The purpose of the present trial was to evaluate safety, tolerability, and effect on systolic blood pressure (SBP) of SER100 in a small group of patients with isolated systolic hypertension (ISH) in treatment with at least 1 antihypertensive drug. Eligible patients were randomized to either SER100 (10 mg) or placebo in a crossover design, and 2 doses were given subcutaneously (SC), 8 hours apart, on 2 consecutive days. On all treatment days patients were monitored with an ambulatory blood pressure measurement device for 12 daytime hours. Seventeen patients completed treatment. There were no serious or severe adverse events. Relative to placebo SER100 induced an average reduction of SBP during the 2 treatment days of 7.0 mm Hg (P = 0.0032), whereas the average reduction of diastolic blood pressure (DBP) over the same period was 3.8 mm Hg (P = 0.0011). For patients with ISH, this short-term cross-over study of SC SER100 demonstrated an acceptable safety profile and consistent, significant lowering of SBP and DBP. As initial clinical proof of concept for a new class of drugs, a nociceptin agonist peptide, the results were encouraging and warrant further research.

译文

本试验的目的是评估一小群接受至少1种降压药治疗的单纯收缩期高血压 (ISH) 患者中SER100的安全性,耐受性和对收缩压 (SBP) 的影响。符合条件的患者在交叉设计中随机分配至SER100 (10 mg) 或安慰剂,并在连续2天的时间间隔8小时皮下注射2剂 (SC)。在所有治疗日中,使用动态血压测量设备对患者进行了12个白天的监测。17名患者完成了治疗。没有严重或严重的不良事件。相对于安慰剂SER100,在2个治疗日期间SBP平均降低7.0毫米Hg (P = 0.0032),而同期舒张压 (DBP) 的平均降低为3.8毫米Hg (P = 0.0011)。对于ISH患者,SC SER100的这项短期交叉研究显示出可接受的安全性以及SBP和DBP的持续显着降低。作为一类新型药物 (伤害肽激动剂肽) 的初步临床概念证明,结果令人鼓舞,值得进一步研究。

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