Therapeutic Drug Monitoring of Lamotrigine

2002 ◽  
Vol 36 (5) ◽  
pp. 917-920 ◽  
Author(s):  
Elaine Chong ◽  
L Lee Dupuis
Keyword(s):  
Decision Making ◽  
Dose Adjustment ◽  
Clinical Evidence ◽  
Therapeutic Drug ◽  
Data Synthesis ◽  
Search Terms ◽  
Pharmacologic Response ◽  
Routine Monitoring ◽  
Data Source ◽  
Lamotrigine Concentration

OBJECTIVE: To evaluate the usefulness of routine monitoring of serum lamotrigine concentration. DATA SOURCE: Literature was accessed through MEDLINE (1990–January 2001). Key search terms included lamotrigine, pharmacokinetics, and epilepsy. DATA SYNTHESIS: A decision-making algorithm was used to evaluate the clinical evidence to support or refute the routine use of serum lamotrigine concentrations to adjust doses. The value of serum lamotrigine concentration monitoring remains controversial, primarily because clear relationships between concentration and pharmacologic response (either efficacy or toxicity) have not been demonstrated. CONCLUSIONS: Serum concentration monitoring of lamotrigine is not recommended as a tool for routine dose adjustment.

Therapeutic Drug Monitoring of Imatinib and Impact on Clinical Decision Making.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4820-4820 ◽  
Author(s):  
Carolyn Blasdel ◽  
Yanfeng Wang ◽  
Theodore Lagattuta ◽  
Brian Druker ◽  
Laurie Letvak ◽  
...  
Keyword(s):  
Decision Making ◽  
Drug Monitoring ◽  
Dose Adjustment ◽  
Clinical Decision Making ◽  
Plasma Concentrations ◽  
Clinical Decision ◽  
Therapeutic Drug ◽  
Dose Increase ◽  
Qrt Pcr ◽  
Drug Concentrations

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

Review of Serum Voriconazole Concentrations and Correlations with Adverse Events and Efficacy

2009 ◽  
Vol 25 (3) ◽  
pp. 183-189
Author(s):  
Michael J Latran
Keyword(s):  
Adverse Events ◽  
Fungal Infections ◽  
Case Reports ◽  
Elevated Serum ◽  
Therapeutic Drug ◽  
Serum Concentrations ◽  
Efficacy And Safety ◽  
Data Synthesis ◽  
Additional Information ◽  
Search Terms

Objective: To review the available evidence regarding the monitoring of serum voriconazole concentrations in terms of efficacy and safety. Data Sources: A literature search of MEDLINE was conducted (1950–February 2009), with combinations of the following search terms: voriconazole, therapeutic drug monitoring, voriconazole serum concentrations, voriconazole levels, trough, and adverse events. Data Collection: All studies and case reports that evaluated serum voriconazole concentrations in adults were reviewed and considered for inclusion. Citations in identified articles were searched for additional information. Data Synthesis: Ten studies and case reports that evaluated serum voriconazole concentrations in terms of efficacy and safety in adults were identified and included in this review. Results from efficacy studies show an association between low serum voriconazole concentrations and disease progression. One study found that a lack of response occurred more often in patients with a serum voriconazole trough of 1 μg/mL or less (p = 0.02). Another study found that patients were more likely to fail voriconazole therapy for invasive fungal infections when serum concentrations were less than or equal to 2 μg/mL. In terms of safety, 6 studies showed an association between elevated serum voriconazole concentrations and adverse events. Conclusions: Available data suggest that serum voriconazole concentrations of 1 μg/mL or less are associated with therapeutic failures, whereas serum voriconazole concentrations of 6 μg/mL or more are associated with adverse events. Studies show that monitoring serum voriconazole concentrations may decrease the incidence of adverse events while increasing efficacy.

