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PubMed1985

A double-blind crossover evaluation of naproxen and piroxicam in osteoarthritis of hip or knee.

Seventy-five patients participated in a randomized, double-blind, crossover study, the aim of which was to compare the efficacy and safety of naproxen 1000 mg once daily with piroxicam 20 mg once daily for the treatment of osteoarthritis of hip or knee. Treatment periods of 4 weeks each were preceded by placebo wash-out periods of up to 1 week. The patients were examined clinically at every stage of the trial. Each treatment group exhibited significant improvement in weight-bearing and night pain, over-all disease severity, and the separate evaluations of patient response by physician and patient. There were no significant differences between the drugs in type, severity, or number of side-effects. Neither of the drugs influenced the patients' laboratory data. Night pain was less for patients using naproxen than for those taking piroxicam, and patients indicated greater preference for naproxen than for piroxicam. Naproxen was statistically superior to piroxicam as measured by decreased weight-bearing pain and over-all disease severity, the separate physician and patient global assessments of patient response to therapy, and physician preference. In this study, naproxen 1000 mg once daily was more effective than piroxicam 20 mg once daily for the treatment of osteoarthritis.

Adult↗
PubMedDate not supplied

The comparative efficacy of naproxen sodium and pirprofen in the treatment of post-operative pain.

A randomized, single-blind, parallel study involving 100 adults was performed to compare the efficacy and safety of naproxen sodium with that of pirprofen in the treatment of moderate to severe pain after orthopaedic surgery. Fifty patients received 550 mg of naproxen sodium initially and 275 mg every 6 h thereafter, and 50 received 400 mg of pirprofen every 8 h until either their pain was completely relieved or the 3-day trial ended. Patients who required additional analgesia were given 500 mg of paracetamol 2 h after administration of the test medication. Both medications significantly relieved post-operative pain, and there were no statistically significant differences in efficacy between the groups. Six patients receiving naproxen sodium and two patients receiving pirprofen withdrew from the study because of lack of efficacy. Thirteen patients receiving naproxen sodium recorded 17 adverse events and 13 patients receiving pirprofen recorded 20 adverse events, again with no statistically significant differences between groups. Six patients in each group withdrew from the study because of these adverse events. Naproxen sodium and pirprofen were equally safe and effective in relieving post-operative pain following musculoskeletal surgery.

Administration, Oral↗
PubMed1991

Naproxen-induced recurrent aseptic meningitis.

Aseptic meningitis has been linked to treatment with several nonsteroidal antiinflammatory drugs (e.g., ibuprofen, tolmetin, sulindac), particularly in patients with disturbed immunity. Naproxen, however, has only once been reported to cause meningitis. We report a case of recurrent aseptic meningitis related to prolonged naproxen usage in a 38-year-old woman with longstanding, minimally symptomatic systemic lupus erythematosus (SLE). Two years after starting naproxen, she experienced three separate episodes of meningitis within a period of 10 months; each episode was preceded by resumption of naproxen administration or an increase in drug dosage. There was no clinical or serologic evidence for the flare-ups of her SLE. Discontinuation of naproxen was followed by prompt recovery once the relationship of the drug to her symptoms was realized. Off the drug, the patient has remained free of meningeal symptoms for more than 18 months. Nonsteroidal antiinflammatory agents should be considered as possible causal agents in evaluating meningitis of obscure etiology.

Adult↗
PubMedDate not supplied

Comparative efficacy and safety of celecoxib and naproxen in the treatment of osteoarthritis of the hip.

