Nederlands Platform voor Farmaceutisch Onderzoek
Het gebruik van incretines en het risico op alvleesklierkanker: een populatiegebaseerde cohortstudie
Lotte M. Knapen a, Nielka P. van Erp b, Hubert G.M. Leufkens c, Sander Croes a, Frank de Vries acde* en Johanna H.M. Driessen acdLees abstract
Use of incretin agents and risk of pancreatic cancer: a population-based cohort study
To determine the association between the use of incretin agents and the risk of pancreatic cancer. Incretins (dipeptidyl peptidase 4 [DPP-4] inhibitors and glucacon-like peptide 1 [GLP-1] receptor analogues) are effective new agents for the treatment of type 2 diabetes mellitus (T2DM). Incretins have been associated with pancreatic cancer, but evidence is limited and conflicting.
DESIGN AND METHODS
A retrospective population-based cohort study was conducted using data from the UK Clinical Practice Research Datalink (CPRD, 2007-2012). 182,428 adult patients with at least one non-insulin antidiabetic drug (NIAD) prescription were matched to non-diabetic controls. Multivariable Cox proportional hazard ratios (HRa) and 95% confidence intervals (CI95) were used to estimate the risk of pancreatic cancer in incretin users (N = 28,370) as compared to controls and to other NIAD users. Adjustments were made for lifestyle, disease and drug history. In a sensitivity analysis, a new user design was used.
The main duration of follow up was 4.1 years for incretin users. Current NIAD use was associated with a 4-fold increased risk of pancreatic cancer and this risk almost doubled among current incretin users as compared to controls. Incretin use was not associated with pancreatic cancer when compared to diabetic controls (HRa 1.36; CI95 0.94-1.96). However, the new user design did show an association between incretin use and pancreatic cancer.
Incretin use was not associated with pancreatic cancer after adjustment for the severity of the underlying T2DM. The presence of confounding by disease severity and the lack of duration of use relationship do not support a causal explanation for the association between incretin agents and pancreatic cancer.
|Datum:||27 september 2016|
R.J. van Marum ab*, S. van Marum b, S. van Driesten b, S. Verdoorn cd, A. Boxman c en A. Grossklaus cLees abstract
Deprescribing for the elderly: comparing opinions of patients, pharmacists and doctors
To study the opinion of elderly patients with polypharmacy regarding their medication and to study the differences in valuation of this medication between patient, community pharmacist and general practitioner (GP).
Interviews and questionnaires.
Patients with 7 or more chronically used drugs were interviewed with the Patient’s Attitudes Towards Deprescribing questionnaire. Furthermore patients were asked to name their medication by heart, to rate the assumed importance of each currently used drug on a numeric rating scale (0-10) and to name three drugs they wanted to continue as well as three drugs they would prefer to stop. These last two questions were also presented to their GPs and community pharmacists.
40 patients (mean age 79 years, average 11 drugs) were interviewed. The median number of drugs spontaneously recalled by name by the patient was 2. Though 85% of the patients believes all used drugs are necessary, 98% of them stated they would like to stop drugs if the GP said it was possible. Patients scored the importance of their drugs slightly higher than pharmacists or GPs (mean score: 7,5 versus 6,7 versus 6,9). Rating of importance for all groups seemed not to be based on comparison of numbers needed to treat.
Patients consider their current medication useful and necessary, but almost all of them are willing to stop some drugs. Their spontaneous knowledge of the drugs used seems low. Before performing medication reviews, GPs and pharmacists should test the patients’ knowledge and provide them with information necessary for making the right decisions.
|Datum:||20 september 2016|
Edwin W. den Haak a, Rianne J. Zaal b*, Teun van Gelder bc, Arnold G. Vulto b en Patricia M.L.A. van den Bemt bLees abstract
Physicians’ acceptance of pharmacists’ recommendations in daily clinical practice
To determine physicians’ acceptance rate of pharmacists’ recommendations from central pharmacy services in routine hospital practice and to identify determinants for acceptance. Detailed knowledge on this acceptance rate and the determinants for acceptance is important to optimize pharmacotherapy.
DESIGN AND METHODS
A retrospective case–control study was performed in adult patients admitted to a university hospital in the Netherlands. Pharmacists’ recommendations, based on alerts for drug–drug interactions and drug dosing in patients with renal failure, recorded between January 2012 and June 2013, were included. The primary outcome was the proportion of accepted recommendations. A mixed effects logistic model was used to identify determinants for physicians’ acceptance as a secondary outcome.
A total of 841 recommendations were included. Physicians accepted 599 recommendations, resulting in an acceptance rate of 71.2%. The mixed effects logistic model showed that acceptance was significantly associated with the number of drugs used (16-20 drugs: ORadj 1.9, CI95 1.1-3.4; > 20 drugs: ORadj 2.9, CI95 1.4-6.0; compared to ≤10 drugs) and severity of the drug-related problem (drug-related problems without potential harm: ORadj 6.4, CI95 1.9-21.4; drug-related problems with potential harm: OR 6.8, CI95 2.1-22.0; compared to clinically irrelevant problems), and inversely associated with continuation of pre-admission treatment (ORadj 0.6, CI95 0.4-0.9).
The majority of pharmacists’ recommendations from a central pharmacy setting are accepted by physicians. The probability of acceptance increases for patients with an increasing number of medication orders, for clinically relevant problems and for treatment initiated during admission.
|Datum:||25 augustus 2016|
Kwalificatie van de zero-residual syringe (Zeringe) als verpakkingsmateriaal voor bevacizumab als intravitreale injectie
Maartje S. Jacobs a*, Wietske L. Hemminga b, Herman J. Woerdenbag c, Marjan Bouma a en Jan Reindert Moes aLees abstract
Qualification of the zero-residual syringe (Zeringe) as a packaging material for bevacizumab as an intravitreal injection
To qualify the Zeringe as approved packaging material according to GMP-Z3 guidelines and to determine the stability of bevacizumab in this syringe. The Zeringe is a newly developed and patented syringe and suitable for the intravitreal administration of bevacizumab.
DESIGN AND METHODS
Qualification of the Zeringe according to the Dutch GMP-Z3 guidelines comprised appearance, pH, silicone oil, subvisible particles, leachables and closure integrity. The shelf life of 0.3 mL bevacizumab repackaged in the Zeringe was investigated based on chemical stability and subvisible particles and compared with data from the conventional BD Luer-Lok syringe.
All but one test met the criteria at t = 37 days. The closure integrity of the Zeringe was based on a robustness test and a microbiological test. The robustness test failed in the dye immersion test, as leakage was found in 1 out of 40 syringes. Microbiological quality was maintained during 37 days.
The Zeringe is suited for individual aseptic preparation of intravitreal injections. It is yet undecided whether this syringe can be used for aseptic stock preparation, because the closure integrity did not meet the robustness test. The chemical stability of the repacked bevacizumab solution is at least 1 month when stored at 2-8°C and filled out in either a 0.3 mL Zeringe or a 1 mL BD Luer-Lok syringe. However, shelf life is limited by the robustness of the cap.
|Datum:||25 augustus 2016|