Discrepancies between the summary of characteristics and the recommended use of metformin in the treatment of type 2 diabetes mellitus patients (response)
Discrepancias entre ficha técnica y recomendaciones de uso de metformina en el tratamiento de pacientes con diabetes mellitus tipo 2 (respuesta)
José L. Górriza, Alberto Martínez-Castelaob, Eva Solac, Carlos Morillasc, Ana Joverc, Francisco Coroneld, Juan Navarro-Gonzáleze, Fernando De Álvarof
a Servicio de Nefrología, Hospital Universitario Dr. Peset. GEENDIAB. REDINREN. S.E.N, Valencia,
b Servicio de Nefrología, Hospital Universitario Bellvitge. IDIBELL. GEENDIAB. REDINREN. S.E.N, Hospitalet de Llobregat, Barcelona,
c Servicio de Endocrinología, Hospital Universitario Dr. Peset, Valencia,
d Servicio de Nefrología, Hospital Clínico de San Carlos, Madrid,
e Servicio de Nefrología, Hospital Universitario Nuestra Señora de Candelaria. GEENDIAB. REDINREN. S.E.N, Santa Cruz de Tenerife,
f Servicio de Nefrología, Hospital Universitario Infanta Sofía. GEENDIAB. REDINREN. S.E.N, Madrid,
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GEENDIAB. REDINREN. S.E.N, Valencia, " "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "affa" ] 1 => array:3 [ "entidad" => "Servicio de Nefrología, Hospital Universitario Bellvitge. IDIBELL. GEENDIAB. REDINREN. S.E.N, Hospitalet de Llobregat, Barcelona, " "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "affb" ] 2 => array:3 [ "entidad" => "Servicio de Endocrinología, Hospital Universitario Dr. Peset, Valencia, " "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "affc" ] 3 => array:3 [ "entidad" => "Servicio de Nefrología, Hospital Clínico de San Carlos, Madrid, " "etiqueta" => "<span class="elsevierStyleSup">d</span>" "identificador" => "affd" ] 4 => array:3 [ "entidad" => "Servicio de Nefrología, Hospital Universitario Nuestra Señora de Candelaria. GEENDIAB. REDINREN. S.E.N, Santa Cruz de Tenerife, " "etiqueta" => "<span class="elsevierStyleSup">e</span>" "identificador" => "affe" ] 5 => array:3 [ "entidad" => "Servicio de Nefrología, Hospital Universitario Infanta Sofía. GEENDIAB. REDINREN. S.E.N, Madrid, " "etiqueta" => "<span class="elsevierStyleSup">f</span>" "identificador" => "afff" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Discrepancias entre ficha técnica y recomendaciones de uso de metformina en el tratamiento de pacientes con diabetes mellitus tipo 2 (respuesta)" ] ] "textoCompleto" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">To the Editor:</span></p><p class="elsevierStylePara">We would like to thank Del Pozo et al.<span class="elsevierStyleSup">1</span> for their interest in our review<span class="elsevierStyleSup">2</span> and their thoughtful question. The use of metformin in patients with a glomerular filtration rate (GFR) <60ml/min/1.73m<span class="elsevierStyleSup">2</span>, that is to say, outside of the appropriate range established by the drug summary of characteristics, continues to be a source of substantial controversy, prompting discussion in several recent scientific conferences and consensus documents.<span class="elsevierStyleSup">3-5</span></p><p class="elsevierStylePara">The prescription of medications in conditions that fall outside of the recommendations established in summary of characteristics is a common practice in our profession, whenever approved and validated by the scientific community through a process of discussion of pros and cons or with the provision of informed consent. The summary of characteristics is a document that is not set in stone, must contain updated and current information regarding the medication, and tends to be modified whenever aspects of drug safety are updated or new indications come to light. However, this does not always occur, since the cost for modifying technical data sheets can be very high, and this can often produce a situation in which modifications are not cost-effective because the medication in question is quite inexpensive, such as in the case of metformin.