scholarly journals Trimetazidine offers myocardial protection in elderly coronary artery disease patients undergoing non-cardiac surgery: a randomized, double-blind, placebo-controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhong-Liang Dai ◽  
Yi-Feng Song ◽  
Ya Tian ◽  
Yin Li ◽  
Miao Lin ◽  
...  
Keyword(s):  
Heart Failure ◽  
Cardiac Surgery ◽  
Elderly Patients ◽  
Primary Endpoint ◽  
Myocardial Ischaemia ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Coronary Events

Abstract Background Trimetazidine (TMZ) pretreatment protects cardiomyocytes during cardiac surgery. TMZ may protect elderly patients with ischaemic heart disease (IHD) undergoing non-cardiac surgery. Methods This was a randomized, double-blind, placebo-controlled trial (registration #ChiCTR1900025018) of patients with IHD scheduled to undergo non-cardiac surgery at Shenzhen People’s Hospital (Shenzhen, Guangdong Province, China) between June 2014 and September 2015, randomized to 60 mg TMZ or placebo 12 h before surgery. The primary endpoint was the occurrence of in-hospital cardiovascular events. The secondary endpoints were myocardial ischaemia on five-lead electrocardiogram (cECG), cardiac troponin I (cTnI) elevation, cardiac death, acute coronary events, heart failure, and arrhythmia requiring treatments. Results Compared with the placebo group, the TMZ group showed a lower occurrence of in-hospital cardiovascular events (primary endpoint, 20.0% vs. 37.5%, P = 0.02), myocardial ischaemia (15.0% vs. 32.5%, P < 0.01), cTnI elevation (2.5% vs. 10%, P < 0.01), acute coronary events (10.0% vs. 20.0%, P < 0.05), heart failure (0% vs. 2.5%, P < 0.05), and arrhythmia requiring treatment (17.5% vs. 35.0%, P < 0.05). There was no acute myocardial infarction during the 30-day postoperative period. Conclusions In elderly patients with IHD undergoing non-cardiac surgery, TMZ pretreatment was associated with myocardial protective effects. Trial registration The trial was prospectively registered at http://www.chictr.org.cn/showproj.aspx?proj=41909 with registration number [ChiCTR1900025018] (7/8/2019).

scholarly journals Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial

The Lancet ◽  
2016 ◽  
Vol 388 (10054) ◽  
pp. 1893-1902 ◽  
Author(s):  
Xian Su ◽  
Zhao-Ting Meng ◽  
Xin-Hai Wu ◽  
Fan Cui ◽  
Hong-Liang Li ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Elderly Patients ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals A randomised, double‐blind, placebo‐controlled trial of metformin on myocardial efficiency in insulin‐resistant chronic heart failure patients without diabetes

2019 ◽  
Vol 22 (9) ◽  
pp. 1628-1637 ◽  
Author(s):  
Anders Hostrup Larsen ◽  
Niels Jessen ◽  
Helene Nørrelund ◽  
Lars Poulsen Tolbod ◽  
Hendrik Johannes Harms ◽  
...  
Keyword(s):  
Heart Failure ◽  
Chronic Heart Failure ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Heart Failure Patients ◽  
Insulin Resistant ◽  
Myocardial Efficiency

Steroid-Sparing Effects of Anti-IL-5 Monoclonal Antibody (Mepolizumab) Therapy in Patients with HES: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 373-373 ◽  
Author(s):  
Marc E. Rothenberg ◽  
Gerald J. Gleich ◽  
Florence E. Roufosse ◽  
Lanny J. Rosenwasser ◽  
Peter F. Weller
Keyword(s):  
Monoclonal Antibody ◽  
Treatment Period ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Blood Eosinophil ◽  
Double Blind ◽  
Prednisone Dose ◽  
Double Blind Placebo ◽  
Steroid Sparing ◽  
Eosinophil Counts

Abstract An international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial has evaluated the effects of mepolizumab, a humanized anti-interleukin-5 monoclonal antibody, on therapeutic prednisone dose requirements, eosinophil levels, signs and symptoms of disease in patients with hypereosinophilic syndrome (HES). The trial enrolled 85 patients (mean age 48.1 years) with HES (blood eosinophil count >1500/μl with evidence of eosinophil-related organ involvement or dysfunction and no known cause of eosinophilia), who tested negative for the FIP1L1-PDGFRα gene rearrangement and required 20–60 mg/day prednisone monotherapy to maintain blood eosinophils at <1000 cells/μL during a run-in period of ≤6 weeks. Patients were randomized to treatment with intravenous mepolizumab 750 mg (n=43) or saline (placebo; n=42) every 4 weeks for 36 weeks (final infusion at Week 32). The prednisone dose was tapered at weekly intervals following the first infusion according to a predefined algorithm based on blood eosinophil counts and HES clinical activity criteria. A total of 84% of patients in the mepolizumab group vs 43% in the placebo group (P<0.001) achieved the primary endpoint (≤10 mg/day prednisone for ≥8 consecutive weeks within the 36-week treatment period). Time to achievement of the primary endpoint, a post-hoc analysis, was significantly shorter in mepolizumab- vs placebo-treated patients (P=0.002). Significantly higher proportions of patients on mepolizumab achieved pre-defined secondary steroid-sparing and eosinophil endpoints vs placebo (Table). Initial assessments of cutaneous disease (based on pruritus visual analog scales and erythema/edema scores) did not differ between the treatment groups. This study, the largest placebo-controlled trial to be conducted in patients with HES to date, has shown that mepolizumab is more effective than placebo at reducing therapeutic prednisone use and stabilizing eosinophil counts in patients with HES. Importantly, a significantly higher proportion of HES patients treated with mepolizumab than placebo achieved the primary endpoint and required ≤10 mg/day prednisone for at least 8 consecutive weeks. These findings indicate that mepolizumab will be an effective therapy for FIP1L1-PDGFRα negative patients with HES. Primary and secondary endpoints Endpoint Placebo (n=42) Mepolizumab (n=43) P-value (95% CI) Patients on ≤10 mg/day prednisone for ≥8 weeks (primary endpoint), % 43% 84% <0.001 (2.69, 23.78) Patients with eosinophils <600 μL for ≥8 weeks, % 45% 95% <0.001 (4.74, 75.17) Primary endpoint in patients on ≤30 mg/day prednisone at baseline, % 57% (n=30) 87% (n=30) 0.011 (1.39, 17.82) Primary endpoint in patients on >30 mg/day prednisone at baseline, % 8% (n=12) 77% (n=13) <0.001 (3.26, 412.26) Patients achieving ≤7.5 mg/day prednisone during the treatment period, % 50% 86% <0.001 (2.04, 15.00) Mean (±SE) prednisone dose at Week 36 (adjusted), mg/day 21.8±1.92 6.2±1.87 <0.001

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