Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0000737 (abdominal pain)
 31,184 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

A 6-month, double-blind, controlled, randomized, parallel study was performed to compare the efficacy and tolerance of nabumetone (1000 mg at bedtime) with naproxen (250 mg twice daily) in the treatment of osteoarthritis. Five efficacy parameters were evaluated: patient's assessment of overall osteoarthritis activity and pain, physician's assessment of overall osteoarthritis activity and pain, and physician's assessment of pain with respect to a defined activity. All 40 patients entered (20 in each group) were available for evaluation of tolerance and 36 patients for efficacy analysis (18 in each group). The efficacy results revealed significant improvement in all five parameters for each medication except measurement of pain with respect to a defined activity for naproxen (p less than 0.07). The frequency of possible or probable drug-related adverse experiences was high for both drugs. However, only 1 patient left the study because of a probable drug-related adverse experience (abdominal pain in a nabumetone patient). Six nabumetone and 4 naproxen patients dropped out of the study because of lack of efficacy. The results indicate that nabumetone and naproxen have comparable efficacy and tolerance at the dosage used, and suggest that a single night-time dosage of nabumetone may be a convenient and useful treatment for osteoarthritis.
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PMID:A 6-month, double-blind study comparing nabumetone to naproxen in the treatment of osteoarthritis. 331 20

71 patients with variously located osteoarthrosis or primary fibromyalgic syndrome were treated with oral diacereine (DAR). The case series was accumulated in successive periods and may be divided into three groups. An "open" test on DAR (100 mg/die for 4 weeks) was conducted on the first group of 31 arthrosis patients. On the second group of 20 other arthrosis patients a "double-blind, cross-over" test was carried out using DAR (100 mg/die) and naproxene (500 mg/die) both for 2 weeks. The third group of 20 patients with fibromyalgia was treated with DAR alone: 100 mg/die 5 days a week for 12 weeks. The efficacy of the treatment was judged on the basis of the following parameters: rest pain, pressure pain, pain on active and passive movement, and functional limitation. In the first group a positive therapeutic effect was noted in 20 cases (68.9%). There were side effects (moderate diarrhea) in 3 patients 2 of whom suspended treatment. In the second group, DAR and naproxene had an almost identical effect. However 7 patients (36.8%) expressed a preference for DAR, 9 (47.4%) expressed no preference and only 3 (15.8%) preferred naproxene. Side effects were encountered in 3 patients treated with naproxene (2 cases of epigastralgia and pyrosis and 1 case of dyspnea so marked as to require suspension of treatment) and in 3 treated with DAR (modest diarrhea). In the third group, a positive therapeutic effect was noted in 68.4% of the patients with fibromyalgia with a 15% incidence of side effects consisting of slight abdominal pain (diarrhea caused suspension of treatment in 1 case only). Blood chemical parameters were studied in all three groups and no alterations attributable to the treatment were found. The obtained result suggests that the new drug is effective and well tolerated in the envisaged indications.
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PMID:[Diacereine: an original approach in the treatment of degenerative and/or extra-articular rheumatism]. 354 79

A 68-year-old man without previous hepatobiliary or pancreatic disease was admitted after five attacks of nausea, vomiting, abdominal pain and high fever. Laboratory investigations indicated cholestatic liver disease and pancreatitis. For 1.5 years the patient had occasionally been taking a non-steroidal anti-inflammatory drug, sulindac (clinoril, MSD, New York), for osteoarthritis. On suspicion of a drug-associated disease, a rechallenge experiment was performed with sulindac. Five hours after drug administration symptoms recurred. There was a pronounced increase in serum alkaline phosphatase and amylase. A liver biopsy 3 d later showed portal tract inflammatory infiltration and abnormal interlobular bile ducts with degeneration and necrosis of the epithelium and neutrophilic infiltration of the ducts. Sulindac-induced cholangitis has not been described previously. The pathogenetic mechanism is considered to be an immunoallergic idiosyncratic reaction to the active metabolite of sulindac absorbed by the bile duct epithelium. The lesion is apparently reversible.
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PMID:Acute cholangitis and pancreatitis associated with sulindac (clinoril). 362 32

