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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Clinical practice guidelines for chronic obstructive pulmonary disease &#40;COPD&#41; describe the main therapeutic goals as reduction of symptoms and minimization of risk&#44;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;2</span></a> but the time horizon to achieve and evaluate both objectives differs&#46; In each medical visit&#44; a cross-sectional evaluation&#44; that is to say&#44; an immediate impression&#44; is made of the reduction of symptoms&#44; which may include the relief of dyspnea and an improvement in exercise tolerance or in the patient&#39;s state of health&#46; Risk reduction&#44; however&#44; is a medium to long-term objective that requires longitudinal assessment&#46; Risk reduction includes reducing exacerbations&#44; slowing disease progression&#44; and reducing mortality&#46; The dichotomy between short and long-term therapeutic goals may be difficult for the clinician to manage&#44; and treatment may need to be tailored to dynamic changes in health status presented by the patient throughout the course of the disease&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">In some other diseases&#44; such as asthma&#44; the more pragmatic and flexible concept of clinical disease control prevails&#46; In asthma&#44; the term &#8220;control&#8221; is clearly defined as no limitation in activities of daily living&#44; no night-time symptoms&#44; minimal or no daytime symptoms&#44; minimal or no need for rescue therapy&#44; no exacerbations&#44; and normal lung function&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> This concept has made it possible to set feasible therapeutic targets&#44; and has helped to standardize treatment and adjust pharmacological regimens dynamically&#44; with the appropriate treatment escalation and de-escalation&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">In the case of COPD&#44; a similar concept of disease control would be very difficult to establish&#46; However&#44; a favorable clinical situation can often be achieved&#44; depending on baseline disease severity&#44; and stability can be maintained over time&#44; so an adapted concept of control could also be applied here&#46; In this setting&#44; the clinical control of COPD has been defined as &#8220;a condition of low clinical impact maintained over a long period of time&#8221;&#46;<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;5</span></a> This definition involves a cross-sectional dimension&#44; namely &#8220;clinical impact&#8221; or impact of the disease on the patient at a given time&#44; and a longitudinal dimension&#44; namely &#8220;stability&#8221;&#46; Clinical impact must always be as low as possible &#40;low impact&#41;&#44; and may vary depending on the severity of the disease&#44; while stability is the absence of exacerbations or clinical worsening over time&#46; Control is a combination of stability and low clinical impact&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">In 2014&#44; our working group proposed certain criteria for COPD control that were subsequently evaluated in various studies&#46;<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6&#44;7</span></a> Control was evaluated on the basis of either the combination of various clinical parameters &#40;degree of dyspnea&#44; rescue medication use&#44; physical activity&#44; color of sputum&#44; the presence of exacerbations or perception of health&#41; or the scores obtained using validated clinical questionnaires&#44; such as the COPD Assessment Test &#40;CAT&#41;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> or the Clinical COPD questionnaire &#40;CCQ&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> In general&#44; the patients classified as controlled showed a lower future risk of exacerbations&#46; In the end&#44; however&#44; the original control criteria &#40;OCC&#41; proved less sensitive&#46; Only between 4&#46;5&#37; and 32&#37; of patients could be classified as controlled when the clinical approach was used&#44; and between 21&#37; and 37&#37; after CAT assessment&#44; figures that were significantly lower in severe cases&#46;<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6&#44;7</span></a> The OCC were developed as a preliminary proposal that needed to be refined and validated to assess the relevance of the