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  1. Article ; Online: Drug therapy management in patients with renal impairment: how to use creatinine-based formulas in clinical practice.

    Eppenga, Willemijn L / Kramers, Cornelis / Derijks, Hieronymus J / Wensing, Michel / Wetzels, Jack F M / De Smet, Peter A G M

    European journal of clinical pharmacology

    2016  Volume 72, Issue 12, Page(s) 1433–1439

    Abstract: Purpose: The use of estimated glomerular filtration rate (eGFR) in daily clinical practice.: Methods: eGFR is a key component in drug therapy management (DTM) in patients with renal impairment. eGFR is routinely reported by laboratories whenever a ... ...

    Abstract Purpose: The use of estimated glomerular filtration rate (eGFR) in daily clinical practice.
    Methods: eGFR is a key component in drug therapy management (DTM) in patients with renal impairment. eGFR is routinely reported by laboratories whenever a serum creatinine testing is ordered. In this paper, we will discuss how to use eGFR knowing the limitations of serum creatinine-based formulas.
    Results: Before starting a renally excreted drug, an equally effective drug which can be used more safely in patients with renal impairment should be considered. If a renally excreted drug is needed, the reliability of the eGFR should be assessed and when needed, a 24-h urine creatinine clearance collection should be performed. After achieving the best approximation of the true GFR, we suggest a gradual drug dose adaptation according to the renal function. A different approach for drugs with a narrow therapeutic window (NTW) is recommended compared to drugs with a broad therapeutic window. For practical purposes, a therapeutic window of 5 or less was defined as a NTW and a list of NTW drugs is presented. Considerations about the drug dose may be different at the start of the therapy or during the therapy and depending on the indication. Monitoring effectiveness and adverse drug reactions are important, especially for NTW drugs. Dose adjustment should be based on an ongoing assessment of clinical status and risk versus the benefit of the used regimen.
    Conclusion: When determining the most appropriate dosing regimen serum creatinine-based formulas should never be used naively but always in combination with clinical and pharmacological assessment of the individual patient.
    MeSH term(s) Creatinine/blood ; Glomerular Filtration Rate ; Humans ; Medication Therapy Management ; Renal Insufficiency/blood ; Renal Insufficiency/metabolism ; Renal Insufficiency/physiopathology
    Chemical Substances Creatinine (AYI8EX34EU)
    Language English
    Publishing date 2016-12
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 121960-1
    ISSN 1432-1041 ; 0031-6970
    ISSN (online) 1432-1041
    ISSN 0031-6970
    DOI 10.1007/s00228-016-2113-2
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  2. Article ; Online: Individualizing pharmacotherapy in patients with renal impairment: the validity of the Modification of Diet in Renal Disease formula in specific patient populations with a glomerular filtration rate below 60 ml/min. A systematic review.

    Eppenga, Willemijn L / Kramers, Cornelis / Derijks, Hieronymus J / Wensing, Michel / Wetzels, Jack F M / De Smet, Peter A G M

    PloS one

    2015  Volume 10, Issue 3, Page(s) e0116403

    Abstract: Background: The Modification of Diet in Renal Disease (MDRD) formula is widely used in clinical practice to assess the correct drug dose. This formula is based on serum creatinine levels which might be influenced by chronic diseases itself or the ... ...

