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4. The INVENT COVID trial: a structured protocol for a randomized controlled trial investigating the efficacy and safety of intravenous imatinib mesylate (Impentri®) in subjects with acute respiratory distress syndrome induced by COVID-19

Author

Atmowihardjo, Leila, Schippers, Job R., Bartelink, Imke H., Bet, Pierre M., van Rein, Nienke, Purdy, Keith, Cavalla, David, Comberiati, Valérie, McElroy, Andrew, Snape, Sue D., Bogaard, Harm Jan, Heunks, Leo, Juffermans, Nicole, Schultz, Marcus, Tuinman, Pieter R., Bos, Lieuwe D. J., and Aman, Jurjan

Published
2022
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6. Imatinib in patients with severe COVID-19: a randomised, double-blind, placebo-controlled, clinical trial

Author

Aman, Jurjan, Duijvelaar, Erik, Botros, Liza, Kianzad, Azar, Schippers, Job R, Smeele, Patrick J, Azhang, Sara, Bartelink, Imke H, Bayoumy, Ahmed A, Bet, Pierre M, Boersma, Wim, Bonta, Peter I, Boomars, Karin A T, Bos, Lieuwe D J, van Bragt, Job J M H, Braunstahl, Gert-Jan, Celant, Lucas R, Eger, Katrien A B, Geelhoed, J J Miranda, van Glabbeek, Yurika L E, Grotjohan, Hans P, Hagens, Laura A, Happe, Chris M, Hazes, Boaz D, Heunks, Leo M A, van den Heuvel, Michel, Hoefsloot, Wouter, Hoek, Rianne J A, Hoekstra, Romke, Hofstee, Herman M A, Juffermans, Nicole P, Kemper, E Marleen, Kos, Renate, Kunst, Peter W A, Lammers, Ariana, van der Lee, Ivo, van der Lee, E Laurien, Maitland-van der Zee, Anke-Hilse, Mau Asam, Pearl F M, Mieras, Adinda, Muller, Mirte, Neefjes, Elisabeth C W, Nossent, Esther J, Oswald, Laurien M A, Overbeek, Maria J, Pamplona, Carolina C, Paternotte, Nienke, Pronk, Niels, de Raaf, Michiel A, van Raaij, Bas F M, Reijrink, Merlijn, Schultz, Marcus J, Serpa Neto, Ary, Slob, Elise M A, Smeenk, Frank W J M, Smit, Marry R, Smits, A Josien, Stalenhoef, Janneke E, Tuinman, Pieter R, Vanhove, Arthur L E M, Wessels, Jeroen N, van Wezenbeek, Jessie C C, Vonk Noordegraaf, Anton, de Man, Frances S, and Bogaard, Harm J

Published
2021
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8. Considerations on implementation of the newest treatment for symptomatic uterine fibroids: Oral GnRH antagonists.

Author

de Lange, Maria E., Semmler, Annika, Clark, T. Justin, Mol, Ben Willem J., Bet, Pierre M., Huirne, Judith A. F., and Hehenkamp, Wouter J. K.

Subjects
UTERINE artery, UTERINE fibroids, GONADOTROPIN releasing hormone, BONE density, MIFEPRISTONE, CONSERVATIVE treatment, TREATMENT effectiveness
Abstract

Novel gonadotrophin releasing hormone (GnRH) antagonist treatments have recently been developed in combination with hormonal add‐back therapy, as an oral treatment option for women suffering from uterine fibroids. Registration trials assessing the GnRH antagonist combination preparations with relugolix, elagolix and linzagolix have assessed treatment efficacy for fibroid‐related heavy menstrual blood loss in comparison to placebo. Marketing authorization has been granted by several agencies including those in Europe, the United Kingdom and the United States. While the registration trials report a robust effect on the reduction of heavy menstrual blood loss and improvement in quality of life scores, reticence is advised before widespread prescription. In this review, we demonstrate limitations in the trial data, namely a lack of generalizability due to the restricted study population, the lack of transparency in the distribution of disease‐level characteristics limiting the predictability of treatment success in the real‐world diverse population, and the absence of any comparison to current alternative treatment methods. Importantly, no clinically meaningful volume reductions were found with GnRH antagonist combination preparations, and long‐term safety data, particularly concerning modest but stable bone mineral density decline, need further addressing. Symptoms related to uterine fibroids adversely affect many women's quality of life and effective medical treatments are lacking. However, despite the urgent need for conservative treatments, it is vitally important that novel drugs, like combination oral GnRH antagonists, undergo sufficiently rigorous evaluation of safety, effectiveness and cost‐effectiveness in a representative population and are compared with alternative treatment methods before introduction into mainstream clinical practice. [ABSTRACT FROM AUTHOR]