variables included in the tool&#44; their different thresholds&#44; the number of criteria required&#44; and the need to adjust them according to severity&#46; The concept of control as a predictor of risk also had to be validated&#46; This task has recently been completed&#44; leading to the publication of our modified control criteria &#40;MCC&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> In a cohort of 265 COPD patients followed for a year&#44; around 60&#37; achieved control according to the MCC&#44; irrespective of their baseline severity&#44; compared to only 27&#46;5&#37; using the OCC&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> The controlled patients reported better health-related quality of life&#44; with a substantially lower CAT score at 1<span class="elsevierStyleHsp" style=""></span>year than uncontrolled patients &#40;5&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;6 vs 10&#46;1<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#46;7&#59; p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#44; and a significantly lower future risk of complication&#46; When the MCC was used&#44; the hazard ratio &#40;HR&#41; of the first compound event &#40;mortality&#44; hospitalization or visit to hospital emergency department&#41; was 2&#46;5 times higher among uncontrolled patients &#40;HR&#58; 2&#46;50&#59; 95&#37; CI&#58; 1&#46;53&#8211;4&#46;07&#41;&#44; whereas the risk of exacerbation and hospitalization doubled in the absence of control&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> In our opinion&#44; these results are promising and point toward the emergence of a new therapeutic target for COPD&#58; clinical control of the disease&#46; This is a therapeutic objective that is comprehensive &#40;it combines a number of both short and long-term targets&#41;&#44; desirable &#40;a controlled patient can be expected to have a lower risk of future complications&#41;&#44; easy to evaluate in clinical practice &#40;using standard clinical variables and&#47;or simple questionnaires&#41;&#44; achievable for most COPD patients&#44; &#40;regardless of their severity at baseline&#41;&#44; dynamic &#40;it can be assessed at all visits&#41;&#44; and potentially useful for clinical decision-making&#46; The results of the validation of the MCC must be considered preliminary&#44; and further studies are needed to confirm the initial findings and&#44; in particular&#44; to assess the influence of different therapeutic alternatives&#46; However&#44; given the temporal dichotomy of the objectives proposed in current clinical practice guidelines&#44; we believe that the concept of clinical control in COPD may prove to be a tool that is inclusive&#44; dynamic and useful for decision-making in our day-to-day practice&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interests</span><p id="par0025" class="elsevierStylePara elsevierViewall">Juan Jos&#233; Soler-Catalu&#241;a has received speaker fees from AstraZeneca&#44; Boehringer Ingelheim&#44; Bial&#44; Ferrer&#44; Laboratorio Esteve&#44; Menarini&#44; Mundipharma&#44; Novartis&#44; Rovi&#44; and TEVA&#59; consultancy fees from AirLiquide&#44; AstraZeneca&#44; Boehringer Ingelheim&#44; Chiesi&#44; Ferrer&#44; GlaxoSmithKline&#44; Laboratorios Esteve&#44; Mundipharma&#44; and Novartis&#44; and research grants from GlaxoSmithKline and Boehringer Ingelheim&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Bernardino Alc&#225;zar has received speaker fees from AstraZeneca&#44; Boehringer Ingelheim&#44; Menarini&#44; and Novartis&#44; and research grants from Menarini and Novartis&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Marc Miravitlles has received speaker fees from AstraZeneca&#44; Boehringer Ingelheim&#44; Chiesi&#44; Cipla&#44; Menarini&#44; Rovi&#44; Bial&#44; Zambon&#44; CSL Behring&#44; Grifols&#44; and Novartis&#59; consultancy fees from AstraZeneca&#44; Boehringer Ingelheim&#44; Chiesi&#44; Ferrer&#44; GlaxoSmithKline&#44; Bial&#44; Gebro Pharma&#44; CSL Behring&#44; Laboratories Esteve&#44; Ferrer&#44; Mereo Biopharma&#44; Verona Pharma&#44; TEVA&#44; pH Pharma&#44; Novartis&#44; and Grifols&#44; 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Editorial
Clinical control in COPD: A New therapeutic objective?
Control clínico en la EPOC: ¿un nuevo objetivo terapéutico?
Juan José Soler-Cataluñaa,b,
Corresponding author
jjsoler@telefonica.net

Corresponding author.