</p><p class="elsevierStylePara">In patients with moderate chronic kidney disease (CKD), the lack of therapeutic alternatives following the suspension of metformin may require the use of much more costly medications (such as dipeptidyl peptidase-4 inhibitors) or insulin treatment, which prompts some reluctance in the affected patients. In addition, the exclusion of patients with CKD from the majority of clinical trials severely limits the breadth of the therapeutic arsenal available to these individuals, as can be seen in paediatric patients as well. In both situations (children and patients with CKD), it is a lack of conclusive study results, not issues with toxicity or efficacy, that limit the indications described on the drug technical data sheet in many cases. In two publications concerning paediatric patients (both in primary care and the hospital setting)<span class="elsevierStyleSup">6-7</span> that compiled the available data from 11 studies, between 36% and 100% of patients were prescribed medications under conditions that fell outside of the recommended situations described in the drug summary of characteristics.</p><p class="elsevierStylePara">With this in mind, to address the question posed by Del Pozo et al<span class="elsevierStyleSup">1</span> regarding whether one can say if it is illegal to employ metformin in patients with an estimated GFR<60ml/min/1.73m<span class="elsevierStyleSup">2</span>, we can state that the use of metformin in patients with an estimated GFR of 30-60ml/min/1.73m<span class="elsevierStyleSup">2</span> does not fall within the legal regulations governing its use.</p><p class="elsevierStylePara">As such, and given the important benefits and low costs associated with this drug, we believe that the implicated scientific societies, health authorities, and pharmaceutical companies should place emphatic priority on the process of reviewing the technical data sheet for metformin in the interest of revising it. This modification should establish the indications for administering metformin in patients based on estimated GFR (ml/min/1.73m<span class="elsevierStyleSup">2</span>), which is the format recommended by current guidelines and consensus documents,<span class="elsevierStyleSup">8</span> instead of using creatinine clearance values as recommended by the current drug technical data sheet. Secondly, the estimated range of GFR within which metformin can be used should be expanded. This modification, which has already been supported by expert consensus opinion, retrospective and observational studies, and meta-analyses,<span class="elsevierStyleSup">3-5</span> should express the reasonable use of metformin, with precautionary measures taken and reduced doses, in patients with a GFR of 30-60ml/min/1.73m,<span class="elsevierStyleSup">2</span> with suspension of treatment with metformin in patients with a GFR<45ml/min/1.73m<span class="elsevierStyleSup">2</span> and risk factors for developing lactic acidosis (peripheral hypoperfusion, diabetic foot, heart failure, advanced liver disease, or a history of previous episodes of lactic acidosis or metabolic acidosis).</p><p class="elsevierStylePara">It is only a matter of time, but the wait until evidence is provided and clinical trials have been completed could involve years of delay in optimising the treatment of hyperglycaemia in patients with CKD among the millions of people afflicted with diabetes mellitus all over the globe.