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Methods: In six randomized controlled trials (RCTs), patients received linaclotide (72 µg, 145 µg, 290 µg) or placebo daily for 12–26 weeks; in two long-term safety (LTS) studies, patients received open-label linaclotide for ≤78 additional weeks. Laboratory values, vital signs, and treatment-emergent adverse events (TEAEs) were assessed.
Results: Overall, 3853 patients received ≥1 dose of linaclotide. The most common TEAE was diarrhea (majority [90.5% in RCTs] mild/moderate). Linaclotide patients experienced 1.1 diarrhea TEAE per patient-year in the RCTs (0.2 in placebo), and 0.3 in the LTS studies. In RCTs, 6.9% linaclotide and 3.0% placebo patients discontinued due to any adverse event (AE); 4.0% linaclotide and 0.3% placebo patients discontinued due to diarrhea. In LTS studies, 9.4% patients discontinued due to any AE, and 3.8% due to diarrhea. Serious AEs (SAEs) were rare and similar across treatment groups; there were no SAEs of diarrhea.
Conclusion: These pooled analyses of patients treated for ≤104 weeks confirm linaclotide’s overall safety. 相似文献
METHODS: Over an 18-month period a total of 159 asymptomatic adults had polyps seen on computed tomography colonography examination and subsequently underwent planned therapeutic optical colonoscopy. The colonoscopists were aware of the findings on CT colonography prior to further evaluation of the colon. Characteristics of polyps and adenomas seen on subsequent optical colonoscopy but not seen or reported on CT colonography were examined.
RESULTS: The adenoma miss rate for CT colonography overall was 18.9% (25/132) including 6.2% (4/65) for polyps >9 mm and 18.2% (8/44) for polyps 6–9 mm. Three of the adenomas >9 mm not seen on CTC were sessile, and two were found in patients with technically difficult CT colonography studies due to poor colonic distention. No adenomas with advanced pathology <6 mm were found on optical colonoscopy but not reported on CT colonography. False-positive CTC referral where no polyp was seen on colonoscopy was 5.0%.
CONCLUSIONS: CT colonography has adenoma miss rates similar to miss rates historically found with optical colonoscopy, with most missed adenomas being <10 mm and sessile in shape. 相似文献