Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD)

Abstract Funding Acknowledgements Type of funding sources: None. Introduction. Polyprenols (natural isoprenoid lipids) are precursors of dolichols which is present in every cell and involved in a dolicholphosphate pathway. It seems the polyprenols from plants can be used for a substitution therapy in dolicholphosphate pathway disorders. There is one polyprenol-containing drug in Russia – Ropren® which contains polyprenols isolated by the original method from needles of European spruce. In clinical trials hepatoprotective, hypolipidemic effects of Ropren® in patients with liver pathology and positive effect in alcoholic psychosis and Alzheimer"s disease were founded. Considering that the myocardial infarction is often accompanied by the phenomena of anxiety, depression and decreased cognitive functions that impair prognosis of the disease the search for a drug aimed at reducing the expression of these conditions is relevant. Purpose. To study the effects of Ropren® on anxiety-depressive condition and cognitive functions in patients with acute coronary syndrome. Methods. Our registered single-center, randomized, double-blind, placebo-controlled trial "POLYNCOR" were included patients (n = 68) with acute coronary syndrome hospitalized on the first day from the beginning of the symptoms. All patients received standard therapy (including atorvastatin 40 mg) and were randomized on 2 groups: the 1st group (n = 34) received Ropren® 8 drops during а meal 3 times a day (144 mg/day) for 3 weeks then 3 drops 3 times a day (90 mg/day) for 5 weeks; the 2nd group 2 (n = 34) received placebo with the same dosage regimen. On the 3rd, 10th days of hospitalization and after 2 months of therapy the following parameters were analyzed: the level of depression on the CES-D scale, anxiety on the Taylor and Sheehan scales, cognitive functions were assessed on the Montreal Cognitive Assessment Scale (MoCA). Statistical data processing was performed using the Statistica v.10.0 package using nonparametric analysis methods. The results are presented as Me (Q1; Q3). Results. At discharge there were no differences between groups and the majority of the patients had signs of anxiety, depression and decreased cognitive functions. After 2 months of therapy comparing with the 3rd day of hospitalization the decrease of anxiety score: 2.5 (1.5; 7.5) vs. 15.5 (9,5; 20,5) respectively (p< 0.05) according to Taylor scale and 5.5 (5; 14) vs. 30 (17,5; 39) respectively (p< 0.05) according to Sheehan scale, and depression score: 8 (6.5; 9.5) vs. 18 (15,5; 20,5) respectively (p< 0.05) according to CES-D scale were founded in the study group. Also in the study group cognitive functions score were improved from 23 (21; 25) to 26.5 (25; 28) (p< 0.05) according to MoCA scale. Conclusion. Polyprenol-containing drug Ropren® contributes to significant reduction of anxiety, depression and improving of cognitive functions in patients with acute coronary syndrome after 2 months of therapy.

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Statin therapy improves serum Annexin A1 levels in patients with acute coronary syndrome: A case-controlled study

International Journal of Critical Illness and Injury Science ◽

10.4103/ijciis.ijciis_49_20 ◽

2021 ◽

Vol 11 (1) ◽

pp. 4

Author(s):

HayderM Al-Kuraishy ◽

AliI Al-Gareeb ◽

OulaMohamed Samy

Keyword(s):

Acute Coronary Syndrome ◽

Statin Therapy ◽

Controlled Study ◽

Annexin A1 ◽

Coronary Syndrome

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TO001EFFECTS OF THE BET-INHIBITOR APABETALONE ON CARDIOVASCULAR EVENTS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ACUTE CORONARY SYNDROME, ACCORDING TO PRESENCE OR ABSENCE OF CHRONIC KIDNEY DISEASE. A BETONMACE TRIAL REPORT

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa141.to001 ◽

2020 ◽

Vol 35 (Supplement_3) ◽

Author(s):

Kam Kalantar-Zadeh ◽

Kausik K Ray ◽

Stephen J Nicholls ◽

Henry N Ginsburg ◽

Kevin A Buhr ◽

...

Keyword(s):

Type 2 Diabetes ◽

Chronic Kidney Disease ◽

Acute Coronary Syndrome ◽

High Risk ◽

Kidney Disease ◽

Myocardial Infarct ◽

Double Blind ◽

Coronary Syndrome ◽

Ckd Stage

Abstract Background and Aims Patients with type 2 diabetes (T2D) and acute coronary syndrome (ACS) are at high risk for recurrent cardiovascular (CV) events, particularly in the presence of chronic kidney disease (CKD). Apabetalone (APB) is a novel inhibitor of bromodomain and extraterminal (BET) proteins. Its cardiovascular efficacy and safety were evaluated in a phase 3 trial, BETonMACE. Method BETonMACE was a randomized, double-blind, comparison of effects of ABP or placebo (PBO) on major adverse CV events (MACE) defined as CV-death, non-fatal myocardial infarct or stroke, in 2425 pts with T2D and recent ACS. Here we report MACE plus CHF hospitalization in subjects with or without CKD Stage 3. Results Baseline characteristics: median age 62 years, 25.6% female, 87.6% white, 90% high intensity statin use, mean LDL-C 70.3 and HDL-C 33.3 mg/dl, median HbA1c 7.3%, and 11% with CKD Stage 3. Overall in the trial, MACE plus CHF hospitalization occurred in 139 (11.5%) patients with ABP and 173 (14.3%) with PBO (HR 0.78, 95% CI 0.63-0.98). In the subgroup with CKD, MACE plus CHF hospitalization occurred in 16 (12.9%) on APB and 41 (25%) on PBO (HR 0.48, 95% CI 0.26-0.89). In the subgroup without CKD, MACE plus CHF hospitalization occurred in 123 (11.3%) and 132 (12.7%) with APB or PBO, respectively (HR 0.89, 95% CI 0.70-1. Conclusion Patients with T2D, ACS, and Stage 3 CKD have a very high risk of subsequent MACE plus CHF hospitalization. The BET protein inhibitor ABP may reduce this risk.

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