Monitoring safety and use of old and new treatment options for type 2 diabetic patients: a two-year (2013–2016) analysis

Leporini, Christian; Piro, Rosanna; Ursini, Francesco; Maida, Francesca; Palleria, Caterina; Arturi, Franco; Pavia, Maria; Sarro, Giovambattista De; Russo, Emilio

doi:10.1080/14740338.2016.1246531

Cited by 7 publications

(12 citation statements)

References 75 publications

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“…Hypoglycaemia risk and associated morbidity still present an important limitation of T2D management. Novel antihyperglyacemic agents (such as incretinbased therapies and SGLT-2 inhibitors) exhibit lower hypoglycaemia risk than established therapies [29] along with increased adherence and QoL [30,31] and thus may alleviate SUs-associated burden factors and enhance both clinical and patient-reported outcomes [32][33][34].…”

Section: Ed-5d-vas Tsqm Global Satisfactionmentioning

confidence: 99%

The Real-Life Effectiveness and Care Patterns of Type 2 Diabetes Management in Greece

Pagkalos¹,

Thanopoulou

Sampanis

et al. 2017

Exp Clin Endocrinol Diabetes

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Section: Ed-5d-vas Tsqm Global Satisfactionmentioning

confidence: 99%

The Real-Life Effectiveness and Care Patterns of Type 2 Diabetes Management in Greece

Pagkalos¹,

Thanopoulou

Sampanis

et al. 2017

Exp Clin Endocrinol Diabetes

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“…These ADRs can result in early readmission and emergency department (ED) visits. An Italian study reported ADRs in 73.8% of patients taking oral antidiabetic drugs within one month of study enrollment (6). However, between 11% and 38% of ambulatory ADRs is preventable (7).…”

mentioning

confidence: 99%

Impact of pharmacotherapeutic education on medication adherence and adverse outcomes in patients with type 2 diabetes mellitus: a prospective, randomized study

et al. 2018

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AimTo evaluate the impact of pharmacotherapeutic education on 30-day post-discharge medication adherence and adverse outcomes in patients with type 2 diabetes mellitus (T2DM).MethodsThe prospective, randomized, single-center study was conducted at the Medical Department of University Hospital Dubrava, Zagreb, between April and June 2018. One hundred and thirty adult patients with T2DM who were discharged to the community were randomly assigned to either the intervention or the control group. Both groups during the hospital stay received the usual diabetes education. The intervention group received additional individual pre-discharge pharmacotherapeutic education about the discharge prescriptions. Medication adherence and occurrence of adverse outcomes (adverse drug reactions, readmission, emergency department visits, and death) were assessed at the follow-up visit, 30 days after discharge.ResultsThe number of adherent patients was significantly higher in the intervention group (57/64 [89.9%] vs 41/61 [67.2%]; χ2 test, P = 0.003]. There was no significant difference between the groups in the number of patients who experienced adverse outcomes (31/64 [48.4%] vs 36/61 [59.0%]; χ2 test, P = 0.236). However, higher frequencies of all adverse outcomes were consistently observed in the control group.ConclusionPharmacotherapeutic education of patients with T2DM can significantly improve 30-day post-discharge medication adherence, without a significant reduction in adverse clinical outcomes.ClinicalTrial.gov identification number: NCT03438162

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“…In the present study, inability to tolerate an ADE was cited as the second reason for inception glucose‐lowering drug withdrawal. As reported in previous studies , experience of non‐serious symptomatic ADEs, although frequently neglected by healthcare professionals, compromises adherence to treatment and represents a limiting factor in type 2 diabetes management. Measures of education and closer monitoring by healthcare providers, which should encompass counselling, active follow‐up and adequately prompt management of ADE, should be secured in order to minimize the risk of failure to adhere to treatment .…”

Section: Discussionmentioning

confidence: 93%

“…With regard to hypoglycaemic episodes, 22% of participants (95% CI [19][20][21][22][23][24] experienced at least one episode, with the majority of episodes classified as mild to moderate (21%; 95% CI [19][20][21][22][23]. Severe/very severe episodes were reported by 1.6% of participants (95% CI 0.9-2.3).…”

Section: Adverse Drug Event Occurrencementioning

confidence: 99%

Intensive monitoring of adverse drug events associated with the use of new glucose‐lowering drugs: results from an inception cohort study in Portugal

Torre

Guerreiro²,

Longo³

et al. 2019

Diabet. Med.

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Aims To determine the frequency and the time‐course profile of adverse drug events associated with new glucose‐lowering drugs in daily practice and to explore factors potentially associated to these events. Methods An inception cohort study was implemented. Adults with type 2 diabetes mellitus initiating a dipeptidyl peptidase‐4 inhibitor, a glucagon‐like peptide‐1 receptor agonist or a sodium‐glucose co‐transporter‐2 inhibitor were eligible for inclusion. Data were collected through baseline and follow‐up telephone questionnaires, administered at 2 weeks, 3 months and 6 months. Kaplan–Meier curves and log‐rank were computed to compare the time to adverse drug event onset. Cox models were used to explore potential factors associated with adverse drug events. Results A total of 1328 participants were recruited to the study. In all, 1118 adverse drug events were reported (of which 36% were not listed in the summary of product characteristics) by 41% of participants. The median latency time of adverse drug events reported in ≥1% of participants ranged from 0 to 2 days. Glucagon‐like peptide‐1 receptor agonist and sodium‐glucose co‐transporter‐2 inhibitor subgroups were associated with an increased likelihood of adverse drug event reporting when compared with the dipeptidyl peptidase‐4 inhibitor subgroup. A total of 328 glucose‐lowering drugs were withdrawn, more than half as a result of an adverse drug event. Conclusions More than two‐fifths of participants reported an adverse drug event; dipeptidyl peptidase‐4 inhibitors led to the highest proportion of unlabelled adverse drug events. Adverse drug event latency time data show that counselling and adverse drug event management should be proactively addressed from treatment initiation. There should be greater focus on prevalent new users of glucose‐lowering drugs, who were more complex participants in this study in terms of type 2 diabetes disease, as they were more likely to report an adverse drug event than the incident new users.

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Monitoring safety and use of old and new treatment options for type 2 diabetic patients: a two-year (2013–2016) analysis

Abstract: A mutual relationship between clinical effectiveness, adverse drug reactions, and adherence has been established, significantly impacting the clinical management of diabetic patients. A careful monitoring of this link by clinicians appears therefore necessary.

Cited by 7 publications

References 75 publications

The Real-Life Effectiveness and Care Patterns of Type 2 Diabetes Management in Greece

The Real-Life Effectiveness and Care Patterns of Type 2 Diabetes Management in Greece

Impact of pharmacotherapeutic education on medication adherence and adverse outcomes in patients with type 2 diabetes mellitus: a prospective, randomized study

Intensive monitoring of adverse drug events associated with the use of new glucose‐lowering drugs: results from an inception cohort study in Portugal

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