Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Naproxen”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 307 records · Page 17Linked to original sources
PubMed1993

The efficacy of Na-naproxen after diagnostic and therapeutic arthroscopy of the knee joint.

The purpose of the study was to evaluate the effect of na-naproxen after diagnostic arthroscopy and arthroscopic surgery of the knee joint. In a double-blind trial, 41 patients were randomized to treatment with na-naproxen, and 46 patients were given placebo after surgery. For additional analgesia, patients got acetaminophen if necessary. In patients who underwent arthroscopic surgery, there were no differences between those treated with na-naproxen and those who received placebo in pain levels, but patients receiving na-naproxen had significantly less need for additional analgesia and returned significantly more quickly to work than patients receiving placebo (median 10 versus 30 days). In patients who had only diagnostic arthroscopy, there were no differences between the na-naproxen and placebo groups.

Acetaminophen↗
PubMed1988

Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy.

The pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily. The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances. The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

Adolescent↗
PubMed1991

Sulfate homeostasis. III. Effect of chronic naproxen or sulindac treatment on inorganic sulfate disposition in arthritic patients with renal impairment.

The purpose of the present investigation was to examine the influence of chronic naproxen (500 mg twice daily) or sulindac (200 mg twice daily) therapy on the disposition of inorganic sulfate in arthritic subjects with impaired renal function. Subjects were studied during a control period (after a 7-day NSAID washout) and after 14 days of treatment with either naproxen or sulindac. During the control period subjects in this investigation exhibited higher serum sulfate concentrations and lower sulfate renal clearance values than reported for younger subjects with normal renal function. Treatment with either sulindac or naproxen significantly decreased creatinine clearance. Sulindac therapy also increased the serum sulfate concentration and decreased the clearance of sulfate; a similar trend was observed after naproxen therapy but the average change was smaller and not statistically significant. There were significant correlations between the creatinine and the sulfate clearances or serum concentrations. The glomerular filtration rate of inorganic sulfate was not altered by drug treatment and there was no impairment of reabsorption. The serum concentrations and renal clearance of other electrolytes (sodium, potassium, magnesium, calcium, phosphorus) were largely unaffected. Therefore, chronic treatment with naproxen or sulindac decreases the renal clearance of endogenous sulfate in humans: this appears to be a consequence of the decrement in renal function observed in subjects with preexisting mild renal impairment.

Aged↗
PubMed1982

Relationship of serum naproxen concentration to efficacy in rheumatoid arthritis.

Twenty-four patients with rheumatoid arthritis were tested in a randomized, double-blind. Latin-square comparison of 250, 750 and 1500 mg of naproxen daily. Each received each dose for 2 wk and baseline disease activity was established during withdrawal of medication before and after the study. Nine standard measures of efficacy were tested at each evaluation. No order effect or change in baseline was found. Total and unbound naproxen concentrations were measured by high-pressure liquid chromatography and equilibrium dialysis, respectively. A linear dose-response relationship (P less than 0.05) was demonstrated between naproxen and joint count, patient's pain assessment, activities of daily living index, physician's global assessment, and grip strength. The relationship to patients' global assessment was of uncertain significance (P less than 0.07). A positive dose to serum level correlation (1, 2, and 12 hr after dose) was apparent (r greater than 0.78). When patients were defined as responders or nonresponders by a summed efficacy score, there was a serum concentration-response relationship; the percentage of responding patients increased with each serum level quartile: 25%, 31%, 59%, and 75%. Patients with a trough total serum naproxen concentration under 18 micrograms/ml did not respond, while 76% of patients with trough total serum concentrations above 50 micrograms/ml responded. No serum naproxen toxicity level relationship was established.

Adult↗
PubMed1989

Construction of a naproxen ion-selective electrode and its application to pharmaceutical analysis.