This was a double-blind study designed to compare the efficacy and tolerability of diclofenac/misoprostol and diclofenac in patients with acute tendinitis/bursitis of the shoulder. Diclofenac 50mg/misoprostol 200 micrograms (n = 185) or diclofenac 50mg (n = 187) was administered twice or 3 times daily for 14 days. Various physician's and patient's assessments performed during and at the end of treatment showed similar improvements with both treatments. Abdominal pain, nausea and vomiting occurred somewhat more frequently with diclofenac/misoprostol, but patient withdrawals due to adverse events did not differ markedly between the groups. Thus, in the short term treatment of acute tendinitis/bursitis of the shoulder diclofenac/misoprostol possesses efficacy similar to that with diclofenac alone and provides the gastroprotective benefit of misoprostol. Previous studies in osteoarthritis and rheumatoid arthritis have established diclofenac/misoprostol to be as effective as diclofenac but with significantly less gastrointestinal damage (Verdickt et al. 1992).
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PMID:Diclofenac/misoprostol vs diclofenac/placebo in treating acute episodes of tendinitis/bursitis of the shoulder. 768 84

The safety of a fixed combination of diclofenac 50mg/misoprostol 200 micrograms has been evaluated in clinical trials involving almost 2000 patients. Short term trials have been conducted in patients with osteoarthritis (n = 1032) and rheumatoid arthritis (n = 685) over 1 or 3 months. Patients randomly received either diclofenac alone or diclofenac/misoprostol. In both groups, the most frequently reported adverse events were gastrointestinal in nature, with abdominal pain reported most frequently (in 22.6% of patients receiving diclofenac/misoprostol and 19.8% of patients receiving diclofenac), followed by diarrhoea (19.5 vs 11.3%), nausea (11.0 vs 6.5%) and dyspepsia (10.6 vs 7.8%). The most frequent nongastrointestinal adverse event was headache, which occurred in 7.9% of diclofenac/misoprostol recipients and 9.3% of diclofenac recipients. Although diclofenac/misoprostol was associated with a slightly higher prevalence of adverse events than diclofenac in these studies, the majority were of mild or moderate severity, and the treatment groups were similar as regards the number of patient withdrawals resulting from adverse events. An interim analysis of the results of an ongoing trial of longer term administration of diclofenac/misoprostol (for up to 24 months) has been conducted. In this uncontrolled study, patients with rheumatoid arthritis, osteoarthritis or ankylosing spondylitis received diclofenac/misoprostol for up to 24 months; to date 1003 patients have been enrolled and treatment has been continued for 6, 12, 18 and 24 months in 640, 327, 108 and 13 patients, respectively. As in the short term trials, the adverse events reported most commonly in this study have been predominantly gastrointestinal.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Review of the safety of diclofenac/misoprostol. 768 86

The comparative safety of nabumetone (1,000-2,000 mg/day) versus diclofenac (100-200 mg/day), naproxen (500-1,500 mg/day), piroxicam (10-20 mg/day), and ibuprofen (1,200-3,200 mg/day) was evaluated in a 12-week, randomized, open-label, multicenter study. Patients with osteoarthritis (OA) or rheumatoid arthritis (RA) were enrolled in a 3:1 ratio (nabumetone:one of the four comparator NSAIDs). The incidence of > or = 1 adverse event considered by the investigator to be related or probably related to therapy was similar in all groups. However, significantly (p < 0.02) more diclofenac-treated patients experienced abdominal pain and/or gastritis than nabumetone-treated patients. Naproxen-treated patients experienced significantly (p < 0.002) more dyspepsia as compared with patients treated with nabumetone or ibuprofen and significantly (p < or = 0.001) more nabumetone-treated patients experienced diarrhea than patients treated with naproxen, ibuprofen, or piroxicam. Ulcers occurred in one (0.03%) nabumetone-treated patient versus six (0.5%) patients treated with one of the comparator NSAIDs (p = 0.001). A decrease in hemoglobin > or = 1.5 g/dL occurred in fewer nabumetone-treated patients than in patients treated with diclofenac (p < 0.04), ibuprofen (p < or = 0.04), or piroxicam (p = 0.055). Finally, a similar percentage of patients in all treatment groups withdrew from the study because of adverse events related or probably related to treatment. More (p < 0.001) diclofenac-treated patients withdrew because of elevated hepatic transaminases than patients treated with the other agents. Withdrawal because of gastritis was also noted for more diclofenac-treated patients than nabumetone-treated patients (p < 0.04). In conclusion, nabumetone was demonstrated to be at least as safe as diclofenac, piroxicam, ibuprofen, and naproxen as related to subjective complaints, such as dyspepsia or gastritis. However, more serious events, such as ulcers or meaningful decreases in hemoglobin, seem to occur less often with nabumetone.
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PMID:Safety experience with nabumetone versus diclofenac, naproxen, ibuprofen, and piroxicam in osteoarthritis and rheumatoid arthritis. 835 97