Published
2024
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10. Efficacy and safety of intravenous imatinib in COVID-19 ARDS: a randomized, double-blind, placebo-controlled clinical trial

Author

Atmowihardjo, Leila N., primary, Schippers, Job R., additional, Duijvelaar, Erik, additional, Bartelink, Imke H., additional, Bet, Pierre M., additional, Swart, Noortje E. L., additional, van Rein, Nienke, additional, Purdy, Keith, additional, Cavalla, David, additional, McElroy, Andrew, additional, Fritchley, Sarah, additional, Vonk Noordegraaf, Anton, additional, Endeman, Henrik, additional, van Velzen, Patricia, additional, Koopmans, Matty, additional, Bogaard, Harm Jan, additional, Heunks, Leo, additional, Juffermans, Nicole, additional, Schultz, Marcus J., additional, Tuinman, Pieter R., additional, Bos, Lieuwe D. J., additional, and Aman, Jurjan, additional

Published
2023
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11. Pharmacokinetics and pharmacodynamics of imatinib for optimal drug repurposing from cancer to COVID-19

Author

Baalbaki, Nadia, primary, Duijvelaar, Erik, additional, Said, Medhat M., additional, Schippers, Job, additional, Bet, Pierre M., additional, Twisk, Jos, additional, Fritchley, Sarah, additional, Longo, Cristina, additional, Mahmoud, Kazien, additional, Maitland-van der Zee, Anke H., additional, Bogaard, Harm Jan, additional, Swart, Eleonora L., additional, Aman, Jurjan, additional, and Bartelink, Imke H., additional

Published
2023
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12. Drugs for BNCT: BSH and BPA

Author

Sauerwein, Wolfgang A. G., Bet, Pierre M., Wittig, Andrea, Sauerwein, Wolfgang, editor, Wittig, Andrea, editor, Moss, Raymond, editor, and Nakagawa, Yoshinobu, editor

Published
2012
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13. Vitamin D supplementation in chronic obstructive pulmonary disease patients with low serum vitamin D: a randomized controlled trial

Author

Rafiq, Rachida, primary, Aleva, Floor E, additional, Schrumpf, Jasmijn A, additional, Daniels, Johannes M, additional, Bet, Pierre M, additional, Boersma, Wim G, additional, Bresser, Paul, additional, Spanbroek, Michiel, additional, Lips, Paul, additional, van den Broek, Tim J, additional, Keijser, Bart JF, additional, van der Ven, André JAM, additional, Hiemstra, Pieter S, additional, den Heijer, Martin, additional, and de Jongh, Renate T, additional

Published
2022
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14. Rivastigmine for ECT-induced cognitive adverse effects in late life depression (RECALL study): A multicenter, randomized, double blind, placebo-controlled, cross-over trial in patients with depression aged 55 years or older: Rationale, objectives and methods

Author

Henstra, Marieke J., primary, Feenstra, Thomas C., additional, Kok, Rob M., additional, Spaans, Harm-Pieter, additional, van Exel, Eric, additional, Dols, Annemiek, additional, Oudega, Mardien, additional, Vergouwen, Anton C. M., additional, van der Loo, Adriano, additional, Bet, Pierre M., additional, Loer, Stephan A., additional, Eikelenboom, Merijn, additional, Sienaert, Pascal, additional, Lambrichts, Simon, additional, Bouckaert, Filip, additional, Bosmans, Judith E., additional, van der Velde, Nathalie, additional, Beekman, Aartjan T. F., additional, Stek, Max L., additional, and Rhebergen, Didi, additional

