94-LB: Long-Term Clinical Benefits of Early Combination Approach in Latin American Subpopulation of VERIFY Study

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 94-LB
Author(s):  
SERGIO VENCIO ◽  
JUAN MANOSALVA ◽  
CHANTAL MATHIEU ◽  
PIETER PROOT ◽  
PAIVI M. PALDANIUS
Keyword(s):  
Latin American ◽  
Clinical Benefits ◽  
Combination Approach

scholarly journals Exploring early combination strategy in Latin American patients with newly diagnosed type 2 diabetes: a sub-analysis of the VERIFY study

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Sérgio Vencio ◽  
Juan P. Manosalva ◽  
Chantal Mathieu ◽  
Pieter Proot ◽  
Hernan Yupanqui Lozno ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Latin American ◽  
Primary Endpoint ◽  
Standard Of Care ◽  
Newly Diagnosed ◽  
Combination Strategy ◽  
Treatment Approaches ◽  
Clinical Benefits

Abstract Background Patients with type 2 diabetes mellitus (T2DM) from Latin American countries face challenges in access to healthcare, leading to under-diagnosis, under-achievement of glycemic target, and long-term complications. Early diagnosis and treatment initiation are of paramount importance in this population due to the high prevalence of risk factors such as obesity and metabolic syndrome. The VERIFY study in patients with newly diagnosed T2DM (across 34 countries), assessed the normoglycemic durability (5 years), with early combination (EC) therapy approach versus the traditional stepwise approach of initiating treatment with metformin monotherapy (MET). Here we present the results from the VERIFY study for participants from eight countries in Latin America. Methods Newly diagnosed adult patients with T2DM, HbA1c 6.5–7.5% and body-mass index (BMI) of 22–40 kg/m2 were enrolled. The primary endpoint was time to initial treatment failure (TF; HbA1c ≥ 7.0% at two consecutive scheduled visits 13 weeks apart). Time to second TF was evaluated when patients in both groups were receiving and failing on the vildagliptin combination. Safety and tolerability were also assessed for both treatment approaches during the study. Results A total of 537 eligible patients (female, 58.8%) were randomly assigned to receive either EC (n = 266) or MET (n = 271). EC significantly reduced the relative risk of time to initial TF by 47% versus MET [HR (95% CI) 0.53 (0.4, 0.7) p < 0.0001]. Overall, 46.4% versus 66.3% of patients achieved the primary endpoint in the EC and MET groups, with a median [interquartile range (IQR)] time to TF of 59.8 (27.5, not evaluable) and 33.4 (12.2, 60.1) months, respectively. The risk for time to second TF was 31% lower with EC (p < 0.0092). A higher proportion of patients receiving EC maintained durable HbA1c < 7.0%, < 6.5%, and < 6.0%. Both treatment approaches were well tolerated, and only 3.2% of participants discontinued the study due to adverse events. All hypoglycemic events (EC: n = 7 and MET: n = 3) were single, mild episodes and did not lead to study discontinuation. Conclusion Similar to the global population, long-term clinical benefits were achieved more frequently and without tolerability issues with EC versus standard-of-care MET in this Latin American sub-population. This study is registered with ClinicalTrials.gov, NCT01528254.

scholarly journals Exploring Early Combination Strategy in Latin American Patients With Newly Diagnosed Type 2 Diabetes: A Sub-analysis of the VERIFY Study 

2021 ◽  
Author(s):  
Sergio Vencio ◽  
Juan P Manosalva ◽  
Chantal Mathieu ◽  
Pieter Proot ◽  
Hernan Yupanqui Lozno ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Latin American ◽  
Primary Endpoint ◽  
Standard Of Care ◽  
Newly Diagnosed ◽  
Combination Strategy ◽  
Treatment Approaches ◽  
Clinical Benefits