In a randomized, open-label, controlled, multicenter, 12-week study, the efficacy and safety of nabumetone (1,000-2,000 mg/day) versus diclofenac (100-200 mg/day), naproxen (500-1,500 mg/day), ibuprofen (1,200-3,200 mg/day), or piroxicam (10-20 mg/day) were evaluated in patients with osteoarthritis (OA) or rheumatoid arthritis (RA). The results in elderly patients (> or = 65 years of age) are presented. Nabumetone was as effective as the comparator nonsteroidal antiinflammatory drugs (NSAIDs) in the treatment of elderly OA and RA patients. Ibuprofen and diclofenac caused significantly (p < 0.05) more abdominal pain than nabumetone (8.5%, 13.1%, and 4.1%, respectively). The frequency of abdominal pain was dose related for all NSAIDs except nabumetone. Diarrhea was reported by significantly (p < 0.02) more nabumetone-treated (6.6%) than ibuprofen-treated (0.9%) elderly patients, but the incidence of diarrhea was not dose related. There were no clinically significant changes in renal function with nabumetone or the comparator NSAIDs. A significant change in hepatic enzymes occurred in elderly patients treated with diclofenac (3.3%), which was different than for patients treated with nabumetone (p < 0.04), naproxen (p < 0.06), or ibuprofen (p < 0.06). With regard to withdrawals for adverse events, more (p < 0.04) piroxicam-treated patients (4.9%) withdrew than nabumetone-treated patients (1%). In addition, doubling the dose of nabumetone from 1,000 mg/day to 2,000 mg/day did not result in a proportional increase in adverse events. However, with the comparator NSAIDs, proportional increases in adverse events occurred with increased dose. Finally, the efficacy and safety of nabumetone in elderly patients were similar to the efficacy and safety observed in nonelderly patients.
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PMID:Efficacy and safety of nabumetone versus diclofenac, naproxen, ibuprofen, and piroxicam in the elderly. 835 98

Meloxicam is a new once daily non-steroidal anti-inflammatory drug (NSAID). Double-blind trials in over 5000 patients with osteoarthritis and rheumatoid arthritis have shown that meloxicam 7.5 mg and 15 mg are significantly more effective than placebo and comparable in efficacy to standard NSAIDs such as naproxen 750-1000 mg, piroxicam 20 mg and diclofenac 100 mg slow release. In a global safety analysis, both meloxicam doses produced significantly fewer gastrointestinal (GI) side effects than the comparators (p < 0/05). Severe GI side effects, discontinuations due to GI side effects and less serious events such as dyspepsia and abdominal pain were also significantly less frequent with meloxicam. Perforations, ulcerations and bleedings occurred in 0.1%, 0.2%, 1.2%, 0.6% and 2.1% of meloxicam 7.5 mg, 15 mg, piroxicam, diclofenac and naproxen patients respectively (p < 0.05 for piroxicam and naproxen compared with meloxicam). This improved safety profile is likely to be due to meloxicam's selective inhibition of COX-2 relative to COX-1.
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PMID:Review of clinical trials and benefit/risk ratio of meloxicam. 862 79