Published
2022
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18. Implementation of a pharmacist‐led transitional pharmaceutical care programme: Process evaluation of Medication Actions to Reduce hospital admissions through a collaboration between Community and Hospital pharmacists (MARCH)

Author

En‐nasery‐de Heer, Selma, primary, Uitvlugt, Elien B., additional, Bet, Pierre M., additional, van den Bemt, Bart J. F., additional, Alai, Aida, additional, van den Bemt, Patricia M. L. A., additional, Swart, Eleonora L., additional, Karapinar‐Çarkit, Fatma, additional, and Hugtenburg, Jacqueline G., additional

Published
2022
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20. Elevated acute phase proteins affect pharmacokinetics in COVID‐19 trials: Lessons from the CounterCOVID ‐ imatinib study

Author

Bartelink, Imke H., primary, Bet, Pierre M., additional, Widmer, Nicolas, additional, Guidi, Monia, additional, Duijvelaar, Erik, additional, Grob, Bram, additional, Honeywell, Richard, additional, Evelo, Amanda, additional, Tielbeek, Ivo P. E., additional, Snape, Sue D., additional, Hamer, Henrike, additional, Decosterd, Laurent A., additional, Jan Bogaard, Harm, additional, Aman, Jurjan, additional, and Swart, Eleonora L., additional

Published
2021
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22. Risk–efficacy balance of ulipristal acetate compared to surgical alternatives:How to value safety in a new drug?

Author

Middelkoop, Mei-An, Bet, Pierre M., Drenth, Joost P. H., Huirne, Judith A. F., and Hehenkamp, Wouter J. K.

Abstract

Aims: Uterine fibroids are benign tumours that cause various complaints. These complaints may significantly compromise quality of life, necessitating a clinical intervention in 25–50% of the affected women. Hysterectomy, myomectomy or embolization may offer symptomatic relief, but are costly, include a recovery period, can cause serious side-effects, sometimes fail to treat symptoms completely and are not always desired by patients. Ulipristal is a conservative long-term treatment that has a fibroid-volume decreasing effect, acceptable side-effects while preserving fertility and may be an alternative to surgical alternatives. Currently, ulipristal is investigated by the European Medicine Agency and suspended from marketing authorization because it may cause drug-induced liver injury (DILI). However, many drugs can cause severe DILI and prospective studies estimate 14–19 DILI cases/100 000 people. Methods: This overview will discuss the risk–benefit balance between ulipristal and DILI, describe the safety–efficacy balance of ulipristal and its alternative treatments and the arguments that led to the suspension of its marketing authorization. Results: Ulipristal may be associated with DILI resulting in a risk of severe liver injury in 1.5:100 000 patients and fatal liver injury in 0.1:100 000 patients. This risk needs to be weighed against the higher mortality risk of >1:1000 and higher incidence of severe complications after surgery. Conclusion: The DILI risk of ulipristal is considerably lower than that of other medicines that are not suspended, nor need additional safety measures. When evaluating drugs and drug safety, risks that apply to the alternative nonpharmacological treatment options should be taken into consideration.

Published
2021

24. Identification of clinical cases to educate pharmacists on medication-related problems leading to hospital readmissions after discharge

Author

En-nasery-de Heer, Selma, Uitvlugt, Elien B., van den Bemt, Patricia M. L. A., van den Bemt, Bart J. F., Bet, Pierre M., Swart, Eleonora L., Karapinar, Fatma, Hugtenburg, Jacqueline G., Clinical pharmacology and pharmacy, APH - Mental Health, APH - Personalized Medicine, Amsterdam Neuroscience - Mood, Anxiety, Psychosis, Stress & Sleep, APH - Aging & Later Life, APH - Health Behaviors & Chronic Diseases, and APH - Quality of Care

Published
2020

25. Is Treatment in Patients With Suspected Nonradiographic Axial Spondyloarthritis Effective? Six‐Month Results of a Placebo‐Controlled Trial

Author

Rusman, Tamara, primary, Weijden, Mignon A. C., additional, Nurmohamed, Michael T., additional, Landewé, Robert B. M., additional, Winter, Janneke J. H., additional, Boden, Bouke J. H., additional, Bet, Pierre M., additional, Bijl, Carmella M. A., additional, Laken, Conny, additional, and Horst‐Bruinsma, Irene E., additional

