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Jefe de Servicio de Farmacia, Hospital Psiquiátrico de Álava, Vitoria-Gasteiz, Álava, " "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "affb" ] 2 => array:3 [ "entidad" => "Servicio de Nefrología, Hospital Santiago Apóstol, Vitoria-Gasteiz, Álava, " "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "affc" ] 3 => array:3 [ "entidad" => "Laboratorio de Análisis Clínicos, Hospital Txagorritxu, Vitoria-Gasteiz, Álava, " "etiqueta" => "<span class="elsevierStyleSup">d</span>" "identificador" => "affd" ] 4 => array:3 [ "entidad" => "Farmacéutica especialista en Farmacia Hospitalaria. Jefa de Servicio de Farmacia, Hospital Galdakao-Usansolo, Galdakao, Vizcaya, " "etiqueta" => "<span class="elsevierStyleSup">e</span>" "identificador" => "affe" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Estimación de la tasa de filtración glomerular para el ajuste posológico de los fármacos. Reina la confusión" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig1" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "figura" => array:1 [ 0 => array:4 [ "imagen" => "11235_16025_26340_en_11235t1.jpg" "Alto" => 433 "Ancho" => 1459 "Tamanyo" => 215119 ] ] "descripcion" => array:1 [ "en" => "Recommended dabigatran dose adjustments according to the glomerular filtration rate estimated by different equations" ] ] ] "textoCompleto" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">To the Editor,</span></p><p class="elsevierStylePara">Two recent events led to our writing this letter.</p><p class="elsevierStylePara"><span class="elsevierStyleBold">One. </span>For 2 or 3 years now, our local biochemistry laboratories calculate the estimated glomerular filtration rate (eGFR) by means of the MDRD-IDMS formula (formerly MDRD) and the isolated creatinine value, as per National Kidney Foundation recommendations.<span class="elsevierStyleSup">1</span></p><p class="elsevierStylePara">Yet in October 2011, we still observe the following:</p><p class="elsevierStylePara">- The constant used by some biochemistry laboratories for the MDRD-IDMS formula is 186, when it should be 175 since the calculation for the serum creatinine value is standardised by IDMS.</p><p class="elsevierStylePara">- Some laboratories deliver MDRD-IDMS results in ml/min instead of ml/min/1.73 m<span class="elsevierStyleSup">2</span>. Although it is dependent on an individual’s body surface area, this could lead one to assume that the measurement is absolute, which could have consequences when adjusting doses.</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Two. </span>While the new formula for measuring glomerular filtration rate (GFR),<span class="elsevierStyleSup">2</span> CKD-EPI, seems to improve on the current MDRD-IDMS formula in both accuracy and precision, it is likely to make things even more confusing when it comes to choosing an equation to adjust a drug dose.</p><p class="elsevierStylePara">Furthermore, an article recently published in this journal comparing the MDRD-IDMS and CKD-EPI formulas in a Spanish population<span class="elsevierStyleSup">3</span> contained what appears to be an erratum in Table 1, which describes the formulas used to calculate CKD-EPI: for males with creatinine levels >80 micromoles/litre, it states to divide by 0.7, and we believe that it should be by 0.9.</p><p class="elsevierStylePara">In light of all of the above, we would like to make the following observation:</p><p class="elsevierStylePara">From the 1980s until quite recently, GFR was estimated using the formula published by Cockcroft and Gault (CG) in 1976.<span class="elsevierStyleSup">4</span> The result of this equation (an estimation of creatinine clearance) was used to evaluate renal function and adjust the doses of any drugs that so required. We would like to stress that the value obtained by this formula is absolute. This means that it accounts for the individual’s size (since it includes weight among its variables) and gives a result in ml/min (if the body surface area differs greatly from the mean, using ideal rather than true weight is recommended.)</p><p class="elsevierStylePara">In 1999, 23 years after the CG formula was published, Levey published a new formula for estimating GFR: the MDRD.<span class="elsevierStyleSup">5</span> Shortly afterwards, in 2002, the KDOQI proposed using this formula for early detection and classification of chronic kidney disease so that patients in earlier stages would have better access to nephrology care.<span class="elsevierStyleSup">1</span> The result given by this formula is dependent on body surface area (ml/min/1.73m<span class="elsevierStyleSup">2</span>), as is also the case with the recently improved MDRD-IMDS and CKD-EPI formulas.