de Cosmo, S.

FALLARINO, Mara

FILARDI, TIZIANA

Massa, M.

MORANO, Susanna

Pacilli, A

TRISCHITTA, VINCENZO

English

A. Pacilli

M. Fallarino

M. Massa

T. Filardi

S. De Cosmo

S. Morano

V. Trischitta

Crossref

Acta Diabetologica

Patient/disease features and glycemic targets in type 2 diabetes: Where do we stand?

Archivio della ricerca- Università di Roma La Sapienza

SHORT COMMUNICATIONPatient/disease features and glycemic targets in type 2 diabetes:Where do we stand?A. Pacilli1 • M. Fallarino2 • M. Massa1 • T. Filardi2 • S. De Cosmo1 •S. Morano2 • V. Trischitta2,3Received: 22 December 2015 / Accepted: 25 December 2015 Springer-Verlag Italia 2016Once again in 2015, the ADA and the EASD haveopportunely pointed the need of a patient-centeredapproach for the management of hyperglycemia in indi-viduals with type 2 diabetes (T2DM) [1]. A HbA1c cut off\7 % has been suggested with more or less stringent tar-gets to be individually pursued according to patient/diseasefeatures (PDFs), including: (a) risks associated withhypoglycemia; (b) disease duration; (c) life expectancy;(d) comorbidities; (e) vascular complications; and (f) pa-tient’s attitude. Since the ADA/EASD made clear that scalefor such approach ‘‘is not designed to be applied rigidly butto be used as a broad construct to guide clinical decisionmaking,’’ many clinicians will appreciate to be told how tomeasure the above-mentioned PDFs. We addressed thisissue by firstly proposing a way to score individual PDFsand then investigating the distribution of such scores in areal-life clinical set.Data from 400 consecutive out-patients with T2DMattending two research-based hospitals in Central-SouthernItaly, ‘‘Casa Sollievo della Sofferenza,’’ Scientific Institutein San Giovanni Rotondo (SGR, n = 200) and ‘‘Sapienza’’University Policlinico Umberto I Hospital in Rome (Rome,n = 200) were collected.Each of the six ADA/EASD suggested PDF was scoredequal to 0 (good), 1 (intermediate) or 2 (poor). Scoringcriteria (Table 1) were pre-specified in a collaborativefashion by all authors and then used independently by fourauthors who are experienced diabetologists (i.e., takingcare of[20 patients/week since 10–35 years; AP, SDC inSGR; MF, SM in Rome). Within each hospital, concor-dance between scores attributed to each single PDF in eachpatient was observed in more than 95 % cases. In theabsence of agreement, the final score was attributed uponconfrontation between the two examiners. Mean valuesattributed to each single PDF were summed to obtain thetotal individual PDFs score.Patients’ clinical features are summarized in Table 2.Median value of individual PDFs score was 6, with onlyone patient scoring 0 and no patients scoring 11 or 12.Patients were then grouped according to score 0–2,(n = 41, 10.2 %), 3–4 (n = 85, 21.2 %), 5–6 (n = 136,34.0 %), 7–8 (n = 111, 27.8 %) and 9–10 (n = 27,6.8 %), arbitrarily defined as ‘‘very good,’’ ‘‘good,’’ ‘‘in-termediate,’’ ‘‘poor’’ and ‘‘very poor,’’ respectively.According to ADA/EASD patient-centered approach,which patients should be targeted to an intensive anti-dia-betes therapy (HbA1c\ 7 %)? Probably, only those with‘‘very good’’ or ‘‘good’’ PDFs scores? If so, more than two-thirds of our patients should be targeted to more relaxedattempts (HbA1c\ 7.5 % or more). In fact, the majority ofstudy patients had a score ranging from ‘‘intermediate’’ to‘‘very poor,’’ while only 31.4 % show a ‘‘very good’’ or‘‘good’’ score. A similar conclusion could have been drawnaccording to a totally independent ADA suggestion,Managed by Antonio Secchi.S. De Cosmo, S. Morano and V. Trischitta have equally supervisedthe study.