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Wednesday August 10th, 2022
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Original Article

Fernando Lavalle-Gonzáleza; Maricela Vidrio-Velázquezb; Rutila Castañeda-Limonesc; Paloma Almeda-Valdésd; Liz Toapanta-Yanchapaxi (0000-0002-1218-1721)e; Ana Ochoa-Guzmán (0000-0002-4870-3966)f; Erwin Chiquete (0000-0002-1142-295X)g.
aDepartment of Endocrinology, Hospital Universitario Dr. José Eleuterio González, Monterrey, NL, México; bDepartment of Endocrinology, Centro Médico Nacional de Occidente, IMSS, Guadalajara, Jal., México; cClinical Epidemiology Unit, Hospital Regional Carlos MacGregor Sánchez Navarro, IMSS, Mexico City, Mexico; dDepartment of Endocrinology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; eDepartment of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; fMolecular Biology Unit, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; gDepartment of Neurology and Psychiatry, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Corresponding Author: , . Tel: ; e-mail: erwin.chiquetea@incmnsz.mx

Citation: Lavalle González F, Vidrio Velázquez M, Castañeda Limones R, Almeda Valdés P, Toapanta Yanchapaxi L, Ochoa Guzmán A, et al. Attainment of Best Practice Recommendations and Late Complications of Patients with Type 1 and Type 2 Diabetes Mellitus.
Lat Am J Clin Sci Med Technol. 2022 Apr; 4: 75-84.
Received: September 2nd, 2021.
Accepted: March 4th, 2022.
Published: April 8th, 2022.
Views: 55
Downloads: 4
ABSTRACT

Background: There is a need for information on the current practices of diabetes management to take some actions and improve the attainment of therapeutic goals. Objective. We aimed to describe the attainment of therapeutic targets and late complications of patients with type 1 (T1D) and type 2 (T2D) diabetes mellitus. Material and Methods. In the fourth wave of the International Diabetes Management Practices Study, 1,966 Mexican patients were analyzed (T1D: n=157, 8%; T2D: n=1809, 92%). The cross-sectional phase regarding metabolic profile, current complications, and management are analyzed. Results. Out of T1D patients, 77.6% received insulin alone, and 27.4% had insulin and oral glucose-lowering drugs (OGLD, mostly metformin). Out of T2D patients, 63% received OGLD exclusively (mostly metformin), 4.3% insulin alone, 30.4% OGLD, and insulin, and 2% were on a diet and exercise exclusively. Only 19.7% T1D and 35.9% T2D patients had HbA1c <7% (p=0.01), and only 5.0% of T1D and 3.9% of T2D met the combined therapeutic target of HbA1c <7% + BP <130/80 mmHg + LDL <100 mg/dl. Late diabetes-related complications occurred in 42.7% of T1D and 52.8% of T2D patients, mostly microvascular disease. Macrovascular complications were more frequent in patients with T2D, as compared with T1D (36.8% vs. 16.4%, p<0.001). The number of late complications increased steadily with disease duration, more pronounced in patients with T2D. Conclusions. This study evidences substantial lags in the attainment of clinical goals of patients with diabetes mellitus. There are noticeable differences in the achievement of current therapeutic targets between patients with T1D and T2D in a sample of the Mexican practice.

Keywords: complications, diabetes, HbA1c, macrovascular, microvascular, treat-to-target
RESUMEN