<span class="elsevierStyleSup">6,2</span> Since the result is dependent on a surface area of 1.73 m<span class="elsevierStyleSup">2</span>, we only need the variables age, sex, serum creatinine and race. This formula was recommended by such societies as the Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC) and the Spanish Society of Nephrology (S.E.N).<span class="elsevierStyleSup">7</span></p><p class="elsevierStylePara">Nevertheless, although generalised use of the MDRD method seems appropriate for categorising individuals in different stages of chronic kidney disease, it causes some problems in adjusting drug doses, especially if the value given by the laboratories is interpreted as an absolute value.</p><p class="elsevierStylePara">If we consider only the relative results (ml/min/1.73m<span class="elsevierStyleSup">2</span>) given by MDRD, MDRD-IMDS or CKD-EPI –those results given by biochemical laboratories– individuals with a body surface area >1.73m<span class="elsevierStyleSup">2</span> will have a higher absolute eGFR value. This could lead to underdosing the patient. If the patient’s body surface area is less than 1.73m<span class="elsevierStyleSup">2</span>, the absolute eGFR will be lower, which could lead to overdosing the patient (Tables 1 and 2).</p><p class="elsevierStylePara">On the other hand, the required dose of a certain drug may vary considerably depending on the equation used to estimate GFR, and this may have clinical repercussions.<span class="elsevierStyleSup">8</span> With this in mind, most published drug adjustment guidelines recommend a dose and/or drug interval according to the Cockcroft-Gault formula; very few guidelines make use of MDRD.<span class="elsevierStyleSup">9</span> In two recent examples, regulatory authorities based their recommendations on the CG formula:</p><p class="elsevierStylePara">- The Spanish Agency for Medicines and Health Products (AEMPS) followed the European Medicines Agency recommendation and modified the SmPC for Pradaxa® (dabigatran) and issued an informative note on 27 October 2011 reminding doctors of the importance of checking renal function before and after treatment with this new drug. They informed that before starting dabigatran treatment, renal function must be assessed in all patients by calculating creatinine clearance (CrCl) in order to exclude patients with severe renal failure (CrCl<30ml/min).<span class="elsevierStyleSup">10</span></p><p class="elsevierStylePara">- The Food and Drug Administration (FDA)’s safety update of 1 September 2011 stated that the SmPC had been changed and issued a reminder that “Reclast should not be used (is contraindicated) in patients with creatinine clearance less than 35ml/min”.<span class="elsevierStyleSup">11</span></p><p class="elsevierStylePara">The FDA guidelines for the industry simply cite the CG and MDRD equations as being the most commonly used.</p><p class="elsevierStylePara">However, experts do not agree on which of the formulas should be used for adjusting doses in patients with renal failure. Some advocate using the equation recommended by the pharmaceutical manufacturer, particularly in the case of elderly patients,<span class="elsevierStyleSup">12</span> while others<span class="elsevierStyleSup">13,14</span> state that the MDRD and CG equations are completely interchangeable.</p><p class="elsevierStylePara">In summary, and as a general rule, using the equation recommended by the pharmaceutical manufacturer (mainly CG) seems reasonable. If there is no specific recommendation, the most reliable method of estimating GFR in the target population should be should.</p><p class="elsevierStylePara">Regardless of which equation is used, we must remember that dose adjustments must be made using absolute GFR values, especially for patients whose body surface area differs greatly from 1.73m<span class="elsevierStyleSup">2</span>.</p><p class="elsevierStylePara"><a href="grande/11235_16025_26340_en_11235t1.jpg" class="elsevierStyleCrossRefs"><img src="11235_16025_26340_en_11235t1.jpg" alt="Recommended dabigatran dose adjustments according to the glomerular filtration rate estimated by different equations"></img></a></p><p class="elsevierStylePara">Table 1. Recommended dabigatran dose adjustments according to the glomerular filtration rate estimated by different equations</p><p class="elsevierStylePara"><a href="grande/11235_16025_26341_en_11235t2.jpg" class="elsevierStyleCrossRefs"><img src="11235_16025_26341_en_11235t2.jpg" alt="Recommended daptomycin dose adjustments according to the glomerular filtration rate estimated by different equations"></img></a></p><p class="elsevierStylePara">Table 2. Recommended daptomycin dose adjustments according to the glomerular filtration rate estimated by different