Osteoarthritis (OA) is responsible for more disability of the lower extremities in the elderly than any other disease in the US. The pain associated with OA is the primary symptom leading to disability in these patients. Current ACR guidelines recommend consideration of acetaminophen for mild-to-moderate pain and conventional non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 specific inhibitors for moderate-to-severe OA symptoms. The aim of this study was to compare the efficacy and safety of the COX-1 sparing, COX-2 specific inhibitor, celecoxib, with the conventional NSAID naproxen, and placebo, in the treatment of OA of the hip. In this multicenter, randomized, placebo-controlled trial, 1061 patients with symptomatic OA of the hip were randomized to receive celecoxib at doses of 100 mg, 200 mg, or 400 mg/day; naproxen 1000 mg/day; or placebo, for 12 weeks. Patients were evaluated using standard measures of efficacy at baseline, 2-4 days after discontinuing previous NSAID or analgesic therapy, and after 2, 6, and 12 weeks of treatment. All doses of celecoxib and naproxen significantly improved the symptoms of OA, at all time points compared with placebo. This sustained treatment effect of celecoxib was dose dependent. In terms of pain relief and improvement in functional capacity, celecoxib 200 mg/day and 400 mg/day were similarly efficacious and were comparable to naproxen. Both drugs were generally well tolerated. Celecoxib at a dose of 200 mg/day is as effective as a standard therapeutic dose of the conventional NSAID, naproxen, in reducing the pain associated with OA of the hip.

Adult↗
PubMed1983

Clinical therapeutic trial of sodium meclofenamate and naproxen in rheumatoid arthritis, with comments on the use of placebos in clinical trials.

Forty patients with active rheumatoid arthritis were entered into a single-blind study of 12-weeks' duration to compare the efficacy and tolerance of 100 mg sodium meclofenamate 3-times daily and 250 mg naproxen twice daily. Disease activity was defined by the presence of a Ritchie Articular Index score of greater than 15. Patients were assessed at 4-week intervals. Analysis of variance of the data from those patients who completed 12 weeks in the trial showed that in the sodium meclofenamate group there was a significant improvement in articular index, left grip strength, pain severity and patients' global assessment over the course of the study. In the naproxen group, there was a significant improvement in articular index, grip strength and pain severity over the study. Pairwise comparisons showed that morning stiffness improved significantly from baseline to 12 weeks only, in both treatment groups. There were no significant differences between the two treatment groups for any of the measurements at any time period during the study. In the sodium meclofenamate group, there were 4 drop-outs due to inadequate efficacy and 6 in the naproxen group. Four patients in the sodium meclofenamate group and 2 patients in the naproxen group dropped out of the study because of side-effects, primarily nausea. These results suggest that sodium meclofenamate was equally well tolerated and as effective as naproxen in the treatment of rheumatoid arthritis in this group of patients.

Adult↗
PubMed1991

Effectiveness of etodolac ('Lodine') compared with naproxen in patients with acute gout.

A double-blind, parallel group study was carried out in 61 patients suffering from acute gouty arthritis to compare the effectiveness of etodolac and naproxen in the relief of symptoms. Patients were allocated at random to receive either 300 mg etodolac twice daily (31 patients) or 500 mg naproxen twice daily (30 patients) for 7 days. Both groups were comparable for sex, age and weight of patients, but there was a tendency for patients in the etodolac group to have more severe gout as shown by baseline clinical assessment scores. The variables assessed on entry and on Days 2, 4 and 7 of treatment were pain intensity, swelling, tenderness, erythema, joint heat, range of motion, and physician's and patients' overall evaluation of the condition. The results showed that there was a significant improvement from baseline in all of the variables at each time point in both treatment groups. However, more etodolac-treated patients (81%) than naproxen-treated patients (53%) showed overall improvement at Day 2, and etodolac was significantly better than naproxen on the Day 2 evaluation of joint swelling and at the Day 4 evaluations of joint tenderness, range of motion and the physician's global assessment. At the final evaluation on Day 7, 97% of the etodolac group reported that their condition had improved as compared to 93% of the naproxen group. Both drugs were well tolerated and only a few mild side-effects were reported.

Acute Disease↗
PubMed2004

A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN beta-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis.

