Farmaceutisch onderzoek

888 artikelen

02 jun 2020

Het effect van aanpassing van de therapeutische INR-range op het optreden van bloedingen en trombo-embolische complicaties bij atriumfibrilleren

  • Rubriek:
    Korte bijdrage
  • Identificatie:
    2020;5:a1724
  • Auteur(s):
    A.G. Prins a*, A.L. van Ojik a, J.W. From a, L.M. Geven-Boere b, M. Hoogendoorn c, W.J. Schuiling d, N.J.G.M. Veeger e en E.N. van Roon af

Het effect van aanpassing van de therapeutische INR-range op het optreden van bloedingen en trombo-embolische complicaties bij atriumfibrilleren

The effect of changing the therapeutic INR range on occurrence of bleeding and thromboembolic complications in patients with atrial fibrillation

Background

To comply with international guidelines, the Dutch therapeutic ranges of the International Normalized Ratio (INR) were adjusted in 2016 from 2-3.5 (target: 2.5-3.5) and 2.5-4 (target: 3-4) to 2-3 and 2.5-3.5 for the low and high intensity treatment groups, respectively.

Objective

To determine the effects of the change in therapeutic ranges on the occurrence of bleeding and thromboembolic complications in patients with atrial fibrillation who started with a vitamin K antagonist (VKA) under surveillance of the Trombosedienst Friesland Noord.

Design and methods

A retrospective cohort study was conducted with patient data of the Trombosedienst Friesland Noord and the Medisch Centrum Leeuwarden. Patients were divided into two groups depending on the start of treatment: before or after the adjustment of the therapeutic range. Between the two groups the occurrence of the composite of bleeding and thromboembolic complications was compared. Additional analyses were carried out on the separate complications, the median INR, and the time in therapeutic range (TTR).

Results

841 patients started with a VKA before and 588 after the adjustment. No significant changes were found in the occurrence of complications between the two groups (hazard ratio [HR] = 1, 95% confidence interval [95%-CI] = 0.8-1.3]). There were also no significant changes in major bleedings (HR = 1.2, 95%CI = 0.6-2.7), clinically relevant minor bleedings (HR = 1.3, 95%CI = 0.8-2.1), other minor bleedings (HR = 0.8, 95%CI = 0.6-1.1), and thromboembolic complications (HR = 0.8, 95%CI = 0.4-1.7). The median INR after the adjustment was significantly lower than before (median INR = 2.3, 95%CI = 1.9-2.8 versus median INR = 2.6, 95%CI = 2.1-3.2, respectively; P < 0.001). Patients had a significantly higher TTR after the adjustment than before (median TTR = 63.5% versus 49.5%, respectively; P < 0.001), while the time below the therapeutic range was significantly lower than before (median TTR = 21.5% versus 37.2%, respectively; P < 0.001).

Conclusion

Adjustment of the therapeutic INR range did not lead to a change in the occurrence of bleeding or thromboembolic complications.

14 mei 2020

De rol van de apotheker bij spierpijnklachten door statinegebruik

  • Rubriek:
    Oorspronkelijk artikel
  • Identificatie:
    2020;5:a1723
  • Auteur(s):
    Harm Geers ab*

De rol van de apotheker bij spierpijnklachten door statinegebruik

The role of the pharmacist when statin-associated muscle symptoms occur

Background and objective

Statin-associated muscle symptoms (SAMS) occur more often in ambulatory statin users compared with patients in randomized clinical trials (RCTs). Adherence to statins is low according to many observational studies and SAMS may be one of the causes for low adherence. Currently no guidelines exist on how to handle SAMS. In this review of reviews an investigation into the symptoms, risk factors, and management of SAMS was performed.

Design and methods

PubMed and Embase were searched using “myalgia” and “statins” as key search terms to identify review articles on SAMS. Definitions on muscle symptoms, risk factors, frequency of symptoms, and management strategies were extracted from these reviews.

Results

13 reviews on SAMS were analyzed. Literature indicates that SAMS occurred more often in daily ambulatory patients than in RCTs. Twenty-one risk factors for SAMS were mentioned – mostly the interaction with CYP3A4 inhibitors – and nineteen different therapeutic options were identified indicating various possibilities to manage SAMS in patients. Consensus existed for maintaining statin therapy if possible, and first try up to three different statins before initiating non-statin therapy.

