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Comparative Efficacy of Adding Sitagliptin to Metformin, Sulfonylurea or Dual Therapy: A Propensity Score-Weighted Cohort Study.

ABSTRACT: INTRODUCTION:The aim of this study was to assess the efficacy of co-administering sitagliptin to patients with inadequate glycemic control following treatment with metformin (MET), sulfonylurea (SU), or MET + SU. METHODS:A cohort of 25,386 patients with type 2 diabetes mellitus (hemoglobin A1c [HbA1C] >53 mmol/mol or 7%), newly treated with sitagliptin between 2007 and 2013, was sourced from UK general practices via The Health Improvement Network database. Among these, eligible patients were segregated into three groups: MET (n = 3364), SU (n = 509), or MET + SU therapy (n = 5929). The relative efficacy of sitagliptin added to SU or MET + SU compared with sitagliptin added to MET monotherapy was assessed with regards to HbA1c and body weight changes from baseline up to 52 weeks. The glycemic efficacy was a measure of average treatment effects obtained from multivariable linear regression models and propensity score-matching analysis. RESULTS:A total of 9802 patients were included in the study. Overall, addition of sitagliptin 100 mg once daily resulted in 5.5 mmol/mol (0.5%) HbA1c reduction (P < 0.001) and 0.8 kg weight reduction at 1 year (P < 0.001). Efficacy was similar across the treatment groups, but in patients with baseline HbA1c ≥9% adding sitagliptin to MET + SU produced a significantly smaller reduction in HbA1c when compared to the reference group MET (MET + SU vs. MET only: -0.5% vs. -0.7%, P < 0.001). The mean HbA1c reduction from baseline within this subgroup of patients was not significantly different between SU and MET monotherapies (-0.8% vs. -0.7%, respectively, P = 0.4). Across treatment groups, HbA1c reductions with add-on sitagliptin occurred after 24 weeks of treatment with a peak reduction occurring between 36 and 48 weeks, and receded after week 48. CONCLUSION:In a real-world general practice setting, sitagliptin was effective in patients with suboptimal glycemic control with MET, SU or dual therapy, maximum between 36 and 48 weeks, but in patients with HbA1c of >9% receiving MET + SU therapy, adding sitagliptin, as a third agent, conferred minimal benefit.

SUBMITTER: Mamza J

PROVIDER: S-EPMC4478174 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionAlogliptin is an oral antihyperglycemic agent that is a selective inhibitor of the enzyme dipeptidyl peptidase-4 (DPP-4), approved for the treatment of type 2 diabetes mellitus (T2DM). There currently exists no comparative data to support the use of alogliptin in combination with metformin (met) and sulfonylurea (SU). A decision-focused network meta-analysis (NMA) was performed to compare the relative efficacy and safety of alogliptin 25 mg once daily to other DPP-4 inhibitors as part of a triple therapy regimen for patients inadequately controlled on metformin and SU dual therapy.MethodsA systematic literature review was conducted to identify published papers of randomized controlled trials (RCTs) that compared alogliptin with other DPP-4 inhibitors (linagliptin, saxagliptin, sitagliptin, and vildagliptin) at their Summary of Product Characteristics (SmPC) recommended daily doses, added on to metformin and SU. Comprehensive comparative analysis involving frequentist meta-analysis and Bayesian NMA compared alogliptin to each DPP-4 inhibitor separately and collectively as a group. Quasi-random effect models were introduced when random effect models could not be estimated.ResultsThe review identified 2186 articles, and 94 full-text articles were assessed for eligibility. Eight RCTs contained appropriate data for inclusion in the NMA. All analyses over all trial population sets produced very similar results, and show that alogliptin 25 mg is as least as effective (as measured by change in HbA1c from baseline, but supported by other outcome measures: change in body weight and FPG from baseline) and safe (as measured by incidence of hypoglycemia and adverse events leading to study discontinuation) as all the other DPP-4 inhibitors in triple therapy.ConclusionThis decision-focused systematic review and NMA demonstrated alogliptin 25 mg daily to have similar efficacy and safety compared to other DPP-4 inhibitors, for the treatment of T2DM in adults inadequately controlled on metformin and SU. (Funded by Takeda Development Centre Americas; EXAMINE ClinicalTrials.gov number, NCT00968708).

Project description:BackgroundMethamphetamines are a common cause of systolic heart failure (HF). There are limited data on the prognosis associated with hospitalizations for decompensated HF in the setting of methamphetamine use. We aimed to evaluate patient characteristics and outcomes among patients admitted with decompensated HF who had positive drug screens for amphetamines as well as to determine whether any parameters from transthoracic echocardiogram (TTE) can predict outcomes in this population.MethodsThis was a retrospective cohort study of consecutive adult patients admitted to the Loma Linda Medical Center who had an active hospital problem of acute on chronic systolic (or systolic and diastolic) HF from 2013 to 2018. Electronic medical records were mined for relevant patient data. Methamphetamine-associated heart failure (MethHF) group was defined as those with an admission urine drug screen (UDS) that was positive for methamphetamines, whereas non-MethHF was defined by patients with negative methamphetamine on UDS or UDS was not done on physician's discretion. The primary outcomes of the study were 30-day composite outcome (defined as combined all-cause readmission and all-cause mortality), 365-day all-cause mortality, and length of stay (LOS). Propensity score weighting for these outcomes was performed using demographics, laboratory and clinical variables, and left ventricular ejection fraction (LVEF) as covariates. TTE parameters from presentation were also evaluated to determine if any had prognostic implications.ResultsA total of 1,655 patients were included (101 patients with positive urine methamphetamine and 1,554 patients without). Patients with MethHF were younger, more likely to be male, had fewer comorbidities, had lower LVEF, and were more likely to have right ventricular systolic dysfunction. In propensity-weighted analyses, there were no significant differences in LOS, 30-day composite outcome, or 365-day mortality between the MethHF and non-MethHF group in (P > 0.05 for all). Presence of at least moderate tricuspid valve regurgitation (TR) was the only TTE predictor of 30-day composite outcome (odds ratio (OR) = 4.67, 95% confidence interval (CI): 1.5 - 14.50, P < 0.01) and 365-day mortality (OR = 4.67, 95% CI: 1.5 - 14.50, P < 0.01) in the MethHF group.ConclusionPatients with MethHF admitted for decompensated HF had similar outcomes compared to non-MethHF after adjusting for baseline characteristics. TR is the only TTE value to predict outcomes in this population.

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Comparative Efficacy of Adding Sitagliptin to Metformin, Sulfonylurea or Dual Therapy: A Propensity Score-Weighted Cohort Study.

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