equations</p>" "pdfFichero" => "P1-E532-S3401-A11235-EN.pdf" "tienePdf" => true "multimedia" => array:2 [ 0 => array:8 [ "identificador" => "fig1" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "figura" => array:1 [ 0 => array:4 [ "imagen" => "11235_16025_26340_en_11235t1.jpg" "Alto" => 433 "Ancho" => 1459 "Tamanyo" => 215119 ] ] "descripcion" => array:1 [ "en" => "Recommended dabigatran dose adjustments according to the glomerular filtration rate estimated by different equations" ] ] 1 => array:8 [ "identificador" => "fig2" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "figura" => array:1 [ 0 => array:4 [ "imagen" => "11235_16025_26341_en_11235t2.jpg" "Alto" => 420 "Ancho" => 1437 "Tamanyo" => 194391 ] ] "descripcion" => array:1 [ "en" => "Recommended daptomycin dose adjustments according to the glomerular filtration rate estimated by different equations" ] ] ] "bibliografia" => array:2 [ "titulo" => "Bibliography" "seccion" => array:1 [ 0 => array:1 [ "bibliografiaReferencia" => array:14 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:3 [ "referenciaCompleta" => "National Kidney Foundation. 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Year/Month | Html | Total | |
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2024 November | 11 | 6 | 17 |
2024 October | 82 | 49 | 131 |
2024 September | 72 | 41 | 113 |
2024 August | 73 | 45 | 118 |
2024 July | 73 | 36 | 109 |
2024 June | 101 | 53 | 154 |
2024 May | 103 | 48 | 151 |
2024 April | 98 | 37 | 135 |
2024 March | 90 | 21 | 111 |
2024 February | 55 | 30 | 85 |
2024 January | 87 | 29 | 116 |
2023 December | 101 | 23 | 124 |
2023 November | 121 | 35 | 156 |
2023 October | 180 | 41 | 221 |
2023 September | 126 | 39 | 165 |
2023 August | 125 | 25 | 150 |
2023 July | 197 | 37 | 234 |
2023 June | 246 | 22 | 268 |
2023 May | 176 | 46 | 222 |
2023 April | 163 | 29 | 192 |
2023 March | 126 | 22 | 148 |
2023 February | 110 | 30 | 140 |
2023 January | 81 | 32 | 113 |
2022 December | 98 | 44 | 142 |
2022 November | 113 | 44 | 157 |
2022 October | 114 | 70 | 184 |
2022 September | 108 | 55 | 163 |
2022 August | 124 | 56 | 180 |
2022 July | 94 | 47 | 141 |
2022 June | 131 | 39 | 170 |
2022 May | 125 | 36 | 161 |
2022 April | 164 | 61 | 225 |
2022 March | 106 | 59 | 165 |
2022 February | 98 | 58 | 156 |
2022 January | 126 | 35 | 161 |
2021 December | 91 | 57 | 148 |
2021 November | 119 | 39 | 158 |
2021 October | 123 | 41 | 164 |
2021 September | 94 | 42 | 136 |
2021 August | 110 | 35 | 145 |
2021 July | 143 | 34 | 177 |
2021 June | 114 | 39 | 153 |
2021 May | 172 | 50 | 222 |
2021 April | 406 | 104 | 510 |
2021 March | 299 | 41 | 340 |
2021 February | 237 | 33 | 270 |
2021 January | 162 | 26 | 188 |
2020 December | 182 | 23 | 205 |
2020 November | 91 | 14 | 105 |
2020 October | 87 | 16 | 103 |
2020 September | 144 | 19 | 163 |
2020 August | 104 | 11 | 115 |
2020 July | 111 | 10 | 121 |
2020 June | 114 | 14 | 128 |
2020 May | 142 | 22 | 164 |
2020 April | 134 | 20 | 154 |
2020 March | 121 | 10 | 131 |
2020 February | 132 | 27 | 159 |
2020 January | 140 | 21 | 161 |
2019 December | 146 | 18 | 164 |
2019 November | 92 | 29 | 121 |
2019 October | 93 | 13 | 106 |
2019 September | 141 | 20 | 161 |
2019 August | 147 | 23 | 170 |
2019 July | 154 | 21 | 175 |
2019 June | 126 | 20 | 146 |
2019 May | 225 | 35 | 260 |
2019 April | 255 | 65 | 320 |
2019 March | 155 | 31 | 186 |
2019 February | 78 | 18 | 96 |
2019 January | 121 | 21 | 142 |
2018 December | 298 | 38 | 336 |
2018 November | 302 | 16 | 318 |
2018 October | 237 | 16 | 253 |
2018 September | 210 | 25 | 235 |
2018 August | 126 | 16 | 142 |
2018 July | 109 | 13 | 122 |
2018 June | 112 | 21 | 133 |
2018 May | 126 | 23 | 149 |
2018 April | 149 | 11 | 160 |
2018 March | 109 | 5 | 114 |
2018 February | 108 | 6 | 114 |
2018 January | 106 | 6 | 112 |
2017 December | 143 | 11 | 154 |
2017 November | 89 | 10 | 99 |
2017 October | 60 | 7 | 67 |
2017 September | 71 | 11 | 82 |
2017 August | 80 | 6 | 86 |
2017 July | 62 | 14 | 76 |
2017 June | 61 | 9 | 70 |
2017 May | 107 | 17 | 124 |
2017 April | 60 | 15 | 75 |
2017 March | 47 | 9 | 56 |
2017 February | 107 | 8 | 115 |
2017 January | 44 | 14 | 58 |
2016 December | 74 | 8 | 82 |
2016 November | 98 | 7 | 105 |
2016 October | 156 | 6 | 162 |
2016 September | 176 | 4 | 180 |
2016 August | 217 | 4 | 221 |
2016 July | 183 | 5 | 188 |
2016 June | 127 | 0 | 127 |
2016 May | 147 | 0 | 147 |
2016 April | 101 | 0 | 101 |
2016 March | 90 | 0 | 90 |
2016 February | 136 | 0 | 136 |
2016 January | 136 | 0 | 136 |
2015 December | 121 | 0 | 121 |
2015 November | 104 | 0 | 104 |
2015 October | 117 | 0 | 117 |
2015 September | 69 | 0 | 69 |
2015 August | 81 | 0 | 81 |
2015 July | 86 | 0 | 86 |
2015 June | 51 | 0 | 51 |
2015 May | 63 | 0 | 63 |
2015 April | 6 | 0 | 6 |