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PubMed1988

Steady state pharmacokinetics of naproxen in elderly rheumatics compared with young volunteers.

The elderly rheumatic patients and 7 healthy young persons received naproxen (Naprosyn, Syntex) 500 mg orally twice a day for 4 weeks. The serum concentrations were determined using mass fragmentography. After an initial 1,000-mg dose, no significant differences were found between the two groups in peak serum concentration, time to peak serum concentration, area below the serum concentration-time curve, volume of distribution, elimination half-life, or total body clearance of naproxen. At steady state, the median total through naproxen concentration was 50.5 mg/l in the elderly and 62.7 in the young (p = 0.08); the unbound concentration was 58 micrograms/l and 44 micrograms/l, respectively (p = 0.06). There was a significant inverse correlation between serum albumin and the free fraction of naproxen (R = -0.58, p = 0.01). The hepatic extraction ratio of naproxen is relatively low and it is suggested that the reduced protein binding in the elderly may conceal the age-related reduction in cellular activity. An estimated value of intrinsic clearance was reduced by 37% in the elderly patients. It is suggested to start naproxen at the lower end of its dose range in the elderly.

Adult↗
PubMed2001

Comparison of the efficacy and safety of naproxen CR and nabumetone in the treatment of patients with osteoarthritis of the knee.

OBJECTIVE: To comparre the safety and efficacy of naproxen CR (1,000 mg once daily) with that of nabumetone (1,000 mg once daily) in the treatment of patients with symptomatic knee osteoarthritis(OA). METHODS: A total of 159 Korean patients (80 in the naproxen CR group and 79 in the nabumetone group) were enrolled in this 4-week, single-blind, controlled, randomized, parallel study and an intention-to-treat model was used for data analysis. Six efficacy parameters were measured: Lequesne index, visual analogue pain scale at rest and atactivity, patient's and physician's global assessment, and time to walk 50 feet. RESULTS: Significant improvement in all efficacy parameters except time to walk 50 feet occurred at Week 2 and Week 4 in both groups. Themean improvement from baseline at Week 2 and Week 4 for the efficacy variables was not different between naproxen CR and nabumetone group. Twenty-four patients (30%) in the naproxen CR group and 18 patients (22.8%) in the nabumetone group withdrew from the study. Among them, only 1patient in the naproxen CR group terminated the study prematurely due to an adverse event of dyspepsia. No statistically significant difference in the frequency of adverse events, including gastrointestinal symptoms, was observed between these 2 groups during the treatment period. Significant laboratory abnormalities also did not occur during the study period in both groups. CONCLUSIONS: Naproxen CR is an effective and tolerable drug in the treatment of knee OA. Efficacy and safety profiles are comparable to those of nabumetone.

Activities of Daily Living↗
PubMed1992

Effects of naproxen on experimental rhinovirus colds. A randomized, double-blind, controlled trial.

OBJECTIVE: To determine whether naproxen, a propionic acid inhibitor of cyclooxygenase, alters the course of experimental rhinovirus colds. DESIGN: A randomized, double-blind, controlled trial. SETTING: Rhinovirus challenge model in volunteers cloistered in individual hotel rooms. VOLUNTEERS: Eighty-seven healthy young adults with serum neutralizing antibody titers of less than or equal to 1:2 to the challenge virus; 79 were evaluable. INTERVENTION: Thirty-nine participants received naproxen (loading dose, 400 mg or 500 mg followed by 200 mg or 500 mg three times daily for 5 days). Forty participants received placebo. Treatment was started 6 hours after viral challenge. MEASUREMENTS: Daily measurement of viral titers, symptoms, nasal mucus production, and nasal tissue use; incidence of infection and illness; and measurement of homotypic serum neutralizing antibody responses. RESULTS: Viral titers and serum homotypic antibody responses were similar in the naproxen and placebo groups. Significant reductions in headache, malaise, myalgia, and cough occurred in the naproxen group. A 29% reduction was noted in the total (5-day) symptom score in the naproxen group (95% CI, 16% to 42%). CONCLUSION: Naproxen treatment did not alter virus shedding or serum neutralizing antibody responses in participants with experimental rhinovirus colds, but it had a beneficial effect on the symptoms of headache, malaise, myalgia, and cough. Prostaglandins may be among the inflammatory mediators that play a role in the pathogenesis of rhinovirus colds.

Adult↗
PubMed1975

Naproxen in rheumatoid arthritis. A controlled trial.