A naproxenate-selective electrode with a liquid membrane consisting of a tetraheptylammonium-naproxenate ion pair dissolved in p-nitrocumene is described. The electrode exhibits a rapid and near-Nernstian response to naproxenate activity from 10(-1) to 10(-4) M at pH 9.0 (borate buffer). No serious interference from common ions and tablet excipients was found and the electrode was used for the direct assay of naproxen tablets by means of the calibration graph technique and of suppositories using the standard additions technique. A dissolution study of naproxen tablets was also carried out and the results compared favourably with those given by the USP XXI methods.

Electrodes↗
PubMed2003

A comparison of the upper gastrointestinal mucosal effects of valdecoxib, naproxen and placebo in healthy elderly subjects.

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.

Administration, Oral↗
PubMed1998

Naproxen incorporated lipid emulsions. I. Formulation and stability studies.

BACKGROUND: Intravenous lipid emulsions stabilized with phospholipids have been an attractive alternative as vehicles for drug delivery, particularly for the parenteral administration of drugs with solubility problems. METHODS: Naproxen (a poorly aqueous soluble non-steroidal anti-inflammatory agent) emulsions were formulated with different types of emulsifiers (soybean lecithin, synperonic PEF-127 and a 50:50 mixture of these). The stability of the various emulsion systems was evaluated at different temperatures (4, 25 and 40 degrees C) for a period of 6 months by measuring changes in pH, droplet size, viscosity and percentage oil separation. The percentage of naproxen incorporation and the degree of haemolysis induced by the different types of emulsion systems was also determined. RESULTS: The emulsifier type showed a pronounced effect on the physicochemical properties of the emulsion systems, whereas storage temperature and time did not. Irrespective of emulsifier type, storage temperature and time, the percentage incorporation of naproxen in emulsions was between 80 and 100%. The degree of haemolysis induced by other emulsion components (dimethylsulfoxide (DMSO) and naproxen solution in DMSO) was about 10 times higher than that induced by emulsion systems. CONCLUSION: Choice of emulsifier is the most important factor in the stability of the naproxen emulsions.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1985

Treatment of acute migraine attack: naproxen and placebo compared.

A double-blind, cross-over, randomized study of acute migraine attack compared treatment results of naproxen with that of placebo. Each treatment period continued for either three months or six migraine attacks, whichever occurred first. The initial dose of naproxen was 750 mg, with additional 250-500 mg doses taken if and when required, to a maximum of five 250 mg tablets within a period of 24 h in each migraine attack. Forty-one patients were enrolled in the study; they had all experienced at least two but not more than eight migraine attacks a month during the preceding year. Thirty-two patients completed the two treatment periods. Naproxen was statistically significantly superior to placebo in reducing the severity of head pain, nausea, and photophobia; in shortening the duration of head pain, nausea, vomiting, photophobia, and lightheadedness; in diminishing the frequency of vomiting; and in decreasing the need for escape medication. Both patient and physician treatment preferences significantly favoured naproxen. Nine side effects were experienced by seven patients while receiving placebo and seven by five patients during naproxen treatment. Mild gastrointestinal discomfort was the main complaint. Only one patient withdrew from treatment because of a side effect, which occurred while receiving placebo.

Acute Disease↗
PubMed1989

Double-blind study of naproxen vs placebo in the treatment of acute migraine attacks.

Naproxen was compared with placebo in a double-blind, crossover trial in classic and common migraine. The trial was terminated at a fixed date; 37 patients had entered, 5 of whom were excluded. Naproxen was given as 750 mg at the first symptom of the attack, a total of 1250 mg per 24 h was allowed. Patients were followed for six attacks or three months in each phase, whichever came first. The severity of the headache was significantly less with naproxen in the first 2 h of the attack (p = 0.047), whereas there was no difference when the whole attack was considered. Significantly more patients preferred naproxen (p = 0.042). Side effects occurred in five patients, causing withdrawal of one patient while on naproxen.

