Effectiveness of dapagliflozin versus comparators on renal endpoints in the real world: A multicentre retrospective study

Fadini, Gian Paolo; Solini, Anna; Manca, Maria Laura; Penno, Giuseppe; Gatti, A; Anichini, Roberto; Prato, Stefano Del; Avogaro, Angelo

doi:10.1111/dom.13508

Cited by 36 publications

(47 citation statements)

References 35 publications

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“…Selection of the primary endpoint may also be disputable, but prioritization of endpoints in observational research is much less important than in RCTs, because real‐world studies are intrinsically hypothesis‐generating and endpoints were not tested hierarchically. As CVOTs have demonstrated the way that achievement of combined targets is associated with better cardiovascular outcomes in T2D, we speculate that, among patients receiving SGLT2is or GLP‐1RAs, those attaining combined treatment goals may benefit more from the cardiovascular protection conveyed by such drugs. Unlike the populations of CVOTs, however, the population addressed in the present study comprised mainly patients without a history of CVD.…”

Section: Discussionmentioning

confidence: 96%

“…Availability of such comparative assessment could contribute to clinical decision‐making and therapeutic tailoring. Interestingly, change in HbA1c, BW and BP can occur independently; change in HbA1c and reduction in BW are unrelated during therapy with GLP‐1RAs, whereas reduction in blood pressure is unrelated to glycaemic control during therapy with SGLT2is …”

Section: Introductionmentioning

confidence: 99%

“…Interestingly, change in HbA1c, BW and BP can occur independently; change in HbA1c and reduction in BW are unrelated during therapy with GLP-1RAs, 15 whereas reduction in blood pressure is unrelated to glycaemic control during therapy with SGLT2is. 16 Real-world evidence from retrospective studies should not substitute for RCTs, but can inform physicians and payers concerning therapeutic effectiveness in clinical practice. Evaluation of surrogate endpoints, such as glycaemia, blood pressure and BW, although correlated with cardiovascular risk, cannot substitute for CVOTs.…”

Section: Introductionmentioning

confidence: 99%

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Similar effectiveness of dapagliflozin and GLP‐1 receptor agonists concerning combined endpoints in routine clinical practice: A multicentre retrospective study

Fadini

Sciannameo

Bottigliengo

et al. 2019

Diabetes Obesity Metabolism

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Aims According to cardiovascular outcome trials, some sodium‐glucose contransporter‐2 inhibitors (SGLT2i) and glucagon‐like peptide‐1 receptor agonists (GLP‐1RA) are recommended for secondary cardiovascular prevention in type 2 diabetes (T2D). In this real‐world study, we compared the simultaneous reductions in HbA1c, body weight and systolic blood pressure after initiation of dapagliflozin or GLP‐1RA as second or a more advanced line of therapy. Materials and methods DARWIN‐T2D was a retrospective multi‐centre study conducted at diabetes specialist clinics in Italy that compared T2D patients who initiated dapagliflozin or GLP‐1RA (exenatide once weekly or liraglutide). Data were collected at baseline and at the first follow‐up visit after 3 to 12 months. The primary endpoint was the proportion of patients achieving a simultaneous reduction in HbA1c, body weight and systolic blood pressure. To reduce confounding, we used multivariable adjustment (MVA) or propensity score matching (PSM). Results Totals of 473 patients initiating dapagliflozin and 336 patients initiating GLP‐1RA were included. The two groups differed in age, diabetes duration, HbA1c, weight and concomitant medications. The median follow‐up was 6 months in both groups. Using MVA or PSM, the primary endpoint was observed in 30% to 32% of patients, with no difference between groups. Simultaneous reduction of HbA1c, BP and SBP by specific threshold, as well as achievement of final goals, did not differ between groups. GLP‐1RA reduced HbA1c by 0.3% more than the reduction achieved with dapagliflozin. Conclusion In routine specialist care, initiation of dapagliflozin can be as effective as initiation of a GLP‐1RA for attainment of combined risk factor goals.

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Section: Discussionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Similar effectiveness of dapagliflozin and GLP‐1 receptor agonists concerning combined endpoints in routine clinical practice: A multicentre retrospective study

Fadini

Sciannameo

Bottigliengo

et al. 2019

Diabetes Obesity Metabolism

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“…A dedicated software was developed to extract all relevant anonymized patient information for placement into a clinical research form without manual intervention. Suitability of this data collection approach for performing real‐world comparative effectiveness studies has been demonstrated extensively …”

Section: Methodsmentioning

confidence: 99%

“…Suitability of this data collection approach for performing real-world comparative effectiveness studies has been demonstrated extensively. [19][20][21][22] The study was promoted by the University Hospital of Padova and approved by the respective ethical committees of each participating centre. As data were anonymized at time of automatic extraction, making patient re-identification impossible, no informed consent was required according to national regulations concerning retrospective studies.…”

