Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0013395 (dyspepsia)
 4,879 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

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

A markedly obese 54 year old woman with seropositive rheumatoid arthritis, anaemia, dyspepsia, controlled hypothyroidism and depression presented with a seven month history of large pyoderma gangrenosum ulcers on the shins. Routine dressings for the ulcers had been ineffective. Her arthritis was being treated with azathioprine and NSAID's. Initial treatment with clobestasol propionate and disodium cromoglycate under occlusion produced only partial healing. Introduction of Cyclosporin A and continuation of topical therapy, with the addition of triamcinolone acetonide injections, led to progressive healing which was complete after seven months. There has been no relapse to date. Cyclosporine can be combined with azathioprine and local therapy for successful treatment of pyoderma gangrenosum.
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PMID:Cyclosporine, azathioprine and local therapy for pyoderma gangrenosum. 799 94

The efficacy and safety of a sustained-release (SR) formulation of etodolac were compared with those of conventional etodolac in two separate, randomized, double-blind, multicenter, 6-week trials. This report presents an interim analysis of the data from these studies. One study included 174 patients with rheumatoid arthritis (RA): 58 received etodolac SR 400 mg once daily (q.d.), 59 received etodolac SR 600 mg q.d., and 57 received etodolac 200 mg twice daily (b.i.d.). The second study included 230 patients with osteoarthritis (OA): 80 patients received etodolac SR 400 mg q.d., 76 received etodolac SR 600 mg q.d., and 74 received etodolac 300 mg b.i.d. Efficacy was evaluated by physician's global and patient's global assessment (both studies), number of painful joints (RA study), number of swollen joints (RA study), pain intensity (OA study), and weight-bearing pain (OA study). The interim analyses of the data from the studies indicates that all three regimens produced significant improvements from baseline in all mean efficacy values at each assessment; there were no significant differences between the treatment groups. The incidence of study events, except for dyspepsia, was comparable among the treatment groups in each study; dyspepsia occurred at a significantly lower rate in patients treated with etodolac SR than in patients treated with the conventional formulation of etodolac. We conclude that etodolac SR is as effective and safe as conventional etodolac for the treatment of patients with RA or OA.
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PMID:A comparison of the efficacy of etodolac SR (Lodine SR) and etodolac (Lodine) in patients with rheumatoid arthritis or osteoarthritis. 821 Sep 19

Effects and side-effects of treating patients with rheumatoid arthritis with methotrexate given as weekly pulse-treatment are examined in an open observation study. One hundred and ten consecutive patients with active rheumatoid arthritis entered the study. Six criteria of remission were registered as effect variables. Median length of treatment at the time of investigation was 17.8 months. At this point, 34 patients were in complete remission, with a median effect score of five point five out of six possible points. Twenty-nine were in partial remission and 47 (42.7%) had not improved. The median effect score for all patients was three point 6 (95% confidence limits (2-4). Methotrexate treatment was stopped in 24 patients, in 15 of these because of a combination of side-effects and lack of therapeutic response. Prednisone treatment could be discontinued in 20 out of 57 patients during the course of methotrexate treatment. Side-effects were registered in 67 cases (62.7%), and led to treatment being discontinued in 21 cases. Nearly half the side-effects consisted of dyspepsia and rises in amino-transferase levels (48 of 67 patients). Consistently raised amino-transferase levels were found in five cases, all returned to normal after methotrexate was stopped. Serious side-effect were registered in four cases, consisting of two cases of short-term pancytopenia following overdosage and two cases of severe hypoxia following methotrexate-induced alveolitis.
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PMID:[Methotrexate therapy of rheumatoid arthritis. An open observation study of 110 patients with median length of treatment of 17.8 month]. 834 72