Conclusion

This review provides an aid for pharmacists on therapeutic options for patients suffering from SAMS.

06 mei 2020

Medicatiebeoordelingen door apothekers voor dialysepatiënten

  • Rubriek:
    Referaat
  • Identificatie:
    2020;5:e1707
  • Auteur(s):
    Martina Teichert

Medicatiebeoordelingen door apothekers voor dialysepatiënten

30 apr 2020

De ontwikkeling van een inhaleerbare levodopadroogpoederformulering

  • Rubriek:
    Referaat
  • Identificatie:
    2020;5:e1708
  • Auteur(s):
    Ithamar H. Brinkman

De ontwikkeling van een inhaleerbare levodopadroogpoederformulering

23 apr 2020

Gevolgen van de vergoedingsbeperking van benzodiazepinen per 2009

  • Rubriek:
    Referaat
  • Identificatie:
    2020;5:e1705
  • Auteur(s):
    Lonneke Timmers

Gevolgen van de vergoedingsbeperking van benzodiazepinen per 2009

16 apr 2020

Patiëntervaringen na start met inhalatiecorticosteroïden

  • Rubriek:
    Referaat
  • Identificatie:
    2020;5:e1706
  • Auteur(s):
    Martina Teichert

Patiëntervaringen na start met inhalatiecorticosteroïden

10 apr 2020

Aseptische procedures voor verplaatsing van materialen van achtergrondruimte naar laminar air flow-kast, veiligheidswerkbank en isolator

  • Rubriek:
    Referaat
  • Identificatie:
    2020;5:e1704
  • Auteur(s):
    C.Y Chui en K.J.M. Schimmel *

Aseptische procedures voor verplaatsing van materialen van achtergrondruimte naar laminar air flow-kast, veiligheidswerkbank en isolator

02 apr 2020

PRISMA-symposium, 21 mei 2019

  • Rubriek:
    Congresabstracts
  • Identificatie:
    2020;5:a1722
  • Auteur(s):
    Redactiebureau NPFO - verscheidene auteurs

PRISMA-symposium, 21 mei 2019

30 mrt 2020

Geschiktheid van orale posaconazolsuspensie in immuungecompromitteerde kinderen

  • Rubriek:
    Referaat
  • Identificatie:
    2020;5:e1703
  • Auteur(s):
    András Vermes

Geschiktheid van orale posaconazolsuspensie in immuungecompromitteerde kinderen

25 mrt 2020

Voorkeuren van patiënten en apothekers bij het afhandelen van geneesmiddelinteracties

  • Rubriek:
    Oorspronkelijk artikel
  • Identificatie:
    2020;5:a1721
  • Auteur(s):
    Mette Heringa abc*, Annemieke Floor-Schreudering ab, Hans Wouters d, Peter A.G.M. de Smet e en Marcel L. Bouvy ab

Voorkeuren van patiënten en apothekers bij het afhandelen van geneesmiddelinteracties

Preferences of patients and pharmacists with regard to the management of drug-drug interactions: a choice-based conjoint analysis

Background

For the management of drug-drug interactions (DDI), a risk-benefit assessment should be combined with the patient’s perspective.

Objective

To investigate patients’ and pharmacists’ preferences regarding DDI management.

Design and methods

We conducted an online choice-based conjoint survey among patients and pharmacists. The choice task was about the management of a fictitious DDI: the combination of a cardiovascular drug and an antibiotic for pneumonia leading to a risk for developing muscle problems. Respondents answered twelve choice sets of two DDI-management options. The options were only described by their five characteristics (attributes) regarding risk for adverse events, benefit, and practical consequences. Each of the five attributes could have two different levels (e.g. low or high risk), which were varied over the 12 choice tasks. Data were analysed by latent class analysis in order to identify potential classes (subgroups) of respondents with similar preference patterns.

Results

The survey was completed by 298 patients and 178 pharmacists. The latent class model for both patients and pharmacists resulted in three classes. The first class of patients attached most importance to fewer adverse events (class probability 41%), the second class attached most importance to avoiding a medication switch (20%), and the third class attached most importance to blood sampling (39%). For pharmacists, the first class attached most importance to curing pneumonia (31%), the second class to avoiding a medication switch (31%), and the third class to avoiding blood sampling (38%).