Published
2021
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27. Carbamazepine and quetiapine:A neglected, but highly relevant interaction

Author

van der Gaag, Suzanne, Kupka, Ralph W., Bet, Pierre M., VU University medical center, Psychiatry, APH - Mental Health, Clinical pharmacology and pharmacy, APH - Personalized Medicine, and Amsterdam Neuroscience - Mood, Anxiety, Psychosis, Stress & Sleep

Abstract

We describe a case of concomitant use of carbamazepine and quetiapine, with a highly relevant interaction that requires attention. The combination of these drugs can be prescribed in psychiatry, for example in bipolar disorder, but also in other disciplines. Pharmacotherapy is one of the cornerstones in the treatment of bipolar disorders, and a combination of drugs is frequently used. Carbamazepine, an anti-epileptic drug that is effective as a mood stabilizer, and quetiapine, a second-generation antipsychotic, are both recommended in the Dutch guideline. Besides monotherapy is a combination of both drugs possible. It is striking that carbamazepine and quetiapine have a strong pharmacokinetic interaction via the metabolizing liver enzyme, CYP3A4. This interaction results in a factor 10 reduction of quetiapine blood levels. This may result in a possible loss of clinical efficacy of quetiapine.

Published
2020

31. Low dose oral haloperidol does not prolong QTc interval in older acutely hospitalised adults: a subanalysis of a randomised double-blind placebo-controlled study

Author

Schrijver, Edmée Jm, Verstraaten, Maaike, van de Ven, Peter M, Bet, Pierre M, van Strien, Astrid M, de Cock, Carel, Nanayakkara, Prabath Wb, Internal medicine, Cardiology, APH - Methodology, ACS - Heart failure & arrhythmias, Epidemiology and Data Science, APH - Personalized Medicine, APH - Mental Health, Clinical pharmacology and pharmacy, Amsterdam Neuroscience - Mood, Anxiety, Psychosis, Stress & Sleep, NCA - Neurobiology of mental health, General practice, APH - Quality of Care, ACS - Diabetes & metabolism, and APH - Digital Health

Subjects
congenital, hereditary, and neonatal diseases and abnormalities, cardiovascular system, cardiovascular diseases, circulatory and respiratory physiology
Abstract

Background: Haloperidol is the most frequently prescribed antipsychotic for delirium symptoms. The risk of QTc prolongation often raises concerns, although the effect of haloperidol on QTc interval has not yet been investigated in a randomised placebo-controlled fixed-dose study.Methods: A subanalysis of a randomised double-blind placebo-controlled study was conducted to evaluate the effect of prophylactic haloperidol 1 mg or placebo 1 mg orally twice-daily (maximum of 14 doses) on QTc interval in patients aged 70 years and over. Bedside, 12-lead ECGs were recorded before, during and after the one-week intervention period. Automatic QTc measurements were obtained in addition to manual measurements of QT and RR intervals, blinded for treatment status. Manual measurements were corrected (QTc) using Bazett (QTc-B), Framingham (QTc-Fa), Fridericia (QTc-Fi) and Hodges (QTc-H) methods. Mixed model analyses were used to test for differences in longitudinal course of QTc between patients receiving haloperidol and placebo.Results: ECG recordings of 72 patients (haloperidol n = 38) were analysed, 45.8% male. Median (range) haloperidol serum concentration on day 4 was 0.71 (0.32-1.82) µg/L (n = 23). Longitudinal course of mean QTc did not significantly differ between treatment arms for any of the automatic or manually derived QTc values.Conclusions: Low dose oral haloperidol did not result in QTc prolongation in older acutely hospitalised patients. Results may not be generalizable to patients with existing ECG abnormalities such as atrial fibrillation.

