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The frequency and severity of capecitabine-induced hypertriglyceridaemia in routine clinical practice: a prospective study.

ABSTRACT: BACKGROUND: Capecitabine is known to rarely cause raised serum triglycerides (TG). In our centre, several patients receiving capecitabine developed raised TG levels corresponding to the 'very high risk' category for potentially serious acute pancreatitis. METHODS: A fasting blood lipid screening protocol was introduced into clinical practice for patients receiving capecitabine. Patients with TGs >5 mmol l(-1) were treated and followed up. An 18-month prospective audit was performed to establish the incidence and severity of capecitabine-induced hypertriglyceridaemia (CIHT). RESULTS: A total of 304 patients received capecitabine for colorectal cancer between January 2008 and June 2009. Of these, 212 patients (70%) were screened and 8 (3.7%) developed clinically significant hypertriglyceridaemia requiring lipid-lowering therapy. Two of the eight patients had diabetes and one had pre-existing dyslipidaemia. One suffered cerebral infarction during chemotherapy. There were no cases of acute pancreatitis. Follow-up showed that serum TGs safely and rapidly returned to normal with appropriate treatment without discontinuation of capecitabine. CONCLUSIONS: This is the first prospective study evaluating CIHT. These results suggest that it should be classed as a 'common' undesired effect of capecitabine. Despite this, the incidence does not justify routine screening in all patients. Targeted screening in those with diabetes or pre-existing hyperlipidaemia is recommended, together with adoption of a clear management policy.

SUBMITTER: Michie CO

PROVIDER: S-EPMC2938254 | biostudies-other | 2010 Aug

REPOSITORIES: biostudies-other

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Project description:ObjectiveTo determine outcomes and safety of endovascular treatment for acute ischaemic stroke, due to proximal intracranial vessel occlusion in the anterior circulation, in routine clinical practice.DesignOngoing, prospective, observational cohort study.Setting16 centres that perform endovascular treatment in the Netherlands.Participants1488 patients included in the Multicentre Randomised Controlled Trial of Endovascular Treatment for Acute Ischaemic Stroke in the Netherlands (MR CLEAN) Registry who had received endovascular treatment, including stent retriever thrombectomy, aspiration, and all alternative methods for acute ischaemic stroke within 6.5 hours from onset of symptoms between March 2014 and June 2016.Main outcome measuresThe primary outcome was the modified Rankin Scale (mRS) score, ranging from 0 (no symptoms) to 6 (death) at 90 days after the onset of symptoms. Secondary outcomes were excellent functional outcome (mRS score 0-1), good functional outcome (mRS score 0-2), and favourable functional outcome (mRS score 0-3) at 90 days; score on the extended thrombolysis in cerebral infarction scale at the end of the intervention procedure; National Institutes of Health Stroke Scale score 24-48 hours after intervention; and complications that occurred during intervention, hospital admission, or three months' follow up period. Outcomes and safety variables in the MR CLEAN Registry were compared with the MR CLEAN trial intervention and control arms.ResultsA statistically significant shift was observed towards better functional outcome in patients in the MR CLEAN Registry compared with the MR CLEAN trial intervention arm (adjusted common odds ratio 1.30, 95% confidence interval 1.02 to 1.67) and the MR CLEAN trial control arm (1.85, 1.46 to 2.34). The reperfusion rate, with successful reperfusion defined as a score of 2B-3 on the extended thrombolysis in cerebral infarction score, was 58.7%, the same as for patients in the MR CLEAN trial. Duration from onset of stroke to start of endovascular treatment and from onset of stroke to successful reperfusion or last contrast bolus was one hour shorter for patients in the MR CLEAN Registry. Symptomatic intracranial haemorrhage occurred in 5.8% of patients in the MR CLEAN Registry compared with 7.7% in the MR CLEAN trial intervention arm and 6.4% in the MR CLEAN trial control arm.ConclusionIn routine clinical practice, endovascular treatment for patients with acute ischaemic stroke is at least as effective and safe as in the setting of a randomised controlled trial.