Conclusion

Among patients and pharmacists diverging preferences regarding DDI management were observed. Some subgroups of respondents attached most value to risk or benefit while others attached more value to practical considerations. Awareness of existing variability in preferences among and between pharmacists and patients can contribute to shared decision making in DDI management.

19 mrt 2020

Vergelijking tussen factor VIII gemeten met een activiteitsassay en met massaspectrometrie bij patiënten met hemofilie A

  • Rubriek:
    Korte bijdrage
  • Identificatie:
    2020;5:a1716
  • Auteur(s):
    Anouk Donners a*, Erik van Maarseveen a, Yrea Weetink a, Mohsin El Amrani ab, Kathelijn Fischer c, Karin Rademaker a, Toine Egberts ad, Albert Huisman b en Ruben Musson b

Vergelijking tussen factor VIII gemeten met een activiteitsassay en met massaspectrometrie bij patiënten met hemofilie A

Comparison between coagulation factor VIII quantified with one-stage activity assay and mass spectrometry in haemophilia A patients

Background

Haemophilia A is a hereditary bleeding disorder caused by a factor VIII (FVIII) deficiency. As biomarker, FVIII activity is used to classify disease severity and to monitor treatment. The one-stage clotting assay (OSA) is used to measure FVIII activity but OSA’s limitations may result in misclassification of disease severity or suboptimal monitoring of treatment. Measurement of FVIII plasma concentration with LC-MS/MS might overcome these challenges.

Objective

To investigate the association between FVIII activity and concentration as well as determinants for discrepancies.

Design and methods

In this cross-sectional study, all haemophilia A patients receiving standard of care were eligible for inclusion. Within the activity categories of < 1%, 1-5%, > 5-40%, > 40-150%, and > 150-600% we randomly selected 15 till 20 plasma samples, and compared FVIII concentration (LC-MS/MS) to FVIII activity (OSA) with linear regression and Bland-Altman analysis. Potential determinants were analysed with linear regression.

Results

87 samples were included. Bland-Altman analysis demonstrated an overall mean difference of –1% with a standard deviation (SD) of 64% between the two methods. Discrepancies were associated with the presence of anti-FVIII antibodies (133%, 95% confidence interval [95%CI] = 81-185, n = 5) and exogenous FVIII products (–37%, 95%CI = –65- –9, n = 58), e.g. plasma-derived and B-domain modified FVIII.

Conclusion

Despite almost no discrepancy overall, the variability between FVIII activity and FVIII concentration was large. Anti-FVIII antibodies or use of exogenous FVIII products might result in differences of potential clinical impact. More research is needed to determine the value of FVIII concentration in addition to activity.

10 mrt 2020

Beslisregels voor geneesmiddelen bij ouderen zijn toepasbaar en leiden tot wijzigingen in voorschriften van risicomedicatie

  • Rubriek:
    Referaat
  • Identificatie:
    2020;5:e1701
  • Auteur(s):
    Sander D. Borgsteede

Beslisregels voor geneesmiddelen bij ouderen zijn toepasbaar en leiden tot wijzigingen in voorschriften van risicomedicatie

02 mrt 2020

Betrouwbaarheid van twee testen voor gammahydroxyboterzuur; prospectief onderzoek naar de DrugCheck GHB Single Test en Viva-E GHB immunoassay

  • Rubriek:
    Korte bijdrage
  • Identificatie:
    2020;5:a1720
  • Auteur(s):
    T.A. Smits a*, F.M.J. Gresnigt b, B.D. van Groen c, E.J.F. Franssen a en M.E. Attema-de Jonge d

Betrouwbaarheid van twee testen voor gammahydroxyboterzuur; prospectief onderzoek naar de DrugCheck GHB Single Test en Viva-E GHB immunoassay

Prospective investigation of the performance of 2 gamma-hydroxybutyric acid tests: DrugCheck GHB Single Test and Viva-E GHB immunoassay

Objective and design

Since results are quickly available, a point-of-care test for GHB in urine can be of great diagnostic value. The objective of this prospective study was to determine the performance of the new DrugCheck GHB Single Test and the Viva-E GHB immunoassay for urine samples from emergency department patients.