The efficacy of naproxen in treating rheumatoid arthritis patients was evaluated in a double-blind clinical trial using aspirin as the control drug. The study was conducted at seven centers and involved 80 patients. After an unequivocal increase in disease activity during a drug-free period, patients were randomly assigned to either drug and continued in the trial for 16 weeks. Some patients took low maintenance doses of corticosteroids, or gold salts, or both throughout the trial. Both test drugs significantly decreased disease activity as measured by a number of ways. By objective measurements, naproxen was as effective as aspirin, although patients in the naproxen-treated group entered the trial with more severe disease. By some subjective evaluations, naproxen was considered more effective than aspirin. Although patients taking naproxen had less frequent gastrointestinal side effects and fewer symptoms VIIIth nerve toxicity, the differences were not statistically significant. We conclude that naproxen is a useful addition to the physician's armamentarium for the treatment of rheumatoid arthritis.

Adrenal Cortex Hormones↗
PubMed1994

A randomised clinical trial of the effect of informed consent on the analgesic activity of placebo and naproxen in cancer pain.

To determine whether informed consent in a therapeutic trial modifies the analgesic effect of naproxen and placebo, we conducted a prospective, randomised, single dose, placebo-controlled trial. Patients were randomly selected to receive or not information concerning the study. All patients included were then given a single dose of naproxen and placebo according to a crossover, double-blind design. Forty-nine patients with mild or moderate cancer pain which did not need narcotic analgesics entered the study. Twenty-five received both treatments without any information and constituted the uninformed group. Twenty-four had a complete information about the trial; six refused to participate. The 18 others constituted the informed-consent group. Visual analogue scales of pain before and 30, 60, 120 and 180 min after the intake of naproxen and placebo were recorded. As an analgesic, naproxen was more effective than placebo in both groups of patients (p = 0.001). For naproxen as well as for placebo, the analgesic effect was better in the informed-consent group compared to the uninformed group (p = 0.012). The difference in therapeutic activity between naproxen and placebo was moderately higher in the uninformed patients (p = 0.08). We concluded that, in contrast with parallel studies, giving information in a crossover, placebo-controlled trial may increase the apparent efficacy of both the tested agent and the placebo, and decrease the perceived difference the two.

Adult↗
PubMed1975

[Clinical-pharmacological and pharmacokinetic studies with naproxen].

d-2-(6'-Methoxy-2'-naphthyl)-propionic acid (naproxen) is bound in blood to a high degree to plasma protein. After oral application naproxen is absorbed rapidly and completely. The mean biological half-life in man is fourteen hours. This gives us the possibility of controlling the symptoms of disease with two daily doses. In man, 99% of naproxen is excreted in the urine, either unchanged or glucuronized and as its 6-des-methyl metabolite. There is a linear increase of plasma levels with daily doses of up to 500 mg. Higher naproxen doses do not produce higher blood levels but lead to a faster excretion. This probably depends in part on a saturation of the binding sites in plasma. Differences in affinity of some compounds for binding sites in plasma are responsible for a potential interaction between naproxen and other agents, such as warfarin, acetyl salicylic acid (ASA) and sulfonylureas. These interactions are discussed. In a double-blind trial the influence of naproxen and ASA on the gastric mucosa of healthy volunteers has been compared. The results of gastroscopic findings as well as laboratory tests are reported.

Administration, Oral↗
PubMed2002

Randomized placebo-controlled trial comparing efficacy and safety of valdecoxib with naproxen in patients with osteoarthritis.

OBJECTIVE: We compared the efficacy and upper gastrointestinal safety of the cyclooxygenase-2-specific inhibitor valdecoxib with naproxen and placebo in treating moderate to severe osteoarthritis of the knee. STUDY DESIGN: This multicenter, randomized, double-blind, placebo-controlled study compared the efficacy and upper gastrointestinal tract safety of valdecoxib at dosages of 5, 10, and 20 mg once daily with placebo and naproxen at the dosage of 500 mg twice daily. POPULATION: We included patients who had been diagnosed with moderate to severe osteoarthritis of the knee according to the modified criteria of the American College of Rheumatology. OUTCOMES MEASURED: The Patient's and Physician's Global Assessment of Arthritis (PaGAA, PhGAA), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), and Western Ontario and McMaster's Universities (WOMAC) Osteoarthritis indices were assessed at baseline and at weeks 2, 6, and 12. Upper gastrointestinal ulceration was assessed by pre- and posttreatment endoscopies. RESULTS: Valdecoxib 10 and 20 mg once daily (but not 5 mg once daily) demonstrated similar efficacy to naproxen at 500 mg twice daily, and all 3 dosages were superior to placebo for the PaGAA, PhGAA, PAAP-VAS, and WOMAC Osteoarthritis indices at most assessments throughout the 12-week study (P <.05). The incidence of endoscopically proven ulcers was significantly higher in the naproxen group than in the 5- and 10-mg valdecoxib groups, but not in the 20-mg valdecoxib group. All 3 valdecoxib doses were comparable to placebo in ulcer incidence. CONCLUSIONS: Valdecoxib (10 and 20 mg once daily) is significantly superior to placebo and as effective as naproxen (500 mg twice daily) in improving moderate to severe osteoarthritis of the knee. Upper gastrointestinal tract safety of valdecoxib (5 and 10 mg) was comparable to that of placebo and significantly better than that of naproxen.