    Abstract Background: The Modification of Diet in Renal Disease (MDRD) formula is widely used in clinical practice to assess the correct drug dose. This formula is based on serum creatinine levels which might be influenced by chronic diseases itself or the effects of the chronic diseases. We conducted a systematic review to determine the validity of the MDRD formula in specific patient populations with renal impairment: elderly, hospitalized and obese patients, patients with cardiovascular disease, cancer, chronic respiratory diseases, diabetes mellitus, liver cirrhosis and human immunodeficiency virus.
    Methods and findings: We searched for articles in Pubmed published from January 1999 through January 2014. Selection criteria were (1) patients with a glomerular filtration rate (GFR) < 60 ml/min (/1.73 m2), (2) MDRD formula compared with a gold standard and (3) statistical analysis focused on bias, precision and/or accuracy. Data extraction was done by the first author and checked by a second author. A bias of 20% or less, a precision of 30% or less and an accuracy expressed as P30% of 80% or higher were indicators of the validity of the MDRD formula. In total we included 27 studies. The number of patients included ranged from 8 to 1831. The gold standard and measurement method used varied across the studies. For none of the specific patient populations the studies provided sufficient evidence of validity of the MDRD formula regarding the three parameters. For patients with diabetes mellitus and liver cirrhosis, hospitalized patients and elderly with moderate to severe renal impairment we concluded that the MDRD formula is not valid. Limitations of the review are the lack of considering the method of measuring serum creatinine levels and the type of gold standard used.
    Conclusion: In several specific patient populations with renal impairment the use of the MDRD formula is not valid or has uncertain validity.
    MeSH term(s) Creatinine/blood ; Diet ; Glomerular Filtration Rate/physiology ; Humans ; Kidney Diseases/blood ; Kidney Diseases/drug therapy ; Kidney Diseases/physiopathology ; Renal Insufficiency/blood ; Renal Insufficiency/drug therapy ; Renal Insufficiency/physiopathology
    Chemical Substances Creatinine (AYI8EX34EU)
    Language English
    Publishing date 2015
    Publishing country United States
    Document type Journal Article ; Review
    ISSN 1932-6203
    ISSN (online) 1932-6203
    DOI 10.1371/journal.pone.0116403
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  3. Article ; Online: Individualizing pharmacotherapy in patients with renal impairment

    Willemijn L Eppenga / Cornelis Kramers / Hieronymus J Derijks / Michel Wensing / Jack F M Wetzels / Peter A G M De Smet

    PLoS ONE, Vol 10, Iss 3, p e

    the validity of the Modification of Diet in Renal Disease formula in specific patient populations with a glomerular filtration rate below 60 ml/min. A systematic review.

    2015  Volume 0116403

    Abstract: The Modification of Diet in Renal Disease (MDRD) formula is widely used in clinical practice to assess the correct drug dose. This formula is based on serum creatinine levels which might be influenced by chronic diseases itself or the effects of the ... ...

    Abstract The Modification of Diet in Renal Disease (MDRD) formula is widely used in clinical practice to assess the correct drug dose. This formula is based on serum creatinine levels which might be influenced by chronic diseases itself or the effects of the chronic diseases. We conducted a systematic review to determine the validity of the MDRD formula in specific patient populations with renal impairment: elderly, hospitalized and obese patients, patients with cardiovascular disease, cancer, chronic respiratory diseases, diabetes mellitus, liver cirrhosis and human immunodeficiency virus.We searched for articles in Pubmed published from January 1999 through January 2014. Selection criteria were (1) patients with a glomerular filtration rate (GFR) < 60 ml/min (/1.73 m2), (2) MDRD formula compared with a gold standard and (3) statistical analysis focused on bias, precision and/or accuracy. Data extraction was done by the first author and checked by a second author. A bias of 20% or less, a precision of 30% or less and an accuracy expressed as P30% of 80% or higher were indicators of the validity of the MDRD formula. In total we included 27 studies. The number of patients included ranged from 8 to 1831. The gold standard and measurement method used varied across the studies. For none of the specific patient populations the studies provided sufficient evidence of validity of the MDRD formula regarding the three parameters. For patients with diabetes mellitus and liver cirrhosis, hospitalized patients and elderly with moderate to severe renal impairment we concluded that the MDRD formula is not valid. Limitations of the review are the lack of considering the method of measuring serum creatinine levels and the type of gold standard used.In several specific patient populations with renal impairment the use of the MDRD formula is not valid or has uncertain validity.
    Keywords Medicine ; R ; Science ; Q
    Subject code 616
    Language English
    Publishing date 2015-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: The validity of the modification of diet in renal disease formula in HIV-infected patients: a systematic review.