Multiple sclerosis (MS) patients initiating IFN beta-1a, Avonex, therapy (Group 1, n = 30) or experiencing side effects after 6 months on therapy (Group 2, n = 30) were randomized for 5 weeks open label adjunct therapy to naproxen (Aleve), acetaminophen (Tylenol) or ibuprofen (Advil). Our hypothesis was that non-prescription pain medications are effective in decreasing or alleviating the side effects associated with IFN beta-1a therapy. Contrary to the hypothesis, most patients in both groups continued to report side effects on all pain medications. After 5 weeks, headache, fever, chills and injection site pain were low in < or = 50% of patients. Moderate to significant fatigue, muscle or joint pain continued in most patients. As a quality of life measure, the Modified Fatigue Impact Scale (mFIS) improved for Group 1 on naproxen or ibuprofen with greatest improvement in physical subset (P = 0.002 for naproxen and P<0.01 for ibuprofen). Total mFIS for Group 1 on acetaminophen improved (P = 0.04) due to improved cognitive subset rather than physical subset. Group 2, with side effects initially, reported less significant fatigue (severity 5-10) but more moderate fatigue (severity 2-4) at study end for all three medications. All medications improved cognitive subset (P = 0.05). Physical mFIS subset did not improve for Group 2 on acetaminophen, but did with naproxen (P = 0.05) or ibuprofen (P = 0.03). Naproxen and ibuprofen were more effective than acetaminophen in minimizing physical side effects of IFN beta-1a. None of the three pain medications tested were as effective as hypothesized for minimizing fatigue or muscle and joint pain.

Acetaminophen↗
PubMed2001

Effect of hydroxypropyl methylcellulose and hydrogenated castor oil on naproxen release from sustained-release tablets.

The effect of the concentration of hydrophilic (hydroxypropyl methylcellulose [HPMC]) and hydrophobic (hydrogenated castor oil [HCO]) products, fillers (lactose and dibasic calcium phosphate), and buffers (sodium bicarbonate, calcium carbonate, and sodium citrate) on naproxen release rate was studied. Matrix tablets were prepared by double compression, and in vitro dissolution tests were performed. The dissolution results showed that an increased amount of HPMC or hydrogenated castor oil resulted in reduced drug release. The inclusion of buffers in the HPMC matrix tablets enhanced naproxen release. For HCO tablets, only sodium bicarbonate enhanced naproxen release. The presence of lactose on HPMC matrix tablets did not show a significantly different result from that obtained with the formulation containing dibasic calcium phosphate as a filler. However, for the tablets containing HCO, the presence of lactose significantly enhanced the naproxen release rate. The matrix-forming materials in this study were suitable for use in sustained-release tablets containing naproxen. The drug release can be modulated by adding suitable amounts of diluents and buffers.

Castor Oil↗
PubMed1990

Naproxen. A reappraisal of its pharmacology, and therapeutic use in rheumatic diseases and pain states.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) advocated for use in painful and inflammatory rheumatic and certain nonrheumatic conditions. It may be administered orally or rectally using a convenient once or twice daily regimen. Dosage adjustments are not usually required in the elderly or those with mild renal or hepatic impairment although it is probably prudent to start treatment at a low dosage and titrate upwards in such groups of patients. Numerous clinical trials have confirmed that the analgesic and anti-inflammatory efficacy of naproxen is equivalent to that of the many newer and established NSAIDs with which it has been compared. The drug is effective in many rheumatic diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and nonarticular rheumatism, in acute traumatic injury, and in the treatment of and prophylaxis against acute pain such as migraine, tension headache, postoperative pain, postpartum pain and pain associated with a variety of gynaecological procedures. Naproxen is also effective in treating the pain and associated symptoms of primary or secondary dysmenorrhoea, and decreases excessive blood loss in patients with menorrhagia. The adverse effect profile of naproxen is well established, particularly compared with that of many newer NSAIDs, and the drug is well tolerated. Thus, the efficacy and tolerability of naproxen have been clearly established over many years of clinical use, and it can therefore be considered as a first-line treatment for rheumatic diseases and various pain states.