Acute Disease↗
PubMed2002

Efficacy and safety of acetaminophen and naproxen in the treatment of tension-type headache. A randomized, double-blind, placebo-controlled trial.

The objective of this study was to evaluate and compare the efficacy and safety of single doses of acetaminophen (paracetamol) 1000 mg and naproxen 375 mg vs. placebo over a six-hour period in the treatment of tension-type headache. The treatments were compared in a randomized, double-blind, multicentre, placebo-controlled study. Efficacy was evaluated using four standard analgesic summary endpoints (the sum of pain intensity differences from baseline, the maximum pain intensity from baseline, the sum of the pain relief scores, and the maximum pain relief score). Both acetaminophen 1000 mg and naproxen 375 mg were significantly superior to placebo (P or=0.498) for these four endpoints. For example, the mean sum of pain intensity differences from baseline was 9.14+/-0.34 for acetaminophen 1000 mg and 8.81+/-0.35 for naproxen 375 mg compared with 7.42+/-0.34 for placebo. Other efficacy endpoints (percentage of responders (pain reduced to none) at two hours, onset of meaningful relief, time to use of rescue medication and subject's overall impression of study medication) showed similar trends. A significantly larger mean pain intensity difference from baseline was observed for acetaminophen 1000 mg (1.13) than for naproxen 375 mg (0.95) (P=0.036) at one hour after treatment. There was no significant difference among the treatment groups in the incidence of adverse events (P=0.730). In summary, the results of this well-controlled, double-blind study demonstrate that over-the-counter acetaminophen 1000 mg and prescription naproxen 375 mg are effective and well tolerated in the treatment of tough (moderate-to-severe) tension-type headache.

Acetaminophen↗
PubMed1991

Effects of short-term treatment with naproxen on kidney function in insulin-dependent diabetic patients with microalbuminuria.

The renal effects of the prostaglandin synthesis inhibitor naproxen was investigated in eight patients with incipient type I diabetes nephropathy. The patients were treated with 1000 mg naproxen daily for 4 days in a placebo-controlled double-blind cross-over study. Naproxen reduced urinary prostaglandin E2 (PGE2) excretion by 60%, from 276 ng/24 h to 110 ng/24 h (P less than 0.05). Plasma renin activity (PRA) was reduced by 45% (P less than 0.05). Glomerular filtration (GFR) (single bolus 99mTc-DTPA technique) and effective renal plasma flow (ERPF) (131I-Hippuran clearance) were unchanged by naproxen. Microalbuminuria and renal albumin clearance was unchanged as was also urinary excretion of sodium, glandular kallikrein and beta 2-microglobulin (beta 2-M). Our results show that albumin excretion in incipient diabetic nephropathy is not solely dependent on the renal prostaglandin system. The difference in action between naproxen in this study and indomethacin in previous reports, could be caused by renal actions of indomethacin independent of the prostaglandin system.

Adult↗
PubMed2001

Acute postoperative swelling after hand surgery: an exploratory, double-blind, randomised study with paracetamol, naproxen, and placebo.

A model using volumetry to evaluate the effect of drugs on acute postoperative swelling after operations for primary Dupuytren's contracture (DC) and carpal tunnel syndrome (CTS) was established and validated. The temperature of the saline and time of measurement during the day influenced the volumetric readings. The error of measurement after volumetry of unoperated and operated hands after operations for DC was 0.7% and 0.6%, respectively. Naproxen (500 mg twice a day), paracetamol (1000 mg four times a day), or placebo were given postoperatively for three days to 35 patients after DC and 42 patients after CTS in a randomised, placebo-controlled study. Hand volume was measured preoperatively and 72 hours after surgery. There was a difference in swelling (p = 0.009) indicating different degree of development of swelling 72 hours postoperatively between the DC and CTS placebo groups, which invalidated pooling of the data. After operations for DC naproxen was slightly but not significantly superior to paracetamol and placebo, with paracetamol numerically superior to placebo. The power of the study, caused by the limited number of patients included, does not permit this difference to reach significance. Operations for CTS caused so little swelling that comparisons were invalidated. Naproxen treatment, irrespective of type of operation, did not require rescue analgesics, while two patients after CTS treated with paracetamol did. Two and six placebo-treated patients required rescue drugs after operations for DC and CTS, respectively. We conclude that naproxen might have a clinical relevant effect on swelling when used on minor surgery in the hand, unlike paracetamol. Naproxen might be a useful analgesic during the immediate postoperative phase.