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

We conducted a pilot study examining the relative preferences for various nonsteroidal antiinflammatory drug associated adverse gastrointestinal events and misoprostol prophylaxis for these events. Thirty patients with rheumatoid arthritis volunteered to participate. A trained nurse interviewer administered the structured pretested interview. Respondents rated 18 hypothetical health states on a category rating scale with anchors at 0 (immediate death) and 100 (full health for life). Linear contrasts were created to test the null hypotheses of equal preferences, using t tests for correlated means. Our results suggest that respondents place a high value on the avoidance of (in order of decreasing importance) surgery, hospitalization, prophylaxis induced diarrhea and uncomplicated ulcer requiring outpatient treatment. The avoidance of ulcer symptoms (primarily dyspepsia) and the inconvenience of an additional medication taken 4 times daily (in the absence of diarrhea) appeared to be substantially less important from these patients' perspective. Further work is underway to confirm these preliminary findings.
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PMID:Patient preferences for nonsteroidal antiinflammatory drug related gastrointestinal complications and their prophylaxis. 847 76

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

We compared the longterm efficacy and safety of 2 dosages of etodolac with that of ibuprofen in the treatment of active rheumatoid arthritis (RA). The ability of etodolac to retard, arrest, reverse, or heal joint damage due to RA was also evaluated. Patients in the early stages of RA were assigned randomly to 3 parallel groups for up to 3 years of therapy: etodolac at 150 mg bid, etodolac at 500 mg bid, and ibuprofen 600 mg qid. Concurrent disease modifying antirheumatic drugs were not permitted; established low dosage corticosteroid therapy could be continued. A total of 1446 patients was enrolled. About 50% of patients completed one year; dropout rates were comparable between groups. Both etodolac dosages provided comparable efficacy to that of ibuprofen during the first 2 months; longterm assessment showed that 1000 mg/day of etodolac produced superior improvement as assessed by patients' opinions and number of swollen joints. About 2% of patients in each group achieved remission, and radiographs showed no difference in disease progression between treatments. The incidences of adverse events were comparable, although dyspepsia and rash occurred less frequently with 300 mg/day of etodolac than with 2400 mg/day ibuprofen. A higher incidence of gastrointestinal ulcers and bleeding was seen with ibuprofen. Changes in hepatic and renal function were of minor clinical significance and were similar between the 3 groups. Both dosages of etodolac were comparable to 2400 mg/day ibuprofen in treating RA. All 3 treatment regimens were well tolerated.
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PMID:Double blind evaluation of the long-term effects of etodolac versus ibuprofen in patients with rheumatoid arthritis. 903 16

Nonsteroidal antiinflammatory drugs (NSAIDs) exert their actions by inhibiting cyclooxygenase (COX). It has recently been postulated that NSAIDs' antiinflammatory efficacy arises from inhibition of the COX-2 isoform of cyclooxygenase, whereas inhibition of the COX-1 isoform produces the troublesome and sometimes serious gastric and renal side effects of NSAIDs. A relatively selective COX-2 inhibitor, such as meloxicam, may combine antiinflammatory efficacy with improved tolerability. In volunteers, indomethacin 75 mg, but not meloxicam 7.5 mg, inhibited renal prostaglandin E2 excretion and platelet aggregation (COX-1 mediated effects). Double-blind, randomized trials in osteoarthritis and rheumatoid arthritis patients have shown equivalent antiinflammatory efficacy among meloxicam 7.5 mg or 15 mg and diclofenac 100 mg, naproxen 750 mg, and piroxicam 20 mg. In a double-blind, placebo-controlled trial, meloxicam (7.5 or 15 mg) caused less endoscopically detected gastrointestinal (GI) damage (Lanza scale) than piroxicam 20 mg. The MELISSA study, a double-blind, randomized, 28-day trial in over 9,000 patients showed that meloxicam 7.5 mg caused statistically less total GI toxicity, dyspepsia, abdominal pain, nausea and vomiting, and diarrhea than diclofenac 100 mg, despite equivalent reductions in pain on movement for each treatment. A global safety analysis of clinical trials, representing over 5,600 patients and comprising 170 and 1,100 patient-years of exposure for meloxicam 7.5 mg and 15 mg, respectively, showed that meloxicam caused less GI toxicity and fewer peptic ulcers and GI bleeds than naproxen, diclofenac, or piroxicam. The renal safety profile and incidence of liver function abnormalities with meloxicam is equivalent to other NSAIDs available for clinical use. In conclusion, relatively selective COX-2 inhibition exemplified by meloxicam may offer effective symptom relief with an improved GI tolerability profile.
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PMID:Meloxicam: selective COX-2 inhibition in clinical practice. 921 16


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