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A comparison of continuous intravenous insulin and subcutaneous insulin among patients with type 2 diabetes and congestive heart failure exacerbation.

ABSTRACT: The study aims to determine whether the route of insulin administration influences glycaemic variability and inflammatory or neurohormonal markers in patients with type 2 diabetes and congestive heart failure (CHF) exacerbation.Patients (n?=?65) were randomized to intravenous (IV) insulin (duration 48 h) or subcutaneous (SQ) insulin. Inflammatory cytokines and markers of lipid oxidation, high-frequency heart rate variability (n?=?27) and cardiac impedance (pre-ejection period, n?=?28) were used to estimate parasympathetic and sympathetic tone in patients with valid cardiac data. Glycaemic variability was measured using a continuous glucose monitor.Mean glucose was lower (7.7?±?1.2 vs 9.4?±?2.7 mmol/L, p?=?0.004), coefficient of variation was higher (p?=?0.03) and glycaemic lability index was similar on day 1 in the IV group compared with the SQ group, but groups were similar by day 2. The IV group had more confirmed hypoglycaemia (p?=?0.005). There were no differences in hospital readmission or hospital length of stay between groups. There were no differences in CHF biomarkers, heart rate variability or pre-ejection period between groups. Increasing log glycaemic lability index was associated with lower on-treatment pre-ejection period (p?=?0.03) while increasing coefficient of variation was associated with increasing brain natriuretic peptide (p?=?0.004) and paroxonase-1 (p?=?0.02). Other univariable analyses were not significant.There were modest, transient differences in glucose control between IV and SQ insulin in hospitalized CHF patients. However, the analyses do not support a link between insulin route and inflammatory markers or autonomic tone. Further study is needed to assess outcomes in hospitalized CHF patients.

SUBMITTER: Dungan KM

PROVIDER: S-EPMC4262716 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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A comparison of continuous intravenous insulin and subcutaneous insulin among patients with type 2 diabetes and congestive heart failure exacerbation.

Dungan Kathleen M KM Osei Kwame K Gaillard Trudy T Moore Jared J Binkley Philip P

Diabetes/metabolism research and reviews 20150101 1

<h4>Background</h4>The study aims to determine whether the route of insulin administration influences glycaemic variability and inflammatory or neurohormonal markers in patients with type 2 diabetes and congestive heart failure (CHF) exacerbation.<h4>Methods</h4>Patients (n = 65) were randomized to intravenous (IV) insulin (duration 48 h) or subcutaneous (SQ) insulin. Inflammatory cytokines and markers of lipid oxidation, high-frequency heart rate variability (n = 27) and cardiac impedance (pre- ...[more]

PMID: 24916838

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Project description:AimsThis multicentre, randomized, controlled, double-blind, parallel-group Phase III study was conducted to confirm the non-inferiority of OPC-61815 (tolvaptan sodium phosphate) intravenous injections to oral tolvaptan tablets in patients with congestive heart failure and volume overload despite receiving diuretics other than vasopressin antagonists.Methods and resultsCongestive heart failure patients with volume overload despite receiving diuretics other than vasopressin antagonists were randomly assigned (1:1) to receive OPC-61815 (16-mg injection; n = 149) or oral tolvaptan (15-mg tablet; n = 145) once daily for 5 days. Most patients were male; the mean age and weight were 74.7 years and 62.1 kg, respectively; other demographic and clinical characteristics were similar between groups. In this study, the primary endpoint was the change in body weight from baseline to the day after the last dose. Secondary endpoints included improvement from baseline in congestive findings and New York Heart Association classification. The change in body weight was -1.67 kg [95% confidence interval (CI): -1.93, -1.41] and -1.36 kg (95% CI: -1.62, -1.10) in the OPC-61815 group and tolvaptan group, respectively; the difference in the least squares mean between the groups was -0.31 kg (95% CI: -0.68, 0.06). Given the upper CI did not exceed the pre-specified limit of 0.48, this confirmed the non-inferiority of injectable OPC-61815 to oral tolvaptan. Daily urine volume and daily fluid intake increased, and daily fluid balance was negative throughout the treatment period; changes were similar for both groups. All evaluated congestive symptoms and New York Heart Association classifications showed improvement and safety findings were similar between the groups. The incidence of hyperkalaemia was higher in the OPC-61815 group, and the incidence of thirst and dry mouth was higher in the tolvaptan group. Most treatment-emergent adverse events were mild to moderate; one serious treatment-emergent adverse event of hyperkalaemia in the OPC-61815 group was considered treatment related.ConclusionsOPC-61815 (16-mg injection) was confirmed as non-inferior to oral tolvaptan (15-mg tablet) in patients with congestive heart failure and inadequate response to diuretics; no new safety concerns were observed.

Project description:BackgroundBeta-blockers are an essential part of standard therapy in adult congestive heart failure and therefore, are expected to be beneficial in children. However, congestive heart failure in children differs from that in adults in terms of characteristics, aetiology, and drug clearance. Therefore, paediatric needs must be specifically investigated. This is an update of a Cochrane review previously published in 2009.ObjectivesTo assess the effect of beta-adrenoceptor-blockers (beta-blockers) in children with congestive heart failure.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and LILACS up to November 2015. Bibliographies of identified studies were checked. No language restrictions were applied.Selection criteriaRandomised, controlled, clinical trials investigating the effect of beta-blocker therapy on paediatric congestive heart failure.Data collection and analysisTwo review authors independently extracted and assessed data from the included trials.Main resultsWe identified four new studies for the review update; the review now includes seven studies with 420 participants. Four small studies with 20 to 30 children each, and two larger studies of 80 children each, showed an improvement of congestive heart failure with beta-blocker therapy. A larger study with 161 participants showed no evidence of benefit over placebo in a composite measure of heart failure outcomes. The included studies showed no significant difference in mortality or heart transplantation rates between the beta-blocker and control groups. No significant adverse events were reported with beta-blockers, apart from one episode of complete heart block. A meta-analysis of left ventricular ejection fraction (LVEF) and fractional shortening (LVFS) data showed a very small improvement with beta-blockers. However, there were vast differences in the age, age range, and health of the participants (aetiology and severity of heart failure; heterogeneity of diagnoses and co-morbidities); there was a range of treatments across studies (choice of beta-blocker, dosing, duration of treatment); and a lack of standardised methods and outcome measures. Therefore, the primary outcomes could not be pooled in meta-analyses.Authors' conclusionsThere is not enough evidence to support or discourage the use of beta-blockers in children with congestive heart failure, or to propose a paediatric dosing scheme. However, the sparse data available suggested that children with congestive heart failure might benefit from beta-blocker treatment. Further investigations in clearly defined populations with standardised methodology are required to establish guidelines for therapy. Pharmacokinetic investigations of beta-blockers in children are also required to provide effective dosing in future trials.

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A comparison of continuous intravenous insulin and subcutaneous insulin among patients with type 2 diabetes and congestive heart failure exacerbation.

Publications

A comparison of continuous intravenous insulin and subcutaneous insulin among patients with type 2 diabetes and congestive heart failure exacerbation.

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