scholarly journals Composite cardiovascular risk and BMI affected comparative profiles of BIAsp 30 + metformin vs BIAsp 30 monotherapy: a MERIT post-hoc analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lixin Guo ◽  
Baocheng Chang ◽  
Li Chen ◽  
Liyong Yang ◽  
Yu Liu ◽  
...  
Keyword(s):  
Cardiovascular Risk ◽  
High Risk ◽  
Safety Profile ◽  
Efficacy And Safety ◽  
Composite Target ◽  
Post Hoc Analysis ◽  
High Risk Patients ◽  
Risk Patients ◽  
Hba1c Target ◽  
Post Hoc

AbstractWe assessed whether comparative efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) plus metformin versus BIAsp 30 monotherapy differed for patients with type 2 diabetes mellitus (T2DM) inadequately controlled with oral antidiabetic drugs with different cardiovascular risk scores and different body mass indexes (BMI) by performing a post hoc analysis of the randomized controlled MERIT study. In the MERIT study, eligible patients were randomized 1:1 to receive BIAsp 30 plus metformin or BIAsp 30 for 16 weeks. Patients in the 2 treatment groups were classified into “low” and “high” risk subgroups based on their GloboRisk scores and into “BMI ≤ 26 kg/m2”and “BMI > 26 kg/m2” subgroups. Primary efficacy endpoint was between-treatments comparison of HbA1c changes from baseline for these 2 sets of subgroups. Between-treatments comparisons of secondary efficacy and safety endpoints were also performed. We found that BIAsp 30 plus metformin led to significantly higher percentage of high-risk patients achieving HbA1c target < 7% than BIAsp 30 monotherapy, with an overall comparable safety profile for high-risk patients. Meanwhile, for patients with BMI ≤ 26 kg/m2, compared with BIAsp 30 monotherapy, BIAsp 30 plus metformin led to significantly higher percentages of patients achieving HbA1c target (47.83% vs 28.17%, P = 0.0165) and composite target of HbA1c < 7% without hypoglycemia or weight gain (20.29% vs 6.85%, P = 0.0187) and have a slightly better safety profile. In conclusion, for T2DM patients at high CV risk or with BMI ≤ 26 kg/m2, BIAsp 30 plus metformin was preferable to BIAsp 30 monotherapy.

scholarly journals The role of idecabtagene vicleucel in patients with heavily pretreated refractory multiple myeloma

2021 ◽  
Vol 12 ◽  
pp. 204062072110196
Author(s):  
Albert Oriol ◽  
Laura Abril ◽  
Anna Torrent ◽  
Gladys Ibarra ◽  
Josep-Maria Ribera
Keyword(s):  
Multiple Myeloma ◽  
High Risk ◽  
Safety Profile ◽  
Proteasome Inhibitors ◽  
Clinical Development ◽  
Phase Iii ◽  
Acceptable Safety Profile ◽  
Refractory Multiple Myeloma ◽  
High Risk Patients ◽  
Risk Patients

The development of several treatment options over the last 2 decades has led to a notable improvement in the survival of patients with multiple myeloma. Despite these advances, the disease remains incurable for most patients. Moreover, standard combinations of alkylating agents, immunomodulatory drugs, proteasome inhibitors, and monoclonal antibodies targeting CD38 and corticoids are exhausted relatively fast in a proportion of high-risk patients. Such high-risk patients account for over 20% of cases and currently represent a major unmet medical need. The challenge of drug resistance requires the development of highly active new agents with a radically different mechanism of action. Several immunotherapeutic modalities, including antibody–drug conjugates and T-cell engagers, appear to be promising choices for patients who develop resistance to standard combinations. Chimeric antigen-receptor-modified T cells (CAR-Ts) targeting B-cell maturation antigen have demonstrated encouraging efficacy and an acceptable safety profile compared with alternative options. Multiple CAR-Ts are in early stages of clinical development, but the first phase III trials with CAR-Ts are ongoing for two of them. After the recent publication of the results of a phase II trial confirming a notable efficacy and acceptable safety profile, idecabtagene vicleucel is the first CAR-T to gain regulatory US Food and Drug Administration approval to treat refractory multiple myeloma patients who have already been exposed to antibodies against CD38, proteasome inhibitors, and immunomodulatory agents and who are refractory to the last therapy. Here, we will discuss the preclinical and clinical development of idecabtagene vicleucel and its future role in the changing treatment landscape of relapsed and refractory multiple myeloma.

scholarly journals Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients

2017 ◽  
Vol 376 (16) ◽  
pp. 1527-1539 ◽  
Author(s):  
Paul M Ridker ◽  
James Revkin ◽  
Pierre Amarenco ◽  
Robert Brunell ◽  
Madelyn Curto ◽  
...  
Keyword(s):  
High Risk ◽  
Efficacy And Safety ◽  
High Risk Patients ◽  
Risk Patients

Cardiovascular risk assessment in diabetes and pre-diabetes

ESC CardioMed ◽  
2018 ◽  
pp. 923-924
Author(s):  
Nikolaus Marx
Keyword(s):  
Risk Assessment ◽  
Cardiovascular Risk ◽  
High Risk ◽  
Target Organ Damage ◽  
Risk Scores ◽  
High Risk Patients ◽  
Patients With Diabetes ◽  
Risk Patients ◽  
Artery Disease ◽  
Very High

Patients with diabetes exhibit an increased propensity to develop cardiovascular disease with an increased mortality. Early risk assessment, especially for coronary artery disease, is important to initiate therapeutic strategies to reduce cardiovascular risk. This chapter reviews the current literature on risk scores in patients with type 1 and type 2 diabetes and summarizes the role of risk assessment based on biomarkers and different imaging strategies. Current guidelines recommend that patients with diabetes are characterized as high-risk or very high-risk patients. In the presence of target organ damage or other risk factors such as smoking, marked hypercholesterolaemia, or hypertension, patients with diabetes are classified as very high-risk patients while most other people with diabetes are categorized as high-risk patients.

Flow-mediated dilatation (FMD) and prevalence of cardiovascular risk factors: the value of FMD assessment in high risk patients is limited

2014 ◽  
pp. 254-261 ◽  
Author(s):  
Katarzyna Mizia-Stec ◽  
Joanna Wieczorek ◽  
Michał Orszulak ◽  
Magdalena Mizia ◽  
Klaudia Gieszczyk-Strózik ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cardiovascular Risk ◽  
High Risk ◽  
Cardiovascular Risk Factors ◽  
High Risk Patients ◽  
Flow Mediated Dilatation ◽  
Risk Patients
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