Acetaminophen↗
PubMed2001

Naproxen particle design using porous starch.

Naproxen (Nap) was embedded in porous starch by preferential grinding, and we examined the physicochemical properties of these particles, including pore diameter, pore volume, and dissolution of naproxen. Porous starch (PS) particles made by preferential grinding with a Mechanofusion system had a higher content of naproxen than those made using the Mechanomill as determined using a mercury porosimeter. Neither sample showed any significant changes in crystallization state of naproxen in particles as determined by powder X-ray diffraction and differential scanning calorimetry (DSC). No interactions occurred between naproxen and porous starch due to preferential grinding as determined by powder X-ray diffraction and DSC. The dissolution rate of drug from particles prepared by preferential grinding was faster than that from physical mixtures.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1991

Age- and dose-dependent naproxen disposition in Fischer 344 rats.

The effects of age and dose on the pharmacokinetics of naproxen were evaluated in young and senescent male Fischer 344 rats after 2.5 and 25 mg/kg doses. Pharmacokinetic parameters based on free naproxen concentrations demonstrated a significant decrease in free clearance and free steady-state volume of distribution in the aged rats. In vitro enzyme kinetic studies also demonstrated an age-related decline in the metabolic activity and affinity of the metabolic enzymes for naproxen in the aged rats. Plasma protein binding studies revealed a larger free fraction of drug in the plasma of senescent rats. Total clearance and steady-state volume of distribution were indistinguishable between young and old rats owing to the higher free fraction in aged rats. Dose had a significant effect with free clearance and free volume of distribution decreasing as dose increased. The binding of naproxen to plasma proteins was dependent on drug concentration. Unlike the parameters based on free naproxen concentrations, total plasma clearance and volume of distribution increased with increasing dose, due to the nonlinear protein binding.

Aging↗
PubMed1982

Naproxen and indomethacin in periarthritis of the shoulder.

Forty-one patients with periarthritis of the shoulder were entered into a double-blind, parallel comparison of naproxen and indomethacin. Both drugs were given twice daily, naproxen 250 mg in the morning and 500 mg at night and indomethacin 50 mg b.d. Twenty patients received naproxen and 21 received indomethacin. Patients were treated for four weeks. Both drugs significantly reduced pain and patients subjective impression of shoulder restriction, but had little significant effect on objective measurements of mobility. Fourteen patients from the naproxen group and 16 patients from the indomethacin group reported side-effects, the most common being nausea and headache. Three patients stopped naproxen and five patients stopped indomethacin because of side-effects. In conclusion, both drugs were equally effective in treating the pain of periarthritis of the shoulder but did little to change the partial loss of movement associated with the disorder.

Clinical Trials as Topic↗
PubMed2002

A randomized controlled trial examining the effect of naproxen on analgesia during the second day after cesarean delivery.