Introducción. Existe la necesidad de información acerca de las prácticas actuales de manejo de la diabetes para tomar algunas acciones y mejorar el alcance de metas terapéuticas. Objetivo. Nuestro objetivo fue describir el logro de los objetivos terapéuticos y las complicaciones tardías de los pacientes con diabetes mellitus tipo 1 (DT1) y tipo 2 (DT2). Material y métodos. Analizamos 1,966 pacientes: 157 (8%) con DT1 y 1809 (92%) con DT2. Aquí se presenta la fase transversal de este estudio con respecto al perfil metabólico y complicaciones crónicas. Resultados. De los pacientes con DT1, el 77.6% recibió insulina sola y el 27.4% recibió insulina y fármacos hipoglucemiantes orales (FHGO). De los pacientes con DT2, el 63% recibió FHGO exclusivamente, 4.3% insulina, 30.4% FHGO e insulina y 2% dieta y ejercicio. Sólo 19.7% de los pacientes con DT1 y 35.9% con DT2 tenían HbA1c <7%, y sólo 5.0% de DT1 y 3.9% de DT2 cumplieron el objetivo combinado de HbA1c <7% + PA <130/80 mmHg + LDL <100 mg/dL. Las complicaciones crónicas ocurrieron en 42.7% y 52.8%, de DT1 y DT2, respectivamente. El número de complicaciones aumentó con la duración de la enfermedad. Conclusiones. Este estudio evidencia rezagos sustanciales en el logro de las metas clínicas de los pacientes con diabetes mellitus. Hay diferencias notables en el logro de los objetivos terapéuticos actuales entre pacientes con DT1 y DT2 en una muestra de la práctica mexicana.

Palabras clave: complicaciones, diabetes, HbA1c, macrovascular, microvascular, tratar-a-objetivo

INTRODUCTION

The prevalence of type 1 diabetes (T1D) has shown a slight increase. Still, type 2 diabetes (T2D) worldwide is facing an explosive increase, especially in low- to middle-income countries experiencing the epidemiological transition to a westernized lifestyle.1-5

The population with diabetes consumes a disproportionate share of health care resources, mainly because of both micro and macrovascular complications.6-9 Diabetes treatment includes lifestyle measures, rigorous treatment of hyperglycemia, hypertension, dyslipidemia, and other comorbidities. Despite these strategies and recommendations, a significant proportion of patients are not well controlled.2,10-12

There is a need for information on the current practices of diabetes management to take some actions and improve the attainment of therapeutic goals. The International Diabetes Management Practice Study (IDMPS) is an ongoing observational study designed to provide information about the management and control of T1D and T2D patients in developing countries.11-15 This international effort aimed to document clinical practice changes in low- to middle-income nations. Herein, we describe the characteristics of management and achievement of therapeutic goals of patients with diabetes mellitus living in Mexico, and the possible relationship with chronic micro and macrovascular complications. This report will set the basis to compare the performance in the forthcoming study waves.

MATERIAL AND METHODS

Study Design

IDMPS is an international, multicenter, prospective, observational study on patients with T1D and T2D.11-15 In brief, IDMPS is composed of cross-sectional surveys called “waves” and aimed to assess changing practices in managing subjects with diabetes mellitus in low- to middle-income countries. Specifically, the fourth wave of the cross-sectional study was carried out in nine countries. Overall, in the fourth wave, 480 physicians included at least one patient.

Each wave consisted of two phases: a 2-week cross-sectional survey and a 9-month longitudinal phase. A 3-month interval separated the end of the longitudinal survey and the start of the next wave. The internal Committee of Ethics of each participating center reviewed and approved the enrollment of patients. This report is prepared according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline.16

Study Subjects

The number of subjects to be recruited in each participating country was determined on a country basis. Based on the assumption that insulin is the least prescribed therapy, the sample was determined in order to establish the frequency of patients treated with insulin. It was estimated to calculate proportions with an absolute precision of 20% and a confidence interval of 95%.

The number and profile of the physicians invited to participate in the study were determined on a country basis, taking into account their professional clinical expertise in diabetes management and willingness to participate after reviewing the study objectives on evaluation of best practice therapeutic goals achievement.11-15

Since each physician was requested to enroll 10 T2D patients, the final number of physicians was the number of patients divided by 10 and rounded off to the next digit. If the minimal sample size was 864 T2D patients, the number of physicians corresponded to at least 87 physicians.

The list of physicians was reviewed yearly at each cross-sectional survey. More than one physician could be recruited in the same healthcare center. In Mexico, the fourth wave was planned to select 150 sites and to recruit 1,800 patients. A total of 139 physicians of 124 centers (mean of 1.12 physicians per center, range 1-3) and 1,970 patients were recruited in the fourth wave of the IDMPS registry.

