Christopher J Derry, R A Moore, Sheena Derry, Henry J McquayAbstract:BACKGROUND: Naproxen, a non-steroidal anti-inflammatory drug, is used to treat various painful conditions including postoperative pain, and is often administered as the sodium salt to improve its solubility. This review updates a 2004 Cochrane review showing that Naproxen sodium 550 mg (equivalent to Naproxen 500 mg) was effective for treating postoperative pain. New studies have since been published. OBJECTIVES: To assess efficacy, duration of action, and associated adverse events of single dose oral Naproxen or Naproxen sodium in acute postoperative pain in adults. SEARCH STRATEGY: We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to October 2008. SELECTION CRITERIA: Randomised, double blind, placebo-controlled trials of single dose orally administered Naproxen or Naproxen sodium in adults with moderate to severe acute postoperative pain. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. Pain relief or pain intensity data were extracted and converted into the dichotomous outcome of number of participants with at least 50% pain relief over four to six hours, from which relative risk and number-needed-to-treat-to-benefit (NNT) were calculated. Numbers of participants using rescue medication over specified time periods, and time to use of rescue medication, were sought as additional measures of efficacy. Information on adverse events and withdrawals were collected. MAIN RESULTS: The original review included 10 studies with 996 participants. This updated review included 15 studies (1509 participants); 11 assessed Naproxen sodium and four Naproxen. In nine studies (784 participants) using 500/550 mg Naproxen or Naproxen sodium the NNT for at least 50% pain relief over four to six hours was 2.7 (95% CI 2.3 to 3.2). No dose response was demonstrated over the range 200/220 mg to 500/550 mg, but limited data was identified. Median time to use of rescue medication was 8.9 hours for Naproxen 500/550 mg and 2.0 hours for placebo. Use of rescue medication was significantly less common with Naproxen than placebo. Associated adverse events were generally of mild to moderate severity and rarely led to withdrawal. AUTHORS' CONCLUSIONS: Doses equivalent to 500 mg and 400 mg Naproxen administered orally provided effective analgesia to adults with moderate to severe acute postoperative pain. About half of participants treated with these doses experienced clinically useful levels of pain relief, compared to 15% with placebo, and half required additional medication within nine hours, compared to two hours with placebo. Associated adverse events did not differ from placebo.
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single dose oral Naproxen and Naproxen sodium for acute postoperative pain in adults
Cochrane Database of Systematic Reviews, 2009Co-Authors: Christopher J Derry, Sheena Derry, Andrew R Moore, Henry J McquayAbstract:BACKGROUND: Naproxen, a non-steroidal anti-inflammatory drug, is used to treat various painful conditions including postoperative pain, and is often administered as the sodium salt to improve its solubility. This review updates a 2004 Cochrane review showing that Naproxen sodium 550 mg (equivalent to Naproxen 500 mg) was effective for treating postoperative pain. New studies have since been published. OBJECTIVES: To assess efficacy, duration of action, and associated adverse events of single dose oral Naproxen or Naproxen sodium in acute postoperative pain in adults. SEARCH STRATEGY: We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to October 2008. SELECTION CRITERIA: Randomised, double blind, placebo-controlled trials of single dose orally administered Naproxen or Naproxen sodium in adults with moderate to severe acute postoperative pain. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. Pain relief or pain intensity data were extracted and converted into the dichotomous outcome of number of participants with at least 50% pain relief over four to six hours, from which relative risk and number-needed-to-treat-to-benefit (NNT) were calculated. Numbers of participants using rescue medication over specified time periods, and time to use of rescue medication, were sought as additional measures of efficacy. Information on adverse events and withdrawals were collected. MAIN RESULTS: The original review included 10 studies with 996 participants. This updated review included 15 studies (1509 participants); 11 assessed Naproxen sodium and four Naproxen. In nine studies (784 participants) using 500/550 mg Naproxen or Naproxen sodium the NNT for at least 50% pain relief over four to six hours was 2.7 (95% CI 2.3 to 3.2). No dose response was demonstrated over the range 200/220 mg to 500/550 mg, but limited data was identified. Median time to use of rescue medication was 8.9 hours for Naproxen 500/550 mg and 2.0 hours for placebo. Use of rescue medication was significantly less common with Naproxen than placebo. Associated adverse events were generally of mild to moderate severity and rarely led to withdrawal. AUTHORS' CONCLUSIONS: Doses equivalent to 500 mg and 400 mg Naproxen administered orally provided effective analgesia to adults with moderate to severe acute postoperative pain. About half of participants treated with these doses experienced clinically useful levels of pain relief, compared to 15% with placebo, and half required additional medication within nine hours, compared to two hours with placebo. Associated adverse events did not differ from placebo.