UNLABELLED: Whereas nonsteroidal antiinflammatory drugs augment spinal morphine on Day l, the analgesia gained by simply combining these drugs with conventional "on request" oral regimens on Day 2 is less clear. In this trial, we randomized 80 women undergoing elective cesarean delivery with spinal morphine (0.2 mg) to receive naproxen (500 mg) or placebo every 12 h after surgery. Both groups received conventional therapy with acetaminophen with codeine (on request) and rescue IM opioids. Incision pain on sitting (IPS), incision pain at rest, uterine cramping, and gas pain were evaluated with visual analog scales (0-100). Worst interval pain (0-10), analgesic use, and side effects were measured over 72 h. At 36 h (primary outcome), naproxen use was associated with reductions in IPS (38.2 +/- 26.0 versus 51.4 +/- 25.7; P = 0.05), incision pain at rest, uterine cramping, and worst interval pain scores. Clinically modest, statistically significant reductions in IPS (P = 0.0001) and opioid use were found over time (P < 0.0l). Reductions in the incidence of inadequate analgesia and improvements in overall pain relief (P = 0.0006) on Day l did not persist on Day 2 (overall pain relief, P = 0.057; inadequate analgesia, 24% naproxen versus 27% controls; P = 1.00). The addition of regular doses of naproxen to conventional oral pain therapy after cesarean delivery leads to reductions in IPS at 36 h and pain over Day 2 but does not reduce the incidence of inadequate analgesia. IMPLICATIONS: This randomized trial suggests that adding regular doses of naproxen to conventional "on request" acetaminophen and codeine therapy provides small reductions in pain on the second day after cesarean delivery. The greatest effects occur at 36 h, when pain peaks.

Adult↗
PubMed1995

Gastric microbleeding following single and repeated dosing with naproxen.

BACKGROUND: Adaptation to gastric damage from nonsteroidal anti-inflammatory drugs (NSAID) has been observed during ongoing dosage in rats and humans. However, this does not always occur, and our previous data suggest that NSAID half-life may be a determining factor. AIM: To investigate whether adaptation occurs during 1 week of naproxen administration in humans. SUBJECTS: Thirteen healthy volunteers were studied at baseline, and after one or seven daily doses of naproxen 750 mg. Gastric microbleeding was measured 4 h after naproxen in gastric washings collected during a 30-min period. Serum thromboxane B concentrations were also assayed, as a marker of cyclo-oxygenase inhibition. RESULTS: Mean blood loss after placebo was 0.60 microL/10 min (95% CI: 0.21-0.98). This rose to 2.15 (0.73-3.57) and 1.75 (0.74-2.76) microL/10 min after one and seven daily doses of naproxen, respectively (P < 0.05 vs. baseline; day 1 vs. 7 not significant). Thromboxane B concentrations were < 10% of control at both day 1 and 7 of dosing. CONCLUSION: In accord with our findings in rats, adaptation to this moderately long acting NSAID in humans was not apparent. We conclude that any adaptation to naproxen is unlikely to be clinically important.

Adaptation, Physiological↗
PubMed1987

Naproxen pharmacokinetics in patients with rheumatoid arthritis during active polyarticular inflammation.

Patients with rheumatoid arthritis often have hypoalbuminaemia as a sign of disease activity. In view of the extensive binding of naproxen to albumin, the pharmacokinetics of total and unbound drug were studied in eight patients and eight healthy male volunteers during chronic intake of 500 mg twice daily. The area under the serum concentration-time curve of total naproxen during a dose interval, AUC (0,12), smaller in patients (641 +/- 101 mg l-1 h) than in volunteers (896 +/- 85 mg l-1 h; P less than 0.0001). The unbound naproxen AUCu (0,12) was larger in patients (1.9 +/- 0.9 mg l-1 h) than in volunteers (0.7 +/- 0.2 mg l-1 h; P less than 0.01). The higher unbound naproxen concentrations in patients were accompanied by an approximately 40% increase in apparent clearance/bioavailability (CL/F) and a 60% increase in volume of distribution (V/F). Both CL/F and V/F were inversely correlated with the individual serum albumin concentration (r = 0.76, P less than 0.001; r = -0.85, P less than 0.001, respectively). The high unbound naproxen concentration in the serum of patients with active rheumatoid arthritis and concomitant hypoalbuminaemia is not known to be accompanied by an increase in side effects and may be beneficial if anti-inflammatory effects correlate with unbound drug concentration.

Acute Disease↗