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Appendix Table 1: Dulaglutide treatment patterns, full populationTreatment VariablesDulaglutide Initiators (Full Population)n=1970Prescribed dose on index date, n (%)0.75 mg1113 (56.5)1.5 mg857 (43.5)Dose change during follow up, n (%)0.75 mg to 1.5 mg343 (17.4)1.5 mg to 0.75 mg19 (1.0)Number of fills,* mean (SD, median)4.83 (2.11, 5.00)Adherence, PDCMean (SD, median)0.74 (0.28, 0.86)PDC ≥ 80%, n (%)1127 (57.2)Persistence/discontinuation (45-day gap between fills)?Days of persistent use, mean (SD, median)145 (57.9, 183)Patients who discontinue, n (%)818 (41.5)Patients initiating insulin post-initiation, among n=1,269 patients without insulin pre-initiation, n (%)85 (6.7)PDC=proportion of days covered; SD=standard deviation*Including index fillAppendix Table 2: HbA1c results pre- and post-initiation, HbA1c samplen (%)Pre-Initiation HbA1c*mean (SD)Post-Initiation HbA1c*mean (SD)Change in HbA1c*mean (SD)All patients308 (100)8.49 (1.70)7.59 (1.51)-0.90 (1.57)**?Dulaglutide strength at initiation???0.75 mg171 (55.5)8.30 (1.66)7.50 (1.45)-0.80 (1.59)1.5 mg137 (44.5)8.74 (1.73)?7.70 (1.57)-1.04 (1.55)Pre-initiation HbA1c???< 7%54 (17.5)6.34 (0.38)6.34 (0.81)0.00 (0.75)≥ 7%254 (82.5)8.95 (1.51) ?7.86 (1.49) ?-1.10 (1.64) ?Pre-initiation prescription for GLP-1 RA???Yes63 (20.5)8.32 (1.91)7.91 (1.77)-0.42 (1.63)No245 (79.5)8.54 (1.65)7.51 (1.42)-1.03 (1.54)?Pre-initiation prescription for insulin???Yes100 (32.5)9.21 (1.72)8.20 (1.72)-1.01 (1.64)No208 (67.5)8.15 (1.59)?7.30 (1.30)?-0.85 (1.54)Pre-initiation prescription for OAD???≤ 1 class150 (48.7)8.35 (1.85)7.36 (1.49)-0.99 (1.57)> 1 class158 (51.3)8.64 (1.55)7.81 (1.50)?-0.83 (1.58)Proportion of days covered???< 80%120 (39.0)8.75 (1.80)8.22 (1.86)-0.53 (1.64)≥ 80%188 (61.0)8.33 (1.62)?7.19 (1.06)?-1.14 (1.49)?Patients who discontinued (45-day gap)???Yes115 (37.3)8.78 (1.80)8.24 (1.84)-0.54 (1.74)No193 (62.7)8.33 (1.62)?7.20 (1.10)?-1.12 (1.43)?GLP-1 RA=glucagon-like peptide-1 receptor agonist; OAD=oral antihyperglycemic drug; SD=standard deviation*p-values obtained using t-test across subgroups**p-value was obtained using paired t-test within the entire cohort (pre vs post)?p<0.01?p<0.05Appendix Table 3. Clinical scoring outcomes, HbA1c sample (n=308)Pre-initiationPre-Initiation N, %Post-initiation, n (%)Mild risk: ≤8% HbA1cModerate risk: 8< HbA1c ≤ 9%Severe risk: >9% HbA1cMild risk: HbA1c ≤8%14045.5%13042.2%82.6%20.6%Moderate risk: 8%< HbA1c ≤9%7123.1%4715.3%123.9%123.9%Severe risk: HbA1c >9%9731.5%4414.3%227.1%3110.1%Total308100.0%22171.8%4213.6%4514.6%Green = clinical scoring success; orange = clinical scoring failure. ‘Success’ was defined as a patient either remaining at the mild risk level, or moving from severe to moderate or mild risk, or moving from moderate to mild risk. All other outcomes were considered ‘failure.’Appendix Table 4: Proportion of patients with pre- and post-initiation HbA1c <7%, HbA1c sample?n (%)Pre-initiation HbA1c <7%*n (%)Post-initiation HbA1c <7%*n (%)All patients308 (100.0)54 (17.5)123 (39.9)Dulaglutide strength at initiation??0.75 mg171 (55.5)38 (22.2)72 (42.1)1.5 mg137 (44.5)16 (11.7)**51 (37.2)Pre-initiation HbA1c??