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The Cochrane Library - Single dose oral Naproxen and Naproxen sodium for acute postoperative pain
Cochrane Database of Systematic Reviews, 2004Co-Authors: L Mason, Jayne E Edwards, R A Moore, Henry J McquayAbstract:BACKGROUND: Postoperative pain is often poorly managed. Treatment options include a range of drug therapies such as non-steroidal anti-inflammatory drugs (NSAIDs) of which Naproxen is one. Naproxen is used to treat a variety of painful conditions including acute postoperative pain, and is often combined with sodium to improve its solubility for oral administration. Naproxen sodium 550 mg (equivalent to 500 mg of Naproxen) is considered to be an effective dose for treating postoperative pain but to date no systematic review of the effectiveness of Naproxen/Naproxen sodium at different doses has been published. OBJECTIVES: To assess the efficacy, safety and duration of action of a single oral dose of Naproxen or Naproxen sodium for acute postoperative pain in adults. SEARCH STRATEGY: We searched The Cochrane Library, MEDLINE, EMBASE and the Oxford Pain Relief Database for relevant studies. Additional studies were identified from the reference list of retrieved reports. The most recent search was undertaken in July 2004. SELECTION CRITERIA: Included studies were randomised, double blind, placebo-controlled trials of a single dose of orally administered Naproxen or Naproxen sodium in adults with moderate to severe acute postoperative pain. DATA COLLECTION AND ANALYSIS: Pain relief or pain intensity data were extracted and converted into dichotomous information to give the number of patients with at least 50% pain relief over four to six hours. Relative risk estimates (RR) and the number-needed-to-treat (NNT) for at least 50% pain relief were then calculated. Information was sought on the percentage of patients experiencing any adverse event, and the number-needed-to-harm was derived. Time to remedication was also estimated. MAIN RESULTS: Ten trials (996 patients) met the inclusion criteria: nine assessed Naproxen sodium; one combined the results from two small trials of Naproxen alone. Included studies scored well for methodological quality. Meta-analysis of six trials (500 patients) that compared Naproxen sodium 550 mg with placebo gave a RR for at least 50% pain relief over 4 to 6 hours of 4.2 (95% confidence interval (CI) 2.9 to 6.0) and an NNT of 2.6 (95% CI 2.2 to 3.2). Three trials (334 patients) assessed Naproxen 400 mg and Naproxen sodium 440 mg, giving a RR of 4.8 (95% CI 2.75 to 8.38). Two small studies indicated that Naproxen 200 mg and Naproxen sodium 220 mg may provide effective postoperative pain relief. There was no significant difference between the number of patients experiencing any adverse event on treatment compared with placebo. Weighted mean time to remedication for Naproxen sodium 550 mg was 7.6 hours compared with 2.6 hours for placebo. REVIEWERS' CONCLUSIONS: Naproxen sodium 550 mg, Naproxen 400 mg and Naproxen sodium 440 mg administered orally are effective analgesics for the treatment of acute postoperative pain in adults. A low incidence of adverse events was found but reporting was not consistent.