& A. Pacillipacillia@libero.it1 Department of Medical Sciences, Scientific Institute ‘‘CasaSollievo della Sofferenza’’, S. Giovanni Rotondo, FG, Italy2 Department of Experimental Medicine, ‘‘Sapienza’’University, Rome, Italy3 Research Unit of Diabetes and Endocrine Diseases, ScientificInstitute ‘‘Casa Sollievo della Sofferenza’’,S. Giovanni Rotondo, FG, Italy123Acta DiabetolDOI 10.1007/s00592-015-0833-xspecifically devoted to elderly people ([65 years). In thissubgroup, the ADA recommends a level of HbA1c\ 7.5 %rather than 7 % if patients are otherwise healthy with intactcognitive and functional status, more relaxed targets areindicated for elderly with comorbidities (HbA1c\ 8.0 %or even\8.5 %) [2]. Of note, 255 (63.7 %) of our studypatients were in fact C65 years old, a finding which issimilar to that reported in larger epidemiological surveys,and thus candidates, by the only virtue of age, to a relaxedHbA1c target (\7.5 % or more). Such a proportion issimilar to that obtained by using the PDFs score (68.6 % ofour patients scored as ‘‘intermediate,’’ ‘‘poor’’ or ‘‘verypoor’’ score), thus somehow validating the results obtainedby PDFs score and reinforcing the idea that, in our clinicalset, intensive anti-diabetes therapy is suggestible for aminority of patients.Are our findings interpretable in the context of meta-analyses of trials addressing the impact of intensive glu-cose lowering therapy on all-cause mortality whichshowed, quite unexpectedly, no benefit at all? Probablyyes; in fact, among possible explanations of such coun-terintuitive negative result is certainly—on one side—thedeleterious role of severe hypoglycemia [3, 4], which isineludibly associated with intensive anti-diabetes therapy,but—on the other side—also the possibility that intensivetreatment should be limited to younger patients, with shortdisease duration and lack of major chronic complicationsand comorbidities, all patients whose PDFs score wouldconceivably be defined as ‘‘very good’’ or ‘‘good’’ by ourscoring method.Although we recognize that our scoring method does notderive from objective standardized measurements (espe-cially the one referring to patient’s attitude, which is onlybased on personal judgment of experienced diabetologists),it is of note that more than 95 % agreement was observedbetween the two examiners within the each hospital, thusinternally validating it.Table 1 Scoring criteria of thesix patient/disease features,ranging from 0 (good) to 1(intermediate) or 2 (poor)Score 0 1 2Duration of diabetes (years) \5 5–10 [10Age (years) \45 45–65 [65orLife expectancy (years)a [10 5–10 \5Comorbidities Absent Mildb SeverecCardiovascular diseaseorAdvanced microangiopathyAbsent Present without clinical events Present with clinical eventsdHypoglycemic episodes Never Moderate SevereePatient’s attitudef Good Intermediate Poora According to the risk defined by our previously published risk engine for predicting all-cause mortality inpatients with type 2 diabetes (De Cosmo et al. Diabetes Care 2013; 36:2830–2835. doi: 10.2337/dc12-1906;also available as a free web-based calculator at http://www.operapadrepio.it/rcalc/rcalc.php): high risk wasgiven a score equal to 2, intermediate risk equal to 1 and low risk equal to 0b Hearing impairment, arthritis, chronic obstructive bronchitis, depression, gastrointestinal and muscu-loskeletal diseases, obesityc Congestive heart failure, hip fracture, tumors, memory or cognitive impairment, vision reductiond Myocardial infarction, heart failure, pulmonary edema, stroke, diabetic foot, amputation, blindness,retinal detachment, nephrosis, acute renal failure, end stage renal diseasee Requiring assistance of another person to actively administer carbohydrate, glucagon, or other resusci-tative actionsf Based on the personal judgment of experienced physiciansTable 2 Clinical features of the 400 study patients with type 2diabetesSex (M/F) 249/151Age (years) 66.8 ± 10.3Body mass index (kg/m2) 29.0 ± 5.3Smokers [n (%)] 58 (14.5)Duration of diabetes (years) 12.8 ± 9.5Glycated hemoglobin (%) 7.6 ± 