< 7%54 (17.5)54 (100.0)?49 (90.7)≥ 7%254 (82.5)0 (0.0)74 (29.1) ?Pre-initiation prescription for GLP-1-RA??Yes63 (20.5)18 (28.6)22 (34.9)No245 (79.5)36 (14.7)?101 (41.2)Pre-initiation prescription for insulin??Yes100 (32.5)8 (8.0)21 (21.0)No208 (67.5)46 (22.1)?102 (49.0)?Pre-initiation prescription for OAD??≤ 1 class150 (48.7)36 (24.0)73 (48.7)> 1 class158 (51.3)18 (11.4)?50 (31.7)?Proportion of days covered??< 80%120 (39.0)18 (15.0)38 (31.7)≥ 80%188 (61.0)36 (19.2)85 (45.2)**Patients who discontinue (45-day gap)??Yes115 (37.3)16 (13.9)33 (28.7)No193 (62.7)38 (19.7)90 (46.6)?GLP-1 RA=glucagon-like peptide-1 receptor agonist; OAD=oral antihyperglycemic drug*p-values obtained using χ2 test across subgroups?p<0.01**p<0.05Appendix Table 5: Proportion of patients with clinical scoring success, HbA1c sample?n (%)Clinical Scoring Success*n (%)All patients308 (100.0)243 (78.9)Dulaglutide strength at initiation?0.75 mg171 (55.5)138 (80.7)1.5 mg137 (44.5)105 (76.6)Pre-initiation HbA1c?< 7%54 (17.5)53 (98.2)≥ 7%254 (82.5)190 (74.8)?Pre-initiation prescription for GLP-1-RA?Yes63 (20.5)43 (68.3)No245 (79.5)200 (81.6)**Pre-initiation prescription for insulin?Yes100 (32.5)67 (67.0)No208 (67.5)176 (84.6)?Pre-initiation prescription for OAD?≤ 1 class150 (48.7)126 (84.0)> 1 class158 (51.3)117 (74.1)**Proportion of days covered?< 80%120 (39.0)73 (60.8)≥ 80%188 (61.0)170 (90.4)?Patients who discontinue (45-day gap)?Yes115 (37.3)72 (62.6)No193 (62.7)171 (88.6)?GLP-1 RA=glucagon-like peptide-1 receptor agonist; OAD=oral antihyperglycemic drug*p-values obtained using χ2 test across subgroups?p<0.01**p<0.05Appendix Table 6: Linear regression results for change in HbA1c, HbA1c sampleEstimateStandard Error95% CIp-ValueAdjusted Group MeanPatients, n308CovariatesGenderMale (ref)––––-0.70Female-0.060.14-0.33 – 0.200.6412-0.77Age (years)-0.010.01-0.02 – 0.010.3629–Pre-initiation QCI score-0.030.06-0.16 – 0.100.6388–Pre-initiation insulin useNo (ref)––––-0.90Yes0.320.160.01 – 0.630.0413-0.58Pre-initiation SGLT-2i useNo (ref)––––-0.70Yes-0.080.17-0.41 – 0.260.6541-0.77Pre-initiation GLP-1 RA useNo (ref)––––-0.97Yes0.470.170.14 – 0.810.0058-0.50Index dose of dulaglutide0.75 mg (ref)––––-0.711.5 mg-0.050.14-0.32 – 0.220.7397-0.76Baseline HbA1c (%)-0.610.04-0.69 – -0.53<.0001–Pre-initiation OAD use≤1 class (ref)––––-0.95>1 class0.430.150.14 – 0.720.0037-0.52Proportion of days covered (per 10% change)-0.180.03-0.23 – -0.13<.0001–CI=confidence interval; GLP-1 RA=glucagon-like peptide-1 receptor agonist; OAD=oral antihyperglycemic drug; QCI=Quan-Charlson Comorbidity Index; ref=reference group; SGLT-2i=sodium glucose cotransporter-2 inhibitorAppendix Figure 1: Logistic regression results for post-initiation HbA1c <7%, HbA1c sample (n=308)GLP-1 RA=glucagon-like peptide-1 receptor agonist; OAD=oral antihyperglycemic drug; OR=odds ratio; QCI=Quan-Charlson Comorbidity Index; SGLT-2i=sodium glucose cotransporter-2 