Prevalent new-user cohort designs for comparative drug effect studies by time-conditional propensity scores

Suissa, Samy; Moodie, Erica E. M.; Dell’Aniello, Sophie

doi:10.1002/pds.4107

Cited by 158 publications

(219 citation statements)

References 20 publications

(38 reference statements)

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“…However, one disadvantage is that it limits the generalizability of findings to patients that have never used either SGLT2i or DPP4i. The prevalent new user study design or the target trial design may offer alternate approaches to the evaluation of early and late effects of SGLT2i on fractures . In addition, longitudinal studies using the nested case‐control design can investigate the effects of cumulative exposure and possible dose‐response relationships.…”

Section: Discussionmentioning

confidence: 99%

Sodium‐glucose co‐transporter 2 inhibitors and the risk of fractures: A propensity score‐matched cohort study

Adimadhyam

Lee

Calip

et al. 2019

Pharmacoepidemiology and Drug

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Purpose To determine the risk of fractures associated with sodium‐glucose co‐transporter 2 inhibitors (SGLT2i) compared with dipeptidyl peptidase‐4 inhibitors (DPP4i). Methods We conducted a retrospective cohort study using data from the Truven Health MarketScan (2009‐2015) databases. Our cohort included patients newly initiating treatment with SGLT2i or DPP‐4i between 1 April 2013 and 31 March 2015 that were matched 1:1 using high dimensional propensity scores. Patients were followed up in an as‐treated approach starting from initiation of treatment until the earliest of any fracture, treatment discontinuation, disenrollment, or end of data (31 December 2015). Risk of fractures was determined at any time during the follow‐up, early in therapy (1‐14 days of the follow‐up), and later in therapy (15 days and beyond). Cox proportional hazards models were used to determine hazard ratios and robust 95% confidence intervals (95% CI). Results After matching, our cohort included 30 549 patients in each treatment group. Over a median follow‐up of 219 days, there were 745 fractures overall. The most common site for fractures was the foot (32.7%). The effect estimates for fracture risk occurring at any time during follow‐up, early in therapy, and later in therapy were HR 1.11 [95% CI 0.96‐1.28], HR 1.82 [95% CI 0.99‐3.32], and HR 1.07 [95% CI 0.92‐1.24], respectively. Conclusion There is a possible increase in risk for fractures early in therapy with SGLT2i. Beyond this initial period, SGLT2is had no apparent effect on the incidence of fractures.

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Section: Discussionmentioning

confidence: 99%

Sodium‐glucose co‐transporter 2 inhibitors and the risk of fractures: A propensity score‐matched cohort study

Adimadhyam

Lee

Calip

et al. 2019

Pharmacoepidemiology and Drug

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“…We excluded all patients aged <40 years as well as those with <1 year of medical history in the CPRD before base cohort entry. The study cohort was formed from the base cohort using a prevalent new‐user design . We identified from the base cohort all patients receiving a first‐time prescription for glimepiride or other second‐generation sulphonylureas (ie, glibenclamide, gliclazide, glipizide, gliquidone, glibornuride or glymidine) between January 1, 1998 and June 30, 2017.…”

Section: Methodsmentioning

confidence: 99%

Comparative cardiovascular and hypoglycaemic safety of glimepiride in type 2 diabetes: A population‐based cohort study

Douros

Dell’Aniello

et al. 2019

Diabetes Obesity Metabolism

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Aim To assess the incidence of cardiovascular and hypoglycaemic adverse events associated with glimepiride compared with other second‐generation sulphonylureas among patients with type 2 diabetes in a real‐world clinical setting. Materials and methods We identified all sulphonylurea initiators between 1998 and 2017 in the UK Clinical Practice Research Datalink. Using a prevalent new‐user design, glimepiride initiators were matched 1:4 with initiators of other second‐generation sulphonylureas on calendar time, prior sulphonylurea use, and time‐conditional high‐dimensional propensity score. Cox proportional hazards models yielded adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for myocardial infarction, ischaemic stroke, severe hypoglycaemia, cardiovascular death, and all‐cause mortality. Results Among 66 032 sulphonylurea new users, 6438 initiated glimepiride and were matched to up to 20 582 initiators of other second‐generation sulphonylureas. During a mean follow‐up of 1.3 years, glimepiride was associated with a similar incidence of myocardial infarction (HR 0.99, 95% CI 0.75–1.30) and ischaemic stroke (HR 0.96, 95% CI 0.72–1.27) compared with other second‐generation sulphonylureas, while there was a non‐significant trend towards a higher incidence of severe hypoglycaemia (HR 1.24, 95% CI 0.92–1.68). Glimepiride was also associated with a lower incidence of all‐cause mortality (HR 0.77, 95% CI 0.67–0.89), and a non‐significant but similar trend for cardiovascular death (HR 0.83, 95% CI 0.65–1.05). Conclusions Glimepiride was associated with a lower incidence of all‐cause mortality compared with other second‐generation sulphonylureas.

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“…As described by Suissa et al . , the study cohort was divided into two subgroups on the basis of participants’ treatment experience: incident new users (participants who were using one of the monitored glucose‐lowering drugs for the first time and had no current or prior experience with DPP‐4 inhibitors, GLP‐1 receptor agonists or SGLT2 inhibitors) and prevalent new users (participants who had previously used at least one glucose‐lowering drug of the monitored drug classes, but not the inception drug).…”

Section: Methodsmentioning

confidence: 99%

“…The data presented in this paper were retrieved from a nationwide observational inception cohort study of people with type 2 diabetes, recruited by Portuguese community pharmacies, initiating one of the novel glucose-lowering drugs that were reimbursed at the time of enrolment: DPP-4 inhibitors (linagliptin, saxagliptin, sitagliptin and vildagliptin) alone or in fixed-dose combination with metformin, GLP-1 receptor agonists (exenatide and liraglutide) or an SGLT2 inhibitor (dapagliflozin) [11,12]. As described by Suissa et al [13], the study cohort was divided into two subgroups on the basis of participants' treatment experience: incident new users (participants who were using one of the monitored glucose-lowering drugs for the first time and had no current or prior experience with DPP-4 inhibitors, GLP-1 receptor agonists or SGLT2 inhibitors) and prevalent new users (participants who had previously used at least one glucose-lowering drug of the monitored drug classes, but not the inception drug).…”

Section: Methodsmentioning

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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Prevalent new-user cohort designs for comparative drug effect studies by time-conditional propensity scores

Abstract: The proposed prevalent new-user cohort design for comparative drug effects studies allows the use of all or most patients exposed to the newer drug, thus permitting a more comprehensive assessment of a new drug's safety. Copyright © 2016 John Wiley & Sons, Ltd.

Cited by 158 publications

References 20 publications

Sodium‐glucose co‐transporter 2 inhibitors and the risk of fractures: A propensity score‐matched cohort study

Sodium‐glucose co‐transporter 2 inhibitors and the risk of fractures: A propensity score‐matched cohort study

Comparative cardiovascular and hypoglycaemic safety of glimepiride in type 2 diabetes: A population‐based cohort 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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