    Eppenga, Willemijn L / van Luin, Matthijs / Richter, Clemens / Derijks, Hieronymus J / De Smet, Peter A G M / Wensing, Michel

    Journal of nephrology

    2013  Volume 27, Issue 1, Page(s) 11–18

    Abstract: Rationale, aims and objectives: Renal dysfunction is highly prevalent in HIV-infected patients and may require dose adjustment of renally excreted antiretroviral drugs. The Modification of Diet in Renal Disease (MDRD)-4 formula is frequently used in ... ...

    Abstract Rationale, aims and objectives: Renal dysfunction is highly prevalent in HIV-infected patients and may require dose adjustment of renally excreted antiretroviral drugs. The Modification of Diet in Renal Disease (MDRD)-4 formula is frequently used in daily practice to estimate patients' renal function. The aim of this systematic review was to assess the validity of the MDRD-4 formula in HIV-infected patients.
    Method: A systematic search in Pubmed and EMBASE was done to identify studies which compared MDRD-4 with measured glomerular filtration rate (mGFR) in HIV-infected patients.
    Results: Five studies were included, which provided data from 464 HIV-infected patients with mean mGFR ranging from 87 to 118 ml/min/1.73 m(2). In all studies, results from the MDRD-4 gave an underestimation of the mGFR. Mean bias ((MDRD-4) - mGFR) ranged from -6 to -11 ml/min/1.73 m(2) across studies. The accuracy expressed in terms of P 30 ranged from 64 to 89 %.
    Conclusions: The MDRD-4 formula is as valid in HIV-positive as in HIV-negative patients. Because the available studies comprised mainly HIV-infected patients with mildly impaired to good renal function (GFR ≥ 60 ml/min/1.73 m(2)), more research is needed to validate the MDRD-4 formula in HIV-infected patients with moderate to severe renal impairment.
    MeSH term(s) AIDS-Associated Nephropathy/physiopathology ; Age Factors ; Creatinine/blood ; Ethnic Groups ; Glomerular Filtration Rate ; HIV Infections/complications ; HIV Infections/drug therapy ; Humans ; Kidney Diseases/complications ; Kidney Diseases/physiopathology ; Mathematical Concepts ; Sex Factors
    Chemical Substances Creatinine (AYI8EX34EU)
    Language English
    Publishing date 2013-12-20
    Publishing country Italy
    Document type Journal Article ; Review ; Systematic Review
    ZDB-ID 1093991-x
    ISSN 1724-6059 ; 1120-3625 ; 1121-8428
    ISSN (online) 1724-6059
    ISSN 1120-3625 ; 1121-8428
    DOI 10.1007/s40620-013-0012-5
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    Zs.A 3369: Show issues Location:
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  5. Article ; Online: Fluctuation of the renal function after discharge from hospital and its effects on drug dosing in elderly patients--study protocol.

    Eppenga, Willemijn L / Wester, Wietske N / Derijks, Hieronymus J / Hoedemakers, Rein M J / Wensing, Michel / De Smet, Peter A G M / Van Marum, Rob J

    BMC nephrology

    2015  Volume 16, Page(s) 95

    Abstract: Background: Chronic kidney disease (CKD) is associated with an increased mortality rate, risk of cardiovascular events and morbidity. Impaired renal function is common in elderly patients, and their glomerular filtration rate (GFR) should be taken into ... ...

