PDF(Pubmed)
Abstract：
UNASSIGNED: We assessed the efficacy and safety of dalbavancin, a long-acting lipoglycopeptide with activity against Gram-positive pathogens, for treatment of acute bacterial skin and skin structure infections (ABSSSI) in patients with high body mass index (BMI) and/or diabetes.
UNASSIGNED: Data from two phase 3 trials of dalbavancin (1000 mg intravenous [IV], day 1; 500 mg IV, day 8) versus comparator and one phase 3b trial of single-dose (1500 mg IV, day 1) versus 2-dose (1000 mg IV, day 1; 500 mg IV, day 8) dalbavancin in adults with ABSSSI were pooled and summarized separately by baseline BMI and diabetes status. Clinical success at 48 to 72 hours (≥20% reduction in lesion size), end of treatment ([EOT] day 14), and day 28 was evaluated in the intent-to-treat (ITT) and microbiological ITT (microITT) populations. Safety data were reported in patients who received ≥1 dose of study drug.
UNASSIGNED: In the dalbavancin ITT population (BMI, n = 2001; diabetes, n = 2010), at 48 to 72 hours (and EOT) clinical success was achieved in 89.3% (EOT, 90.9%) of patients with normal BMI and 78.9% to 87.6% (EOT, 91.0% to 95.2%) of patients with elevated BMI. Clinical success after dalbavancin treatment was achieved in 82.4% (EOT, 90.8%) of patients with diabetes and 86.0% (EOT, 91.6%) of patients without diabetes. Similar trends were observed for infections due to methicillin-resistant Staphylococcus aureus or methicillin-susceptible S aureus (microITT population).
UNASSIGNED: Dalbavancin is effective, with sustained clinical success rates in patients with obesity or diabetes, with a similar safety profile across patient groups.
UNASSIGNED: Data from two phase 3 trials of dalbavancin (1000 mg intravenous [IV], day 1; 500 mg IV, day 8) versus comparator and one phase 3b trial of single-dose (1500 mg IV, day 1) versus 2-dose (1000 mg IV, day 1; 500 mg IV, day 8) dalbavancin in adults with ABSSSI were pooled and summarized separately by baseline BMI and diabetes status. Clinical success at 48 to 72 hours (≥20% reduction in lesion size), end of treatment ([EOT] day 14), and day 28 was evaluated in the intent-to-treat (ITT) and microbiological ITT (microITT) populations. Safety data were reported in patients who received ≥1 dose of study drug.
UNASSIGNED: In the dalbavancin ITT population (BMI, n = 2001; diabetes, n = 2010), at 48 to 72 hours (and EOT) clinical success was achieved in 89.3% (EOT, 90.9%) of patients with normal BMI and 78.9% to 87.6% (EOT, 91.0% to 95.2%) of patients with elevated BMI. Clinical success after dalbavancin treatment was achieved in 82.4% (EOT, 90.8%) of patients with diabetes and 86.0% (EOT, 91.6%) of patients without diabetes. Similar trends were observed for infections due to methicillin-resistant Staphylococcus aureus or methicillin-susceptible S aureus (microITT population).
UNASSIGNED: Dalbavancin is effective, with sustained clinical success rates in patients with obesity or diabetes, with a similar safety profile across patient groups.
摘要：
■我们评估了dalbavancin的疗效和安全性，具有抗革兰氏阳性病原体活性的长效脂糖肽，用于治疗高体重指数（BMI）和/或糖尿病患者的急性细菌性皮肤和皮肤结构感染（ABSSSI）。
■来自达巴万星的两项3期试验的数据（1000mg静脉注射[IV]，第1天；500毫克静脉注射，第8天)与对照和一项单剂量3b期试验(1500毫克静脉注射，第1天）与2剂量（1000mgIV，第1天；500毫克静脉注射，收集成人ABSSSI患者的第8天)dalbavancin,并分别按基线BMI和糖尿病状态进行汇总.48至72小时的临床成功率（病灶大小减少≥20%），治疗结束（[EOT]第14天），在意向治疗（ITT）和微生物学ITT（microITT）人群中评估第28天。报告了接受≥1剂量研究药物的患者的安全性数据。
■在dalbavancinITT人群中（BMI，n=2001；糖尿病，n=2010)，在48至72小时(和EOT)，89.3%(EOT，90.9%)BMI正常的患者和78.9%~87.6%(EOT、91.0%至95.2%)的患者BMI升高。达巴万星治疗后的临床成功率为82.4%(EOT，90.8%)的糖尿病患者和86.0%(EOT、91.6%)的患者无糖尿病。对于耐甲氧西林金黄色葡萄球菌或甲氧西林易感金黄色葡萄球菌（microITT人群）引起的感染也观察到了类似的趋势。
■Dalbavancin是有效的，肥胖或糖尿病患者的持续临床成功率，患者组之间具有相似的安全性。
■来自达巴万星的两项3期试验的数据（1000mg静脉注射[IV]，第1天；500毫克静脉注射，第8天)与对照和一项单剂量3b期试验(1500毫克静脉注射，第1天）与2剂量（1000mgIV，第1天；500毫克静脉注射，收集成人ABSSSI患者的第8天)dalbavancin,并分别按基线BMI和糖尿病状态进行汇总.48至72小时的临床成功率（病灶大小减少≥20%），治疗结束（[EOT]第14天），在意向治疗（ITT）和微生物学ITT（microITT）人群中评估第28天。报告了接受≥1剂量研究药物的患者的安全性数据。
■在dalbavancinITT人群中（BMI，n=2001；糖尿病，n=2010)，在48至72小时(和EOT)，89.3%(EOT，90.9%)BMI正常的患者和78.9%~87.6%(EOT、91.0%至95.2%)的患者BMI升高。达巴万星治疗后的临床成功率为82.4%(EOT，90.8%)的糖尿病患者和86.0%(EOT、91.6%)的患者无糖尿病。对于耐甲氧西林金黄色葡萄球菌或甲氧西林易感金黄色葡萄球菌（microITT人群）引起的感染也观察到了类似的趋势。
■Dalbavancin是有效的，肥胖或糖尿病患者的持续临床成功率，患者组之间具有相似的安全性。
