Safety and efficacy of nabumetone in osteoarthritis: emphasis on gastrointestinal safety.
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AIM: To compare the efficacy and gastrointestinal (GI) safety of nabumetone with two comparator non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac SR and piroxicam. METHODS: Two randomized, double-blind, multicentre, parallel group trials were carried out in patients with moderate to severe osteoarthritis of the hip or knee. During the 6 month treatment phase, the safety and efficacy of nabumetone (1500-2000 mg/day) was compared to diclofenac SR (100 mg/day) or piroxicam (20-30 mg/day). GI safety was evaluated by reviewing all adverse events reported during the trials and presenting all cases of ulcers (complicated and uncomplicated), as well as other bleeding events that may have been associated with NSAID administration. RESULTS: Most of the efficacy parameters showed no significant differences between the NSAIDs, although diclofenac SR was significantly better than nabumetone in one of 18 efficacy parameters. Nabumetone-treated patients experienced significantly fewer ulcer and bleeding events compared to patients treated with the comparator NSAIDs [1.1% (4/348) vs. 4.3% (15/346), P = 0.01]. Bleeding events, including outright upper or lower GI bleeding or a significant decline in haemoglobin, occurred in significantly fewer patients treated with nabumetone than with the comparator NSAIDs [1.1% (4/348) vs. 3.5% (12/346), P < 0.05]. More importantly, complications associated with either ulcers (perforation) or bleeding (leading to hospitalization or withdrawal) occurred in significantly fewer patients receiving nabumetone [0% (0/348)] than with comparator NSAIDs [1.4% (5/346), (P < 0.05)]. CONCLUSION: The results suggest that nabumetone was similar in efficacy by most criteria to diclofenac SR and piroxicam in relieving the symptoms of osteoarthritis; however, nabumetone's GI safety profile was generally superior to that of both comparator NSAIDs. In the pooled analysis, nabumetone was associated with a significantly lower total incidence of ulcers and bleeding events, and a significantly lower incidence of complications associated with these events. (+info)
Current management of upper gastrointestinal bleeding.
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Over a four-year period, 585 patients were hospitalized for massive upper gastrointestinal bleeding. Endoscopy diagnosed the cause of bleeding in 80% of 200 patients so studied. Selective angiography localized the bleeding site in 12 of 20 patients, and infusion of vasopressor stopped hemorrhage in six. Barium studies was 90% accurate in diagnosing ulcer disease but failed to detect gastritis. One hundred thirty (22%) patients were operated upon for medically uncontrolled bleeding. The proportion of patients requiring surgery fell from 33% in year one to 13% in year four. Benign ulcer disease caused bleeding in 51% of surgical patients, while gastritis was found in 20%, esophageal varices in 15% and stress ulcer in 8%. Overall operative mortality was 29%. Among 38 duodenal ulcer patients, mortality was 18%. Vagotomy and pyloroplasty were more effective than resection in this group. Resection for distal gastric ulcers in 22 patients resulted in a mortality of 14% and no rebleeding. While V&P controlled bleeding in 12 alcoholics with gastritis, five (42%) died postoperatively. Mortality among 20 patients with esophageal varices was 35%, although all five survived who had porto-caval shunts. Eight of 10 patients operated upon for stress ulcer bleeding died. Postoperative rebleeding occurred in 14 patients, eight of whom were again operated upon. In all but one a new lesion was found to be responsible for hemorrhage. Increasing use of gastroscopy and selective angiography can be expected to improve diagnostic capabilities in patients with upper gastrointestinal bleeding. Infusing vasopressor into selected arteries should reduce the need for surgical control of gastritis, variceal and stress ulcer bleeding, conditions poorly managed by current operative techniques. (+info)
Emergency arteriography in acute gastrointestinal bleeding.
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Emergency arteriography was carried out on 35 patients with acute gastrointestinal bleeding, in 31 of them within two hours of active bleeding (a haematemisis; a diagnostic change in central venous pressure, pulse rate, or blood pressure; or gastric aspiration of fresh blood). A definite site of bleeding was identified in 27 patients (77%)-this being a small-intestinal vascular abnormality in three--and a probable site in three. Confirmation of the bleeding site was obtained in 20 out of 23 patients treated surgically. An intra-arterial vasoconstrictor infusion was given as a temporary measure before surgery in seven patients, only one of whom showed active bleeding at operation. An intra-arterial vasoconstrictor infusion was tried as definitive treatment in an additional 10 patients, but in four out of seven with a chronic ulcer bleeding recurred after 5-68 hours and was therefore treated surgically. We recommend the diagnostic use of arteriography in patients with reliable evidence of active bleeding if its site cannot be determined by endoscopy. We do not recommend its therapeutic use in those with a chronic ulcer, except to facilitate resuscitation before surgery; further studies are needed to define its role in those with an acute lesion. (+info)
Comparison of emergent endoscopy and upper gastrointestinal series radiography in acute upper gastrointestinal haemorrhage.
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A prospective study of early diagnostic procedures in acute upper gastrointestinal haemorrhage was conducted in a series of 76 patients. The diagnostic procedures included upper gastrointestinal series radiography (UGIS) and endoscopy (ENDO). The clinicians' diagnosis and management improved in a statistically significant way as a result of the findings of endoscopy. The findings of UGIS did not significantly improve diagnostic accuracy and resulted in a statistically significant adverse effect on patient management. The results suggest that endoscopy is more effective in promoting early accurate diagnosis and management in patients with acute upper gastrointestinal haemorrhage. (+info)
Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers.
