PERS&amp;O (PERsistent Sitagliptin treatment &amp; Outcomes): observational retrospective study on cardiovascular risk evolution in patients with type 2 diabetes on persistent sitagliptin treatment

Buonaiuto, G.; Mori, V. De; Braus, A; Balini, Annalisa; Berzi, D.; Carpinteri, R.; Forloni, Franco; Meregalli, Giancarla; Ronco, Gian Luca; Bossi, Antonio

doi:10.1136/bmjdrc-2016-000216

Cited by 3 publications

(5 citation statements)

References 37 publications

(36 reference statements)

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“…The UK Prospective Diabetes Study Risk Engine has been used in an observational retrospective study in 170 patients with type 2 diabetes in Italy on sitagliptin to evaluate cardiovascular risk evolution and found analysis of variance testing showed a significant effect on increased CV risk at 12 months ( P = 0.003) and 48 months ( P = 0.04) …”

Section: Hierarchy Of Evidencementioning

confidence: 99%

“…53 The findings of these massive observational studies of real world data provides some reassurance regarding this serious outcome, despite the conflicting results from RCTs for DPP-IV inhibitors.. [28][29][30]54 The UK Prospective Diabetes Study Risk Engine has been used in an observational retrospective study in 170 patients with type 2 diabetes in Italy on sitagliptin to evaluate cardiovascular risk evolution and found analysis of variance testing showed a significant effect on increased CV risk at 12 months (P = 0.003) and 48 months (P = 0.04). 55 An observational propensity score-matched study of 414 213 participants aged 65 years or more identified from the National…”

Section: Safetymentioning

confidence: 99%

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What have we learnt from “real world” data, observational studies and meta‐analyses

Chatterjee

Davies

Khunti

2018

Diabetes Obesity Metabolism

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The incretin therapies glucagon-like peptide-1 receptor agonists (GLP-1 RA) and dipeptidyl peptidase-IV (DPP-IV) inhibitors are now well-established as second and third-line therapies and in combination with insulin for the treatment of type 2 diabetes. Over the last decade, there is accumulating evidence of their efficacy and safety from both large multicentre randomized clinical trials (RCT) and observational studies. Cardiovascular outcome trials have confirmed that several of these agents are also non-inferior to placebo with the GLP-1 RA liraglutide and semaglutide recently found to be superior in terms of major adverse cardiovascular events. Observational studies and post-marketing surveillance provide real world evidence of safety and effectiveness of these agents and have provided reassurance that signals for pancreatitis and pancreatic cancer seen in clinical trials are not of major concern in large patient populations. Well-designed real world studies complement RCTs and systematic reviews but appropriate data and methodologies, which are constantly improving, are necessary to answer appropriate clinical questions relating to the use of incretin therapies. Real world data are collected outside the controlled restrictions of RCTs and are therefore more representative of usual clinical practice. 3 Specific differences that can be identified include the fact that there is a clear sequence of outcomes with RCT and a wider range of outcomes with real world studies, follow-up is longer with real world studies and in general they are cheaper to conduct compared with RCTs. RCTs are often highly selective and exclude elderly patients (65 years and older), those with co-morbidities or taking other drugs whereas in real world practice, patients are often older than 65 years, suffer from multiple diseases and take several drugs and can be classified as " diverse and complex." 4 This review will consider what has been learnt from these two important but different sources of evidence for determining the place of incretin therapies in current type 2 diabetes management. and GIP by preventing rapid enzymatic degradation following secretion.Due to the glucose-dependent mechanism of action, these agents are 3 | HIERARCHY OF EVIDENCE | Clinical research trialsA RCT is considered the gold standard when assessing new interventions and therefore systematic reviews and meta-analyses with homogeneity of RCT are the highest level of evidence. Real-world data and observational studies provide important clinical data and outcomes beyond that gained from RCT and help us to understand the true impact of the intervention including its effectiveness, costeffectiveness and adverse effects ( Figure 1). Whereas RCT answer the question "can it work?" real world data are more concerned with answering "does it work?" 12 The primary focus of RCTs is efficacy, safety, quality and cost-effectiveness. Real world studies extend this to assess effectiveness, safety, quality, cost-effectiveness, natural history, compliance and adherence as we...

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Section: Hierarchy Of Evidencementioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

What have we learnt from “real world” data, observational studies and meta‐analyses

Chatterjee

Davies

Khunti

2018

Diabetes Obesity Metabolism

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“…The findings of several RWE trials support the effectiveness of dulaglutide, but to our knowledge only two of these were prospective studies [ 14 , 15 ], both of which have a number of limitations, such as short duration (3–6 months) and a limited number of cases (< 200). The centers which participated in the present study have some experience in collecting real-life retrospective data [ 16 ], and both the European Medicines Agency and the US Food and Drug Administration have approved the use of RWE to integrate data from RCTs for regulatory decisions [ 17 – 19 ]. We became interested in conducting an independent prospective real-world observational study [ 15 ] on the clinical utilization of dulaglutide shortly after it became available clinical use in Italy in 2016, involving 16 different centers in Lombardy region.…”