T1D and T2D, male or female patients, aged 18 years or older, visiting the physician during each recruitment period were eligible to enter the study. The patients were consecutively invited to participate without random selection, but investigators were requested to recruit patients in a strictly consecutive manner to limit selection biases. Written informed consent was required for all participants.

Patients were excluded if they had concomitant participation in another clinical descriptive or interventional study, participated in a previous wave of IDMPS, or were under temporary insulin treatment (gestational diabetes, surgery, pancreas cancer, sepsis, and other conditions).

Data Collection

Demographics, medical history, pharmacologic and lifestyle therapy, glycemic control, plasma lipid management, blood pressure (BP) control, and other therapeutic targets were collected on standardized case report forms (CRF) the same day of the study visits.

Other management data such as blood glucose self-monitoring, access to diabetes education, access to specialized care, hospitalizations, and medical complications were also documented. Late diabetes-related complications were recorded as diagnosed by the treating physician.

Therapeutic targets were registered for three main variables: HbA1c <7%, BP <130/80 mmHg, and LDL-cholesterol <100 mg/dl (either alone or combined). However, other targets as weight, total cholesterol, HDL-cholesterol, triglycerides, uric acid levels, creatinine, and proteinuria were also collected. The participating physicians filled data in the paper CRF. The filled CRF was sent to the CRA of the Sanofi affiliate.

Statistical Methods

Parametric continuous variables are expressed as geometric means and standard deviations (SD), or minimum and maximum.

Categorical variables are expressed as percentages. Interquartile range (IQR) was computed for quantitative variables following a non-parametric distribution.

Student t-test was performed to compare quantitative variables parametrically distributed between two groups. Chi-square statistics were used to compare nominal variables in univariate analyses. All P values are two-sided and regarded as significant when P < 0.05. Statistical analyses were conducted with the SAS Software version 8.02.

RESULTS

In Mexico, 1,970 patients with diabetes were recruited in the fourth wave of the IDMPS registry; among them, a total of 1,966 patients met the selection criteria and are here analyzed.

The 139 physicians included at least one patient in this part of the study: 49 were endocrinologists or diabetologists, and 90 were general practitioners / primary care practitioners / internists / cardiologists. They had been practicing medicine for 19.7 years on average for endocrinologists or diabetologists, and 21.9 years on average for general practitioners / primary care practitioners / internists / cardiologists. Most of the physicians (92%) practiced medicine in urban areas, mostly private (47.8%) or mixed (public and private, 47.1%) practice.

Characteristics of T1D Patients

A total of 157 patients with T1D participated in the fourth wave (53.8% females and 46.2% males). The mean age of T1D patients was 32.01 years (SD: 12.82) (median: 29, IQR: 22-38 years) (Table 1). Mean BMI was 24.52 (SD: 4.55), median 23.38 (IQR: 22-26, 10.8% with BMI >30). Mean waist circumference was 85.06 cm (SD: 14.77), median 86 cm (IQR: 75-92 cm).

Table 1. Characteristics of Mexican patients with diabetes mellitus included in the IDMPS-4w study
Baseline characteristicsT1D patients (n = 157)T2D patients (n = 1809)
Age, median (IQ range), years29.0 (22-38)59 (51-67)

Female, n (%)84 (53.8 %)1078 (59.8 %)

History of hypertension, n (%)27 (17.2 %)997 (55.3 %)

Current smoking status, n (%)17 (10.8 %)1654 (91.4 %)

Antiplatelet therapy, n (%)37 (23.6)707 (39.1)

Time since diagnosis, median (IQ range), years12.0 (5-19)8.0 (13-15)

Any diabetes-related complication, n (%)67 (42.7)956 (52.8)

BMI, mean (SD)24.52 (4.55)29.12 (5.38)

Waist circumference, mean (SD), cm85.06 (14.77)98.07 (13.45)

SBP, mean (SD), mmHg114.89 (15.38)127.68 (18.32)

DBP, mean (SD), mmHg73.89 (10.27)77.13 (9.76)