Sialorrhea — Therapeutic Drug Options

2002 ◽  
Vol 36 (11) ◽  
pp. 1785-1790 ◽  
Author(s):  
Dorothy Z Tscheng
Keyword(s):  
Small Sample Size ◽  
Symptom Relief ◽  
Small Sample ◽  
The Other ◽  
Therapeutic Drug ◽  
Efficacy And Safety ◽  
Drug Induced ◽  
Data Synthesis ◽  
Search Terms ◽  
Drug Treatments

OBJECTIVE: To review the efficacy and safety of various drug treatments for sialorrhea. Pharmacotherapy for drug-induced sialorrhea is not addressed. DATA SOURCES: Clinical studies were identified using PubMed (1966–October 2001). Key search terms included sialorrhea and drug therapy. DATA SYNTHESIS: Sialorrhea is a social and physical detriment to patients. Drug treatment, although not necessarily the treatment of choice for all patients, can offer some symptom relief. CONCLUSIONS: Literature has documented that benztropine, glycopyrrolate, and scopolamine can reduce the incidence of sialorrhea. Although the literature evaluating the therapeutic options has limitations (e.g., small sample size, inconsistent outcome measurements), glycopyrrolate may have an advantage over the other agents due to fewer adverse effects.

Chronic Metoclopramide Therapy for Diabetic Gastroparesis

2003 ◽  
Vol 37 (1) ◽  
pp. 122-126 ◽  
Author(s):  
Paul F Lata ◽  
Denise L Walbrandt Pigarelli
Keyword(s):  
Medical Literature ◽  
Diabetic Gastroparesis ◽  
Sufficient Evidence ◽  
Limited Data ◽  
Drug Induced ◽  
Data Synthesis ◽  
Search Terms ◽  
Routine Monitoring ◽  
Chronic Use

OBJECTIVE To review the safety and efficacy of chronic metoclopramide for diabetic gastroparesis. DATA SOURCES Medical literature was accessed through MEDLINE (1965 to October 2002) and PubMed (1965 to October 2002). Key search terms included metoclopramide; diabetic gastroparesis; and dyskinesia, drug induced. DATA SYNTHESIS Metoclopramide is often used for diabetic gastroparesis, despite the risk of tardive dyskinesia. Published information is limited regarding long-term efficacy and toxicity of metoclopramide. The literature was assessed concerning these topics. CONCLUSIONS Limited data do not provide sufficient evidence to conclude whether metoclopramide is efficacious for chronic use. Routine monitoring may mitigate the risk associated with metoclopramide therapy.

Safety of Selegiline with Cold Medications

2003 ◽  
Vol 37 (3) ◽  
pp. 438-441 ◽  
Author(s):  
Jeena E Jacob ◽  
Mary L Wagner ◽  
Jacob I Sage
Keyword(s):  
Adverse Events ◽  
Drug Interactions ◽  
Interaction Potential ◽  
Data Sources ◽  
Data Synthesis ◽  
Search Terms ◽  
Clinical Literature

OBJECTIVE: To evaluate the safety of the coadministration of selegiline with cold medications. DATA SOURCES: Clinical literature accessed through MEDLINE(1965–September 2002), IPA database, and Drug-Reax System. The following search terms were used: selegiline, pseudoephedrine, dextromethorphan, MAOI, and drug interactions. Somerset Pharmaceuticals, the marketers of Eldepryl (selegiline HCI), were also contacted. DATA SYNTHESIS: Despite a warning against its concomitant use with pseudoephedrine and dextromethorphan, interactions with selegiline have not been reported. However, there have been reports of patients experiencing adverse events with related agents. CONCLUSIONS: Patients taking selegiline should try to avoid pseudoephedrine and dextromethorphan or use drugs without interaction potential. If selegiline is used with these medications, watch for adverse events or replace selegiline with another drug.

scholarly journals Promoting Diet and Physical Activity in Nurses

2016 ◽  
Vol 31 (1) ◽  
pp. 19-27 ◽  
Author(s):  
Luciana Torquati ◽  
Toby Pavey ◽  
Tracy Kolbe-Alexander ◽  
Michael Leveritt
Keyword(s):  
Physical Activity ◽  
English Language ◽  
Data Extraction ◽  
Student Nurses ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Data Synthesis ◽  
Diet And Physical Activity ◽  
Data Source