inhibitorAppendix Figure 2: Logistic regression results for clinical scoring outcome success, HbA1c sample (n=308)GLP-1 RA=glucagon-like peptide-1 receptor agonist; HEDIS=Healthcare Effectiveness Data and Information Set; OAD=oral antihyperglycemic drug; OR=odds ratio; QCI=Quan-Charlson Comorbidity Index; SGLT-2i=sodium glucose cotransporter-2 inhibitorMethods AppendixQuan-Charlson Comorbidity IndexComorbiditiesICD-9-CM Diagnostic CodesICD-10-CM Diagnostic CodesMyocardial infarction 410.xx, 412.xxI21.x, I22.x, I25.2Congestive heart failure398.91, 402.01, 402.11, 402.91, 404.01, 404.03, 404.11, 404.13, 404.91, 404.93, 425.4x-425.9x, 428.xxI09.9, I11.0, I13.0, I13.2, I25.5, I42.0, I42.5–I42.9, I43.x, I50.x, P29.0Peripheral vascular disease 093.0x, 437.3x, 440.xx, 441.xx, 443.1x-443.9x, 447.1x 557.1x, 557.9x, V43.4xI70.x, I71.x, I73.1, I73.8, I73.9, I77.1, I79.0, I79.2, K55.1, K55.8, K55.9, Z95.8, Z95.9Cerebrovascular disease362.34, 430.xx – 438.xxG45.x, G46.x, H34.0, I60.x–I69.xDementia290.xx, 294.1x, 331.2xF00.x–F03.x, F05.1, G30.x, G31.1Chronic pulmonary disease416.8x, 416.9x, 490.xx-505.xx, 506.4x, 508.1x, 508.8xI27.8, I27.9, J40.x–J47.x, J60.x–J67.x, J68.4, J70.1, J70.3Connective tissue/rheumatic disease446.5x, 710.0x – 710.4x, 714.0x – 714.2x, 714.8x, 725.xxM05.x, M06.x, M31.5, M32.x–M34.x, M35.1, M35.3, M36.0Peptic ulcer disease531.xx – 534.xxK25.x–K28.xLiver disease?Mild070.22, 070.23, 070.32, 070.33, 070.44, 070.54, 070.6x, 070.9x, 570.xx, 571.xx, 573.3x, 573.4x, 573.8x, 573.9x, V42.7xB18.x, K70.0–K70.3, K70.9, K71.3–K71.5, K71.7, K73.x, K74.x, K76.0, K76.2–K76.4, K76.8, K76.9, Z94.4Moderate or severe456.0x-456.2x, 572.2x-572.8xI85.0, I85.9, I86.4, I98.2, K70.4, K71.1, K72.1, K72.9, K76.5, K76.6, K76.7Paraplegia and hemiplegia334.1x, 342.xx, 343.xx, 344.0x-344.6x, 344.9xG04.1, G11.4, G80.1, G80.2, G81.x, G82.x, G83.0–G83.4, G83.9Renal disease403.01, 403.11, 403.91, 404.02, 404.03, 404.12, 404.13, 404.92, 404.93, 582.0x – 583.7x, 585.xx, 586.xx, 588.0x, V42.0x, V45.1x, V56.xI12.0, I13.1, N03.2–N03.7, N05.2–N05.7, N18.x, N19.x, N25.0, Z49.0–Z49.2, Z94.0, Z99.2DiabetesDiabetes without chronic complications/mild to moderate250.0x – 250.3x; 250.8x, 250.9xE10.0, E10.1, E10.6, E10.8, E10.9, E11.0, E11.1, E11.6, E11.8, E11.9, E12.0, E12.1, E12.6, E12.8, E12.9, E13.0, E13.1, E13.6, E13.8, E13.9, E14.0, E14.1, E14.6, E14.8, E14.9Diabetes with chronic complications250.4x – 250.7xE10.2–E10.5, E10.7, E11.2–E11.5, E11.7, E12.2–E12.5, E12.7, E13.2–E13.5, E13.7, E14.2–E14.5, E14.7Any malignancy, including lymphoma and leukemia, exceptmalignant neoplasm of skin140.xx – 172.xx, 174.xx – 195.8x, 200.xx – 208.xx, 238.6xC00.x–C26.x, C30.x–C34.x, C37.x–C41.x, C43.x, C45.x–C58.x, C60.x–C76.x, C81.x–C85.x, C88.x, C90.x–C97.xMetastatic solid tumor196.xx – 199.xxC77.x–C80.xAIDS/HIV042.xx, 043.xx, 044.xxB20.x–B22.x, B24.xICD-9-CM=International Classification of Diseases, Ninth Revision, Clinical Modification; ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical ModificationThe table above outlines the QCI index. To