scholarly journals PTH-133 herapeutic drug monitoring supports clinical decision making when employed before and after biosimilar infliximab switching

Author(s):  
Katy Waddell ◽  
Rebecca Haggarty ◽  
Jennifer Veryan ◽  
Emma Nowell ◽  
John Paul Seenan ◽  
...  
Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4820-4820 ◽  
Author(s):  
Carolyn Blasdel ◽  
Yanfeng Wang ◽  
Theodore Lagattuta ◽  
Brian Druker ◽  
Laurie Letvak ◽  
...  

Abstract OBJECTIVES: Imatinib (IM) has demonstrated durable clinical efficacy in the majority of chronic myeloid leukemia (CML) patients. Optimal response may be influenced by multiple innate and external factors, some of which may be controlled by monitoring plasma concentrations of the drug. This abstract reports 6 cases where analyzing plasma IM trough concentrations (Cmin) in patients treated with three commonly used IM doses (400, 600, and 800 mg daily) influenced clinical decision making. METHODS: IM trough blood samples were collected at a time before that day’s IM dosing. Plasma concentrations of IM were determined by a validated LC/MS/MS method. RESULTS: In large population studies of CML patients enrolled in Phase I, II, and III clinical trials, the mean Cmin levels of IM at 400 mg qd, 600 mg qd, and 400 mg bid doses were: 981 (±543, 55%, n=394), 1572 (±1032, 66%, n=14), and 3479 (±1264, 36%, n=14) ng/mL, respectively. Large inter-patient variability was shown at all three doses. Of the 6 cases detailed in the table below, 4 (ID 1, 3, 4, and 5) had dose reduction due to tolerability concerns with subsequent improvement of symptoms following dose adjustment. One patient (ID 2) had a dose increase because of a poor qRT-PCR response. Another (ID 6) had a dose increase due to low plasma IM exposure resulting from drug-drug interaction with phenytoin, a known inducer of CYP3A4 (the major metabolizing isozyme for IM). After dose adjustment, all six patients showed good clinical response to IM treatment. The new mean Cmin value in these patients was 2000 (±471) ng/mL, representing a 24% coefficient of variability. CONCLUSIONS: Although the data is limited, IM drug monitoring proved useful in managing tolerability, lack of efficacy, adherence or potential drug interactions that modulate imatinib drug concentrations. More prospective studies are needed to demonstrate the value of IM drug monitoring in routine clinical practice. Patient ID Age, Sex CML Stage IM Daily Dose 1st Cmin (ng/mL) Reason for Dose Change New Dosing Regimen New Cmin (ng/mL) CP, chronic phase1 1 54, f CP 200 mg bid, Jan 03 3048, Sep 05 transfusion-dependent, anemia, Sep 05 300 mg, Oct 05 2130, Jan 06 2 9, f CP 300 mg, Jan 05 not done qRT-PCR 0.016, Jan 06 400 mg, Jan 06 2341, Jul 06 3 13, f CP 300 mg bid, May 05; 700 mg, Aug 05; 600 mg, Sep 05 1966, Feb 06 nausea, fatigue, arthralgias, myalgia, ongoing 400 mg, Mar 06 1222, May 06 4 67, f CP 400 mg, Feb 05 not done myelosuppression, Mar 05 200 mg, Mar 05 1928, May 06 5 53, f CP 400 mg, Apr 03; 600 mg, May 03; 800 mg, Jul 04 not done inflammatory pulmonary reaction with shortness of breath; dose held, Mar 05 400 mg, Oct 05 2378, May 06 6 73, m CP 350 mg, on phenytoin, Apr 99 35, Jun 99 stopped phenytoin, Jul 99 500 mg, Jul 99 not done; qRT-PCR negative, Jul 06


2019 ◽  
Vol 7 (15) ◽  
pp. 2480-2483
Author(s):  
Mona Elsherbiny ◽  
Yaser Abdelwahab ◽  
Kareem Nagy ◽  
Asser Mannaa ◽  
Yasmin Hassabelnaby

AIM: This study is based on the hypothesis that the routine use of transesophageal echocardiography in cardiac surgery will influence the surgical decision taken by the surgeon intra-operatively in Kasr-Alainy hospitals. METHODS: Patients were examined with intraoperative transesophageal echocardiography (TEE) before and after cardiopulmonary bypass. Complete and comprehensive intraoperative TEE examinations will be performed by TEE certified cardiac anesthesiologists. Data that will be collected from the intraoperative examination and will be compared with preoperative transthoracic echocardiography, and the surgical decision that was taken preoperatively will be revised again with the cardiothoracic surgeon before the start of surgery. Also, TEE will be used again after weaning from bypass for revision and assessment of our decision. RESULTS: We examined the utility of TEE in 100 patients undergoing different types of cardiac procedures in Kasr Al-Ainy hospital. This prospective clinical investigation found that the pre- and post-CPB TEE examinations influenced surgical decision making in 10% of all evaluated patients. CONCLUSION: Intraoperative TEE has the potential to influence clinical decision making for cardiac surgical patients significantly. It is useful in surgical planning, guiding various hemodynamic interventions, and assessing the immediate results of surgery. Thus, IOTEE should be used routinely in all patients undergoing all types of cardiac surgeries.


2021 ◽  
Vol 12 ◽  
Author(s):  
Fabian Holzhüter ◽  
Florian Schuster ◽  
Stephan Heres ◽  
Johannes Hamann

Introduction: For psychiatric in-patients, ward rounds are a prominent occasion for decision making. As previous findings on shared decision-making (SDM) patterns mostly derive from out-patients and one-to-one-consultations, it was our aim to investigate SDM during psychiatric ward rounds.Methods: We conducted a cross-sectional study and included n = 62 in-patients from seven different psychiatric wards. We collected data from the patient and the treating physician before and after ward rounds and recorded the interaction.Results: We identified two groups of patients regarding their attitude toward ward rounds (no expectations vs. clear agenda). The latter showed higher active engagement, expected more decisions to be made and discussed more topics. Generally, observer rated SDM was low, with vast differences between the doctors' and the patients' perception.Conclusion: Doctors and patients perceive ward rounds differently and there is a discrepancy between subjective and objective involvement. A rather paternalistic doctor-patient-relationship is observed, while patients feel sufficiently involved and vastly satisfied. The potential of ward rounds maximizes if patients have an agenda. Consequently, motivating patients to prepare themselves toward ward rounds should be part of the weekly routine, as well as improving patient participation and information procedures during ward rounds.


2011 ◽  
Vol 20 (4) ◽  
pp. 121-123
Author(s):  
Jeri A. Logemann

Evidence-based practice requires astute clinicians to blend our best clinical judgment with the best available external evidence and the patient's own values and expectations. Sometimes, we value one more than another during clinical decision-making, though it is never wise to do so, and sometimes other factors that we are unaware of produce unanticipated clinical outcomes. Sometimes, we feel very strongly about one clinical method or another, and hopefully that belief is founded in evidence. Some beliefs, however, are not founded in evidence. The sound use of evidence is the best way to navigate the debates within our field of practice.


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