HbA1c, mean (SD), %8.73 (2.14)7.97 (1.96)

Total cholesterol, mean (SD), mg/dl185.55 (46.65)193.29 (49.37)

LDL-cholesterol, mean (SD), mg/dl127.11 (150.98)131.42 (144.08)

HDL-cholesterol, mean (SD), mg/dl57.20 (66.04)54.96 (81.50)

Triglycerides, mean (SD), mg/dl140.37 (71.64)202.16 (132.97)

Uric acid levels, mean (SD), mg/dl6.58 (16.43)6.04 (9.81)

BMI: body mass index; DBP: diastolic blood pressure; HDL: high-density lipoprotein; LDL: low-density lipoprotein; SBP: systolic blood pressure; SD: standard deviation; T1D: type 1 diabetes mellitus; T2D: type 2 diabetes mellitus

In all, 94.2% of patients were living in urban areas, 59.4% had a university or higher education, and a health insurance system covered 80.3%. The median time since T1D diagnosis was 12 years (IQR: 5-19 years). Any diabetes-related complication was recorded in 67 (42.7%) patients, and 37 (23.57%) subjects had two or more complications.

Characteristics of T2D Patients

In this study, 1,809 T2D patients were enrolled (59.8% females and 40.2% males), with a mean age of 58.9 years (SD: 12.15) (median: 59, IQ range: 51-67 years). Mean BMI was 29.12 (SD: 5.38), median 28.34 (IQ range: 25-32, 37.8% with BMI >30) (Table 1). Mean waist circumference was 98.07 cm (SD: 13.45), median 86 cm (IQR: 89-106 cm).

Age, BMI, and waist circumference were significantly higher in T2D patients than in T1D individuals (in all, P < 0.001). In all, 86.9% T2D patients were living in urban areas, 30.7% had a university or higher education, and 80.3% were covered by a health insurance system (compared with that of T1D patients, P = 0.002). The median time since diagnosis of T2D was eight years (IQR: 3-15 years); 956 (52.8%) patients were registered with any diabetes related-complication and 535 (29.57%) with two or more complications.

Management and Achievement of Therapeutic Targets

Among T2D patients, 1,145 (63.3%) received oral glucose-lowering drug (OGLD) treatment alone, 78 (4.3%) received insulin alone, 550 (30.4%) received OGLD + insulin, and 36 (2%) received only diet and exercise.

Among T1D patients these figure numbers were 0%, 77.6%, 27.4% and 0%, respectively. In T2D users of OGLD, 49.9% were receiving only one drug, 37.1% two drugs, and 6.4% more than two. Most T2D patients under OGLD were receiving metformin alone or in combination, while metformin alone was the most common OGLD used in T1D patients (Table 2). The preferred insulin formulation was basal in T2D patients (70.2%), and basal + prandial in T1D subjects (61.2%) (Table 2). Lispro and regular insulin were the preferred prandial formulations for both T1D and T2D patients, whereas glargine and NPH were the most frequently used basal schemes.

Table 2. Treatment characteristics of Mexican patients with diabetes mellitus included in the IDMPS-4w study
VariableT1D
patients
T2D patients
OGLD treatment aloneInsulin treatment aloneOGLD + insulinDiet and exerciseTotal T2DM patients
Class of OGLD treatment, %
Metformin65.721.1027.2022.9

Sulphonylureas5.76.106.506.2

Metformin + sulphonylureas2.947.5042.4046.0

Other25.725.3023.9024.9
Current insulin treatment, %
Basal alone24.3061.071.5070.2

Basal + prandial61.2020.811.8012.9

Others2.0001.301.1

Prandial alone2.005.22.002.4

Premix alone10.5013.013.4013.4
Detail of prandial insulin for basal + prandial scheme, %
Basal + aspart5.4012.59.4010.0

Basal + lispro50.5043.831.3033.8

Basal + regular insulin34.4031.334.4033.8

Basal + glulisine/td>8.6012.525.0022.5<
Detail of basal insulin for basal + prandial scheme, %
Prandial + NPH44.1037.532.8033.8