Published
2018

32. Comparative effect of collaborative care, pain medication, and duloxetine in the treatment of depression and comorbid pain in outpatient care: results of a randomized, placebo-controlled, multi-center trial

Author

de Heer, Eric W, Dekker, Jack, Beekman, Aartjan T F, van Marwijk, Harm W J, Holwerda, Tjalling J, Bet, Pierre M, Roth, Joost, Timmerman, Lotte, and van der Feltz-Cornelis, Christina M

Abstract

Objective: Evidence exists for efficacy of collaborative care (CC) against MDD, for efficacy of consequent use of pain medication against pain, and for efficacy of duloxetine against both MDD and neuropathic pain. However, their relative effectiveness in comorbid major depression (MDD) and pain has never been established so far. This study evaluates the effectiveness of CC, pain medication and duloxetine, and CC, pain medication and placebo, compared to duloxetine alone, on depressive and pain outcomes.\ud Methods:\ud Three armed cluster randomized multi-centre placebo controlled trial in consecutive patients presented at three specialized mental health outpatient clinics who screened positive for MDD. All interventions lasted 12 weeks. In the CC groups duloxetine or placebo was prescribed. Pain medication was administered according to an algorithm that avoids opiate prescription as much as possible as an alternative to the current WHO pain ladder, with paracetamol, COX inhibitors and pregabalin as steps before opiates are considered. Patients who did not show up for three or more sessions were registered as noncompliant. Explorative, intention-to-treat and per protocol, multilevel regression analyses were performed. The trial is listed in the trial registration (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1089; NTR number: NTR1089).\ud Results:\ud This study was prematurely terminated because of massive reorganisations and reimbursement changes for mental health care during the study. 60 patients completed the study. Patients in all treatment groups reported significant less depressive and pain symptoms after 12 weeks. CC with placebo condition showed the fastest decrease of depressive symptoms compared to the duloxetine alone group (b = -.78; p = .01), Noncompliant patients did not improve over the 12 weeks period. Pain outcomes did not differ between the three groups.\ud Conclusions: In MDD and pain, compliance of patients and placebo effects are more important than choice of one of the three treatments. Active pain management in CC with COX inhibitors and pregabalin as alternatives to Tramadol or other opiates might provide an attractive alternative to the current WHO pain ladder as it avoids opiate prescription as much as possible. The study was sufficiently powered to show an exploratory result, but the generalizability is limited due to the small sample size. Larger studies are needed.

Published
2018

33. Vitamin D supplementation for the prevention of depression and poor physical function in older persons: the D-Vitaal study, a randomized clinical trial.

Author

Koning, Elisa J de, Lips, Paul, Penninx, Brenda W J H, Elders, Petra J M, Heijboer, Annemieke C, Heijer, Martin den, Bet, Pierre M, Marwijk, Harm W J van, and Schoor, Natasja M van

Subjects
PREVENTION of mental depression, THERAPEUTIC use of vitamin D, ELDER care, DIETARY supplements, VITAMIN D, VITAMIN D deficiency, CHOLECALCIFEROL, BODY movement, RANDOMIZED controlled trials, TREATMENT effectiveness, STATISTICAL models
Abstract

Background Depressive symptoms and impaired physical functioning are prevalent among older adults. Supplementation with vitamin D might improve both conditions, particularly in persons with low vitamin D status. Objective The D-Vitaal study primarily aimed to investigate the effect of vitamin D supplementation on depressive symptoms, functional limitations, and physical performance in a high-risk older population with low vitamin D status. Secondary aims included examining the effect of vitamin D supplementation on anxiety symptoms, cognitive functioning, mobility, handgrip strength, and health-related quality of life. Methods This study was a randomized placebo-controlled trial with 155 participants aged 60–80 y who had clinically relevant depressive symptoms, ≥1 functional limitations, and serum 25-hydroxyvitamin D [25(OH)D] concentrations of 15–50/70 nmol/L (depending on season). Participants received 1200 IU/d vitamin D3 (n  = 77) or placebo tablets (n  = 78) for 12 mo. Serum 25(OH)D was measured at baseline and 6 mo; outcomes were assessed at baseline, 6 mo, and 12 mo. Linear mixed-models analyses were conducted to assess the effect of the intervention. Results The supplementation increased serum 25(OH)D concentrations in the intervention group to a mean ± SD of 85 ± 16 nmol/L compared with 43 ± 18 nmol/L in the placebo group after 6 mo (P  < 0.001). No relevant differences between the treatment groups were observed regarding depressive symptoms, functional limitations, physical performance, or any of the secondary outcomes. Conclusions Supplementation with 1200 IU/d vitamin D for 12 mo had no effect on depressive symptoms and physical functioning in older persons with relatively low vitamin D status, clinically relevant depressive symptoms, and poor physical functioning. This trial is registered with the Netherlands Trial Register (www.trialregister.nl) under NTR3845. [ABSTRACT FROM AUTHOR]

