Nederlands Platform voor Farmaceutisch Onderzoek
Risico’s en klinische relevantie van medicatiediscrepanties op poliklinieken voor angst- en stemmingsstoornissen (verkorte vertaling)
Risks and clinical relevance of medication discrepancies at outpatient departments for mood and anxiety disorders
To identify discrepancies between actual drug use by outpatients with mood and anxiety disorders and medication overviews from health care providers as well as to investigate the clinical relevance of those discrepancies.
Cross-sectional cohort study.
We included adults visiting one of four participating outpatient departments for mood and anxiety disorders between March and November 2014. Primary outcome was the number of discrepancies between the actual medication use as determined by medication reconciliation with the patient and the medication overview from the outpatient department, general practitioner and community pharmacy. Our secondary outcome was the clinical relevance of discrepancies, as assessed by an expert panel that reviewed all discrepancies for their potential to cause patient harm.
Of 367 patients included, 94.8% had at least one discrepancy in the medication overview from the outpatient department. On average 3.9 discrepancies existed per patient. Of all discrepancies at the outpatient departments, 22.7% had the potential to cause moderate to severe discomfort or clinical deterioration, affecting 49.3% of the patients. Both total number and number of clinically relevant discrepancies were lower in medication overviews from general practitioners and pharmacies.
Patients from outpatient departments for mood and anxiety disorders may be at substantial risk of medication discrepancies which are often clinically relevant. Medication reconciliation at mental health care outpatient departments is in need of improvement.
|Datum:||28 maart 2017|
De prevalentie van incorrecte anti-Xa-bloedspiegels bij patiënten met een verminderde nierfunctie die laag-moleculairgewicht-heparines gebruiken
The prevalence of incorrect anti-Xa activity in patients with renal insufficiency who use low-molecular-weight heparins
To determine the prevalence of incorrect anti-Xa activity in patients with renal insufficiency after three days of therapeutic use of nadroparin, as advised in the guideline of the Dutch federation of Nephrology.
Prospective, observational study.
The source population consisted of patients aged ≥18 years old with renal insufficiency (eGFR [MDRD] < 60 mL/min/1.73 m2) from the Jeroen Bosch hospital who were treated therapeutically with nadroparin. All patients were followed from the start of nadroparin use (index date) for three days. At day three (t=3) the anti-Xa activity was monitored. Weight, eGFR (MDRD) and nadroparin use during the three days were obtained from the electronic patient file. We also checked if the patients received a dose of nadroparin according to the guideline during the three days of use.
In total 15 patients were included. Nadroparin dose was not adjusted according to the guideline in 13 patients. 4 of these patients (31%) still had a correct anti-Xa activity at t=3 and 9 had an incorrect anti-Xa activity. Only 2 patients received a nadroparin dose according to the guideline but had an incorrect anti-Xa activity at t=3.
The results of this study suggest that therapeutic use of nadroparin with and without dose adjustment often leads to incorrect anti-Xa activity in patients with renal insufficiency. Therefore we advise to individualise nadroparin dose according to the first anti-Xa activity which is measured at day three of nadroparin use. To confirm this conclusion, additional research with more patients is needed.
|Datum:||28 maart 2017|
Is er een plaats voor voedingsmiddelen verrijkt met fytosterolen bij cardiovasculair risicomanagement? Kritische analyse van de bewijskracht voor cholesterolverlaging
Is there a place for phytosterol-enriched food products in cardiovascular risk management? Critical analysis of the evidence for cholesterol reduction
To analyse the literature of the past decade regarding the cholesterol-lowering effect of phytosterol-enriched food products.
A literature study over a 10-year period, 2006-2016.
PubMed was searched, using MeSH terms and free search terms, for studies on the effect of phytosterol-enriched food products on serum cholesterol levels and on the additive effect of such products on the lipid-lowering effect of statins. Only randomized placebo-controlled clinical studies, published between January 2006 and May 2016 were included. Total cholesterol (TC) and LDL cholesterol were considered as outcome measures.
In total, 32 studies fulfilled the inclusion criteria. Most studies showed a significant reduction of TC and LDL cholesterol blood levels after a daily intake of phytosterol-enriched functional foods. Most studies were short, covering a period of about four weeks, and performed in relatively healthy populations. The optimal daily dose was 2-2.5 g of phytosterols. A daily dose of > 3 g did not result in an extra cholesterol-lowering effect. Combined with statins, phytosterol-containing functional foods may have an additional effect.
Despite the positive effect of phytosterol-enriched food products in hypercholesteraemic patients as reported in various studies, inclusion of these food products in the guidelines for cardiovascular risk management is not yet justified. From the studies performed so far, no evidence was obtained on long-term effects or on the effect on cardiovascular morbidity and mortality. These issues are still to be addressed.
|Datum:||28 maart 2017|
Busulfanblootstelling geassocieerd met event-vrije overleving na allogene stamceltransplantatie bij kinderen: een retrospectieve multicentrumstudie
Busulfan exposure associated with event-free survival in children after allogeneic haematopoietic stem cell transplantation: a retrospective multicenter cohort study
To determine the relationship between busulfan cumulative area under the curve (AUC) and event-free survival (EFS) in children undergoing allogeneic haematopoietic stem cell transplantation (alloHCT).
Retrospective, multicenter cohort study.
Children who underwent alloHCT in 15 different centres worldwide were included in this study (2000-2013). Participants had to be on intravenous busulfan and pharmacokinetic samples had to be available. Exposure of interest was the cumulative AUC of busulfan, and primary outcome was EFS (time to graft failure, relapse or all-cause mortality). Cox regression models were used to derive relative risks (RR), and the optimal busulfan AUC level was estimated using propensity adjusted Weibull models.
A total of 674 subjects (41% malignant, 59% non-malignant) with a median age of 4.5 years (interquartile range 1.4-10.7 years) were included in the analysis. We observed a significant U-shaped relationship between busulfan cumulative AUC and EFS (P = 0.011). The optimal target was estimated at 90 mg·h/L (78-101 mg·h/L), and was independent of any of the investigated patient characteristics. An AUC below the target increased the risk of graft failure and relapse (relative risk 1.75, P = 0.004), while transplant-related mortality was more pronounced when the AUC was too high (relative risk 2.99, P < 0.001).
This is the largest study on the relationship between busulfan and clinical outcomes in children undergoing alloHCT. Our results strongly advocate the use of therapeutic drug monitoring of busulfan, using 90 mg·h/L (78-101 mg·h/L) as a target.
|Datum:||20 februari 2017|