Prandial + glargine49.5062.557.8058.8

Prandial + detemir5.4009.407.5

Prandial + other basal1.100000

NPH: neutral protamine Hagedorn; OGLD: oral glucose-lowering drugs; T1D: type 1 diabetes mellitus; T2D: type 2 diabetes mellitus

Only 19.7% of T1D and 35.9% of T2D patients had HbA1c <7% (Table 3), and only 5.0% of T1D and 3.9% of T2D met the combined therapeutic target of HbA1c <7% + BP <130/80 mmHg + LDL-cholesterol <100 mg/dl (Table 3). The number of targets met was not different between groups; nonetheless, plasma lipids profile and body mass were, in general, better in T1D than in T2D individuals.

Table 3. Achievement of therapeutic targets in Mexican patients with diabetes mellitus included in the IDMPS-4w registry
VariableT1D patientsT2D patientsp value
Achievement of therapeutic targets, % *
HbA1c <7 %19.735.90.011

Blood pressure <130/80 mmHg59.933.4>0.001

LDL-cholesterol <100 mg/dl50.034.70.032

HbA1c <7 % + BP <130/80 mmHg + LDL <100 mg/dl5.03.90.799

Fasting blood glucose <100 mg/dl23.118.80.487

Total cholesterol <200 mg/dl71.558.80.075

HDL-cholesterol >40 mg/dl in men and >50 mg/dl in women62.941.40.002

Triglycerides <150 mg/dl62.739.6>0.001

BMI <3089.162.20.003

* Pre-specified IDMPS targets. BMI: body mass index; BP: blood pressure; HDL: high-density lipoprotein; LDL: low-density lipoprotein; T1D: type 1 diabetes mellitus; T2D: type 2 diabetes mellitus

The vast majority (96.2%) of T2D patients met criteria for metabolic syndrome according to National Cholesterol Education Program / Adult Treatment Panel (NCEP/ATP)-III criteria, whereas 86.1% met criteria according to the International Diabetes Federation (IDF) definition.

In all, 13.4% of T1D and 6.6% of T2D patients were in a diabetes association or peer support group, 43.9% of T1D patients declared they regularly visit a diabetes-related website, compared with 9.8% of T2D individuals (P < 0.001). Nonetheless, 78.3% and 55% of T1D and T2D, respectively, had received diabetes education, mainly delivered by their treating physicians (67.5% and 72%, respectively). In contrast, only 28% of T1D and 20.6% of T2D individuals were systematic diabetes education program users.

T2D patients treated with insulin more frequently received a formal program of diabetes education (25.5%) than T2D patients on OGLDs alone (18.4%) and more frequently than patients managed with diet and exercise only (5.6%). In the past three months, T2D patients on insulin received more endocrinologist or diabetologist follow-up visits than patients without insulin (mean 0.50 vs. 0.23 visits per month; respectively).

However, insulin-treated patients were not in better glycemic control than those on OGLD or lifestyle modifications only (mean last HbA1c measurement: 8.53% vs. 7.97%; respectively). Compared with subjects treated with lifestyle interventions or OGLDs alone, T2D patients under insulin were similar in age (mean age 58.8 vs. 58.9 years, respectively) but with longer disease duration (mean duration: 15.6 vs. 10.29 years, respectively).

Diabetes-Related Complications

Any late diabetes-related complication was recorded in 42.7% and 52.8% of T1D and T2D, respectively (Table 4, Graphic 1A), mostly microvascular conditions (Graphic 1B). However, the prevalence ≥1 chronic complication was associated with the time elapsed since diabetes diagnosis, so that >60% of T1D and >80% of T2D had at least one late complication, in the group with >20 years since diagnosis (Graphic 2).

Macrovascular complications were more prevalent in T2D than T1D patients, while a non-significant tendency was observed for T1D individuals having more microvascular complications (Graphic 1B). Sensory neuropathy and retinopathy were the most common complications in both groups (Table 4).