Objective. To systematically review the effectiveness of intervention studies promoting diet and physical activity (PA) in nurses. Data Source. English language manuscripts published between 1970 and 2014 in PubMed, Scopus, CINAHL, and EMBASE, as well as those accessed with the PICO tool, were reviewed. Study Inclusion and Exclusion Criteria. Inclusion criteria comprised (1) nurses/student nurses working in a health care setting and (2) interventions where PA and/or diet behaviors were the primary outcome. Exclusion criteria were (1) non–peer-reviewed articles or conference abstracts and (2) interventions focused on treatment of chronic conditions or lifestyle factors other than PA or diet in nurses. Data Extraction. Seventy-one full texts were retrieved and assessed for inclusion by two reviewers. Data were extracted by one reviewer and checked for accuracy by a second reviewer. Data Synthesis. Extracted data were synthesized in a tabular format and narrative summary. Results. Nine (n = 737 nurses) studies met the inclusion criteria. Quality of the studies was low to moderate. Four studies reported an increase in self-reported PA through structured exercise and goal setting. Dietary outcomes were generally positive, but were only measured in three studies with some limitations in the assessment methods. Two studies reported improved body composition without significant changes in diet or PA. Conclusions. Outcomes of interventions to change nurses’ PA and diet behavior are promising, but inconsistent. Additional and higher quality interventions that include objective and validated outcome measures and appropriate process evaluation are required.

Pharmaceutical Calculations — A Basic Review

2002 ◽  
Vol 18 (5) ◽  
pp. 257-259
Author(s):  
Nicole M Russo
Keyword(s):  
Drug Delivery ◽  
Pharmaceutical Preparation ◽  
Medication Administration ◽  
Patient Specific ◽  
Specific Drug ◽  
Mathematical Concepts ◽  
Data Synthesis ◽  
Drug Concentrations ◽  
Data Source ◽  
Stock Solutions

Objective: To review mathematical topics used in pharmaceutical preparation, specifically ratios and proportions, percentage concentrations, and stock solutions. Data Source: Online pharmaceutics sources and current pharmaceutics textbooks were consulted. Data Synthesis: Ratios and proportions are basic tools for adjusting drug concentrations. Using proportions, medications can be provided in any concentration desired. By extending this technique to percentage concentrations, prescriptions can be interpreted and calculated. In the same manner, the ability to dilute stock solutions provides patient-specific drug delivery. Conclusions: The mathematical concepts of ratios and proportions, percentage concentrations, and stock dilutions are essential for correct medication administration in any setting.

PP205 The Use Of Real-World Evidence To Support National Institute For Health And Care Excellence Medical Technology Submissions

2021 ◽  
Vol 37 (S1) ◽  
pp. 26-26
Author(s):  
Scott Gibson ◽  
Sita Saunders ◽  
Maximilian Blüher ◽  
Amanda Hansson Hedblom ◽  
Rafael Torrejon Torres ◽  
...  
Keyword(s):  
Decision Making ◽  
Real World ◽  
Trial Design ◽  
Clinical Evidence ◽  
Patient Characteristics ◽  
The United Kingdom ◽  
Real World Evidence ◽  
Guidance Documents ◽  
Meta Analyses ◽  
Positive Recommendation

IntroductionAlthough randomized controlled trials (RCTs) are recognized as providing the highest level of clinical evidence, few medical device RCTs are available due to underfunding or inherent challenges associated with trial design. This study examines the extent to which real-world evidence (RWE) supports the recommendations made by the National Institute for Health and Care Excellence Medical Technologies Evaluation Programme (MTEP).MethodsAll MTEP guidance documents published online prior to October 2020 were reviewed. The “case for adoption” recommendation, type of clinical data, and clinical critiques for each MTEP submission were extracted and categorized. RWE was defined as studies with neither blinding nor prospective selection or control of patient characteristics.ResultsOf the MTEP submissions reviewed, 34 of 45 (76%) received a positive recommendation. Independent of outcome, all submissions included RWE, but only 19 (42%) utilized RCT evidence (15 were recommended and four were not). Meta-analyses of RWE were used whenever possible. The most common clinical critiques in unsuccessful submissions were the following: (i) not generalizable to the United Kingdom National Health Service (NHS); (ii) low quality; (iii) likelihood of bias; (iv) trial design faults; (v) uncertain benefit; and (vi) evidence unrelated to scope.ConclusionsThis study suggests that while the use of RCTs has not always led to a positive recommendation, RWE can be valuable in decision-making. Evidence that is generalizable to the NHS, is related to the scope, and shows clear indication of benefit is more likely to positively influence MTEP decision-making.

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