1.7Anti-hyperglycemic therapyDiet alone [n (%)] 44 (11.0)Oral antidiabetes drugs [n (%)] 198 (49.5)Insulin ± oral antidiabetes drugs [n (%)] 88 (39.5)Anti-hypertensive treatment [n (%)] 314 (78.5)Anti-dyslipidemic treatment [n (%)] 252 (63.0)Data are number (n) and percentage (%) or mean ± SDActa Diabetol123A further limitation of our scoring method, which isbased on the arbitrary assumption of an equivalent roleplayed by each PDF, is that the contribution of each featureis not ‘‘weighted’’ according to its own importance indetermining the level of treatment intensiveness. Thismight end up to different individual HbA1c targeting. Forexample, it is conceivable, and probably agreeable, thatindividuals with previous major cardiovascular events,even in the absence of other counter-indications (thusscoring only 2), should be preferentially targeted to arelaxed glycemic control. It is worth noting that, under thisscenario (or similar ones), our scoring method, if any,underestimates the proportion of patients targetable tomore relaxed HbA1c levels. In all, though some suggestionsfrom experienced people have been recently offered [5],specifically designed prospective studies aimed at objec-tively addressing the individual weight to be attributable toeach PDF are definitively needed.In conclusion, despite the above-mentioned limitations,we believe our present report has the merit of proposing amethod for measuring ADA/EASD suggested PDFs toeventually be used for pursuing a patient-centered glucoselowering treatment. According to the proposed method, inthe real-life clinical set of Central-Southern Italy, themajority of patient attending diabetes clinics fromresearch-based hospitals seems not to be eligible to inten-sive anti-diabetes treatments. Additional attempts are nee-ded to address the generalizability of our finding and tobetter shape the specific weight of each single PDF indetermining the degree of intensiveness of anti-diabetestreatments.Compliance with ethical standardsConflict of interest The authors declare that they have no conflictof interest.Ethical standard The study was approved by local ethical committee.Human and animal rights statement All procedures followedwere in accordance with the ethical standards of the responsiblecommittee on human experimentation (institutional and national) andwith the Helsinki Declaration of 1975, as revised in 2008.Informed consent statement Informed consent was obtained fromall patients for being included in the study.References1. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E,Nauck M et al (2015) Management of hyperglycemia in type 2diabetes, 2015: a patient centered approach update to a positionstatement of the American Diabetes Association and the EuropeanAssociation for the Study of Diabetes. Diabetes Care 38:140–1492. American Diabetes Association (2015) Glycemic targets. Sec. 6. instandards of medical care in diabetes 2015. Diabetes Care 38:S33–S403. Yeh JS, Sung SH, Huang PC, Hsu PF, Huang HM, Yang HL, YouLK, Chuang SY, Cheng HM, Chen CH (2015) Hypoglycemia andrisk of vascular events and mortality: a systematic review andmeta-analysis. Acta Diabetol. doi:10.1007/s00592-015-0803-34. Nicolucci A, Pintaudi B, Rossi MC, Messina R, Dotta F, FrontoniS, Caputo S, Lauro R (2015) The social burden of hypoglycemia inthe elderly. Acta Diabetol 52:677–6855. Cahn A, Raz I, Kleinman Y, Balicer R, Hoshen M, Lieberman N,Brenig N, Del Prato S, Cefalu WT (2015) Clinical assessment ofindividualized glycaemic goals in patients with type 2 diabetes:formulation of an algorithm based on a survey among leadingworldwide diabetologists. Diabetes Care 38:2293–2300Acta Diabetol123

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Patient/disease features and glycemic targets in type 2 diabetes: Where do we stand?

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