quantify comorbidity, the QCI score is computed by adding the weights that are assigned to the specific diagnoses. A score of 1 is attributed to myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, connective tissue/rheumatologic disease, peptic ulcer disease, mild liver disease, and diabetes without chronic complications. The following diseases are scored as 2: hemiplegia or paraplegia, renal disease, diabetes with complications, and malignancy including leukemia and lymphoma. Moderate or severe liver disease is scored 3. Finally, a score of 6 is assigned to metastatic solid carcinoma and AIDS/HIV. Each diagnosis is only counted once (e.g., a patient with ICD-9 code 410.xx and 412.xx will receive a score of 1 for MI, not 2). The minimum possible score is 0 and the maximum possible score is 33.Based on Quan H, Sundararajan V, Halfon P, et al. Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. Med Care. 2005;43(11):1130-1139.Adapted Diabetes Complications Severity IndexComplicationsICD-9-CM CodesICD-10-CM CodesaDCSI Score12Retinopathy????Diabetic ophthalmologic disease250.5xE08.3%, E10.3%, E11.3%, E13.3%??Background retinopathy362.01H35.0%??Other non-diabetic proliferative retinopathy362.1xH35.2%, H35.4%, H35.7%, H35.8%??Retinal edema362.83H35.81%??CSME362.53H35.351, H35.352. H35.353, H35.359??Other retinal disorders362.81, 362.82H35.9%??Proliferative diabetic retinopathy362.02H35.2%, E08.35%, E10.35%, E11.35%, E13.35%???Retinal detachment361.xxH33.0%, H33.2%???Blindness369.xx H54.0%, H54.1%, H54.4%, H54.8%???Vitreous hemorrhage379.23H43.1%???Nephropathy????Diabetic nephropathy250.4xE08.2%, E10.2%, E11.2%, E13.2%??Acute glomerulonephritis (nephritic syndrome)580.xxN00.%??Nephrotic syndrome581.xxN04.%??Hypertension, nephrosis581.81I12.%, I13.%??Chronic glomerulonephritis582.xxN03.%??Unspecified Nephritis/nephropathy583.xxN05.%??Chronic renal failure (disease)585.xxN18.%???Renal failure NOS586.xxN19.%???Renal insufficiency593.9xN28.9%, N18.9%???Neuropathy????Diabetic neuropathy356.9x, 250.6xE08.4%, E10.4%, E11.4%, E13.4%??Amyotrophy (nondiabetic)358.1xG12.21%, G54.5%??Cranial nerve palsy (including ophthalmic)951.0x, 951.1x, 951.3xG51.0%, G52.%, H49.0%, H49.1%, H49.2%??Mononeuropathy354.0x-355.9xG56.%, G57.%, G58.%, G59.0%??Charcot’s arthropathy713.5xM14.6%??Polyneuropathy357.2xG61.%, G62.%, G63.%, G60.3%??Neurogenic bladder 596.54N31.9%??Autonomic neuropathy 337.0x, 337.1xG90.0%, G90.8%, G90.9%??Gastroparesis (including diabetic)564.5x, 536.3xK31.84%, E08.43%, E10.43%, E11.43%, E13.43%??Orthostatic hypotension458.0xI95.1%, I95.2%, G90.3%??Cerebrovascular????TIA435.xxG45.%??Stroke431.xx, 433.xx, 434.xx, 436.xxI63.%???Cardiovascular????Atherosclerosis440.xxI70.%??Other IHD411.xxI24.%, ??Angina pectoris413.xxI20.%??Other chronic IHD414.xxI25.1%, I25.5%, I25.6%, I25.7%, I25.8%, I25.9%??Myocardial infarction (acute)410.xxI21.%, I22.%,I23.%???Ventricular fibrillation427.1x, 427.3xI49.0%???Atrial fibrillation427.4x, 427.5xI48.%???Other ASCVD429.2x-??Old myocardial infarction412.xxI25.2%???Heart failure428.xxI50.