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BACKGROUND: After endoscopic treatment of bleeding peptic ulcers, bleeding recurs in 15 to 20 percent of patients. METHODS: We assessed whether the use of a high dose of a proton-pump inhibitor would reduce the frequency of recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. Patients with actively bleeding ulcers or ulcers with nonbleeding visible vessels were treated with an epinephrine injection followed by thermocoagulation. After hemostasis had been achieved, they were randomly assigned in a double-blind fashion to receive omeprazole (given as a bolus intravenous injection of 80 mg followed by an infusion of 8 mg per hour for 72 hours) or placebo. After the infusion, all patients were given 20 mg of omeprazole orally per day for eight weeks. The primary end point was recurrent bleeding within 30 days after endoscopy. RESULTS: We enrolled 240 patients, 120 in each group. Bleeding recurred within 30 days in 8 patients (6.7 percent) in the omeprazole group, as compared with 27 (22.5 percent) in the placebo group (hazard ratio, 3.9; 95 percent confidence interval, 1.7 to 9.0). Most episodes of recurrent bleeding occurred during the first three days, which made up the infusion period (5 in the omeprazole group and 24 in the placebo group, P<0.001). Three patients in the omeprazole group and nine in the placebo group underwent surgery (P=0.14). Five patients (4.2 percent) in the omeprazole group and 12 (10 percent) in the placebo group died within 30 days after endoscopy (P=0.13). CONCLUSIONS: After endoscopic treatment of bleeding peptic ulcers, a high-dose infusion of omeprazole substantially reduces the risk of recurrent bleeding. (+info)
Ulcer-healing drugs are required after eradication of Helicobacter pylori in patients with gastric ulcer but not duodenal ulcer haemorrhage.
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AIM: To study the efficacy of a 2-week anti-Helicobacter therapy in the healing of H. pylori-associated bleeding peptic ulcers. METHODS: Omeprazole 20 mg, clarithromycin 500 mg and amoxycillin 1 g, twice daily, were given for 2 weeks to 180 patients with H. pylori-associated bleeding peptic ulcers. Endoscopy was repeated 4 weeks after the eradication therapy to assess healing of the peptic ulcers. RESULTS: Repeat endoscopies were performed in 168 patients (42 gastric ulcer and 126 duodenal ulcer) who followed the protocol. Thirty-eight patients with bleeding gastric ulcers and 124 patients with bleeding duodenal ulcers healed 4 weeks after treatment (per protocol analysis; gastric ulcer: 91% vs. duodenal ulcer: 98%; P=0. 035). No patients who were compliant to the study medications suffered from re-bleeding. Stepwise discriminant analysis demonstrated that small ulcers (< 15 mm) and the presence of duodenal ulcers best predicted healing of the peptic ulcers. CONCLUSIONS: Ulcer-healing drugs should be continued after a 2-week course of omeprazole-containing anti-Helicobacter therapy for gastric ulcers and large peptic ulcers that have bled, but can be omitted in most patients with a bleeding duodenal ulcer. (+info)
Helicobacter pylori infection in sickle cell disease.
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Abdominal pain is a common presenting symptom in adults with sickle cell disease (SCD). One case of Helicobacter pylori gastritis has been reported in a child with sickle cell anemia. H. pylori-induced peptic ulcer disease (PUD) has not previously been reported in adults with SCD. We report eight cases of H. pylori infection in adult sickle cell patients presenting with acute or recurrent abdominal pain and/or gastrointestinal bleeding. In all cases, H. pylori serology (IgG) was positive, and three patients had gastric or duodenal ulcer by endoscopic examination. All patients responded to H. pylori treatment with complete resolution of symptoms by 4 weeks. The prevalence of H. pylori infection in SCD is unknown, but patients may be at increased risk for H. pylori-induced PUD and complications due to pre-existing anemia, increased nonsteroidal anti-inflammatory drug use, and alloimmunization which may delay necessary transfusion. It is important that the differential diagnosis of abdominal pain in adults with SCD include nonsickle cell-related disorders such as PUD. When confirmed, a definitive etiology of PUD must be determined so that appropriate treatment strategies can be initiated promptly and excess morbidity avoided. (+info)
Acid suppression in peptic ulcer haemorrhage: a 'meta-analysis'.
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BACKGROUND: The use of acid-decreasing agents in the management of peptic ulcer haemorrhage continues to be controversial. Most clinical trials examining the efficacy of these drugs contain small numbers of patients, making it difficult to draw conclusions about their efficacy. METHODS: We report a meta-analysis that examined the effect of these drugs in the management of peptic ulcer haemorrhage. Included studies were located using a search of the Medline database between 1980 and 1999. Studies were published in English, randomized and controlled by a placebo group. Mantel-Haenszel and blinded random models were used in conducting the statistical processing of this meta-analysis. RESULTS: Twenty-one randomized placebo-controlled trials were included. The total number of patients was 3566 and the mean study size was 170 (range 20-1005). Seventeen of the papers assessed the efficacy of H2-antagonists, three assessed proton pump inhibitors and one was concerned with antacid therapy. The meta-analysis showed a significant reduction in re-bleeding rates (odds ratio, OR 0.727, 0.618-0.855, P < 0.001) and surgery rates (OR 0.707, 0.582-0.859, P < 0.001) when acid decreasing agents are used for acute peptic ulcer haemorrhage. Mortality rates appear to be unaffected (OR 1.140, 0.818-1.588, P=0. 49). CONCLUSIONS: This meta-analysis demonstrates a significant beneficial effect of acid-decreasing agents in lowering re-bleeding and surgery rates, but demonstrated no effect upon mortality. (+info)