Abstract Background: Patients with type 2 diabetes mellitus (T2DM) from Latin American countries face challenges in access to healthcare, leading to under-diagnosis, under-achievement of glycemic target, and long-term complications. Early diagnosis and treatment initiation are of paramount importance in this population due to the high prevalence of risk factors such as obesity and metabolic syndrome. The VERIFY study in patients with newly diagnosed T2DM (across 34 countries), assessed the normoglycemic durability (5 years), with early combination (EC) therapy approach versus the traditional stepwise approach of initiating treatment with metformin monotherapy (MET). Here we present the results from the VERIFY study for participants from eight countries in Latin America. Methods: Newly diagnosed adult patients with T2DM, HbA1c 6.5%–7.5% and body-mass index (BMI) of 22–40 kg/m² were enrolled. The primary endpoint was time to initial treatment failure (TF; HbA1c ≥7.0% at two consecutive scheduled visits 13 weeks apart). Time to second TF was evaluated when patients in both groups were receiving and failing on the vildagliptin combination. Safety and tolerability were also assessed for both treatment approaches during the study.Results: A total of 537 eligible patients (female, 58.8%) were randomly assigned to receive either EC (n=266) or MET (n=271). EC significantly reduced the relative risk of time to initial TF by 47% versus MET (HR [95% CI] 0.53 [0.4, 0.7]; p<0.0001). Overall, 46.4% versus 66.3% of patients achieved the primary endpoint in the EC and MET groups, with a median (interquartile range [IQR]) time to TF of 59.8 (27.5, not evaluable) and 33.4 (12.2, 60.1) months, respectively. The risk for time to second TF was 31% lower with EC (p<0.0092). A higher proportion of patients receiving EC maintained durable HbA1c <7.0%, <6.5%, and <6.0%. Both treatment approaches were well tolerated, and only 3.2% of participants discontinued the study due to adverse events. All hypoglycemic events (EC: n=7 and MET: n=3) were single, mild episodes and did not lead to study discontinuation. Conclusion: Similar to the global population, long-term clinical benefits were achieved more frequently and without tolerability issues with EC versus standard-of-care MET in this Latin American sub-population.This study is registered with ClinicalTrials.gov, NCT01528254.

Nesting Expectations: What Can the Mexican and Argentinean Cash Transfers Tell Us about the Development of Development?

1969 ◽  
Vol 59 (1) ◽  
pp. 157-169
Author(s):  
Andrés Dapuez
Keyword(s):  
Latin America ◽  
Latin American ◽  
A Priori ◽  
Cash Transfers ◽  
Conditional Cash Transfers ◽  
Cash Transfer ◽  
Short Term ◽  
Transfer Programs

Latin American cash transfer programs have been implemented aiming at particular anticipatory scenarios. Given that the fulfillment of cash transfer objectives can be calculated neither empirically nor rationally a priori, I analyse these programs in this article using the concept of an “imaginary future.” I posit that cash transfer implementers in Latin America have entertained three main fictional expectations: social pacification in the short term, market inclusion in the long term, and the construction of a more distributive society in the very long term. I classify and date these developing expectations into three waves of conditional cash transfers implementation.

scholarly journals Gene therapy for Wiskott-Aldrich Syndrome—Long-term reconstitution and clinical benefits, but increased risk for leukemogenesis

Rare Diseases ◽  
2014 ◽  
Vol 2 (1) ◽  
pp. e947749 ◽  
Author(s):  
Christian Joerg Braun ◽  
Maximilian Witzel ◽  
Anna Paruzynski ◽  
Kaan Boztug ◽  
Christof von Kalle ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Wiskott Aldrich Syndrome ◽  
Increased Risk ◽  
Clinical Benefits

scholarly journals Reframing political violence and mental health outcomes: outlining a research and action agenda for Latin America and the Caribbean region

2006 ◽  
Vol 11 (2) ◽  
pp. 293-302 ◽  
Author(s):  
Duncan Pedersen
Keyword(s):  
Mental Health ◽  
Health Outcomes ◽  
Political Violence ◽  
Latin American ◽  
Mental Health Outcomes ◽  
Guerrilla Warfare ◽  
Caribbean Region ◽  
Post Conflict ◽  
Forms Of Violence

In recent decades, the number of people exposed to traumatic events has significantly increased as various forms of violence, including war and political upheaval, engulf civilian populations worldwide. In spite of widespread armed conflict, guerrilla warfare and political violence in the Latin American and Caribbean region, insufficient attention had been paid in assessing the medium and long-term psychological impact and additional burden of disease, death, and disability caused by violence and wars amongst civilian populations. Following a review of the literature, a few central questions are raised: What is the short, medium and long-term health impact of extreme and sustained forms of violence in a given population? How political violence is linked to poor mental health outcomes at the individual and collective levels? Are trauma-related disorders, universal outcomes of extreme and sustained violence? These questions lead us to reframe the analysis of political violence and mental health outcomes, and reexamine the notions of trauma, after which a research and action agenda for the region is outlined. In the concluding sections, some basic principles that may prove useful when designing psychosocial interventions in post-conflict situations are reviewed.

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