Aged↗
PubMed2003

Microbial transformation of naproxen by Cunninghamella species.

AIM: The metabolites of naproxen produced by Cunninghamella species were isolated and identified, and further to compare the similarities between microbial transformation and mammalian metabolism. METHODS: Naproxen was transformed by three strains of Cunninghammella species (Cunninghamella blakeslesna AS 3.153, Cunninghamella echinulata AS 3.2004, and Cunninghamella elegans AS 3.156). The metabolites of naproxen were separated and assayed by liquid chromatography-mass spectrometry method. Semi-preparative HPLC was used to isolate the major metabolite, and the structure was identified by nuclear magnetic resonance (NMR) and mass spectrometry. RESULTS: Naproxen was transformed into 2 metabolites, desmethylnaproxen and desmethylnaproxen-6-O-sulfate, both were the known mammalian metabolites. The conjugated metabolite was newly detected in microbial transformation samples. CONCLUSION: The microbial transformation of naproxen has some similarities with the metabolism of naproxen in mammals. The fungi belonging to Cunninghamella species could be used as complementary in vitro models for drug metabolism to predict and produce the metabolites of drugs in mammals.

Biotransformation↗
PubMed1992

A prospective randomized study of the injurious effects of aspirin and naproxen on the gastroduodenal mucosa in patients with rheumatoid arthritis.

A prospective double-blind randomized placebo-controlled study was conducted to compare the injurious effects of aspirin and naproxen on the gastroduodenal mucosa. Patients with rheumatoid arthritis attending the immunology clinic of a tertiary care center were included in the study. Ninety consecutive patients were randomized to receive aspirin, naproxen, or placebo. Clinical evaluation was done every 2 wk. Upper gastrointestinal endoscopy, biopsies from the gastric antrum and duodenum for histological examination, and Helicobacter pylori studies were done at entry and after 2 months. The number of patients with dyspeptic symptoms was similar in the aspirin (12) and naproxen (9) groups. In both cases, however, it was higher (p less than 0.01) than in the placebo group (none). Naproxen was associated with a higher score of endoscopic abnormalities in the gastric body (0.6 +/- 1.3) than aspirin (0.2 +/- 0.6) or placebo (0.03 +/- 0.18). H. pylori was present in a similar proportion of patients in the three groups (33-43%). A greater fall in hemoglobin was observed with aspirin (0.35 +/- 0.48 g%) and naproxen (0.44 +/- 0.53 g%) than with placebo (0.09 +/- 0.4 g%). The present study suggests that aspirin and naproxen produce a similar degree of injury to the gastroduodenal mucosa.

Adult↗
PubMedDate not supplied

Stereoselective disposition of carprofen, flunoxaprofen, and naproxen in rats.

The stereoselective dispositions of carprofen, flunoxaprofen, and naproxen were studied in rats after i.v. administration of racemate (11 mumol/kg) or enantiomer (5.5 mumol/kg). The total clearances of the (R)-enantiomers of carprofen and flunoxaprofen were significantly greater than those of the (S)-enantiomers. The clearance of (S)-naproxen was similar to the value for (R)-naproxen. There were no marked differences in steady-state volume of distribution between (R)- and (S)-enantiomers for carprofen, flunoxaprofen, or naproxen. The (R)- to (S)-enantiomer inversion ratio for flunoxaprofen in rats was 0.54. The ratios for naproxen and carprofen were 0.02 and 0.003, respectively. Biliary excretion of (R)-carprofen and of its glucuronide were higher than those of the (S)-enantiomer and its glucuronide. In contrast, biliary excretion of the (S)-enantiomers of flunoxaprofen, naproxen, and of their glucuronides were greater than those of their antipodes. Insignificant amounts of the parent enantiomers and of the glucuronides of these three drugs were excreted in urine. These results indicate that there is a wide variation in the extent of inversion at a chiral center for these three 2-arylpropionates and in the stereoselective disposition of their acyl glucuronides.

