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Effects of smoking cessation, acute re-exposure and nicotine replacement in smokers on AIR? inhaled insulin pharmacokinetics and glucodynamics

机译:吸烟者戒烟,急性再暴露和尼古丁替代对AIR 吸入胰岛素药代动力学和糖动力学的影响

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What is already known about this subject ? Only one other study (Becker et al. ) has reported on the influence of smoking cessation and smoking resumption on inhaled insulin pharmacokinetics and glucodynamics, concluding that the rapid changes associated with smoking resumption carry the risk for hypoglycaemia and thus should not be used by active smokers. What this study adds ? This is the first euglycaemic clamp study on the impact of smoking cessation, acute smoking re-exposure and nicotine replacement on AIR ? inhaled insulin pharmacokinetics and glucodynamics. ? We demonstrate clinically and statistically significant shifts in glucodynamic response to acute re-exposure to a single cigarette, leading us to conclude that active smokers should be advised against inhaled insulin therapy until smoking abstinence is stable. ? Additionally, these results are also the first to demonstrate an apparent independent effect of nicotine replacement therapy on insulin exposure and glucodynamic response. Aims To explore the effects of smoking cessation and acute smoking re-exposure on the pharmacokinetic (PK) and glucodynamic (GD) profiles of AIR ? inhaled insulin (AIR Insulin) with or without nicotine replacement therapy (NRT). Methods Nondiabetic smokers ( n = 24) with normal pulmonary function completed a two-phase (four-period), open-label, randomized euglycaemic clamp study. During the initial study phase, subjects underwent glucose clamps following AIR Insulin dosing, shortly after smoking, 8–12 h after smoking, or following subcutaneous insulin lispro shortly after smoking. AIR Insulin PK and GD were again assessed during and after a 4-week smoking-cessation period with or without NRT. In the last study period, subjects smoked one cigarette shortly before final AIR Insulin dosing and glucose clamp, to study the effect of acute smoking re-exposure on inhaled insulin PK and GD. Results Compared with the preceding active smoking phase, the administration of AIR Insulin in nondiabetic subjects undergoing a 4-week period of smoking abstinence resulted in a decrease in PK and GD of approximately 25% ( P = 0.008 for both), an effect which was greater in subjects using NRT. Following rechallenge with a single cigarette (without NRT), GD response to AIR Insulin increased significantly ( P = 0.006) towards precessation levels, relative to smoking abstinence. In subjects using NRT, however, the increase in GD was less pronounced. Conclusion Smoking, smoking cessation and acute re-exposure with a single cigarette are associated with clinically significant alterations in AIR Insulin pharmacokinetics and glucodynamics. AIR Insulin should not be used by smokers or those at risk for recidivism.
机译:关于这个问题已经知道了什么?只有另一项研究(Becker等人)报道了戒烟和戒烟对吸入胰岛素的药代动力学和糖动力学的影响,认为与戒烟有关的快速变化具有低血糖的风险,因此不应被主动使用吸烟者。这项研究增加了什么?这是关于停止吸烟,急性再次吸烟和尼古丁替代对AIR 影响的正常血糖钳夹研究。 吸入胰岛素的药代动力学和糖动力学。 ?我们证明了对单支香烟再次急性暴露的糖动力学反应的临床和统计学显着变化,使我们得出结论,应建议积极吸烟者不要吸入胰岛素疗法,直到戒烟稳定为止。 ?此外,这些结果也是首次证明尼古丁替代疗法对胰岛素暴​​露和糖动力反应具有明显的独立作用。目的探讨戒烟和再次急性吸烟对AIR ?的药代动力学(PK)和糖动力学(GD)谱的影响。 吸入或不吸入尼古丁替代疗法(NRT)的胰岛素(AIR Insulin)。方法正常肺功能的非糖尿病吸烟者(n = 24)完成了一项两阶段(四期),开放标签,随机性正常血糖钳夹研究。在初始研究阶段,受试者在服用AIR胰岛素后,抽烟后不久,抽烟后8-12小时或抽烟后不久进行赖脯胰岛素皮下注射葡萄糖钳。在有或没有NRT的4周戒烟期间和戒烟期间和之后,再次评估AIR胰岛素PK和GD。在最后一个研究期中,受试者在最终使用AIR胰岛素和葡萄糖钳夹之前不久抽了一支烟,以研究急性再暴露对吸入的胰岛素PK和GD的影响。结果与之前的积极吸烟阶段相比,在进行了4周戒烟的非糖尿病患者中,服用AIR胰岛素可导致PK和GD降低约25%(两者均为P = 0.008),使用NRT的对象更大。用单支香烟(无NRT)进行挑战后,相对于戒烟,GD对AIR胰岛素的反应朝着进动水平显着增加(P = 0.006)。然而,在使用NRT的受试者中,GD的增加不太明显。结论吸烟,戒烟和单支烟急性再暴露与AIR胰岛素的药代动力学和糖动力学相关的临床显着改变。吸烟者或有再犯风险的人不应使用空气胰岛素。

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