Animals↗
PubMed1996

Hematologic and body fluid changes during simulated high altitude exposure in naproxen-treated rats.

Arterial blood oxygen saturation, body fluid and hematological parameters were studied in control, naproxen (a prostaglandin synthesis inhibitor)-treated control, altitude-exposed, and naproxen-treated altitude-exposed rats after intermittent exposure of 8 h/d for 6 consecutive days to a simulated high altitude of 6,100 m (barometric pressure 349 +/- 3 mmHg). Arterial blood oxygen saturation was reduced in altitude-exposed rats, but increased significantly to near control level in naproxen-treated rats. On the other hand, 2,3-diphosphoglycerate in erythrocytes increased in altitude-exposed rats, but naproxen prevented this increase. The red blood cell count, hemoglobin concentration and hematocrit ratio were reduced significantly in drug-treated altitude-exposed rats when compared to the altitude-exposed group (without drug). Red cell mass was increased in the altitude-exposed group in comparison with control. Both red cell mass and mean corpuscular volume of altitude-exposed rats were shifted towards the control value when they were treated with naproxen. Drug-treated high altitude-exposure reduced the thiocyanate space, intracellular fluid volume and total body water content compared to drug-treated control rats. On the other hand, thiocyanate space and total body water content were increased significantly in drug-treated control rats in comparison with the control group.

Altitude↗
PubMed1979

Naproxen and indomethacin in the treatment of primary dysmenorrhea.

The efficacy of naproxen and indomethacin in the treatment of dysmenorrhea was compared in a double-blind, cross-over study. Both drugs were given to 24 female undergraduates with severe primary dysmenorrhea in four consecutive cycles in a randomized schedule. Both drugs were equally effective. Good or moderate overall relief was achieved in 73% of 48 cycles treated with indomethacin and in 61% of the 48 cycles treated with naproxen. The difference was not statistically significant. Gastrointestinal side-effects occurred in 5 and 7 patients during naproxen and indomethacin treatment respectively. Central nervous system side-effects, dizziness, headache, tiredness, were more common with indomethacin than with naproxen (p less than 0.02). The most important and frequent of these side-effects, dizziness, was complained of by six patients in association with indomethacin but by none with naproxen (p less than 0.05). Only one patient discontinued the treatment because of side-effects.

Adult↗
PubMed1986

Worldwide studies comparing piroxicam and naproxen.

In double-blind, crossover studies, piroxicam was compared with naproxen. Piroxicam 40 mg was given once daily for two days, followed by 20 mg once daily and is compared with naproxen 750 mg daily for two days, followed by 500 mg daily (N = 85) and with naproxen 1,000 mg daily (N = 83) in the treatment of primary dysmenorrhea. The different parameters studied included pain intensity, treatment preference and side effects. Piroxicam 40 mg/day was effective and well tolerated and produced a significantly greater reduction in menstrual pain on the first day of the cycle than naproxen 750 mg/day. When compared to naproxen 1,000 mg/day, piroxicam 40 mg/day was equally effective. It is concluded that both drugs were well tolerated, but in both studies patients preferred piroxicam.

Adolescent↗
PubMed1995

Comparative effects of nabumetone, naproxen, piroxicam, and diclofenac on rat gastric irritancy following acute exposure to OTC non-steroidal anti-inflammatory agents and other gastric irritants.

