| 4. |
- Ben-Menachem, Elinor, 1945, et al.
(författare)
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Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies
- 2016
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Ingår i: Neurology. - 0028-3878. ; 87:3, s. 314-323
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To assess the efficacy, safety, and tolerability of adjunctive brivaracetam (BRV), a selective, high-affinity ligand for SV2A, for treatment of partial-onset (focal) seizures (POS) in adults. Methods: Data were pooled from patients (aged 16-80 years) with POS uncontrolled by 1 to 2 antiepileptic drugs receiving BRV 50, 100, or 200 mg/d or placebo, without titration, in 3 phase III studies of BRV (NCT00490035, NCT00464269, and NCT01261325, ClinicalTrials.gov, funded by UCB Pharma). The studies had an 8 -week baseline and a 12 -week treatment period. Patients receiving concomitant levetiracetam were excluded from the efficacy pool. Results: In the efficacy population (n = 1,160), reduction over placebo (95% confidence interval) in baseline-adjusted POS frequency/28 days was 19.5% (8.0%-29.6%) for 50 mg/d (p = 0.0015), 24.4% (16.8%-31.2%) for 100 mg/d (p < 0.00001), and 24.0% (15.3%-31.8%) for 200 mg/d (p < 0.00001). The >50% responder rate was 34.2% (50 mg/d, p 0.0015), 39.5% (100 mg/d, p < 0.00001), and 37.8% (200 mg/d, p = 0.00003) vs 20.3% for placebo (p < 0.01). Across the safety population groups (n = 1,262), 90.0% to 93.9% completed the studies. Treatment -emergent adverse events (TEAEs) were reported by 68.0% BRV overall (n 803) and 62.1% placebo (n = 459). Serious TEAEs were reported by 3.0% (BRV) and 2.8% (placebo); 3 patients receiving BRV and one patient receiving placebo died. TEAEs in >5% patients taking BRV (vs placebo) were somnolence (15.2% vs 8.5%), dizziness (11.2% vs 7.2%), headache (9.6% vs 10.2%), and fatigue (8.7% vs 3.7%). Conclusions: Adjunctive BRV was effective and generally well tolerated in adults with POS.
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| 5. |
- Lindholm, S., et al.
(författare)
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Measuring quality in colorectal cancer surgery in low- and middle-income countries: The Clavien-Dindo classification in a Sri Lankan cohort
- 2022
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Ingår i: Annals of Medicine and Surgery. - : Ovid Technologies (Wolters Kluwer Health). - 2049-0801. ; 79
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Tidskriftsartikel (refereegranskat)abstract
- Background: The colorectal cancer (CRC) incidence is increasing in low- and middle-income countries (LMICs) as part of an ongoing epidemiological transition. Surgery is the main treatment and surgical services are scaled up to meet the need. This warrants the establishment of frugal systems to measure safety and quality of surgical care that are tailored for low-resource settings. The aim of this study was to test the applicability of the Clavien-Dindo classification (CDC) for measurement of surgical complications in an LMIC setting where medical records are paper-based. Material and methods: 88 patients who underwent CRC resection at Colombo South Teaching Hospital, Sri Lanka, from January 2017 to January 2020 were included. Medical records were retrospectively reviewed for postoperative complications and the severity was graded using the CDC. Results: One or more postoperative complications (CDC >= grade II) occurred in 45.5% (n = 40) of the patients. The complications were distributed as grade II n = 46, grade III n = 3, grade IV n = 2 and grade V n = 0. The most common complication (22.7%, n = 20) was postoperative anemia treated with blood transfusion. The second most common complication was incisional surgical site infection (11.4%, n = 10). Conclusion: Postoperative outcome could be evaluated by using the CDC in a Sri Lankan facility based on retrospective review of medical records. This suggests that the CDC is a feasible standardized system appropriate for measuring surgical quality also in other LMICs. Identified fields for possible quality improvement at the study site were to limit blood transfusions and minimize treatment with antibiotics.
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