Comparative risk for cardiovascular diseases of dipeptidyl peptidase-4 inhibitors vs. sulfonylureas in combination with metformin: Results of a two-phase study

Enders, Dirk; Kollhorst, Bianca; Engel, Susanne; Linder, Roland; Verheyen, Frank; Pigeot, Iris

doi:10.1016/j.jdiacomp.2016.05.015

Cited by 6 publications

(3 citation statements)

References 34 publications

(26 reference statements)

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“…The study was based on routine data of a German statutory health insurance and data of the disease management program diabetes type 2 from 2010 to 2013. More details on the original cohort can be found in Enders et al 11 The underlying database of the routine data was described in Behr et al 12 and Pigeot and Ahrens. 13 Here, we restricted the original cohort to new users of the predominantly used OAD metformin and estimated the effect of initiating a second OAD, namely, dipeptidyl phase 4 (DPP4) inhibitors, on the hazard of the combined event of heart failure, ischemic stroke, or myocardial infarction.…”

Section: Application In a Pharmacoepidemiological Study Based On Routmentioning

confidence: 99%

“…We simulated unmeasured confounding by including only the half of the confounders with a positive effect on the treatment (L 1 (k), L 2 (k), L 4 (k), L 1 (k − 1), L 2 (k − 1) and L 4 (k − 1) for J = 5 and L 1 (k), L 2 (k), L 4 (k), … , L 20 (k) and L 1 (k − 1), L 2 (k − 1), L 4 (k − 1), … , L 20 (k − 1) for J = 20), in the model to calculate the IPT and IPC weights. To assess the performance of the consistent variance estimator (11) and of the robust variance estimator (9), we calculated the coverage rate, ie, the proportion of simulations, in which the respective Wald-type 95% confidence interval covered the true value of (see, eg, Ali et al 3 ). To evaluate the overall performance of the weighted logistic regression, we also calculated the bias of the IPT and IPC weighted estimator.…”

Section: A Simulation Studymentioning

confidence: 99%

“…CR r = coverage rate of̂based on the robust variance estimator (9). CR s = coverage rate of̂based on the consistent variance estimator(11).…”

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confidence: 99%

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Robust versus consistent variance estimators in marginal structural Cox models

Enders

Engel

Linder

et al. 2018

Statistics in Medicine

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In survival analyses, inverse-probability-of-treatment (IPT) and inverse-probability-of-censoring (IPC) weighted estimators of parameters in marginal structural Cox models are often used to estimate treatment effects in the presence of time-dependent confounding and censoring. In most applications, a robust variance estimator of the IPT and IPC weighted estimator is calculated leading to conservative confidence intervals. This estimator assumes that the weights are known rather than estimated from the data. Although a consistent estimator of the asymptotic variance of the IPT and IPC weighted estimator is generally available, applications and thus information on the performance of the consistent estimator are lacking. Reasons might be a cumbersome implementation in statistical software, which is further complicated by missing details on the variance formula. In this paper, we therefore provide a detailed derivation of the variance of the asymptotic distribution of the IPT and IPC weighted estimator and explicitly state the necessary terms to calculate a consistent estimator of this variance. We compare the performance of the robust and consistent variance estimators in an application based on routine health care data and in a simulation study. The simulation reveals no substantial differences between the 2 estimators in medium and large data sets with no unmeasured confounding, but the consistent variance estimator performs poorly in small samples or under unmeasured confounding, if the number of confounders is large. We thus conclude that the robust estimator is more appropriate for all practical purposes.

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Section: Application In a Pharmacoepidemiological Study Based On Routmentioning

confidence: 99%

Section: A Simulation Studymentioning

confidence: 99%

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Robust versus consistent variance estimators in marginal structural Cox models

Enders

Engel

Linder

et al. 2018

Statistics in Medicine

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Reporting and variability of constructing medication treatment episodes in pharmacoepidemiology studies: A methodologic systematic review using the case study of DPP‐4 inhibitors and cardiovascular outcomes

Weisman

King

Mamdani

2020

Pharmacoepidemiology and Drug

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PurposeIn pharmacoepidemiologic studies, estimating medication adherence, persistence, and exposure patterns is critical. Constructing medication treatment episodes from prescription claims data involves assumptions related to grace period, carry‐over, and lag effect, but there are no guidelines for these assumptions. We evaluated reporting and variability of these parameters in pharmacoepidemiology studies, using a case study of antihyperglycemic medications and major adverse cardiovascular events (MACE).MethodsWe conducted a systemic review using MEDLINE and EMBASE for studies published prior to January 2, 2020 comparing the risk of MACE between dipeptidyl peptidase 4 (DPP‐4) inhibitors and active comparators. We extracted study characteristics and results, including grace period, carry‐over, and lag effect. Risk of bias was assessed by the Newcastle‐Ottawa scale, and assessments for prevalent user, immortal time, time lag, and time window biases.ResultsA total of 14/1850 studies identified were included. Grace period was not reported in 5 (35.7%) studies and ranged from 0 days to 180 days when reported. Carry‐over was not reported in 10 studies (71.4%). Lag effect was not reported in nine (71.4%) studies and ranged from 0 days to 180 days when reported. No studies conducted sensitivity analyses examining the effects of these assumptions on study findings. Predominant biases were inadequate follow‐up time, comparability of cohorts, prevalent use, and lag time bias.ConclusionsUse of grace period, carry‐over, and lag effect were poorly reported and highly variable. Future pharmacoepidemiology studies should improve reporting, justify ranges for these parameters, and conduct sensitivity analyses to evaluate effects of these assumptions.

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Diabetes and Stroke: The Role of Glucose Regulation

Lowe

Feng

2019

The Diabetes Textbook

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Comparative risk for cardiovascular diseases of dipeptidyl peptidase-4 inhibitors vs. sulfonylureas in combination with metformin: Results of a two-phase study

Cited by 6 publications

References 34 publications

Robust versus consistent variance estimators in marginal structural Cox models

Robust versus consistent variance estimators in marginal structural Cox models

Reporting and variability of constructing medication treatment episodes in pharmacoepidemiology studies: A methodologic systematic review using the case study of DPP‐4 inhibitors and cardiovascular outcomes

Diabetes and Stroke: The Role of Glucose Regulation

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