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"><span class="elsevierStyleBold">Conflicts of interest</span></p><p class="elsevierStylePara"> </p><p class="elsevierStylePara">The authors state that they have no potential conflicts of interest related to the contents of this article.</p><p class="elsevierStylePara"> </p>" "pdfFichero" => "P1-E544-S3784-A11783-EN.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "Bibliography" "seccion" => array:1 [ 0 => array:1 [ "bibliografiaReferencia" => array:8 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:3 [ "referenciaCompleta" => "del Pozo-Fernández C, Pardo-Ruiz C, Sánchez-Botella C, López-Menchero R. 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| 2023 June | 85 | 27 | 112 |
| 2023 May | 106 | 32 | 138 |
| 2023 April | 84 | 30 | 114 |
| 2023 March | 114 | 37 | 151 |
| 2023 February | 64 | 23 | 87 |
| 2023 January | 66 | 32 | 98 |
| 2022 December | 88 | 39 | 127 |
| 2022 November | 70 | 54 | 124 |
| 2022 October | 66 | 70 | 136 |
| 2022 September | 55 | 35 | 90 |
| 2022 August | 56 | 39 | 95 |
| 2022 July | 53 | 58 | 111 |
| 2022 June | 57 | 48 | 105 |
| 2022 May | 44 | 35 | 79 |
| 2022 April | 58 | 43 | 101 |
| 2022 March | 64 | 55 | 119 |
| 2022 February | 46 | 51 | 97 |
| 2022 January | 64 | 40 | 104 |
| 2021 December | 58 | 39 | 97 |
| 2021 November | 43 | 34 | 77 |
| 2021 October | 45 | 39 | 84 |
| 2021 September | 44 | 39 | 83 |
| 2021 August | 26 | 35 | 61 |
| 2021 July | 36 | 37 | 73 |
| 2021 June | 35 | 17 | 52 |
| 2021 May | 25 | 28 | 53 |
| 2021 April | 47 | 24 | 71 |
| 2021 March | 42 | 30 | 72 |
| 2021 February | 30 | 25 | 55 |
| 2021 January | 35 | 20 | 55 |
| 2020 December | 15 | 15 | 30 |
| 2020 November | 24 | 13 | 37 |
| 2020 October | 15 | 12 | 27 |
| 2020 September | 20 | 3 | 23 |
| 2020 August | 32 | 15 | 47 |
| 2020 July | 21 | 14 | 35 |
| 2020 June | 25 | 13 | 38 |
| 2020 May | 31 | 15 | 46 |
| 2020 April | 33 | 20 | 53 |
| 2020 March | 25 | 8 | 33 |
| 2020 February | 33 | 23 | 56 |
| 2020 January | 33 | 23 | 56 |
| 2019 December | 36 | 15 | 51 |
| 2019 November | 38 | 14 | 52 |
| 2019 October | 11 | 6 | 17 |
| 2019 September | 25 | 19 | 44 |
| 2019 August | 17 | 8 | 25 |
| 2019 July | 23 | 22 | 45 |
| 2019 June | 22 | 6 | 28 |
| 2019 May | 18 | 14 | 32 |
| 2019 April | 39 | 24 | 63 |
| 2019 March | 19 | 24 | 43 |
| 2019 February | 21 | 14 | 35 |
| 2019 January | 27 | 16 | 43 |
| 2018 December | 54 | 36 | 90 |
| 2018 November | 109 | 15 | 124 |
| 2018 October | 91 | 28 | 119 |
| 2018 September | 56 | 23 | 79 |
| 2018 August | 38 | 16 | 54 |
| 2018 July | 38 | 23 | 61 |
| 2018 June | 44 | 18 | 62 |
| 2018 May | 41 | 18 | 59 |
| 2018 April | 53 | 14 | 67 |
| 2018 March | 61 | 14 | 75 |
| 2018 February | 31 | 7 | 38 |
| 2018 January | 49 | 8 | 57 |
| 2017 December | 45 | 9 | 54 |
| 2017 November | 26 | 10 | 36 |
| 2017 October | 29 | 5 | 34 |
| 2017 September | 28 | 14 | 42 |
| 2017 August | 35 | 13 | 48 |
| 2017 July | 35 | 16 | 51 |
| 2017 June | 25 | 7 | 32 |
| 2017 May | 33 | 12 | 45 |
| 2017 April | 25 | 11 | 36 |
| 2017 March | 21 | 12 | 33 |
| 2017 February | 18 | 25 | 43 |
| 2017 January | 24 | 18 | 42 |
| 2016 December | 44 | 6 | 50 |
| 2016 November | 56 | 9 | 65 |
| 2016 October | 81 | 10 | 91 |
| 2016 September | 93 | 7 | 100 |
| 2016 August | 152 | 12 | 164 |
| 2016 July | 170 | 14 | 184 |
| 2016 June | 123 | 0 | 123 |
| 2016 May | 131 | 0 | 131 |
| 2016 April | 114 | 0 | 114 |
| 2016 March | 90 | 0 | 90 |
| 2016 February | 127 | 0 | 127 |
| 2016 January | 106 | 0 | 106 |
| 2015 December | 128 | 0 | 128 |
| 2015 November | 107 | 0 | 107 |
| 2015 October | 86 | 0 | 86 |
| 2015 September | 77 | 0 | 77 |
| 2015 August | 66 | 0 | 66 |
| 2015 July | 60 | 0 | 60 |
| 2015 June | 42 | 0 | 42 |
| 2015 May | 54 | 0 | 54 |
| 2015 April | 5 | 0 | 5 |
Show all
