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2.
Medicina (Kaunas) ; 58(9)2022 Aug 27.
Article in English | MEDLINE | ID: covidwho-2006132

ABSTRACT

Background and Objectives: Individuals with type 2 diabetes mellitus (T2DM) have an increased risk of cardiovascular disease. Arterial stiffness is an independent prognostic marker for cardiovascular disease development. We aimed at determining the effect of two different sodium-glucose co-transporter-2 (SGLT-2) inhibitors on ambulatory arterial stiffness in individuals with T2DM. Materials and Methods: In this single-center, single-arm, prospective study performed from January 2020 to August 2021, we planned to enroll adult subjects with T2DM and stable antidiabetic and antihypertensive treatment, assigned either to empagliflozin or dapagliflozin for 6 months. All eligible subjects underwent ambulatory blood pressure monitoring. We set as the primary efficacy outcome the change in ambulatory pulse wave velocity (PWV) from baseline to week 24. Results: We finally enrolled 46 diabetic subjects, with a mean age of 62.89 (8.53) years and mean T2DM duration of 9.72 (6.37) years. Thirty patients received dapagliflozin, while sixteen patients received empagliflozin. Due to COVID-19 pandemic restrictive measures during the study, the mean follow-up period extended from 6 months to 9.98 (3.27) months. Regarding the prespecified primary efficacy outcome, we found that the SGLT-2 inhibitor treatment did not have a significant effect on PWV (p = 0.65). Prior history of cardiovascular disease did not significantly affect the observed effects. Other indices of arterial stiffness, such as augmentation index and central pulse pressure, were not significantly affected, neither by empagliflozin nor by dapagliflozin. Conclusions: SGLT-2 inhibitor treatment with empagliflozin or dapagliflozin in subjects with T2DM failed to improve ambulatory PWV over a mean follow-up of 10 months. Registration number: ISRCTN88851713.


Subject(s)
COVID-19 , Cardiovascular Diseases , Diabetes Mellitus, Type 2 , Sodium-Glucose Transporter 2 Inhibitors , Symporters , Vascular Stiffness , Antihypertensive Agents/pharmacology , Benzhydryl Compounds , Blood Pressure Monitoring, Ambulatory , Cardiovascular Diseases/chemically induced , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/drug therapy , Glucose , Glucosides , Humans , Hypoglycemic Agents/adverse effects , Middle Aged , Morbidity , Pandemics , Prospective Studies , Pulse Wave Analysis , Sodium , Sodium-Glucose Transporter 2 Inhibitors/adverse effects , Symporters/pharmacology , Treatment Outcome
3.
J Hypertens ; 40(Suppl 1): e188, 2022 Jun 01.
Article in English | MEDLINE | ID: covidwho-1937751

ABSTRACT

OBJECTIVE: Cardiovascular disease remains the leading cause of mortality among patients with type 2 diabetes mellitus (T2DM). Sodium-glucose co-transporter-2 (SGLT-2) inhibitors is a new class of antidiabetics, conferring a significant cardiovascular risk reduction. However, underlying mechanisms are not fully understood. Right ventricular (RV) function is adversely affected early in the course of diabetes. Herein we sought to determine the effect of long-term use of SGLT-2 inhibitors on RV function. DESIGN AND METHOD: In this pilot, observational study, we enrolled 20 patients with T2DM and stable antidiabetic and antihypertensive treatment over the last 6 months. Patients were planned to undergo a thorough echocardiographic assessment of RV function twice, before and 6 months after initiation of a SGLT-2 inhibitor. We set as primary efficacy outcome the change in tricuspid annular plane systolic excursion (TAPSE). RESULTS: Mean age of participants was 62.8 ± 7.9 years, with a mean T2DM duration of 8.7 ± 6.1 years. Thirteen subjects were administered dapagliflozin, while the rest 7 were prescribed empagliflozin. Due to special regulations imposed in the context of coronavirus disease-19 (COVID-19) pandemic, mean treatment duration and follow-up period was 9.35 ± 3.4 months. SGLT-2 inhibitors led to a significant increase in TAPSE from 2.01 ± 0.23 to 2.12 ± 0.15 cm (p = 0.022). The result was significant for dapagliflozin (p = 0.015), while administration of empagliflozin resulted in a non-significant increase in TAPSE (p = 0.28). However, no significant difference between the two SGLT-2 inhibitors was shown (p = 0.7). Change in TAPSE was significant in subjects with prior history of cardiovascular disease (p = 0.024), while it was non-significant for subjects without previous cardiovascular disease (p = 0.26). Other parameters of RV function or RV dimensions were unchanged. CONCLUSIONS: This is the first study to assess the effect of long-term treatment with SGLT-2 inhibitors on RV function in subjects with T2DM, demonstrating a significant increase in TAPSE.