Section: Discussionmentioning

confidence: 99%

ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide

Bossi¹,

Mori

Scaranna

et al. 2020

Diabetes Ther

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Introduction: Dulaglutide, a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), became available in Italy in April 2016. The aim of ANDREW (Active Notes on Dulaglutide in the REal World), a multicenter, prospective, observational study, was to evaluate glycemic control and weight (co-primary outcomes) for up to 24 months in the real-life setting in consecutive outpatients with type 2 diabetes (T2D) who initiated dulaglutide. Co-secondary outcomes were durability of treatment effects on both glycated hemoglobin (HbA1c) and body weight. Methods: Overall, 1584 subjects (696 women, 888 men) with T2D (mean age [± standard deviation] 61.7 ± 10.2 years; mean T2D duration 9.9 ± 6.9 years) were treated with dulaglutide (0.75 or 1.5 mg once weekly) between April 2016 and December 2019. Results: A total of 1130 patients completed 12 months of follow-up, while 170 patients interrupted treatment before the 12-month endpoint. At 12 months, average HbA1c and average fasting plasma glucose (FPG) were significantly lower compared to baseline levels (-10 mmol/mol and-24.9 mg/dL, respectively), as were body weight (-3.4 kg) and waist circumference (-3.3 cm) values (all p \ 0.0001). Among subjects that completed 24 months of follow-up (n = 270), the rapid decline in HbA1c and FPG values in the first 12 months was followed by stabilization in the following 12 months (p value for 12-24 months trend: 0.4 and 0.6, respectively). Conclusions: Dulaglutide is an effective drug for the treatment of T2D that is administered once weekly using a simple auto-injector device. Real-life data confirm the observations in randomized controlled trials that persistent treatment with dulaglutide may help patients with T2D achieve an improvement in some metabolic features and in body weight. It is important that the benefits of therapy with dulaglutide, i.e., the effects of the ''glycemic'' Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12937394. A complete list of the diabetes centers and clinical investigators participating in the ANDREW study is provided in the Acknowledgement section.

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“… 10 The present study (PERS&O 2.0) is a long-term real-world retrospective, observational, single-center, longitudinal study performed in a general hospital in Northern Italy. 1 We collected data about 440 patients with T2D prescribed sitagliptin in accordance with the Italian Pharmacological Agency (AIFA), meaning that some limitations (in terms of HbA1c values and possible drug association) were present. Nevertheless, the most important thing was to obtain a better glycemic control (stated by HbA1c evolution), independently of diabetes duration, body weight, previous CV disease.…”

Section: Discussionmentioning

confidence: 99%

“…The PERsistent Sitagliptin treatment & Outcomes (PERS&O) study 1 was a ‘real-world’ retrospective, observational, single-center study performed in a general hospital in Northern Italy in order…”

Section: Introductionmentioning

confidence: 99%

PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness

Bossi¹,

Mori²,

Galeone

et al. 2020

BMJ Open Diab Res Care

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IntroductionSitagliptin is a dipeptidyl peptidase 4 inhibitor for the treatment of type 2 diabetes (T2D). Limited real-world data on its effectiveness and safety are available from an Italian population.Research design and methodsWe evaluated long-term clinical data from the single-arm PERsistent Sitagliptin Treatment & Outcomes (PERS&O) study, which collected information on 440 patients with TD2 (275 men, 165 women; mean age 64.1 years; disease median duration: 12 years) treated with sitagliptin ‘add-on’. For each patient, we estimated the 10-year cardiovascular (CV) risk using the UK Prospective Diabetes Study (UKPDS) Risk Engine (RE). Drug survival was evaluated using Kaplan-Meier survival curves; repeated measures mixed effects models were used to evaluate the evolution of glycated hemoglobin (HbA1c) and CV risk during sitagliptin treatment.ResultsAt baseline, most patients were overweight or obese (median body mass index (BMI) (kg/m2) 30.2); median HbA1c was 8.4%; median fasting plasma glucose: 172 mg/dL; median UKPDS RE score: 24.8%, being higher in men (median 30.2%) than in women (median 17.0%) as expected. Median follow-up from starting sitagliptin treatment was 5.6 years. From Kaplan-Meier curves, the estimated median drug survival was 32.8 months when considering discontinuation for any cause and 58.4 months when considering discontinuation for loss of efficacy. A significant improvement in HbA1c was evident during treatment with sitagliptin (p<0.01): the reduction was rapid (median HbA1c after 4–6 months: 7.5%) and continued at longer follow-up. When comparing patients treated with sitagliptin versus those stopping sitagliptin and switching to another antihyperglycemic drug, we detected a significant difference in the evolution of HbA1c in favor of patients who continued sitagliptin treatment. The UKPDS RE score at 10 years and the BMI significantly improved during treatment with sitagliptin (p<0.001). Adverse events were relatively uncommon.ConclusionPatients with T2D treated with sitagliptin achieved an improvement in metabolic control and a reduction in CV risk and did not experience relevant adverse events.

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PERS&O (PERsistent Sitagliptin treatment & Outcomes): observational retrospective study on cardiovascular risk evolution in patients with type 2 diabetes on persistent sitagliptin treatment

Cited by 3 publications

References 37 publications

What have we learnt from “real world” data, observational studies and meta‐analyses

What have we learnt from “real world” data, observational studies and meta‐analyses

ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide

PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness

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