Comparative Assessment of Lixisenatide, Exenatide, and Liraglutide Pen Devices

Stauder, Udo; Enginee, Diplom; Elton, Hina; Penfornis, A.; Edelman, Steve

doi:10.1177/1932296813511733

Cited by 15 publications

(16 citation statements)

References 30 publications

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“…Errors related to an "incorrect dose setting" were most common. These refer to either setting up an incorrect dose (Stauder et al, 2014;Fujioka et al, 2015;Rohrer et al, 2013;Jeannerot et al, 2016;Lange et al, 2014;Schertz et al, 2011;Pfützner et al, 2012;Mahony et al, 2015;Saunders et al, 2012) or not setting a dose at all (Fujioka et al, 2015;Rohrer et al, 2013). A close call was also reported in Table 1 Categories of use errors and close calls (Continued)…”

Section: Categories Of Identified Use Errors and Close Callsmentioning

confidence: 99%

“…Auto-injection devices must be easy and intuitive to use (Stauder et al, 2014). A device's design must also allow it to be used by people with no or only minimal medical training (Frew, 2011;Reimer et al, 2008).…”

Section: Introductionmentioning

confidence: 99%

“…A device's design must also allow it to be used by people with no or only minimal medical training (Frew, 2011;Reimer et al, 2008). Ease of use is also essential because of the target user groups for auto-and pen injectors -elderly people, for example, who may have more difficulty learning how to use a device (Stauder et al, 2014). Auto-injection devices are also used by people suffering from impairments that make the devices more difficult to handle (Davidson et al, 2007;Pfützner et al, 2011).…”

Section: Introductionmentioning

confidence: 99%

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Improving the safety of disposable auto-injection devices: a systematic review of use errors

et al. 2018

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Auto-injection devices must be easy and intuitive to use, especially in emergency situations. However, there are many reports of safety-related issues affecting auto-injectors and pen injectors, due to usability deficits. To minimize this type of problem, the identification of potential use errors is an important and critical task in usability engineering. The aim of this systematic, qualitative literature review was to identify and catalog use errors related to disposable auto-injection devices. The key terms "auto-injector", "usability", and "safety/errors" were used to search in the PubMed and Scopus databases for articles from peer-reviewed journals and conference proceedings published in English or French between 2000 and 2017. Use errors, close calls, and operational difficulties were identified, extracted and hierarchically classified. The analysis showed that of the 1415 initially identified publications, 38 met all the eligibility criteria. A qualitative analysis identified 232 instances of use errors and close calls, which were classified into 10 main categories and then 39 subcategories. The present results could be used to guide the design, evaluation and risk analyses of disposable autoinjection devices. Our approach is in line with the European Union's latest regulations on improving the safety of medical devices-especially those concerning transparency and traceability.

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Section: Categories Of Identified Use Errors and Close Callsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Improving the safety of disposable auto-injection devices: a systematic review of use errors

et al. 2018

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“…Other aspects to consider when prescribing lixisenatide include patient satisfaction and convenience, as well as cost. A pilot study comparing pen devices for lixisenatide, exenatide, and liraglutide showed a lower error rate and higher user satisfaction among patients receiving lixisenatide compared with those receiving exenatide . According to the prescription drug information Web site GoodRx (https://www.goodrx.com/), lixisenatide is priced at a lower level than the other GLP‐1 RAs, with the exception of albiglutide.…”

Section: Considerations For the Use Of Lixisenatide In Patients With T2dmentioning

confidence: 99%

Lixisenatide, a Once‐Daily Prandial Glucagon‐Like Peptide‐1 Receptor Agonist for the Treatment of Adults with Type 2 Diabetes

Trujillo

Goldman

2017

Pharmacotherapy

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Lixisenatide, a short-acting glucagon-like peptide-1 receptor agonist (GLP-1 RA), has been available in Europe since 2013 and was recently approved in the United States for the treatment of type 2 diabetes (T2D) as an adjunct to diet and exercise. The objective of this systematic review is to describe the pharmacology, pharmacokinetics, safety, and efficacy of lixisenatide in patients with T2D. We conducted a search of the EMBASE database, limited to human studies with abstracts available in English. Published conference abstracts, limited to the American Diabetes Association (ADA) and the European Association for the Study of Diabetes meetings in 2015, as well as abstracts presented at the ADA meeting in 2016, were also screened. The abstracts retrieved were assessed for relevance; review articles and meta-analyses focusing on GLP-1 RAs as a class were excluded. Lixisenatide induced mean reductions of 0.46-0.99% in glycated hemoglobin A (Hb ), 55.86-143.43 mg/dl in 2-hour postprandial glucose (PPG) levels, and 56.58-127.75 mg/dl in mealtime glucose level variations. Changes in fasting plasma glucose (FPG) levels and weight ranged from -21.98 to +5.41 mg/dl and from -2.96 to +0.3 kg, respectively, in patients with T2D enrolled in the GetGoal clinical program (a program of clinical trials that established the efficacy and safety profile of lixisenatide 20 μg once/day across patients with T2D with differing background therapies). Lixisenatide was well tolerated, demonstrating rates of symptomatic hypoglycemia of 0.8-42.9% and a very low rate of severe hypoglycemia (< 1.5%) as well as no increased risk of cardiovascular events. The most common adverse events were gastrointestinal in nature, mainly transient nausea and vomiting of mild-to-moderate severity. Lixisenatide effectively lowers Hb levels in patients with T2D through a mechanism of action complementary to that of agents that mainly target FPG, with the additional benefit of weight loss. Its once-daily administration schedule and effect on PPG levels make it an attractive option as add-on treatment to basal insulin therapy or oral antidiabetic agents.

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“…В небольшом открытом пилотном иссле-довании удовлетворенность пациентов при применении ликсисенатида и лираглутида была выше, чем при при-менении шприц-ручки эксенатида 2 р/сут; шприц-ручка ликсисенатида также была быстрее в использовании и характеризовалась меньшим количеством ошибок при использовании в сравнении со шприц-ручкой эксена-тида [56]. В неконтролируемом открытом исследовании шприц-ручки дулаглутида большинство пациентов, ранее не выполнявших инъекции, сообщили, что использова-ние шприц-ручки было «простым» или «очень простым» (99%) и удобным (98,1%), и что они были удовлетворены проведением инъекций (97,1%) [57].…”

Section: приверженность средства введения и предпочтения пациентаunclassified

Evolution of glucagon-like peptide-1 receptor agonists for the treatment of type 2 diabetes

Galstyan¹,

Karataeva²,

Yudovich³

2017

Diabetes mellitus

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Comparative Assessment of Lixisenatide, Exenatide, and Liraglutide Pen Devices

Cited by 15 publications

References 30 publications

Improving the safety of disposable auto-injection devices: a systematic review of use errors

Improving the safety of disposable auto-injection devices: a systematic review of use errors

Lixisenatide, a Once‐Daily Prandial Glucagon‐Like Peptide‐1 Receptor Agonist for the Treatment of Adults with Type 2 Diabetes

Evolution of glucagon-like peptide-1 receptor agonists for the treatment of type 2 diabetes

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