    Abstract Background: Chronic kidney disease (CKD) is associated with an increased mortality rate, risk of cardiovascular events and morbidity. Impaired renal function is common in elderly patients, and their glomerular filtration rate (GFR) should be taken into account when prescribing renally excreted drugs. In a hospital care setting the GFR may fluctuate substantially, so that the renal function group and therefore the recommended dose, can change within a few days. The magnitude and prevalence of the fluctuation of renal function in daily clinical practice and its potential effects on appropriateness of drug prescriptions after discharge from the hospital is unknown.
    Methods/design: This is a prospective observational study. Patients ≥ 70 years with renal impairment (eGFR < 60 ml/min/1.73 m(2)) admitted to a geriatric ward are eligible to participate. Participants undergo blood sample collection to measure serum creatinine level at three time points: at discharge from hospital, 14 days, and 2 months after discharge. At these time points the actual medication of the participants is assessed and the number of incorrect prescriptions according to the Dutch guidelines in relation to their estimated renal function is measured. In addition, for a hypothetical selection of drugs, the need for drug dose adaptation in relation to renal function is measured. The outcome of interest is the percentage of patients that changes from renal function group after discharge from hospital compared to the renal function at discharge. In addition, the percentages of patients whose actual medications are incorrectly prescribed and for the hypothetical selection of drugs that would have required dose adaptation will be determined at discharge, 14 days and 2 months after discharge. For each outcome, risk factors which may lead to increased risk for fluctuation of renal function and/or incorrect drug prescribing will also be identified and analysed.
    Discussion: This study will provide data on changes in renal function in elderly patients after discharge from the hospital with a focus on the medications used. The benefits for healthcare professionals comprise of the creation, adjustment or confirmation of recommendations for the monitoring of the renal function after discharge from hospital of elderly patients.
    MeSH term(s) Aged ; Aged, 80 and over ; Anti-Inflammatory Agents, Non-Steroidal/administration & dosage ; Anti-Inflammatory Agents, Non-Steroidal/pharmacokinetics ; Creatinine/blood ; Diuretics/administration & dosage ; Diuretics/pharmacokinetics ; Female ; Humans ; Kidney/metabolism ; Male ; Netherlands ; Patient Discharge ; Pharmaceutical Preparations/administration & dosage ; Polypharmacy ; Prospective Studies ; Renal Insufficiency, Chronic/blood ; Renal Insufficiency, Chronic/metabolism ; Renin-Angiotensin System
    Chemical Substances Anti-Inflammatory Agents, Non-Steroidal ; Diuretics ; Pharmaceutical Preparations ; Creatinine (AYI8EX34EU)
    Language English
    Publishing date 2015-07-07
    Publishing country England
    Document type Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 2041348-8
    ISSN 1471-2369 ; 1471-2369
    ISSN (online) 1471-2369
    ISSN 1471-2369
    DOI 10.1186/s12882-015-0095-4
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  6. Article ; Online: Comparison of a basic and an advanced pharmacotherapy-related clinical decision support system in a hospital care setting in the Netherlands.

    Eppenga, Willemijn L / Derijks, Hieronymus J / Conemans, Jean M H / Hermens, Walter A J J / Wensing, Michel / De Smet, Peter A G M

    Journal of the American Medical Informatics Association : JAMIA

    2011  Volume 19, Issue 1, Page(s) 66–71

    Abstract: Unlabelled: OBJECTIVE To compare the clinical relevance of medication alerts in a basic and in an advanced clinical decision support system (CDSS).: Design: A prospective observational study.: Materials and methods: We collected 4023 medication ... ...

