Influence of chronic comorbidity and medication on the efficacy of treatment in patients with diabetes in general practice

Wami, Welcome M.; Buntinx, Frank; Bartholomeeusen, Stephaan; Goderis, Geert; Mathieu, Chantal; Aerts, Marc

doi:10.3399/bjgp13x665233

Cited by 22 publications

(19 citation statements)

References 31 publications

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“…The presence of CV disease and CV risk factors can complicate T2DM management [8]. This post hoc analysis evaluated the efficacy and safety of canagliflozin 100 and 300 mg in patients with T2DM based on history of CV disease, history of hypertension, baseline use of statins, and the number of CV risk factors.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data

Davies

Merton

Vijapurkar

et al. 2017

Cardiovasc Diabetol

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BackgroundTreatment of patients with type 2 diabetes mellitus (T2DM) and a history of cardiovascular (CV) disease or CV risk factors may present clinical challenges due to the presence of comorbid conditions and the use of concomitant medications. The sodium glucose co-transporter 2 inhibitor, canagliflozin, has been shown to improve glycaemic control and reduce body weight and blood pressure (BP) with a favourable tolerability profile in a broad range of patients with T2DM. This post hoc analysis assessed the efficacy and safety of canagliflozin in patients with T2DM based on CV disease history or CV risk factors.MethodsAnalyses were based on pooled data from four 26-week, placebo-controlled, Phase 3 studies that evaluated canagliflozin 100 and 300 mg in patients with T2DM (N = 2313; mean HbA1c, 8.0%; body weight, 89 kg; systolic BP, 128 mmHg). Changes from baseline to week 26 in HbA1c, body weight, and systolic BP were assessed based on history of CV disease, history of hypertension, baseline statin use, and number of CV risk factors. Safety was assessed based on adverse event (AE) reports.ResultsAt week 26, both canagliflozin doses lowered HbA1c, body weight, and systolic BP compared with placebo in patients with and without CV disease history or risk factors. Placebo-subtracted HbA1c reductions with canagliflozin 100 and 300 mg were similar in patients with a history of CV disease (−0.95 and −1.07%) versus no history of CV disease (−0.71 and −0.90%), history of hypertension (−0.72 and −0.89%) versus no history of hypertension (−0.73 and −0.95%), baseline statin use (−0.77 and −0.99%) versus no statin use (−0.69 and −0.85%), and 0–1 CV risk factor (−0.72 and −0.87%) versus ≥2 CV risk factors (−0.74 and −1.02%). Similar body weight and systolic BP reductions were seen with canagliflozin versus placebo across subgroups. The incidence of AEs, AEs leading to discontinuation, and serious AEs was similar across subgroups.ConclusionsThe efficacy and safety of canagliflozin were generally consistent across subgroups of patients with T2DM and varying degrees of CV disease history or risk factors. Trial registration numbers and dates ClinicalTrials.gov: NCT01081834, 4 March 2010; NCT01106625, 1 April 2010; NCT01106677, 1 April 2010; NCT01106690, 1 April 2010Electronic supplementary materialThe online version of this article (doi:10.1186/s12933-017-0517-7) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data

Davies

Merton

Vijapurkar

et al. 2017

Cardiovasc Diabetol

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“…For moderate exacerbations, antidiabetics showed a protective effect. In this case the effect could be explained by an underestimation of the outcome due to the contraindicated use of oral corticosteroids in patients with diabetes . To apply the propensity score adjustment, we calculated the distribution of the probability of receiving a given treatment.…”

Section: Discussionmentioning

confidence: 99%

“…In this case the effect could be explained by an underestimation of the outcome due to the contraindicated use of oral corticosteroids in patients with diabetes. 44 To apply the propensity score adjustment, we calculated the distribution of the probability of receiving a given treatment. Unexpectedly, this analysis did not identify any factors, even for variables related to COPD severity, which are strong predictors of treatment choice.…”

Section: Discussionmentioning

confidence: 99%

Role of Tiotropium in Reducing Exacerbations of Chronic Obstructive Pulmonary Disease When Combined With Long‐Acting β₂‐Agonists and Inhaled Corticosteroids: The OUTPUL Study