Table 4. Late complications in Mexican patients with diabetes mellitus included in the IDMPS-4w registry
Variable
Any late diabetes-related complication
T1D patients
%
T2D patients
%
Sensory neuropathy61.266.1

Retinopathy52.235.5

Proteinuria34.320.1

Microalbuminuria22.420.6

Peripheral vascular disease14.921.0

Dialysis10.43.1

Foot ulcer4.57.7

Angina3.05.8

Heart failure1.54.8

Lower-limb amputation1.53.2

Myocardial infarction0.07.2

History of revascularization0.03.8

Stroke with full recovery0.01.5

Stroke with partial recovery0.01.4

T1D: type 1 diabetes mellitus; T2D: type 2 diabetes mellitus
T1D: type 1 diabetes mellitus; T2D: type 2 diabetes mellitus
DISCUSSION

It is a subject of significant concern that there is still a considerable lag in the proper management of patients with diabetes mellitus in Mexico. In this study, less than half of the patients met any of the main therapeutic targets. Moreover, less than 10% of patients met the combined target of controlled glycemia, blood pressure, and LDL-cholesterol, which contrasts with other countries.17-21 This finding partly explains the very high prevalence of documented late complications in our study.

Another troubling finding was that even when IDMPS included health care providers familiar with insulin therapy11-15, in Mexican T2D patients, this option is reserved for complicated cases in which lifestyle modifications and initial OGLD treatment had failed.

A significant proportion of patients with T1D were receiving OGLD (mainly metformin) combined with insulin. Worryingly, in the present study, the usage of basal and prandial insulin was suboptimal in T1D patients, with sulfonylureas in this population being near 6%.

In high-income nations, a transition towards better practice and quality of care delivered to patients with diabetes19-21 has been observed, but in Mexico, there is still a different scenario.2,10-12

In a significant number of low-income countries, insulin therapy and cardiovascular disease prevention are implemented late, and management of non-glycemic goals is usually reserved for later stages, only after glycemic control is achieved.13-15 However, tight glycemic control has proved beneficial in reducing microvascular but not macrovascular complications.22

The evidence suggests that other precipitating factors for atherothrombosis should be managed optimally, such as plasma lipid profile, lifestyle characteristics, and other pro-inflammation factors.23 A pending scientific issue is the optimal patient profiling allowing the identification of subjects who may benefit the most from tight glycemic control and early insulin therapy, and those who need a different approach.24

The recent experience has proven that in the management of diabetes mellitus, “one size does not fit all”.22

Epidemiologic studies and meta-analyses have clearly shown a direct relationship between HbA1c, microvascular complications and macrovascular disease.25-28 Likewise, results from randomized controlled trials have conclusively demonstrated that the risk of microvascular complications can be reduced with intensive glycemic control in both T1D and T2D patients groups.22 However, these randomized trials failed in demonstrating that stringent glycemic control (i.e., HbA1c <7%) reduces the risk of macrovascular complications.25-27

As stated before, this emphasizes the need for better management of non-glycemic therapeutic goals. Comparable conclusions have been drawn from studies evaluating thigh blood pressure control in patients with diabetes and coronary artery disease at study entry.29 Nevertheless, this should not be interpreted as evidence of benefit from relaxed clinical care, since tight control of other cardiovascular risk factors may delay the occurrence of many complications.30 These findings suggest the necessity of intervention at early stages before irreversible vascular degeneration accumulates.

Here T2D patients treated with insulin were more frequently trained on diabetes than patients on OGLD and more frequently trained than patients managed with diet and exercise only. Within the past three months, T2D patients on insulin received a specialist follow-up visit more often than patients without insulin. Still surprisingly, insulin-treated patients were not in better glycemic control than those on OGLD or lifestyle modifications only. Likewise, T2D patients under insulin had a longer disease duration. This study suggests that insulin is reserved for long-lasting complicated cases.