    Abstract Unlabelled: OBJECTIVE To compare the clinical relevance of medication alerts in a basic and in an advanced clinical decision support system (CDSS).
    Design: A prospective observational study.
    Materials and methods: We collected 4023 medication orders in a hospital for independent evaluation in two pharmacotherapy-related decision support systems. Only the more advanced system considered patient characteristics and laboratory test results in its algorithms. Two pharmacists assessed the clinical relevance of the medication alerts produced. The alert was considered relevant if the pharmacist would undertake action (eg, contact the physician or the nurse). The primary analysis concerned the positive predictive value (PPV) for clinically relevant medication alerts in both systems.
    Results: The PPV was significantly higher in the advanced system (5.8% vs 17.0%; p<0.05). Significant differences were found in the alert categories: drug-(drug) interaction (9.9% vs 14.8%; p<0.05), drug-age interaction (2.9% vs 73.3%; p<0.05), and dosing guidance (5.6% vs 16.9%; p<0.05). Including laboratory values and other patient characteristics resulted in a significantly higher PPV for the advanced CDSS compared to the basic medication alerts (12.2% vs 23.3%; p<0.05).
    Conclusion: The advanced CDSS produced a higher proportion of clinically relevant medication alerts, but the number of irrelevant alerts remained high. To improve the PPV of the advanced CDSS, the algorithms should be optimized by identifying additional risk modifiers and more data should be made electronically available to improve the performance of the algorithms. Our study illustrates and corroborates the need for cyclic testing of technical improvements in information technology in circumstances representative of daily clinical practice.
    MeSH term(s) Clinical Pharmacy Information Systems ; Decision Support Systems, Clinical ; Humans ; Medical Order Entry Systems ; Medication Systems, Hospital ; Netherlands ; Observation ; Pharmacy Service, Hospital/organization & administration ; Prospective Studies
    Language English
    Publishing date 2011-09-02
    Publishing country England
    Document type Comparative Study ; Journal Article
    ZDB-ID 1205156-1
    ISSN 1527-974X ; 1067-5027
    ISSN (online) 1527-974X
    ISSN 1067-5027
    DOI 10.1136/amiajnl-2011-000360
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  7. Article ; Online: Risk of lactic acidosis or elevated lactate concentrations in metformin users with renal impairment: a population-based cohort study.

    Eppenga, Willemijn L / Lalmohamed, Arief / Geerts, Arjen F / Derijks, Hieronymus J / Wensing, Michel / Egberts, Antoine / De Smet, Peter A G M / de Vries, Frank

    Diabetes care

    2014  Volume 37, Issue 8, Page(s) 2218–2224

    Abstract: ... defined as either a CPRD READ code lactic acidosis or a record of a plasma lactate concentration >5 mmol/L ...

    Abstract Objective: The objective of this study was to determine whether treatment with metformin in patients with renal impairment is associated with a higher risk of lactic acidosis or elevated lactate concentrations compared with users of a noninsulin antidiabetic drug (NIAD) who had never used metformin.
    Research design and methods: A cohort of 223,968 metformin users and 34,571 diabetic patients who had never used metformin were identified from the Clinical Practice Research Datalink (CPRD).The primary outcome was defined as either a CPRD READ code lactic acidosis or a record of a plasma lactate concentration >5 mmol/L. The associations between renal impairment, dose of metformin, and the risk of lactic acidosis or elevated lactate concentrations were determined with time-dependent Cox models and expressed as hazard ratios (HRs).
    Results: The crude incidence of lactic acidosis or elevated lactate concentrations in current metformin users was 7.4 per 100,000 person-years (vs. 2.2 per 100,000 person-years in nonusers). Compared with nonusers, risk of lactic acidosis or elevated lactate concentrations in current metformin users was significantly associated with a renal function <60 mL/min/1.73 m(2) (adjusted HR 6.37 [95% CI 1.48-27.5]). The increased risk among patients with impaired renal function was further increased in users of ≥730 g of metformin in the preceding year (adjusted HR 11.8 [95% CI 2.27-61.5]) and in users of a recent high daily dose (>2 g) of metformin (adjusted HR 13.0 [95% CI 2.36-72.0]).
    Conclusions: Our study is consistent with current recommendations that the renal function of metformin users should be adequately monitored and that the dose of metformin should be adjusted, if necessary, if renal function falls below 60 mL/min/1.73 m(2).
    MeSH term(s) Acidosis, Lactic/blood ; Acidosis, Lactic/chemically induced ; Acidosis, Lactic/diagnosis ; Acidosis, Lactic/epidemiology ; Adult ; Aged ; Cohort Studies ; Comorbidity ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/epidemiology ; Female ; Humans ; Hypoglycemic Agents/administration & dosage ; Hypoglycemic Agents/adverse effects ; Incidence ; Lactic Acid/blood ; Male ; Metformin/administration & dosage ; Metformin/adverse effects ; Middle Aged ; Renal Insufficiency/drug therapy ; Renal Insufficiency/epidemiology ; Research Design ; Risk Assessment ; Risk Factors
    Chemical Substances Hypoglycemic Agents ; Lactic Acid (33X04XA5AT) ; Metformin (9100L32L2N)
    Language English
    Publishing date 2014-08
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 441231-x
    ISSN 1935-5548 ; 0149-5992
    ISSN (online) 1935-5548
    ISSN 0149-5992
    DOI 10.2337/dc13-3023
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  8. Article ; Online: Ineffectiveness and adverse events of nitrofurantoin in women with urinary tract infection and renal impairment in primary care.