8.
Clin Rheumatol ; 40(11): 4671-4674, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1371359

ABSTRACT

Coronavirus disease-2019 (COVID-19) represents a global public health nightmare. The "cytokine storm," the most prominent underlying pathophysiologic mechanism of this disease, can theoretically be targeted at several stages. Janus kinase (JAK) inhibitors constitute a drug class that could ameliorate the inflammatory response and enhance antibody production. Herein, we aimed to evaluate the efficacy of JAK inhibitors in patients with COVID-19, performing the most updated relevant meta-analysis. We searched two major databases for randomized controlled trials (RCTs) enrolling adult patients with documented COVID-19 in the in-hospital setting, assigned either to JAK inhibitor treatment plus standard of care or standard of care alone. We set as primary efficacy outcome the endpoint of COVID-19 death on day 28 and as secondary efficacy composite outcome that of mechanical ventilation or initiation of extracorporeal membrane oxygenation (ECMO). We finally pooled data of interest from 4 RCTs in a total of 1338 subjects with documented COVID-19 infection, utilizing the following JAK inhibitors: baricitinib, ruxolitinib, tofacitinib, and nezulcitinib. Treatment with JAK inhibitor compared to control resulted in a significant reduction in the risk for COVID-19 death by 43%, while it also led to a significant decrease in the risk for mechanical ventilation or ECMO initiation by 36%. Herein, we demonstrate a clear benefit with JAK inhibitors added to standard of care in patients with COVID-19 in terms of risk reduction concerning major outcomes. Larger RCTs will elucidate their place in treatment armamentarium against COVID-19.


Subject(s)
COVID-19 , Janus Kinase Inhibitors , Humans , Janus Kinase Inhibitors/therapeutic use , Protein Kinase Inhibitors/therapeutic use , Randomized Controlled Trials as Topic , SARS-CoV-2
10.
JMIR Mhealth Uhealth ; 9(4): e24271, 2021 04 13.
Article in English | MEDLINE | ID: covidwho-1181293

ABSTRACT

BACKGROUND: Heart failure (HF) remains a major public health challenge, while HF self-care is particularly challenging. Mobile health (mHealth)-based interventions taking advantage of smartphone technology have shown particular promise in increasing the quality of self-care among these patients, and in turn improving the outcomes of their disease. OBJECTIVE: The objective of this study was to co-develop with physicians, patients with HF, and their caregivers a patient-oriented mHealth app, perform usability assessment, and investigate its effect on the quality of life of patients with HF and rate of hospitalizations in a pilot study. METHODS: The development of an mHealth app (The Hellenic Educational Self-care and Support Heart Failure app [ThessHF app]) was evidence based, including features based on previous clinically tested mHealth interventions and selected by a panel of HF expert physicians and discussed with patients with HF. At the end of alpha development, the app was rated by mHealth experts with the Mobile Application Rating Scale (MARS). The beta version was tested by patients with HF, who rated its design and content by means of the Post-Study System Usability Questionnaire (PSSUQ). Subsequently, a prospective pilot study (THESS-HF [THe Effect of a Specialized Smartphone app on Heart Failure patients' quality of self-care, quality of life and hospitalization rate]) was performed to investigate the effect of app use on patients with HF over a 3-month follow-up period. The primary endpoint was patients' quality of life, which was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the 5-level EQ-5D version (EQ-5D-5L). The secondary endpoints were the European Heart Failure Self-care Behavior Scale (EHFScBS) score and the hospitalization rate. RESULTS: A systematic review of mHealth-based HF interventions and expert panel suggestions yielded 18 separate app features, most of which were incorporated into the ThessHF app. A total of 14 patients and 5 mHealth experts evaluated the app. The results demonstrated a very good user experience (overall PSSUQ score 2.37 [SD 0.63], where 1 is the best, and a median MARS score of 4.55/5). Finally, 30 patients (male: n=26, 87%) participated in the THESS-HF pilot study (mean age 68.7 [SD 12.4] years). A significant increase in the quality of self-care was noted according to the EHFScBS, which increased by 4.4% (SD 7.2%) (P=.002). The mean quality of life increased nonsignificantly after 3 months according to both KCCQ (mean increase 5.8 [SD 15] points, P=.054) and EQ-5D-5L (mean increase 5.6% [SD 15.6%], P=.06) scores. The hospitalization rate for the follow-up duration was 3%. CONCLUSIONS: The need for telehealth services and remote self-care management in HF is of vital importance, especially in periods such as the COVID-19 pandemic. We developed a user-friendly mHealth app to promote remote self-care support in HF. In this pilot study, the use of the ThessHF app was associated with an increase in the quality of self-care. A future multicenter study will investigate the effect of the app use on long-term outcomes in patients with HF.


Subject(s)
COVID-19 , Heart Failure , Mobile Applications , Aged , Heart Failure/diagnosis , Heart Failure/therapy , Humans , Male , Multicenter Studies as Topic , Pandemics , Pilot Projects , Prospective Studies , Quality of Life , SARS-CoV-2 , User-Computer Interface
15.
SN Compr Clin Med ; 2(9): 1419-1429, 2020.
Article in English | MEDLINE | ID: covidwho-692464

ABSTRACT

Coronavirus disease-19 (COVID-19) may result in serious complications involving several organ systems, including myocardial tissue. An exaggerated host inflammatory response, described as a cytokine storm, has been linked to play a major role in these complications. Colchicine and other pharmaceutical agents have been proposed to counter the cytokine storm and improve outcomes. In this exploratory review, we utilized a PubMed and Cochrane Database search aiming to identify the biochemical characteristics of the cytokine storm as well as to identify the potential effect of colchicine on these inflammatory biomarkers. The research yielded 30 reports describing the characteristics of the cytokine storm and 44 reports describing the effect of colchicine on various inflammatory biomarkers. According to our research, colchicine may be an agent of interest in the treatment of COVID-19 via its anti-inflammatory properties. However, there are potential drug interactions with cytochrome P450 3A4 inhibitors resulting in acute colchicine toxicities. Additionally, there is scarce evidence regarding the efficacy of colchicine in the acute phase of disease, since most trials evaluated its effect in chronic conditions. In this direction, our team proposes three different hypotheses for evaluating the place of colchicine in the treatment of COVID-19.

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