This study has several limitations that should be addressed. The most important are the lack of follow-up data, as well as the lack of standardized assessments of diabetes-related complications instead of diagnoses performed at the discretion of the treating physicians. Moreover, this study may not be representative of some sectors of the Mexican population (no representation of rural communities and under representation of the public sectors with poor access to current standards of care), such as frequent HbA1c measurements, access to the whole range of antidiabetic medications, as well as access to specialist consultations to diagnose and manage late diabetes complications.

Knowledge is needed for action; hence, these data provide an essential basis for institutional efforts towards improving the management of patients with the most relevant chronic disease in Mexico. Motivation and education improve the attainment of therapeutic goals of patients with diabetes.8,17,23,30

CONCLUSIONS

This study provides real-life experience information on the management and attainment of therapeutic goals of patients with diabetes mellitus living in Mexico. There are essential differences in the achievement of current therapeutic targets between patients with T1D and T2D in Mexico. Only a small proportion of patients met standard therapeutic targets, which parallelizes the increasing morbidity and mortality associated with diabetes in Mexico. Our findings highlight the need for an impending action from the National Health System aimed to change the unfortunate but foreseeable fate of a significant proportion of the Mexican population.

ACKNOWLEDGMENTS

This registry received unrestricted funds from Sanofi. The company designed the study; nonetheless, it did not participate in selection of patients, data capture, data analysis, manuscript draft or the decision to summit for publication. The authors are indebted to all IDMPS-4W collaborators in Mexico (in alphabetic order) as follows:

Acevedo G., Acosta I., Alpízar M., Altamirano E., Álvarez A., Álvarez P., Anaya C., Arellano S., Arreola M., Arroyo A., Arteaga V., Ascensión D., Baeza B., Bancalari C., Baqueiro J., Barón D., Barragán A., Barrientos M., Bastidas M., Bautista J., Beltrán L., Blanco A., Caballero S., Calarco E., Calderón R., Camacho L., Cano R., Caracas N., Cardoso S., Carrillo P., Carvajal M., Casco S., Castañeda R., Castelán F., Castillo O., Cerda I., Cervantes A., Chávez M., Chávez L., Chavira I., Cilia J., Cisneros H., Colín M., Collado E., Colome J., Conrado S., Correa A., Covarrubias M., Cruz E., Dávila O., De la garza N., Del pozo J., Díaz E., Domínguez C., Encinas E., Escalante A., Escalante J., Escalante M., Escudero I., Espinoza J., Estrada A., Estrada K., Fabián M., Fanghanel G., Farjat J., Fernández A., Flores M., Flores V., Franco M., Franco V., Gallardo V., Gamboa F., Garcia H., Garcia J., Garcia L., Garcia J., García P., Garza R., Gomez V., Gonzalez A., Gonzalez G., Gonzalez I., González A., Granillo M., Grover F., Guajardo M., Guerrero J., Gutierrez M., Guzmán J., Guzmán A., Hall J., Hamilton L., Handall V., Hernandez A., Hernandez F., Hernández A., Hernández J., Herrera L., Herrera M., Hinojos L., Ibáñez M., Ibarra A., Ibarra M., Jiménez M., Jurado M., Lavalle F., Lechuga D., Llanas D., Lopez S., López H., López R., Lozano J., Lucio F., Luna R., Macedo N., Macías A., Magallanes F., Maldonado D., Maldonado J., Mancillas L., Mar F., Marquez E., Martínez A., Martínez R., Martínez R., Matildes M., Mauricio G., Mejía A., Mejía J., Mejía L., Mejía M., Mendoza E., Mendoza P., Mercado F., Meza E., Moctezuma J., Moleres J., Monreal R., Montemayor D., Monterrubio N., Montoya J., Mora F., Morales D., Morales F., Morales M., Moreno F., Moreno L., Moreno M., Muñoz A., Muñoz T., Navalles E., Nevares L., Nevarez L., Niño J., Núñez A., Ochoa A., Olmedo V., Ortega A., Osorio D., Ovando R., Parra F., Pascoe S., Pérez C., Pérez H., Pérez N., Quezada M., Radillo P., Rajme V., Ramírez B., Ramírez J., Ramos L., Ramos M., Ríos E., Rivera E., Robles J., Rodriguez H., Rodriguez J., Rodriguez J., Rodriguez J., Rodríguez H., Rodríguez R., Romero A., Rosado C., Rosas M., Rosiles S., Rubio Y., Ruiz D., Ruiz E., Saavedra E., Salas R., Salazar H., Salinas S., Sanchez B., Sanchez H., Sanchez L., Sanchez R., Sanchez S., Sanchez S., Sanchez B., Sandoval R., Sandoval B., Santibáñez M., Seamanduras L., Secchi N., Solís T., Sosa A., Taméz H., Tapia M., Téllez J., Torres J., Torres E., Torres P., Trasviña K., Trejo M., Triano A., Triano M., Uribe A., Vadillo M., Valdez M., Valdovinos S., Valencia H., Vales M., Valladares Z., Vargas M., Vázquez J., Vázquez J., Vázquez J., Vázquez P., Vidrio M., Villanueva S., Wakida H., Yamamoto J., Zamora A., Zayas F.