Project description:Introduction:Extracorporeal circuit (EC) anticoagulation with heparin is a key advance in hemodialysis (HD), but anticoagulation is problematic in inpatients at risk of bleeding. We prospectively evaluated a heparin-avoidance HD protocol, clotting of the EC circuit (CEC), impact on dialysis efficiency, and associated risk factors in our acute care inpatients who required HD (January 17, 2014 to May 31, 2015). Methods:HD sessions without routine EC heparin were performed using airless dialysis tubing. Patients received systemic anticoagulation therapy and/or antiplatelets for non-HD indications. We observed patients for indications of CEC (interrupted HD session, circuit loss, or inability to return blood). The primary outcome was CEC. Logistic regression with generalized estimating equations assessed associations between CEC and other variables. Results:HD sessions (n = 1200) were performed in 338 patients (204 with end-stage renal disease; 134 with acute kidney injury); a median session was 211 minutes (interquartile range [IQR]: 183-240 minutes); delivered dialysis dose measured by Kt/V was 1.4 (IQR: 1.2 Kt/V 1.7). Heparin in the EC was prescribed in only 4.5% of sessions; EC clotting rate was 5.2%. Determinants for CEC were temporary catheters (odds ratio [OR]: 2.8; P < 0.01), transfusions (OR: 2.4; P = 0.04), therapeutic systemic anticoagulation (OR: 0.2; P < 0.01), and antiplatelets (OR: 0.4; P < 0.01). CEC was associated with a lower delivered Kt/V (difference: 0.39; P < 0.01). Most CEC events during transfusions (71%) occurred with administration of blood products through the HD circuit. Discussion:We successfully adopted heparin avoidance using airless HD tubing as our standard inpatient protocol. This protocol is feasible and safe in acute care inpatient HD. CEC rates were low and were associated with temporary HD catheters and transfusions. Antiplatelet agents and systemic anticoagulation were protective.ClinicalTrials.gov Identifier:NCT02086682.

Project description:BACKGROUND:Care coordination between general practitioners (GPs) and cardiovascular specialists is expected to play a key role in establishing appropriate oral anticoagulant (OAC) treatment in atrial fibrillation (AF) patients. The aim of this study was to assess the impact of care coordination on oral anticoagulant therapy in the management of AF in Japan. METHODS:This study was a multi-center, single-arm, prospective cohort study with retrospective chart and claims data review for historical controls. The study included three study periods: a 12-month pre-campaign period; a 12-month campaign period for AF screening and care coordination; and a 3-month post-campaign period for follow-up of care coordination. During the campaign period, patients aged ≥65 years who attended participating GP clinics underwent opportunistic AF screening by GPs under the campaign. At the discretion of the GP, newly diagnosed AF patients after the screening were referred to a cardiovascular specialist for care coordination. To assess the impact of care coordination and evaluate the effects of the campaign, implementation of care coordination, antithrombotic therapies, and patient-reported outcomes were compared between patients with and without care coordination, and between patients during the pre-campaign and campaign periods. RESULTS:There were 86 newly diagnosed AF patients during the pre-campaign period and 90 during the campaign period. The percentage of patients with care coordination increased from 3.5% (3/86) in the pre-campaign period to 14.4% (n = 13/90) during the campaign period. The percentage of patients who received OAC therapies, according to the definition from the Japanese AF medication guideline, increased from 55.8% (48/86) to 71.1% (64/90) during the campaign period regardless of care coordination. Younger patients were referred to cardiovascular specialists for care coordination. Implementation of OAC therapy did not differ between patients with and without care coordination. Adherence to OAC therapy was low regardless of care coordination. CONCLUSIONS:This GP-targeted campaign was effective at raising awareness regarding the implementation of care coordination and appropriate OAC therapy at local clinical practices in Japan. Improvement of adherence to OAC therapy in elderly patients is a critical issue, and measures such as education programs targeted to patients and healthcare professionals should be undertaken.

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The frequency and severity of capecitabine-induced hypertriglyceridaemia in routine clinical practice: a prospective study.

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