This study examined the relative effects of equally-effective anti-inflammatory doses of nabumetone, naproxen, piroxicam and diclofenac on gastric irritancy induced by over-the-counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs) aspirin and ibuprofen and a variety of necrotizing agents (0.6 N HCl, 0.2 N NaOH and 25% NaCl). Within one hour, aspirin 100 and 200 mg/kg and ibuprofen up to 15 mg/kg produced significant gastric mucosal injury. Aspirin 50 mg/kg produced only minimal damage that was enhanced by 5 x ID25 piroxicam and naproxen, but not by nabumetone or diclofenac. 5 x ID25 naproxen, piroxicam, and diclofenac significantly enhanced mucosal damage produced by ibuprofen 2.5 mg/kg. An equivalent anti-inflammatory dose of nabumetone failed to enhance the gastric irritancy produced by ibuprofen 2.5 mg/kg. Similarly, naproxen, piroxicam, and diclofenac enhanced the susceptibility of the gastric mucosa to the necrotizing actions of 0.6 N HCl, 0.2 N NaOH or 25% NaCl. Naproxen, piroxicam, or diclofenac are more likely than nabumetone to enhance gastric mucosal injury produced by OTC NSAIDs (aspirin and ibuprofen) or other gastric irritants.

Animals↗
PubMed1995

Naproxen-induced pseudoporphyria: appearance of new skin lesions after discontinuation of treatment.

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 parents of fair-skinned children should be alerted to the possibility of this rare adverse effect.

Arthritis, Juvenile↗
PubMedDate not supplied

[Effect of naproxen sodium on serum concentrations of IL-1, IL-6, and TNF in patients with acute, purulent pharyngo-tonsillitis].

BACKGROUND: Cytokines produced by macrophages and neutrophils participate in the host's defense mechanism; in infectious processes. Interleukins such as LI-1, IL-6, and tumor necrosis factor (TNF) also have a role in these acute phase mechanisms. OBJECTIVE: Assess the effect of sodium naproxen on the serum concentration of IL-1, IL-6 and TNF in acute infectious process. MATERIAL A METHODS: Eighteen patients with clinical diagnosis of acute purulent pharyngitis and/or tonsillitis were randomly assigned to one of two groups of 9 patients each. RESULTS: The patients in the first group received sodium naproxen and those in the other group received placebo. Patients of both groups received procaine G penicillin. Patients in the group receiving sodium naproxen showed improvement of the infectious and febrile syndromes within 72 hours. Patients receiving placebo showed signs and symptoms; of the infections and febrile syndromes for more than three days. DISCUSSION: Patients receiving treatment with sodium naproxen had a statistically significant reduction of the serum concentration of IL-1b as compared to basal and 72 h measurements; there were also statistically significant differences with respect to patients receiving placebo. IL-6 and TNF did not change in any of the groups. These results show that serum IL-1b levels dropped in both groups with a more striking reduction in the group receiving sodium naproxen , that also showed a faster improvement of the symptoms.

Acute Disease↗
PubMed2000

Upper gastrointestinal tolerability of celecoxib, a COX-2 specific inhibitor, compared to naproxen and placebo.