Animals↗
PubMed1991

Pharmacokinetics of a controlled release preparation of naproxen.

The pharmacokinetics of a controlled release preparation of naproxen (750 mg) was compared with that of standard release naproxen, in 12 healthy volunteers. The plasma levels of naproxen and urinary recoveries of naproxen and metabolites were determined both after single doses and chronic administration. The experimental data show that the bioavailability of the controlled release preparation is equal to that of standard release naproxen; however, the controlled release preparation allows more constant plasma levels of naproxen and, when administered once a day for prolonged periods, is capable of maintaining effective concentrations for most of the dosing period.

Adult↗
PubMed1988

Two double blind trials of diclofenac sodium with aspirin and with naproxen in the treatment of patients with rheumatoid arthritis.

In 2 multicenter, double blind studies, the efficacy and safety of diclofenac, 150 mg/day, were compared with those of aspirin, 3.6 g/day, in 194 patients with rheumatoid arthritis (RA) in Study 1 and with those of naproxen, 1000 mg/day, in 223 patients with RA in Study 2. After single blind, placebo washout periods of 2 days to 2 weeks, patients entered 12-week treatment periods in each study. In both studies, diclofenac, aspirin, and naproxen produced statistically significant improvement (p less than or equal to 0.01) from baseline in all primary efficacy variables at each assessment visit. There were no significant differences between treatments. In both studies, significantly fewer (p less than or equal to 0.05) patients receiving diclofenac experienced adverse effects compared to the aspirin and naproxen groups. Significantly fewer (p less than 0.05) patients in the diclofenac group compared to the aspirin group discontinued the trial due to side effects (primarily tinnitus and deafness). In Study 2, fewer patients in the diclofenac group discontinued the trial due to adverse effects than in the naproxen group. In conclusion, diclofenac, aspirin, and naproxen demonstrated similar efficacy; however, diclofenac was significantly better tolerated than either aspirin or naproxen.

Adult↗
PubMed1988

[The effect of naproxen on fever following transcatheter arterial embolization of hepatic tumors].

In the cases of trans-catheter arterial embolization (TAE) for hepatic malignancies, naproxen has been evaluated for its antipyretic effect. Each patient not given naproxen manifested a remarkable and prolonged fever despite treatment by antibiotics. In those who received an administration of naproxen, however, a significant suppression of fever was achieved (P 0.01-0.001). No remarkable influence was found on the white blood cell counts, the serum GOT and LDH levels by the naproxen. Similarly, no untoward effect due to naproxen was found on the ulcerogenicity in the gastro-duodenum. Thus, for hepatic malignancies, naproxen could be useful in the symptomatic treatment of a fever following a TAE.

Adult↗
PubMed1977

Butacote and naproxen: a comparison of effectiveness in rheumatoid arthritis.

A double-blind crossover trial compared Butacote, 200 mg b.d. with naproxen, 250 mg b.d., each given for four weeks, in the treatment of rheumatoid arthritis. The trial was multicentre, and twenty-six general practitioners admitted forty-eight patients. Seven patients dropped out: two for technical reasons; one in each treatment group because of exacerbation of symptoms; one because of intolerance of rescue analgesic; and two with gastric intolerance to naproxen. Both drugs were effective in relieving pain, morning stiffness, and joint tenderness, as compared with the condition before the trial. There was little effect on grip strength or joint size, and no real differences between the two drugs. The two preparations had a similar frequency and spectrum of side-effects, except that oedema did not occur with naproxen, and rash did not occur with Butacote. Gastro-intestinal upsets were the commonest unwanted effect but only two patients had to stop treatment for this reason, both while taking naproxen. Although the doctors preferred each drug on an equal number of occasions, the patients preferred Butacote to naproxen almost twice as often (20:11), particularly when Butacote was given after naproxen. The reason for this divergence of opinions is not obvious.

Arthritis, Rheumatoid↗
PubMed1988

Lack of influence of sulglycotide on naproxen bioavailability in healthy volunteers.