Section: Methodsmentioning

confidence: 99%

Fixed versus flexible combination of GLP‐1 receptor agonists with basal insulin in type 2 diabetes: A retrospective multicentre comparative effectiveness study

Morieri

Rigato

Frison³

et al. 2019

Diabetes Obesity Metabolism

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Background and Aims The combination of basal insulin (BI) and GLP‐1 receptor agonists (GLP‐1RAs) is a rational and effective therapy for patients with uncontrolled type 2 diabetes (T2D). We compared the effectiveness of fixed and flexible BI/GLP‐1RA combinations using routinely accumulated clinical data. Methods This was a retrospective, multicentre, real‐world study concerning T2D patients initiating a fixed or flexible BI/GLP‐1RA combination (NCT03959865). The primary endpoint was change in HbA1c. Secondary endpoints were changes in body weight, fasting plasma glucose (FPG) and systolic blood pressure (SBP). Confounding was addressed by propensity score matching (PSM) or multivariable adjustment (MVA). Results A total of 609 patients were included in the study, 131 in the fixed group and 478 in the flexible group. The two groups differed in terms of diabetes duration, body weight and concomitant medications. After 5.7 months, observed HbA1c reductions were 0.6% and 0.8%, and body weight reductions were 2.8 kg and 1.2 kg in the flexible and fixed groups, respectively. Following PSM, HbA1c declined similarly in the two groups, whereas reduction in body weight was significantly in favour of the flexible combination. Findings were robust in sensitivity analyses, with the exception that, with MVA, a significantly higher reduction in HbA1c was detected in the fixed group. Final doses of BI were higher in the fixed group, whereas those of GLP‐1RA were higher in the flexible group. Conclusions In routine specialist care, initiation of the fixed or flexible BI/GLP‐1RA combination allowed similar improvement in glycaemic control, but greater weight loss was observed with the flexible combination. This difference reflected dosages of BI and GLP‐1RAs.

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Long‐term renal outcomes associated with sodium glucose cotransporter 2 inhibitors in patients with type 2 diabetes mellitus: A systematic review and meta‐analysis

Zhang

Zhong²,

et al. 2020

Diabetes Metabolism Res

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AimsThe long‐term impact of sodium glucose cotransporter 2 (SGLT2) inhibitors on renal functions remains undefined. This study was undertaken to investigate the renal outcomes associated with SGLT2 inhibitors in patients with type 2 diabetes (T2DM) in the long term.MethodsA systematic literature search of PubMed and ClinicalTrials.gov was conducted. Randomized controlled trials which reported renal outcomes at the study endpoint in patients with T2DM receiving treatments of SGLT2 inhibitors were included. Renal adverse events were determined using prespecified lists from the Medical Dictionary for Regulatory Activities or laboratory values. Odds ratio with 95% confidence interval (CI) was used for assessment of dichotomous data. The mean difference or standardized mean difference with 95% CI was used for assessment of continuous data. Random effects models were adopted to measure the pooled outcomes.ResultsThirty‐nine studies involving 35 trials were identified. Compared with placebo or other anti‐diabetic medications, SGLT2 inhibitors were associated with significant lower incidence of composite renal outcome and acute renal failure or injury in patients with T2DM. The risk of progression of albuminuria also appeared to be decreased. No significant changes of estimated glomerular filtration rate levels or urine albumin‐creatinine ratios were found in patients receiving SGLT2 inhibitors.ConclusionsOverall renal safety and beneficial effects are indicated for SGLT2 inhibitors. Further confirmative data from large trials and real‐world studies are needed.

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Effectiveness of dapagliflozin versus comparators on renal endpoints in the real world: A multicentre retrospective study

Abstract: The antiproteinuric effect of dapagliflozin is confirmed here for the first time by real-world data. Despite a mild decline in eGFR, there was no evidence of clinically relevant worsening in renal function.

Cited by 36 publications

References 35 publications

Similar effectiveness of dapagliflozin and GLP‐1 receptor agonists concerning combined endpoints in routine clinical practice: A multicentre retrospective study

Similar effectiveness of dapagliflozin and GLP‐1 receptor agonists concerning combined endpoints in routine clinical practice: A multicentre retrospective study

Fixed versus flexible combination of GLP‐1 receptor agonists with basal insulin in type 2 diabetes: A retrospective multicentre comparative effectiveness study

Long‐term renal outcomes associated with sodium glucose cotransporter 2 inhibitors in patients with type 2 diabetes mellitus: A systematic review and meta‐analysis

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