OBJECTIVE: To determine the upper gastrointestinal (GI) tolerability of celecoxib, naproxen, and placebo in patients with rheumatoid arthritis (RA) and osteoarthritis (OA). METHODS: An analysis of 5, 12-week, randomized, double blind, parallel group, placebo controlled clinical trials was conducted. In these trials, patients were randomized to: naproxen 500 mg bid (n = 1,099), placebo (n = 1,136), celecoxib 50 mg bid (n = 690) (subtherapeutic dose), celecoxib 100 mg (n = 1,131) or 200 mg bid (n = 1,125) (therapeutic dose), or celecoxib 400 mg bid (n = 434) (supratherapeutic dosage). The incidence and time until moderate to severe abdominal pain, dyspepsia, nausea, and any of the aforementioned 3 upper GI symptoms (composite endpoint) were determined using time-to-event analysis. RESULTS: The cumulative incidences of moderate to severe abdominal pain, dyspepsia, or nausea (composite endpoint) were: naproxen 500 mg (12.0%; 95% CI 9.9%-14.0%), celecoxib 50 mg bid (7.1%; 95% CI 5.0%-9.2%), celecoxib 100 mg bid (7.8%; 95% CI 6.0%-9.5%), celecoxib 200 mg bid (8.1%; 95% CI 6.4%-9.9%), celecoxib 400 mg bid (6.0%; 95% CI 3.6%-8.4%), and placebo (8.5%; 95% CI 6.5%-10.8%). After controlling for independent predictors of the composite endpoint, relative risks (RR) for the various treatments relative to naproxen 500 mg bid were: celecoxib 50 mg (RR 0.54; 95% CI 0.37-0.77; p < 0.001), celecoxib 100 mg (RR 0.60; 95% CI 0.45-0.80; p < 0.001), celecoxib 200 mg bid (RR 0.63; 95% CI 0.47-0.83; p = 0.001), celecoxib 400 mg bid (RR 0.56; 95% CI 0.35-0.89; p = 0.015), and placebo (RR 0.63; 95% CI 0.47-0.85; p = 0.002). After controlling for independent predictors of the composite endpoint, celecoxib treatment group patients did not differ from placebo patients when reporting the composite endpoint, with p values ranging from 0.40 to 0.96. CONCLUSION: The upper GI tolerability of celecoxib is superior to naproxen. A dose-response relationship between celecoxib and upper GI symptoms was not apparent.

Abdominal Pain↗
PubMed2001

Naproxen-Eudragit microspheres: screening of process and formulation variables for the preparation of extended release tablets.

The objectives of the present study were to screen the formulation and process variables for the preparation of extended release naproxen tablets with Eudragit L100-55. The tablets were prepared by compression of microspheres that were obtained by a coprecipitation technique. The process involved dissolution of naproxen and Eudragit L 100-55 in alcohol USP followed by the addition of an aqueous solution containing a surfactant and deaggregating agents. The mixture was stirred for a specified time period to obtain microspheres, which were filtered and air-dried to a constant weight. The microspheres were then compressed to obtain plain tablets with a diameter of 12 mm. A 7-factor 12-run Plackett-Burman screening design was employed to evaluate the main effects of homogenization time (X1), rate of water addition (X2), amount of polymer (X3), amount of precipitating solution (X4), concentration of electrolytes (X5), compression pressure (X6), and the concentration of lubricant (X7) on the rate of drug release. The response variable was cumulative percent of naproxen dissolved in 12 h in simulated intestinal fluid with constraints on responses that included percent yield, hardness, thickness, and the angle of repose. Mathematical relationship for percent of naproxen dissolved in 12 h (Y5) with various factors yielded the following polynomial equation; Y5 (% dissolved in 12 h) = 95.48 + 0.53 X1 + 3.51 X2 + 3.84 X3 - 3.80 X4 - 2.46 X5 - 2.90 X6 - 3.91 X7. The results showed that all the seven factors affected, with varying order, the release of naproxen from its compressed tablets.

Acrylic Resins↗
PubMedDate not supplied

[Effect of naproxen on serum concentrations of IL-I, IL-6, and TNF in patients with osteoarthritis].

AIMS: Non-steroid anti-inflammatory drugs can inhibit bone loss and preserve bone mineral density in in vitro models by inhibiting prostaglandins and inflammatory cytokines. Naproxen inhibits prostaglandin and cytokine biosynthesis. Our objective was to assess the effect of naproxen on the serum levels of IL-I, IL-6 and TNF in 18 patients with osteoarthritis. MATERIAL AND METHOD: Two groups of nine patients each were formed randomly. One of them received naproxen 10 mg/kg BW bid for 2 weeks, and the other received placebo and paracetamol as needed. Cytokines were measured before and 2 weeks after naproxen administration by ELISA test. RESULTS: Serum IL-I and IL-6 levels were reduced in the group receiving naproxen, suggesting a reduction of the degenerative changes in the patients with osteoarthritis, that may prevent the progression of the disease.

Adult↗