We explored the bioavailability and kinetics of naproxen (N) in 12 healthy volunteers treated orally with single doses of 500 mg and retreated after a washout period with the same dose of N plus sulglycotide (S) 200 mg. Naproxen blood levels were measured by high-performance liquid chromatography (HPLC) in samples collected at 0.5, 1, 2, 4, 8, 12, and 24 h of dosing with N or with N + S. No statistically significant difference in terms of naproxen blood levels emerged as the product was administered alone or concurrently with sulglycotide. Peak plasma concentrations and AUC values were 71 +/- 3.16 micrograms/ml and 685 +/- 27 micrograms/ml/h, respectively for N alone, and 72.5 +/- 2.85 micrograms/ml and 651 +/- 28 micrograms/ml/h, respectively for N + S. The difference was not significant. Similarly, the kinetic behavior of naproxen was not modified by the simultaneous presence of sulglycotide, as shown by the t1/2 beta-values obtained with N alone (8.39 +/- 0.31 h) and with N + S (7.93 +/- 0.30 h), and likewise by the distribution volumes at equilibrium (7.63 +/- 0.42 and 7.9 +/- 0.38, respectively), Cmax (63.3 +/- 2.86 and 60.4 +/- 2.9 micrograms/ml, respectively) and tmax (0.95 +/- 0.06 and 1.10 +/- 0.10 h, respectively). From these findings it seems legitimate to claim that sulglycotide can be administered concurrently with naproxen to prevent possible gastric injury by the anti-inflammatory agent thanks to its wellknown antiulcer and cytoprotective activity on the gastric mucosa, without any undue interference with the absorption (hence effectiveness) of naproxen.

Adult↗
PubMed1988

Pharmacokinetics of high-dosage naproxen in elderly patients.

After multiple oral doses of 500 mg naproxen twice daily, eight young healthy male volunteers and six male and female elderly patients participated in a pharmacokinetic study. Serum naproxen levels were measured by high-pressure liquid chromatography; protein-unbound drug was determined after equilibrium dialysis. A significantly lower maximal serum concentration (Cpeak), smaller area under the curve during one dose interval [AUC(0-12)], larger total body clearance (CL/F) and apparent volume of distribution (V/F body wt-1) were found for the total drug in elderly patients. The pharmacokinetics of the protein-unbound drug showed higher trough and peak concentrations, larger AUC(0-12)u, and smaller (CL/F)u and (V/F)u in the elderly patients. The unbound fraction (less than 1% of total naproxen) showed concentration dependency; in the elderly, a larger unbound fraction was found. Pharmacokinetic differences between the elderly and the young may be explained by a lower serum albumin concentration in the aged, together with a decrement in binding affinity of naproxen to albumin; moreover, the clearance of unbound drug was significantly reduced in the elderly (281 +/- 96 l/h) as compared with the young (713 +/- 164 l/h). We conclude that age-related factors increase serum unbound naproxen concentrations. It is, therefore, advisable to start treatment with naproxen in the elderly at a low dosage.

Adult↗
PubMed1985

Comparison of isoxicam and naproxen in patients with rheumatoid arthritis. A 4-week parallel group, double-blind study.

A 4-week parallel-group, double-blind study comparing isoxicam with naproxen was carried out in patients with rheumatoid arthritis. Both isoxicam and naproxen were found to be effective. In patients on isoxicam significant improvements in the articular index, grip strength, joint swelling, morning stiffness and the patients' overall clinical condition were observed: the results for naproxen were similar, but joint swelling did not improve. At the 2-week assessment naproxen produced significantly better results than isoxicam in terms of the articular index and the physician's assessment of the patients' condition, but this difference was not maintained at the 4-week assessment. This apparently more rapid onset of activity of naproxen is probably related to its shorter elimination half-life. No adverse experiences were reported during isoxicam treatment and this drug was better tolerated than naproxen.

Adult↗
PubMed1981

Reduction by naproxen of excessive menstrual bleeding in women using intrauterine devices.

Thirty-four patients using intrauterine contraceptive devices and experiencing excessive menstrual bleeding (more than 80 ml average loss for 2 cycles) were treated with the prostaglandin synthetase inhibitor naproxen. The trial was conducted according to a double-blind placebo-controlled crossover design. Each patient received 2 of 3 treatments: naproxen in high dose (1250 mg/day for 5 days), naproxen in low dose (500-mg loading dose, than 750 mg/day for 5 days), or placebo. Each treatment was taken during 2 consecutive menstruations. When all data were pooled, statistically significant reduction in menstrual bleeding was found with both high- and low-dose naproxen treatment compared with placebo therapy (P < .002). Low- and high-dose naproxen reduced menstrual blood loss by 22% and 32%, respectively, whereas the change with placebo was minimal. Although the dose had no significant effect on mean menstrual loss, the number of treatment cycles in which menstrual blood loss was reduced by 50% as compared with pretreatment cycles strongly suggested a dose response. In almost 60% of naproxen-treated cycles, mean menstrual blood loss was less than 80 ml, whereas during placebo-treated cycles the distribution of menstrual loss was similar to that of control cycles.

Clinical Trials as Topic↗