Methods

Patients presented to the emergency department of OLVG hospital in Amsterdam with a Glasgow Coma Scale < 15 and a potential intoxication with drugs of abuse were included. Urine of these patients was tested for presence of GHB using the DrugCheck GHB Single Test and the Viva-E GHB immunoassay (cutoff for a positive result: 10 or 50 mg/L GHB). Results were compared for agreement with a validated gas chromatography method. Possible cross-reactivity with ethanol was investigated by analyzing ethanol concentrations in patients’ urine and serum. Furthermore, the diagnostic performance of emergency medicine physicians for possible GHB-intoxicated patients was assessed.

Results

A total of 375 patients were prospectively included. The specificity and sensitivity of the DrugCheck GHB Single Test were 90% and 73%, respectively. Results improved using a cutoff value of 50 mg/L to a specificity of 97% and a sensitivity of 75%. Serum and urine ethanol levels in the false positive group were significantly higher compared to the true negative group (P < 0.05). Using the Viva-E GHB immunoassay the specificity was 99% and the sensitivity was 94% (cutoff value 50 mg/L and excluding samples with ethanol levels ≥ 2 g/L). The specificity and sensitivity of the physicians were 93% and 66%, respectively.

Conclusion

The DrugCheck GHB Single Test shows a sufficient specificity of > 90%, but a poor sensitivity and is therefore not suitable for use in clinical practice. In contrast, the Viva-E GHB immunoassay showed acceptable results when using a cutoff value of 50 mg/L in case samples with ethanol levels ≥ 2 g/L were excluded.

27 feb 2020

SEH-bezoek als gevolg van intoxicaties

  • Rubriek:
    Referaat
  • Identificatie:
    2020;5:e1702
  • Auteur(s):
    András Vermes

SEH-bezoek als gevolg van intoxicaties

25 feb 2020

Een landelijke inventarisatie naar geprotocolleerde zorg voor het gebruik van antidepressiva, antihypertensiva en tocolytica tijdens zwangerschap en lactatie

  • Rubriek:
    Korte bijdrage
  • Identificatie:
    2020;5:a1719
  • Auteur(s):
    N. Huijgen, MSc a, drs. L. de Vries b, dr. T.W. de Vries c, prof. dr. E.P. van Puijenbroek bd en dr. P.G.J. ter Horst e*

Een landelijke inventarisatie naar geprotocolleerde zorg voor het gebruik van antidepressiva, antihypertensiva en tocolytica tijdens zwangerschap en lactatie

National inventory of protocoled care for the use of antidepressants, antihypertensives and tocolytics during pregnancy and lactation

Objective

To gain insight into medical guidelines for perinatal use of antidepressants, tocolytics and antihypertensive drugs in Dutch hospitals.

Design

Observational inventory study.

Methods

We contacted the departments of gynaecology, and paediatrics of the Dutch hospitals either by mail, e-mail, or searched for specific guidelines on the websites of the according hospitals. These included guidelines regarding antidepressants, antihypertensives and drugs used during delivery (tocolytics and uterotonics) during the perinatal period. Those guidelines were analysed and categorised based on user advices just before delivery, during the lactation period and precautions for the neonate after maternal use of the aforementioned drug categories.

Results

We received local guidelines of 53 Dutch hospitals, among which are five university hospitals. We found information on the use of antidepressants (50 SSRIs; 16 TCAs), antihypertensive drugs (21), and drugs used during partus (tocolytics and uterotonic drugs, 21 in total). The guidelines of all drug categories differed in number of controls, kind of controls, length of postpartum hospital stay, and whether or not to use antidepressants during pregnancy and lactation.

Conclusion

There is a large heterogeneity in advices given to pregnant women and health care workers about the safe use of antidepressants, antihypertensive drugs and tocolytics. We believe there is a need for a national guideline that comprises all aspects of perinatal use of drugs.

21 feb 2020

Geneesmiddelen als oorzaak van heropname na ontslag uit het ziekenhuis: verschil in inzicht tussen patiënt en zorgverlener

  • Rubriek:
    Referaat
  • Identificatie:
    2020;5:e1700
  • Auteur(s):
    Sander D. Borgsteede

Geneesmiddelen als oorzaak van heropname na ontslag uit het ziekenhuis: verschil in inzicht tussen patiënt en zorgverlener