Published
2019
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34. Comparative Effect of Collaborative Care, Pain Medication, and Duloxetine in the Treatment of Major Depressive Disorder and Comorbid (Sub)Chronic Pain: Results of an Exploratory Randomized, Placebo-Controlled, Multicenter Trial (CC:PAINDIP)

Author

de Heer, Eric W., primary, Dekker, Jack, additional, Beekman, Aartjan T. F., additional, van Marwijk, Harm W. J., additional, Holwerda, Tjalling J., additional, Bet, Pierre M., additional, Roth, Joost, additional, Timmerman, Lotte, additional, and van der Feltz-Cornelis, Christina M., additional

Published
2018
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35. Haloperidol versus placebo for delirium prevention in acutely hospitalised older at risk patients: a multi-centre double-blind randomised controlled clinical trial

Author

Schrijver, Edmée J M, primary, de Vries, Oscar J, additional, van de Ven, Peter M, additional, Bet, Pierre M, additional, Kamper, Ad M, additional, Diepeveen, Sabine H A, additional, van Marum, Rob J, additional, van Strien, Astrid M, additional, Anten, Sander, additional, Lagaay, Anne M, additional, Boelaarts, Leo, additional, Bloemers, Frank W, additional, Kramer, Mark H H, additional, and Nanayakkara, Prabath W B, additional

Published
2017
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38. Vitamin D supplementation to prevent depression and poor physical function in older adults: Study protocol of the D-Vitaal study, a randomized placebo-controlled clinical trial

Author

de Koning, Elisa J., primary, van Schoor, Natasja M., additional, Penninx, Brenda W.J.H., additional, Elders, Petra J.M., additional, Heijboer, Annemieke C., additional, Smit, Jan. H., additional, Bet, Pierre M., additional, van Tulder, Maurits W., additional, den Heijer, Martin, additional, van Marwijk, Harm W.J., additional, and Lips, Paul, additional

Published
2015
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40. Prevention of exacerbations in patients with COPD and vitamin D deficiency through vitamin D supplementation (PRECOVID): a study protocol

Author

Rafiq, Rachida, primary, Aleva, Floor E., additional, Schrumpf, Jasmijn A., additional, Heijdra, Yvonne F., additional, Taube, Christian, additional, Daniels, Johannes MA, additional, Lips, Paul, additional, Bet, Pierre M., additional, Hiemstra, Pieter S., additional, van der Ven, André JAM, additional, den Heijer, Martin, additional, and de Jongh, Renate T., additional

Published
2015
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41. Efficacy and safety of haloperidol prophylaxis for delirium prevention in older medical and surgical at-risk patients acutely admitted to hospital through the emergency department: study protocol of a multicenter, randomised, double-blind, placebo-controlled clinical trial

Author

Schrijver, Edmée JM, primary, de Vries, Oscar J, additional, Verburg, Astrid, additional, de Graaf, Karola, additional, Bet, Pierre M, additional, van de Ven, Peter M, additional, Kamper, Ad M, additional, Diepeveen, Sabine HA, additional, Anten, Sander, additional, Siegel, Andrea, additional, Kuipéri, Esther, additional, Lagaay, Anne M, additional, van Marum, Rob J, additional, van Strien, Astrid M, additional, Boelaarts, Leo, additional, Pons, Douwe, additional, Kramer, Mark HH, additional, and Nanayakkara, Prabath WB, additional

Published
2014
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42. Effectiveness and cost-effectiveness of transmural collaborative care with consultation letter (TCCCL) and duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: design of a randomized placebo-controlled multi-Centre trial: TCC:PAINDIP

Author

de Heer, Eric W, primary, Dekker, Jack, additional, van Eck van der Sluijs, Jonna F, additional, Beekman, Aartjan TF, additional, van Marwijk, Harm WJ, additional, Holwerda, Tjalling J, additional, Bet, Pierre M, additional, Roth, Joost, additional, Hakkaart-Van Roijen, Leona, additional, Ringoir, Lianne, additional, Kat, Fiona, additional, and van der Feltz-Cornelis, Christina M, additional

Published
2013
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43. Reply.

