■帕瑞瑞德,生长抑素受体配体,被批准用于治疗肢端肥大症和库欣病(CD)。由于药物的作用机制,治疗期间可发生高血糖,虽然很少需要停止治疗。未来的,随机化,IV期SOM230B2219(NCT02060383)试验旨在评估帕瑞肽相关高血糖的最佳管理。这里,我们调查了帕瑞肽治疗期间需要使用抗高血糖药物的预测因素.
■肢端肥大症或CD的参与者在随机化前(≤16周)期间,肌内注射长效帕瑞奥肽40mg/28天(肢端肥大症)或每天两次皮下注射帕瑞奥肽600μg。那些不需要抗高血糖药物的人,用二甲双胍管理,或从基线开始接受胰岛素进入16周结束的观察组。那些需要额外/替代抗高血糖药物来治疗二甲双胍的患者被随机分配到基于肠促胰岛素的治疗或胰岛素治疗另外16周。Logistic回归分析评估了随机化前需要降血糖药物的定量和定性因素。
■在190名患有肢端肥大症的参与者和59名患有CD的参与者中,分别为88和15,不需要降血糖药物;大多数年龄<40岁(肢端肥大症62.5%,CD86.7%),基线糖化血红蛋白(HbA1c)<6.5%(<48mmol/mol;肢端肥大症98.9%,CD100%)和空腹血糖(FPG)<100mg/dL(<5.6mmol/L;肢端肥大症76.1%,CD100%)。通过逻辑回归,在肢端肥大症参与者中,基线HbA1c(比值比[OR]3.6;P=0.0162)和FPG(OR1.0;P=0.0472)以及糖尿病/糖尿病前期病史(OR3.0;P=0.0221)升高预测接受降血糖药物治疗;在CD参与者中,基线HbA1c(OR12.6;P=0.0276)升高也是预测的.研究者报告的高血糖相关不良事件记录在47.9%和54.2%的肢端肥大症和CD参与者中。分别,主要是糖尿病/糖尿病前期患者。
■年龄增长,HbA1c,FPG和糖尿病前期/糖尿病与帕瑞肽治疗期间需要抗高血糖药物的可能性增加相关.这些风险因素可用于识别那些需要更多警惕监测以优化帕西雷肽治疗期间的结果的人。
UNASSIGNED: Pasireotide, a somatostatin receptor ligand, is approved for treating acromegaly and Cushing\'s disease (CD). Hyperglycemia during treatment can occur because of the drug\'s mechanism of action, although treatment discontinuation is rarely required. The prospective, randomized, Phase IV SOM230B2219 (NCT02060383) trial was designed to assess optimal management of pasireotide-associated hyperglycemia. Here, we investigated predictive factors for requiring antihyperglycemic medication during pasireotide treatment.
UNASSIGNED: Participants with acromegaly or CD initiated long-acting pasireotide 40 mg/28 days intramuscularly (acromegaly) or pasireotide 600 μg subcutaneously twice daily during pre-randomization (≤16 weeks). Those who did not need antihyperglycemic medication, were managed with metformin, or received insulin from baseline entered an observational arm ending at 16 weeks. Those who required additional/alternative antihyperglycemic medication to metformin were randomized to incretin-based therapy or insulin for an additional 16 weeks. Logistic-regression analyses evaluated quantitative and qualitative factors for requiring antihyperglycemic medication during pre-randomization.
UNASSIGNED: Of 190 participants with acromegaly and 59 with CD, 88 and 15, respectively, did not need antihyperglycemic medication; most were aged <40 years (acromegaly 62.5%, CD 86.7%), with baseline glycated hemoglobin (HbA1c) <6.5% (<48 mmol/mol; acromegaly 98.9%, CD 100%) and fasting plasma glucose (FPG) <100 mg/dL (<5.6 mmol/L; acromegaly 76.1%, CD 100%). By logistic regression, increasing baseline HbA1c (odds ratio [OR] 3.6; P=0.0162) and FPG (OR 1.0; P=0.0472) and history of diabetes/pre-diabetes (OR 3.0; P=0.0221) predicted receipt of antihyperglycemic medication in acromegaly participants; increasing baseline HbA1c (OR 12.6; P=0.0276) was also predictive in CD participants. Investigator-reported hyperglycemia-related adverse events were recorded in 47.9% and 54.2% of acromegaly and CD participants, respectively, mainly those with diabetes/pre-diabetes.
UNASSIGNED: Increasing age, HbA1c, and FPG and pre-diabetes/diabetes were associated with increased likelihood of requiring antihyperglycemic medication during pasireotide treatment. These risk factors may be used to identify those who need more vigilant monitoring to optimize outcomes during pasireotide treatment.