Large scale application of the Finnish diabetes risk score in Latin American and Caribbean populations: a descriptive study.

Background: The prevalence of type 2 diabetes (T2D) continues to increase in the Americas. Identifying people at risk for T2D is critical to the prevention of T2D complications, especially cardiovascular disease. This study gauges the ability to implement large population-based organized screening campaigns in 19 Latin American and Caribbean countries to detect people at risk for T2D using the Finnish Diabetes Risk Score (FINDRISC). Methods: This cross-sectional descriptive analysis uses data collected in a sample of men and women 18 years of age or older who completed FINDRISC via eHealth during a Guinness World Record attempt campaign between October 25 and November 1, 2021. FINDRISC is a non-invasive screening tool based on age, body mass index, waist circumference, physical activity, daily intake of fruits and vegetables, history of hyperglycemia, history of antihypertensive drug treatment, and family history of T2D, assigning a score ranging from 0 to 26 points. A cut-off point of ≥ 12 points was considered as high risk for T2D. Results: The final sample size consisted of 29,662 women (63%) and 17,605 men (27%). In total, 35% of subjects were at risk of T2D. The highest frequency rates (FINDRISC ≥ 12) were observed in Chile (39%), Central America (36.4%), and Peru (36.1%). Chile also had the highest proportion of people having a FINDRISC ≥15 points (25%), whereas the lowest was observed in Colombia (11.3%). Conclusions: FINDRISC can be easily implemented via eHealth technology over social networks in Latin American and Caribbean populations to detect people with high risk for T2D. Primary healthcare strategies are needed to perform T2D organized screening to deliver early, accessible, culturally sensitive, and sustainable interventions to prevent sequelae of T2D, and reduce the clinical and economic burden of cardiometabolic-based chronic disease.

Evaluating the TUITEK® patient support program in supporting caregivers of children diagnosed with growth hormone deficiency in Argentina.

Introduction: The appropriate use of recombinant human growth hormone (r-hGH) treatment provides an opportunity to improve growth outcomes among pediatric patients with growth hormone deficiency (GHD). However, a major challenge in clinical practice is to adequately recognize and address factors that negatively affect treatment adherence. TUITEK® patient support program (PSP) was designed to help caregivers of children diagnosed with GHD to personalize the care pathway, improve adherence, and achieve better outcomes. Effectiveness of TUITEK® PSP has been demonstrated previously in a smaller sample (n = 31) in Taiwanese population. Here, we present the results from Argentina. Methods: TUITEK® PSP was piloted among 76 caregivers of children with GHD administering r-hGH using easypod™ (Merck KGaA, Darmstadt, Germany) auto-injector device in Argentina. Based on TUITEK® personalization questionnaire, caregivers were assigned to high- and low-risk groups across four categories that may influence adherence, including disease and treatment coherence (DTC), self-administration (SA), treatment-related anxiety (TRA), and emotional burden (EB). The caregivers who were included in atleast one high-risk group had the provision of telephone calls with a nurse practitioner every 2 weeks for 3 months. The Wilcoxon signed-rank test was employed to assess changes in questionnaire-based scoring patterns between baseline and follow-up evaluations. Results: Statistically significant changes (p < 0.05) in questionnaire scores between baseline and follow-up evaluations were observed across the four categories. The mean/median DTC (n = 11) and SA (n = 23) scores changed from 2.45/3 and 2.17/2, respectively, to 4/4, with all the caregivers moving to low-risk group following program completion (100%) for both categories. The mean/median TRA score (n = 40) changed from 3.58/3 to 2.5/2 and 67.5% of patients (27/40) moved to low-risk group. The mean/median EB score (n = 32) changed from 3.69/3 to 3.13/3 however, none of the caregivers moved to low-risk group (0%). Conclusion: TUITEK® PSP is a simple, practical, and time-efficient interventional tool that can be used to address key adherence-related issues among caregivers of children with GHD and provide personalized adherence support. Our findings demonstrate that TUITEK® PSP has the potential to improve treatment adherence and self-management, thereby improving growth outcomes in Argentina.

Adherence to Growth Hormone Treatment Using a Connected Device in Latin America: Real-World Exploratory Descriptive Analysis Study.

BACKGROUND: Recombinant human growth hormone (rhGH) therapy is an effective treatment for children with growth disorders. However, poor outcomes are often associated with suboptimal adherence to treatment. OBJECTIVE: The easypod connected injection device records and transmits injection settings and dose data from patients receiving rhGH. In this study, we evaluated adherence to rhGH treatment, and associated growth outcomes, in Latin American patients. METHODS: Adherence and growth data from patients aged 2-18 years from 12 Latin American countries were analyzed. Adherence data were available for 6207 patients with 2,449,879 injections, and growth data were available for 497 patients with 2232 measurements. Adherence was categorized, based on milligrams of rhGH injected versus milligrams of rhGH prescribed, as high (≥85%), intermediate (>56%-<85%), or low (≤56%). Transmission frequency was categorized as high (≥1 per 3 months) or low (<1 per 3 months). Chi-square tests were applied to study the effect of pubertal status at treatment start and sex on high adherence, and to test differences in frequency transmission between the three adherence levels. Multilevel linear regression techniques were applied to study the effect of adherence on observed change in height standard deviation score (∆HSDS). RESULTS: Overall, 68% (4213/6207), 25% (n=1574), and 7% (n=420) of patients had high, intermediate, and low adherence, respectively. Pubertal status at treatment start and sex did not have a significant effect on high adherence. Significant differences were found in the proportion of patients with high transmission frequency between high (2018/3404, 59%), intermediate (608/1331, 46%), and low (123/351, 35%) adherence groups (P<.001). Adherence level had a significant effect on ∆HSDS (P=.006). Mean catch-up growth between 0-24 months was +0.65 SD overall (+0.52 SD in patients with low/intermediate monthly adherence and +0.69 SD in patients with high monthly adherence). This difference translated into 1.1 cm greater catch-up growth with high adherence. CONCLUSIONS: The data extracted from the easypod Connect ecosystem showed high adherence to rhGH treatment in Latin American patients, with positive growth outcomes, indicating the importance of connected device solutions for rhGH treatment in patients with growth disorders.

