Roberto Giuseppe, Barone-Adesi Francesco, Giorgianni Francesco, Pizzimenti Valeria, Ferrajolo Carmen, Tari Michele, Bartolini Claudia, Da Cas Roberto, Maggini Marina, Spila-Alegiani Stefania, Francesconi Paolo, Trifirò Gianluca, Poluzzi Elisabetta, Baccetti Fabio, Gini Rosa
Epidemiology Unit, Agenzia regionale di sanità della Toscana, Florence, Italy.
Department of Pharmaceutical Sciences, University of Eastern Piedmont, Novara, Italy.
BMC Endocr Disord. 2019 Feb 7;19(1):18. doi: 10.1186/s12902-019-0334-y.
The incretin-based medicines GLP1 analogues (GLP1a) and dipeptidyl peptidase-4 inhibitors (DPP4i) are hypoglycaemic agents licensed for the treatment of type 2 diabetes mellitus (T2DM). Although these drugs possess comparable efficacy and low risk of hypoglycaemia, differences in terms of route of administration (subcutaneous versus oral), effect on body weight and gastrointestinal tolerabily can impact their actual use in clinical practice. This study aimed to describe the real-world utilization of incretin-based medicines in the Italian clinical practice.
A multi-database, population-based, descriptive, cohort study was performed using administrative data collected between 2008 and 2014 from three Italian geographic areas. Subjects aged ≥18 were selected. New users were defined as those with ≥1 dispensing of GLP1a or DPP4i during the year of interest and none in the past. Trends of cumulative annual incidence of use in the general adult population were observed. New users of GLP1a or DPP4i were respectively described in terms of demographic characteristics and use of antidiabetic drugs during 1 year before and after the first incretin dispensing.
The overall study population included 4,943,952 subjects. A total of 7357 new users of GLP1a and 41,907 of DPP4i were identified during the study period. Incidence of use increased between 2008 (0.2‰ for both GLP1a and DPP4i) and 2011 (GLP1a = 0.6‰; DPP4i = 2.5‰) and slightly decreased thereafter. In 2014, 61% of new GLP1a users received once-daily liraglutide while 52% of new DPP4i users received metformin/DPP4i in fixed-dose. The percentage of new DPP4i users older than 65 years of age increased from 30.9 to 62.6% during the study period. Around 12% of new users had not received any antidiabetic before starting an incretin.
During the study period, DPP4i rapidly became the most prescribed incretin-based medicine, particularly among older new user. The choice of the specific incretin-based medicine at first prescription appeared to be directed towards those with higher convenience of use (e.g. oral DPP4i rather than subcutaneous GLP1a, once-daily liraglutide rather than twice-daily exenatide). The non-negligibile use of incretin-based medicines as first-line pharmacotherapy for T2DM warrants further effectiveness and safety evaluations to better define their place in therapy.
基于肠促胰素的药物，即胰高血糖素样肽-1类似物（GLP1a）和二肽基肽酶-4抑制剂（DPP4i），是被许可用于治疗2型糖尿病（T2DM）的降血糖药物。尽管这些药物具有相当的疗效且低血糖风险较低，但给药途径（皮下注射与口服）、对体重的影响以及胃肠道耐受性方面的差异会影响它们在临床实践中的实际应用。本研究旨在描述意大利临床实践中基于肠促胰素药物的实际使用情况。
利用2008年至2014年间从意大利三个地理区域收集的管理数据进行了一项多数据库、基于人群的描述性队列研究。选择年龄≥18岁的受试者。新使用者被定义为在感兴趣年份内至少有1次GLP1a或DPP4i配药记录且过去无用药记录的人。观察了普通成年人群中年度累计使用发病率的趋势。分别根据人口统计学特征以及首次使用肠促胰素药物前1年和后1年的抗糖尿病药物使用情况，对GLP1a或DPP4i的新使用者进行了描述。
总体研究人群包括4943952名受试者。在研究期间，共确定了7357名GLP1a新使用者和41907名DPP4i新使用者。使用发病率在2008年（GLP1a和DPP4i均为0.2‰）至2011年（GLP1a = 0.6‰；DPP4i = 2.5‰）之间有所上升，此后略有下降。2014年，61%的GLP1a新使用者接受每日一次的利拉鲁肽治疗，而52%的DPP4i新使用者接受固定剂量的二甲双胍/DPP4i治疗。在研究期间，65岁以上的DPP4i新使用者比例从30.9%增至62.6%。约12%的新使用者在开始使用肠促胰素药物之前未接受过任何抗糖尿病治疗。
在研究期间，DPP4i迅速成为最常处方的基于肠促胰素的药物，尤其是在老年新使用者中。首次处方时对特定基于肠促胰素药物的选择似乎倾向于使用便利性更高的药物（如口服DPP4i而非皮下注射GLP1a，每日一次的利拉鲁肽而非每日两次的艾塞那肽）。将基于肠促胰素的药物作为T2DM的一线药物治疗的不可忽视的使用情况，需要进一步进行有效性和安全性评估，以更好地确定它们在治疗中的地位。
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