%???Atherosclerosis, severe440.23, 440.24-???Aortic aneurysm/dissection441.xxI71.%???Peripheral vascular disease????Diabetic PVD250.7xE08.5%, E10.5%, E11.5%. E13.%??Other aneurysm, LE442.3xI72.4%??Foot wound + complication892.1xE08.621, E08.52%, E10.621, E10.52%, E11.621, E11.52%, E13.621, E13.621, L89.5%, L89.6%, ??PVD/claudication, intermittent443.81, 443.9x, 443.9xI73.9%??Embolism/thrombosis (LE)444.22I74.3%???Gangrene (non-diabetic)785.4xI96.%???Gas gangrene040.xxA48.0%???Ulcer of lower limbs707.1xL97.%???Metabolic????Ketoacidosis250.1xE08.1%, E10.1%, E11.1%, E13.1%???Hyperosmolar250.2xE08.0%, E10.0%, E11.0%, E13.0%???Other coma250.3xE08.01%, E08.11%, E10.11%, E11.01%, E13.01%, E13.11%, E16.2%, E08.641, E10.641, E11.641, E13.641???aDCSI=adapted Diabetes Complications Severity Index; ASCVD=atherosclerotic cardiovascular disease; CSME=clinically significant macular edema; ICD-9-CM=International Classification of Diseases, Ninth Revision, Clinical Modification; ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification; IHD=ischemic heart disease; LE=lower extremity; NOS=not otherwise specified; PVD=peripheral vascular disease; TIA=transient ischemic attackBased on Chang HY, Weiner JP, Richards TM, Bleich SN, Segal JB. Validating the adapted Diabetes Complications Severity Index in claims data. Am J Manag Care. 2012;18(11):721-726. for ICD-9-CM codes, and Wilke T, Mueller S, Groth A, et al. Treatment-dependent and treatment-independent risk factors associated with the risk of diabetes-related events: a retrospective analysis based on 229,042 patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2015;14:14 for ICD-10-CM codes. Minor modifications to the ICD-10-CM code list were made for this study.The aDCSI index is based on a scale ranging from 0 to 2 for each complication as follows: 0=no abnormality, 1=some abnormality, 2=severe abnormality. Solid circle (?) indicates a count of 1 added to aDCSI; double solid circle (??) indicates a count of 2 added to aDCSI. Each patient receives 1 score from each of the 7 complication categories. The higher aDCSI score is used when a patient has >1 condition in a given category. After summing scores from all 7 categories, a patient may have a total aDCSI score between 0 to a maximum of 13.Other Disease CodesDiseaseICD-9-CM Diagnosis CodesICD-10-CM Diagnosis CodesType 1 DM250.x1, 250.x3E10.%Type 2 DM250.x0, 250.x2E11.%Secondary diabetes249.xxE08.%, E09.%, E13.%DM complicating pregnancy, childbirth or the puerperium (including gestational diabetes)648.0x, 648.8xO24.%Hypertension401.xx, 402.xx, 403.xx, 404.xx, 405.xxI10.%, I11.%, I12.%, I13.%, I15.%, H35.03, I67.4%Dyslipidemia272.xxE78.0%, E78.1%, E78.2%, E78.3%, E78.4%, E78.5%, E78.6%,Obesity278.00, 278.01, V85.3x, V85.4xE66.%Depression296.2x, 296.3x, 311.xxF32.%, F33.%DM=diabetes mellitus; ICD-9-CM=International Classification of Diseases, Ninth Revision, Clinical Modification; ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification ................
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