Positive Impact of Targeted Educational Intervention in Children With Low Adherence to Growth Hormone Treatment Identified by Use of the Easypod™ Electronic Auto-injector Device.

Background: It is important to identify patients with low adherence to recombinant human growth hormone (r-hGH) therapy and initiate actions to improve adherence. The Merck Patient Support Program (PSP) aims to raise the awareness of these patients and their parents of the importance of good adherence in achieving optimal growth outcomes. The easypod™ digitally-enhanced injection device provides accurate, reliable adherence data for the PSP by recording the exact dose, time and date of injections given. In this study, we aimed to measure the effect of an educational intervention on adherence in patients using the easypod™ device to deliver their r-GH therapy. Methods: This was a 12-month observational, retrospective cohort study. Patients previously identified by data recorded from their easypod™ injection device as having low adherence (<80%) were followed over the 6 months before and after a targeted educational visit by a PSP nurse. Patient adherence and demographic data were extracted from the PSP database. Statistical analyzes were carried out with STATA 15.0 software. Results: Data from 80 patients (65% male) with low adherence were analyzed. Patients were aged 2-18 (mean: 11.77) years with diagnoses of growth hormone deficiency (71.25%), small for gestational age (20%), Turner syndrome (7.50%) and chronic renal disease (1.25%). Duration of treatment was 0.40-11.13 (median: 3.62) years. At baseline, median adherence to r-hGH therapy was 67%; after the intervention it increased to 76%, a statistically significant median improvement of 9% (p = 0.0000, Wilcoxon signed-rank test). Additionally, 36% (29/80) of patients increased their adherence to r-hGH therapy to 'good' (≥80%). Both changes were clinically relevant. Conclusions: We conclude that a nurse-led educational intervention, supported by digital medication adherence monitoring, is a simple method to improve adherence to r-hGH therapy, and recommend this intervention to reduce the gap between the indication/recommendation of the specialist and patients' behavior.

Comparative bioavailability of 2 tablet formulations of levodopa/benserazide in healthy, fasting volunteers: a single-dose, randomized-sequence, open-label crossover study.

BACKGROUND: Currently, levodopa administered with decarboxylase inhibitors is the gold standard for the management of the motor symptoms of Parkinson's disease, a neurodegenerative disorder characterized by the degeneration of dopaminergic neurons in the substantia nigra pars compacta. In Argentina, only 1 commercial product is available with such composition; this study was contracted by the manufacturer to comply with new generic product regulations. OBJECTIVE: The aim of this study was to evaluate the fasting bioavailability of a new generic formulation of levodopa 200 mg/benserazide 50 mg tablets (test) and compare this generic formulation with the branded formulation (reference) to meet regulatory criteria for marketing the test product in Argentina. METHODS: A randomized-sequence, open-label, 2-period, crossover study was conducted between August and October 2009 in healthy Caucasian volunteers (n = 24; 18 males, aged 21 to 42 years, with a body mass index ranging from 19.7 to 26.0 kg/m(2)) in the fasted state. A single oral dose of the test or reference formulation was administered, and after a 7-day washout period, the other formulation was given. Blood samples were collected at baseline and at 10, 20, 30, 40, 50, 60, 70, 80, 90, and 105 minutes and 2, 2.5, 3, 3.5, 4, and 6 hours after dosing. Levodopa plasma concentrations were measured by high-performance liquid chromatography with electrochemical detection, without stereo-specificity assessment. The formulations were considered bioequivalent if the 90% CI of the geometric mean ratios (test/reference) for the C(max) and AUC(0-t) of levodopa were within the 0.8 to 1.25 range. Adverse events were monitored throughout the study, based on clinical parameters and patient reports. RESULTS: The geometric means (90% CI) of the C(max) for the test and reference formulations were 2462.02 (2312.06-3492.40) and 2542.85 (2394.49-3231.29) ng/mL, respectively; the AUC(0-t) was 3878.04 (3623.88-5393.09) and 3972.10 (3765.88-5393.02) ng/mL/h, respectively; and the AUC(0-∞)was 4610.37 (4315.71-6315.70) and 4728.96 (4502.17-6828.26) ng/mL/h, respectively. There were no significant differences in pharmacokinetic parameters between the 2 formulations. The test:reference ratios for C(max), AUC(0-t), and AUC(0-∞) were 96.82% (90% CI, 83.87-111.77), 97.63% (90% CI, 85.95-110.91), and 97.49% (90% CI, 84.09-113.02), respectively. No clinically significant adverse events were reported; this finding is probably the result of subjects not believing that their side effects were severe enough to be reported and not because of a genuine and absolute lack of predictable side effects. CONCLUSIONS: In this single-dose study, the test formulation of levodopa/benserazide tablets met the Argentinean criterion for bioequivalence to the reference formulation. (www.clinicaltrials.gov: NCT01327261).