Celecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: results of a randomized double-blind trial

BACKGROUND & AIMS: The gastric safety of cyclooxgenase-2 inhibitors and prophylactic antisecretory therapy in high-risk arthritis patients is unclear. We studied the ulcer incidence and factors predicting ulcer recurrence in a prospective, double-blinded trial. METHODS: We studied patients who presented with nonsteroidal anti-inflammatory drug-associated ulcer bleeding. After ulcer healing, patients who were negative for Helicobacter pylori were randomly assigned to celecoxib 200 mg twice a day plus omeprazole placebo once daily or diclofenac 75 mg twice daily plus omeprazole 20 mg once daily for 6 months. Patients underwent endoscopy if they developed recurrent bleeding. Those without recurrent events underwent endoscopy at their last follow-up visit. RESULTS: Two hundred eighty-seven patients were enrolled; 24 had recurrent gastrointestinal complications. Among 259 patients without events, 222 underwent endoscopy (116 received celecoxib and 106 received diclofenac plus omeprazole). The probability of recurrent ulcers in 6 months was 18.7% in the celecoxib group and 25.6% in the diclofenac plus omeprazole group (difference, -6.7%; 95% CI: -17.8% to 3.9%) (P = 0.21). Combining bleeding and endoscopic ulcers, 24.1% in the celecoxib group and 32.3% in the diclofenac plus omeprazole group had recurrent ulcers in 6 months (difference, -8.2%; 95% CI: -19.5% to 2.9%) (P = 0.15). Treatment-induced significant dyspepsia (hazard ratio, 5.3; 95% CI: 2.6-10.8), age > or =75 (hazard ratio, 2.0; 95% CI: 1.1-3.5), and comorbidity (hazard ratio, 2.1; 95% CI: 1.2-3.7) independently predicted ulcer recurrence. CONCLUSIONS: Among patients with previous ulcer bleeding, neither celecoxib nor diclofenac plus omeprazole adequately prevents ulcer recurrence. Treatment-induced significant dyspepsia is an indication for endoscopic evaluation.     

Long-term outcome of Helicobacter pylori-negative idiopathic bleeding ulcers: a prospective cohort study

BACKGROUND & AIMS: Helicobacter pylori-negative idiopathic ulcers are increasingly recognized. The secular trend and long-term outcome of this condition are unknown. METHODS: We prospectively studied consecutive patients with bleeding gastroduodenal ulcers from January to December 2000. The incidence and etiology of ulcers during this period were compared with that between September 1997 and August 1998. H. pylori-negative idiopathic ulcers were defined as negative tests for H. pylori, no exposure to analgesics within 4 weeks, and absence of other risk factors for ulcers. After the ulcers had healed, patients with H. pylori-negative idiopathic ulcers and patients with H. pylori ulcers who received eradication therapy were followed up for 12 months without anti-ulcer drugs. RESULTS: Six hundred thirty-eight patients had bleeding ulcers: 213 (33.4%) were H. pylori ulcers, and 120 (18.8%) were H. pylori-negative idiopathic ulcers (vs 480 [50.3%] H. pylori ulcers and 40 [4.2%] H. pylori-negative idiopathic ulcers in 1997-1998; P < .001). H. pylori-negative idiopathic ulcers accounted for 16.1% of patients who were admitted for bleeding and 42.4% of patients who bled while in the hospital (P < .0001); 28.3% of patients with H. pylori-negative idiopathic ulcers had histologic evidence of past H. pylori infection. The probability of recurrent ulcer complications in 12 months was 13.4% (95% CI: 7.3%-19.5%) in patients with H. pylori-negative idiopathic ulcers and 2.5% (95% CI: 0.4%-4.6%) in patients with H. pylori ulcers who received eradication therapy (P = .0002). CONCLUSIONS: The incidence of H. pylori-negative idiopathic bleeding ulcers is rising. These ulcers are prone to recurrent complications.     

22G versus 25G biopsy needles for EUS-guided tissue sampling of solid pancreatic masses: a randomized controlled study

Background/Objectives: No comparative study of 22-gauge biopsy needles (PC22) and 25-gauge biopsy needles (PC25) has been conducted. We prospectively compared the diagnostic accuracy of PC22 and PC25 in patients with pancreatic and peripancreatic solid masses.

Methods: We conducted a randomized noninferiority clinical study from January 2013 to May 2014 at Samsung Medical Center. A cytological and histological specimen of each pass was analyzed separately by an experienced pathologist. The primary outcome was to assess the diagnostic accuracy using the PC22 or PC25. Secondary outcomes included the optimal number of passes for adequate diagnosis, core specimen yield, sample adequacy, and complication rates.

Results: Diagnostic accuracy of combining cytology with histology in three cumulative passes was 97.1% (100/103) for the PC22 and 91.3% (94/103) for the PC25 group. Thus, noninferiority of PC25 to PC22 was not shown with a 10% noninferiority margin (difference, ?5.8%; 95% CI, ?12.1 to ?0.5%). In a pairwise comparison with each needle type, two passes was non-inferior to three passes in the PC22 (96.1% vs. 97.1%; difference, ?0.97%; 95% CI ?6.63 to 4.69%) but noninferiority of two passes to three passes was not shown in the PC25 group (87.4% vs. 91.3%; difference, ?3.88%; 95% CI, ?13.5 to 5.7%).

Conclusions: Non-inferiority of PC25 to PC22 diagnostic accuracy was not observed for solid pancreatic or peripancreatic masses without on-site cytology. PC22 may be a more ideal device because only two PC22 needle passes was sufficient to establish an adequate diagnosis, whereas PC25 required three or more needle passes.     

A randomized trial comparing heparin initiation 6 h or 24 h after pacemaker or defibrillator implantation

OBJECTIVES

The purpose of this randomized study was to evaluate the prevalence of pocket hematomas in patients treated with heparin 6 h or 24 h after pacemaker or defibrillator implantation.

BACKGROUND

The risks of pocket hematoma and need for evacuation after device implantation have not been defined in patients who require anticoagulation.

METHODS

Forty-nine consecutive patients with an indication for anticoagulation with heparin after implantable defibrillator or pacemaker implantation were randomized to receive intravenous heparin either 6 h (n = 26) or 24 h (n = 23) postoperatively. Both groups also received warfarin on a daily basis starting the evening of surgery. Twenty-eight patients who received postoperative warfarin alone and 115 patients who did not receive anticoagulation were followed up in a study registry.

RESULTS

A pocket hematoma developed in 6 of 26 patients (22%) who were treated with intravenous heparin 6 h postoperatively, as compared with 4 of 23 patients (17%) who were treated with intravenous heparin 24 h postoperatively (p = 0.7). In total, a pocket hematoma developed in 10 of 49 patients (20%) treated with heparin, 1 of 28 patients (4%) treated with warfarin alone and 2 of 115 (2%) patients who received no anticoagulation (p < 0.001).

CONCLUSIONS

Intravenous heparin initiation 6 h or 24 h after pacemaker or defibrillator implantation is associated with a 20% prevalence of pocket hematoma formation. Warfarin therapy or no anticoagulation is associated with only a 2% to 4% risk of pocket hematoma formation.