Author

Rusman, Tamara, van der Weijden, Mignon A. C., Nurmohamed, Michael T., van der Bijl, Carmella M. A., van der Laken, Conny J., Bet, Pierre M., Landewé, Robert B. M., de Winter, Janneke J. H., Boden, Bouke J. H., and van der Horst‐Bruinsma, Irene E.

Subjects
DRUG efficacy, INFLAMMATION, BACKACHE, ETANERCEPT
Published
2021
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47. Majority of Dietary Glutamine Is Utilized in First Pass in Preterm Infants

Author

SCHOOR, SOPHIE R.D. van der, SCHIERBEEK, HENK, BET, PIERRE M., VERMEULEN, MARIJN J., LAFEBER, HARRIE N., GOUDOEVER, JOHANNES B. van, and ELBURG, RUURD M. van

Abstract

Glutamine is a conditionally essential amino acid for very low-birth weight infants by virtue of its ability to play an important role in several key metabolic processes of immune cells and enterocytes. Although glutamine is known to be used to a great extend, the exact splanchnic metabolism in enterally fed preterm infants is unknown. We hypothesized that preterm infants show a high splanchnic first-pass glutamine metabolism and the primary metabolic fate of glutamine is oxidation. Five preterm infants (mean ± SD birth weight 1.07 ± 0.22 kg and GA 29 ± 2 wk) were studied by dual tracer (U-13Cglutamine and 15N2glutamine) cross-over techniques on two study days (at postnatal week 3 ± 1 wk). Splanchnic and whole-body glutamine kinetics were assessed by plasma isotopic enrichment of U-13Cglutamine and 15N2glutamine and breath 13CO2enrichments. Mean fractional first-pass glutamine uptake was 73 ± 6% and 57 ± 17% on the study days. The splanchnic tissues contributed for a large part (57 ± 6%) to the total amount of labeled carbon from glutamine retrieved in expiratory air. Dietary glutamine is used to a great extent by the splanchnic tissues in preterm infants and its carbon skeleton has an important role as fuel source.

Published
2010
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48. Vitamin D supplementation to prevent depression and poor physical function in older adults: Study protocol of the DVitaal study, a randomized placebocontrolled clinical trial.

Author

de Koning, Elisa J., van Schoor, Natasja M., Penninx, Brenda W. J. H., Elders, Petra J. M., Heijboer, Annemieke C., Smit, Jan. H., Bet, Pierre M., van Tulder, Maurits W., den Heijer, Martin, van Marwijk, Harm W. J., and Lips, Paul

Subjects
VITAMIN D in human nutrition, DIETARY supplements, PREVENTION of mental depression, MENTAL health of older people, RESEARCH protocols, CLINICAL trials
Abstract

Background: Depressive symptoms and decreased physical functioning are interrelated conditions and common in older persons, causing significant individual and societal burden. Evidence suggests that vitamin D supplementation may be. beneficial for both mental and physical functioning. However, previous randomized controlled trials have yielded inconsistent results and often had suboptimal designs. This study examines the effect of vitamin D supplementation on both depressive symptoms and physical functioning in a high-risk population of older persons with low vitamin D status. Methods/design: The D-Vitaal study is a randomized, double-blind, placebo-controlled trial investigating the effects of a daily dose of 1200 IU vitamin D3 versus placebo for one year on depressive symptoms and physical functioning (primary outcomes) in older adults. Participants (N = 155, age 60-80 years) were recruited from the general population. Eligibility criteria included the presence of depressive symptoms, =1 functional limitation and serum 25-hydroxyvitamin D levels between 15 and 50/70 nmol/L (depending on season). Secondary outcomes include incidence of major depressive disorder, anxiety symptoms, health-related quality of life, cognitive function and cost-effectiveness of the intervention. Discussion: With this study, we aim to elucidate the effects of vitamin D supplementation on depressive symptoms and physical functioning in older persons who are at high risk of developing more substantial mental and physical problems. If effective, vitamin D supplementation can be a preventive intervention strategy that is easy to implement in the primary care setting. [ABSTRACT FROM AUTHOR]

Published
2015
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49. Peripheral infiltration of remdesivir in 3 patients with COVID-19: Case series and discussion.