Meloxicam is a new preferential cyclooxygenase-2 (COX-2) inhibitor for the treatment of rheumatic disease. This paper presents a global safety analysis of data from meloxicam clinical studies, focusing on gastrointestinal (GI) adverse events. Meloxicam 7.5 and 15 mg (n = 893 and 3282) were compared with piroxicam 20 mg (n = 906), diclofenac 100 mg slow release (n = 324) and naproxen 750-1000 mg (n = 243). With respect to all GI adverse events, meloxicam 7.5 and 15 mg were significantly better than all comparators in a pooled analysis of double-blind studies in rheumatoid arthritis (RA) and osteoarthritis (OA). When examining non-serious GI events, severe GI events, discontinuous due to GI events, dyspepsia, abdominal pain and upper GI events, both meloxicam doses were significantly better than comparator non-steroidal anti-inflammatory drugs (NSAIDs) in most cases. Where statistical significance was not demonstrated, there was generally a trend in favour of meloxicam. With respect to upper GI perforations, ulcerations and bleedings, the most serious of NSAID-associated side-effects, meloxicam was better tolerated than the comparators, reaching statistical significance for piroxicam and naproxen. Meloxicam's improved GI safety profile is likely to be due to its preferential inhibition of inducible COX-2 relative to constitutive COX-1.
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PMID:Safety of meloxicam: a global analysis of clinical trials. 863 Jun 41

An investigator-blind, parallel-group, multicentre study was undertaken to compare the efficacy and tolerability of once-daily, sustained-release (s-r) ibuprofen and diclofenac sodium in patients (mean age 59.8 years) suffering from painful osteoarthritis affecting chiefly the knee and/or hip. Patients attending eight Swiss centres received either two s-r tablets of ibuprofen (daily dose 1600 mg; n = 30) or a single s-r diclofenac 100 mg tablet (n = 31) each evening for 21 days. Clinical assessments were performed prior to initiating therapy and after 7 and 21 days of treatment. Both treatments were efficacious, but statistically significant differences in favour of s-r ibuprofen were observed for the principal measure of efficacy, the investigator's assessment of the overall change in clinical condition; by Day 21, 37% of ibuprofen-treated patients vs 10% of diclofenac-treated patients were 'much improved' (p = 0.04). Patients' assessments of the efficacy of their treatment also favoured s-r ibuprofen at Day 7 for the relief of night pain (p = 0.048), at Day 21 for alleviation of day pain (p = 0.006) and for the ability to carry out normal activities (p = 0.01), and at both Days 7 and 21 for quality of sleep (p = 0.04 and 0.03, respectively). The patients' overall opinion of treatment was also significantly in favour of s-r ibuprofen, which was rated 'good or excellent' by 80% (24/30), compared with only 38% of patients (11/29) receiving s-r diclofenac sodium (p = 0.002). Two patients (6%) receiving s-r diclofenac sodium ceased treatment owing to dizziness and severe diarrhoea, respectively; there were no withdrawals in the ibuprofen-treated group. Ten (32%) patients in the s-r diclofenac group reported a total of 12 adverse events (mostly gastrointestinal in nature), compared with three (10%) patients in the s-r ibuprofen group who reported only three events (abdominal pain, insomnia and constipation). In conclusion, although both NSAID treatments improved the clinical condition of patients with painful osteoarthritis, statistically significant differences in favour of once-daily s-r ibuprofen (1600 mg) were demonstrated in terms of efficacy, indicating a potential therapeutic advantage for this formulation. Ibuprofen was also better tolerated than diclofenac sodium (100 mg/day), the latter being associated with gastrointestinal side effects in a significant proportion of patients. Sustained-release ibuprofen (Brufen Retard) thus represents an important addition to the available therapeutic armamentarium of once-daily NSAID formulations.
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PMID:Ibuprofen and diclofenac sodium in the treatment of osteoarthritis: a comparative trial of two once-daily sustained-release NSAID formulations. 901 Jun 10


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