, Bernardino Alcázarb,c, Marc Miravitllesb,d
a Servicio de Neumología, Hospital Arnau de Vilanova-Lliria (Valencia), Valencia, Spain
b CIBER de Enfermedades Respiratorias (CIBERES), Spain
c Unidad de Neumología, Hospital de Alta Resolución de Loja, Loja, Granada, Spain
d Servicio de Neumología, Hospital Universitari Vall d’Hebron, Barcelona, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Clinical practice guidelines for chronic obstructive pulmonary disease &#40;COPD&#41; describe the main therapeutic goals as reduction of symptoms and minimization of risk&#44;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;2</span></a> but the time horizon to achieve and evaluate both objectives differs&#46; In each medical visit&#44; a cross-sectional evaluation&#44; that is to say&#44; an immediate impression&#44; is made of the reduction of symptoms&#44; which may include the relief of dyspnea and an improvement in exercise tolerance or in the patient&#39;s state of health&#46; Risk reduction&#44; however&#44; is a medium to long-term objective that requires longitudinal assessment&#46; Risk reduction includes reducing exacerbations&#44; slowing disease progression&#44; and reducing mortality&#46; The dichotomy between short and long-term therapeutic goals may be difficult for the clinician to manage&#44; and treatment may need to be tailored to dynamic changes in health status presented by the patient throughout the course of the disease&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">In some other diseases&#44; such as asthma&#44; the more pragmatic and flexible concept of clinical disease control prevails&#46; In asthma&#44; the term &#8220;control&#8221; is clearly defined as no limitation in activities of daily living&#44; no night-time symptoms&#44; minimal or no daytime symptoms&#44; minimal or no need for rescue therapy&#44; no exacerbations&#44; and normal lung function&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> This concept has made it possible to set feasible therapeutic targets&#44; and has helped to standardize treatment and adjust pharmacological regimens dynamically&#44; with the appropriate treatment escalation and de-escalation&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">In the case of COPD&#44; a similar concept of disease control would be very difficult to establish&#46; However&#44; a favorable clinical situation can often be achieved&#44; depending on baseline disease severity&#44; and stability can be maintained over time&#44; so an adapted concept of control could also be applied here&#46; In this setting&#44; the clinical control of COPD has been defined as &#8220;a condition of low clinical impact maintained over a long period of time&#8221;&#46;<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;5</span></a> This definition involves a cross-sectional dimension&#44; namely &#8220;clinical impact&#8221; or impact of the disease on the patient at a given time&#44; and a longitudinal dimension&#44; namely &#8220;stability&#8221;&#46; Clinical impact must always be as low as possible &#40;low impact&#41;&#44; and may vary depending on the severity of the disease&#44; while stability is the absence of exacerbations or clinical worsening over time&#46; Control is a combination of stability and low clinical impact&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">In 2014&#44; our working group proposed certain criteria for COPD control that were subsequently evaluated in various studies&#46;<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6&#44;7</span></a> Control was evaluated on the basis of either the combination of various clinical parameters &#40;degree of dyspnea&#44; rescue medication use&#44; physical activity&#44; color of sputum&#44; the presence of exacerbations or perception of health&#41; or the scores obtained using validated clinical questionnaires&#44; such as the COPD Assessment Test &#40;CAT&#41;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> or the Clinical COPD questionnaire &#40;CCQ&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> In general&#44; the patients classified as controlled showed a lower future risk of exacerbations&#46; In the end&#44; however&#44; the original control criteria &#40;OCC&#41; proved less sensitive&#46; Only between 4&#46;5&#37; and 32&#37; of patients could be classified as controlled when the clinical approach was used&#44; and between 21&#37; and 37&#37; after CAT assessment&#44; figures that were significantly lower in severe