Author

Merendonk, Lisanne N van, Leeuwerik, Anke F, Brok, Monique W J den, Hekking, Pieter-Paul W, Korevaar, Daniel A, Jacobs, Christian J, and Bet, Pierre M

Subjects
*COVID-19, *HEMATOMA, *ANTIVIRAL agents, *TREATMENT effectiveness, *GLYCOSIDASES, *EXTRAVASATION, *EDEMA
Abstract

Purpose The coronavirus disease 2019 (COVID-19) pandemic resulted in accelerated market access to remdesivir worldwide. Therefore, data about complications experienced during use of the drug are limited. This is the first published case series (1 case report exists) to describe remdesivir infiltration in 3 patients with COVID-19. Summary In the first case, a 91-year-old woman experienced remdesivir infiltration resulting in edema, hematoma at the area of infiltration; on palpation, the affected area felt cooler than the surrounding areas. Swelling was still present after 6 weeks. In the second case, remdesivir infiltration occurred in a 72-year-old male, resulting in edema, hematoma, and pain at the area of infiltration. The hematoma lasted for 7 days. The third case concerned a 67-year-old woman, in whom remdesivir infiltration led to edema and a small hematoma. The hematoma regressed to a negligible size within 3 days. However, a week after infiltration, redness had reappeared. In 2 cases, the patient was immediately treated with hyaluronidase injections, but no specific treatments were provided in the other case. Conclusion Based on the product information provided by remdesivir's manufacturer, we believe symptoms and signs observed in the 3 cases may have resulted from the low pH (~4) of the nonbuffered remdesivir solution, although the patients were not formally assessed for caustic injury. Previous experience with other noncytotoxic medications suggests that infusion-specific factors (eg, volume of leaked fluid) and patient-specific factors (eg, advanced age) may have a role in the outcome of remdesivir infiltration. The possibility of symptoms caused by cyclodextrins in the formulation or by intrinsic toxicity of remdesivir warrants exploration. [ABSTRACT FROM AUTHOR]

Published
2021
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50. Low dose oral haloperidol does not prolong QTc interval in older acutely hospitalised adults: a subanalysis of a randomised double-blind placebo-controlled study.

Author

Schrijver EJ, Verstraaten M, van de Ven PM, Bet PM, van Strien AM, de Cock C, and Nanayakkara PW

Abstract

Background: Haloperidol is the most frequently prescribed antipsychotic for delirium symptoms. The risk of QTc prolongation often raises concerns, although the effect of haloperidol on QTc interval has not yet been investigated in a randomised placebo-controlled fixed-dose study., Methods: A subanalysis of a randomised double-blind placebo-controlled study was conducted to evaluate the effect of prophylactic haloperidol 1 mg or placebo 1 mg orally twice-daily (maximum of 14 doses) on QTc interval in patients aged 70 years and over. Bedside, 12-lead ECGs were recorded before, during and after the one-week intervention period. Automatic QTc measurements were obtained in addition to manual measurements of QT and RR intervals, blinded for treatment status. Manual measurements were corrected (QTc) using Bazett (QTc-B), Framingham (QTc-Fa), Fridericia (QTc-Fi) and Hodges (QTc-H) methods. Mixed model analyses were used to test for differences in longitudinal course of QTc between patients receiving haloperidol and placebo., Results: ECG recordings of 72 patients (haloperidol n = 38) were analysed, 45.8% male. Median (range) haloperidol serum concentration on day 4 was 0.71 (0.32-1.82) µg/L ( n = 23). Longitudinal course of mean QTc did not significantly differ between treatment arms for any of the automatic or manually derived QTc values., Conclusions: Low dose oral haloperidol did not result in QTc prolongation in older acutely hospitalised patients. Results may not be generalizable to patients with existing ECG abnormalities such as atrial fibrillation.

Published
2018
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