Ferroni¹,

Belleudi²,

Cascini³

et al. 2016

The Journal of Clinical Pharma

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Combined inhaled therapy in chronic obstructive pulmonary disease (COPD) is commonly used, but its benefits remain controversial. We assessed the effect of tiotropium in reducing COPD exacerbations when combined with long‐acting β2 agonists (LABA) and/or inhaled corticosteroids (ICS). This new‐user cohort study is based on administrative data from 3 Italian regions. We identified adults hospitalized for COPD from 2006 to 2009 who were newly prescribed a fixed LABA/ICS combination (double therapy). We classified patients according to whether tiotropium was also prescribed (triple therapy), using both intention‐to‐treat and as‐treated approaches, and followed them for 1 year. COPD exacerbations were measured as outcomes. Multivariate and propensity score‐adjusted hazard ratios (HRs, 95%CI) were calculated with Cox regression models. We identified 5717 new users of LABA/ICS of which 31.9% initiated triple therapy. In the intention‐to‐treat analysis, the multivariate adjusted HR for moderate, severe, and any exacerbations were 1.02 (95%CI 0.89‐1.16), 0.92 (95%CI 0.76‐1.12), and 1.08 (95%CI 0.91‐1.28), respectively. The propensity score adjustment produced similar results. In the subcohort of patients with previous exacerbations, triple therapy was significantly associated with reduced risk of moderate exacerbations, compared to double therapy (HR 0.68, 95%CI 0.48‐0.98 in intention‐to‐treat approach). In conclusion, the addition of tiotropium to LABA/ICS did not reduce COPD exacerbations compared to LABA/ICS alone. A protective role for moderate exacerbations was found in patients at risk of frequent exacerbations. Given the impact of exacerbations on health status and prognosis, it is crucial to target COPD patients for optimal treatment.

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“…In the foremost, the drug prescribed for a particular condition could exacerbate another co-existing disease [2,3], but how the disease attenuates the intended drug efficacy is rarely discussed [4]. Due to limited information, the current practice in addressing drug-disease interaction is perhaps unbalanced and it is mostly limited to how the drug worsens disease [2,3].…”

Section: Introductionmentioning

confidence: 99%

Drug-disease interactions: narrative review of aspirin in gastric ulcer

Nwose

Yee

2016

Expert Opinion on Drug Metabolism & Toxicology

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There seems to be oversight in definition and description of drug-disease interaction, which is often limited to 'how drug exacerbates disease'. The implication of this limited definition is that the discussions, research and teaching of the topic either lacks information, or are not clear on 'how disease affects drug efficacy'. For example, gastric ulcer has the potential to enhance absorption, bioavailability and therapeutic effects of aspirin, but this is rarely discussed in preference to the probability of gastro-intestinal bleeding side-effect.

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Influence of chronic comorbidity and medication on the efficacy of treatment in patients with diabetes in general practice

Abstract: BackgroundEvidence on the influence of comorbidity and comedication on clinical outcomes in patients with type 2 diabetes mellitus is scarce.

Cited by 22 publications

References 31 publications

Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data

Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data

Role of Tiotropium in Reducing Exacerbations of Chronic Obstructive Pulmonary Disease When Combined With Long‐Acting β₂‐Agonists and Inhaled Corticosteroids: The OUTPUL Study

Drug-disease interactions: narrative review of aspirin in gastric ulcer

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Influence of chronic comorbidity and medication on the efficacy of treatment in patients with diabetes in general practice

Abstract: BackgroundEvidence on the influence of comorbidity and comedication on clinical outcomes in patients with type 2 diabetes mellitus is scarce.

Cited by 22 publications

References 31 publications

Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data

Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data

Role of Tiotropium in Reducing Exacerbations of Chronic Obstructive Pulmonary Disease When Combined With Long‐Acting β2‐Agonists and Inhaled Corticosteroids: The OUTPUL Study

Drug-disease interactions: narrative review of aspirin in gastric ulcer

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Role of Tiotropium in Reducing Exacerbations of Chronic Obstructive Pulmonary Disease When Combined With Long‐Acting β₂‐Agonists and Inhaled Corticosteroids: The OUTPUL Study