cases&#46;<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6&#44;7</span></a> The OCC were developed as a preliminary proposal that needed to be refined and validated to assess the relevance of the variables included in the tool&#44; their different thresholds&#44; the number of criteria required&#44; and the need to adjust them according to severity&#46; The concept of control as a predictor of risk also had to be validated&#46; This task has recently been completed&#44; leading to the publication of our modified control criteria &#40;MCC&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> In a cohort of 265 COPD patients followed for a year&#44; around 60&#37; achieved control according to the MCC&#44; irrespective of their baseline severity&#44; compared to only 27&#46;5&#37; using the OCC&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> The controlled patients reported better health-related quality of life&#44; with a substantially lower CAT score at 1<span class="elsevierStyleHsp" style=""></span>year than uncontrolled patients &#40;5&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;6 vs 10&#46;1<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#46;7&#59; p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#44; and a significantly lower future risk of complication&#46; When the MCC was used&#44; the hazard ratio &#40;HR&#41; of the first compound event &#40;mortality&#44; hospitalization or visit to hospital emergency department&#41; was 2&#46;5 times higher among uncontrolled patients &#40;HR&#58; 2&#46;50&#59; 95&#37; CI&#58; 1&#46;53&#8211;4&#46;07&#41;&#44; whereas the risk of exacerbation and hospitalization doubled in the absence of control&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> In our opinion&#44; these results are promising and point toward the emergence of a new therapeutic target for COPD&#58; clinical control of the disease&#46; This is a therapeutic objective that is comprehensive &#40;it combines a number of both short and long-term targets&#41;&#44; desirable &#40;a controlled patient can be expected to have a lower risk of future complications&#41;&#44; easy to evaluate in clinical practice &#40;using standard clinical variables and&#47;or simple questionnaires&#41;&#44; achievable for most COPD patients&#44; &#40;regardless of their severity at baseline&#41;&#44; dynamic &#40;it can be assessed at all visits&#41;&#44; and potentially useful for clinical decision-making&#46; The results of the validation of the MCC must be considered preliminary&#44; and further studies are needed to confirm the initial findings and&#44; in particular&#44; to assess the influence of different therapeutic alternatives&#46; However&#44; given the temporal dichotomy of the objectives proposed in current clinical practice guidelines&#44; we believe that the concept of clinical control in COPD may prove to be a tool that is inclusive&#44; dynamic and useful for decision-making in our day-to-day practice&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interests</span><p id="par0025" class="elsevierStylePara elsevierViewall">Juan Jos&#233; Soler-Catalu&#241;a has received speaker fees from AstraZeneca&#44; Boehringer Ingelheim&#44; Bial&#44; Ferrer&#44; Laboratorio Esteve&#44; Menarini&#44; Mundipharma&#44; Novartis&#44; Rovi&#44; and TEVA&#59; consultancy fees from AirLiquide&#44; AstraZeneca&#44; Boehringer Ingelheim&#44; Chiesi&#44; Ferrer&#44; GlaxoSmithKline&#44; Laboratorios Esteve&#44; Mundipharma&#44; and Novartis&#44; and research grants from GlaxoSmithKline and Boehringer Ingelheim&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Bernardino Alc&#225;zar has received speaker fees from AstraZeneca&#44; Boehringer Ingelheim&#44; Menarini&#44; and Novartis&#44; and research grants from Menarini and Novartis&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Marc Miravitlles has received speaker fees from AstraZeneca&#44; Boehringer Ingelheim&#44; Chiesi&#44; Cipla&#44; Menarini&#44; Rovi&#44; Bial&#44; Zambon&#44; CSL Behring&#44; Grifols&#44; and Novartis&#59; consultancy fees from AstraZeneca&#44; Boehringer Ingelheim&#44; Chiesi&#44; Ferrer&#44; GlaxoSmithKline&#44; Bial&#44; Gebro Pharma&#44; CSL Behring&#44; Laboratories Esteve&#44; Ferrer&#44; Mereo Biopharma&#44; Verona Pharma&#44; TEVA&#44; pH Pharma&#44; Novartis&#44; and Grifols&#44; 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Article information
ISSN: 15792129
Original language: English
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