    Geerts, Arjen F J / Eppenga, Willemijn L / Heerdink, Rob / Derijks, Hieronymus J / Wensing, Michel J P / Egberts, Toine C G / De Smet, Peter A G M

    European journal of clinical pharmacology

    2013  Volume 69, Issue 9, Page(s) 1701–1707

    Abstract: Purpose: To determine whether treatment with nitrofurantoin in women with urinary tract infection (UTI) and renal impairment in primary care is associated with a higher risk of ineffectiveness and/or serious adverse events than in women without renal ... ...

    Abstract Purpose: To determine whether treatment with nitrofurantoin in women with urinary tract infection (UTI) and renal impairment in primary care is associated with a higher risk of ineffectiveness and/or serious adverse events than in women without renal impairment.
    Methods: A cohort of 21,317 women treated with nitrofurantoin and a cohort of 7,926 women treated with trimethoprim, identified from the Pharmo Record Linkage System, were analysed. The primary outcome was ineffectiveness of treatment of nitrofurantoin defined as the start of a second antibacterial within 1 month after the start of nitrofurantoin. The secondary outcome was the occurrence of serious adverse events of nitrofurantoin leading to hospitalization within 90 days. A cohort of trimethoprim users was used to determine if the associations found for nitrofurantoin were mainly related to nitrofurantoin itself. The association between renal impairment and the risk of these outcomes was determined with Cox regression and expressed as hazard ratios (HRs).
    Results: Overall, the incidence density for ineffectiveness was 5.4 per 1,000 person-days, and moderate renal impairment was not associated with ineffective treatment [HR 1.1, 95 % confidence interval (CI) 0.74-1.51]. The overall incidence density for adverse events was 0.02 per 1,000 person-days. In patients with renal impairment (<50 ml/min/1.73 m²) the risk of pulmonary adverse events leading to hospitalization was significantly increased (HR 4.1, 95 % CI 1.31-13.09) CONCLUSIONS: Nitrofurantoin treatment was not associated with a higher risk of ineffectiveness in women with UTI and moderate renal impairment (30-50 ml/min/1.73 m²). However, we did find a significant association between renal impairment (<50 ml/min/1.73 m²) and pulmonary adverse events leading to hospitalization.
    MeSH term(s) Adolescent ; Adult ; Anti-Infective Agents, Urinary/adverse effects ; Female ; Humans ; Middle Aged ; Netherlands/epidemiology ; Nitrofurantoin/adverse effects ; Primary Health Care ; Renal Insufficiency/drug therapy ; Renal Insufficiency/epidemiology ; Retrospective Studies ; Treatment Outcome ; Trimethoprim/adverse effects ; Urinary Tract Infections/drug therapy ; Urinary Tract Infections/epidemiology ; Young Adult
    Chemical Substances Anti-Infective Agents, Urinary ; Nitrofurantoin (927AH8112L) ; Trimethoprim (AN164J8Y0X)
    Language English
    Publishing date 2013-05-10
    Publishing country Germany
    Document type Comparative Study ; Journal Article
    ZDB-ID 121960-1
    ISSN 1432-1041 ; 0031-6970
    ISSN (online) 1432-1041
    ISSN 0031-6970
    DOI 10.1007/s00228-013-1520-x
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