CONFLICT OF INTEREST

Dr. Fernando Lavalle-González has received research grants from Sanofi; has served as a research advisor for Sanofi, Novo Nordisk and Eli Lilly; and has received speaker honoraria from Sanofi, Novo Nordisk and Eli Lilly. Dr. Maricela Vidrio-Velázquez has received research grants from Sanofi; has served as a research advisor for Sanofi, Novo Nordisk and Eli Lilly; and has received speaker honoraria from Sanofi, Novo Nordisk and Eli Lilly. Dr. Rutila Castañeda-Limones has served as a research advisor for Sanofi, Novo Nordisk and Eli Lilly; and has received speaker honoraria from Sanofi, Novo Nordisk and Eli Lilly. Dr. Paloma Almeda-Valdés has served as a research advisor for Sanofi, Novo Nordisk and Eli Lilly; and has received speaker honoraria from Sanofi, Novo Nordisk and Eli Lilly. Dr. Liz Toapanta-Yanchapaxi has no potential conflicts of interest to declare. Dr. Ana Ochoa-Guzmán has no potential conflicts of interest to declare. Dr. Erwin Chiquete has received research grants from Sanofi and Ferrer Grupo; has served as a research advisor for Sanofi, Novartis, Pfizer, LFB, Grifols, and CSL Behring; and has received speaker honoraria from Sanofi, Novartis, Boehringer-Ingelheim, Asofarma, CSL Behring, and Ferrer Grupo.

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All Rights Reserved® 2019

Latin American Journal of Clinical Sciences and Medical Technology,
Año 1, No. 1, octubre, 2019 es una publicación contínua editada por Vesalio S.C.; http://www.lajclinsci.com/    Editor responsable: Gilberto Castañeda Hernández.    Reserva de Derechos al Uso Exclusivo: 04-2019-062013242000-203; ISSN: 2683-2291; ambos otorgados por el Instituto Nacional del Derecho de Autor.    Responsable de la última actualización de este número, Web Master Hunahpú Velázquez Martínez,
Calle San Luis Potosí #182-1, Col. Roma, Alcaldía Cuauhtémoc, C.P. 06700, Ciudad de México; teléfono: 55 64 40 41    Fecha de última modificación, 30 de marzo de 2020.
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All Rights Reserved® 2019

Latin American Journal of Clinical Sciences and Medical Technology,
Año 1, No. 1, octubre, 2019 es una publicación contínua editada por Vesalio S.C.; http://www.lajclinsci.com/    Editor responsable: Gilberto Castañeda Hernández.    Reserva de Derechos al Uso Exclusivo: 04-2019-062013242000-203; ISSN: 2683-2291; ambos otorgados por el Instituto Nacional del Derecho de Autor.    Responsable de la última actualización de este número, Web Master Hunahpú Velázquez Martínez,
Calle San Luis Potosí #182-1, Col. Roma, Alcaldía Cuauhtémoc, C.P. 06700, Ciudad de México; teléfono: 55 64 40 41    Fecha de última modificación, 30 de marzo de 2020.