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Status of fasting in Ramadan of chronic hemodialysis patients all over Egypt: A multicenter observational study.
Megahed, AF, El-Kannishy, G, Sayed-Ahmed, N
Saudi journal of kidney diseases and transplantation : an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia. 2019;(2):339-349
Abstract
There is a paucity of data concerning safety of fasting in Ramadan in chronic kidney disease patients on hemodialysis (HD). The aim of the present study was to assess the frequency of fasting in Ramadan in HD patients in Egypt and the possible effect of fasting on clinical and biochemical variables. This observational multicentric study was carried out during 2016 when fasting duration was around 16 h.
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A randomized, placebo-controlled trial of late Na current inhibition (ranolazine) in coronary microvascular dysfunction (CMD): impact on angina and myocardial perfusion reserve.
Bairey Merz, CN, Handberg, EM, Shufelt, CL, Mehta, PK, Minissian, MB, Wei, J, Thomson, LE, Berman, DS, Shaw, LJ, Petersen, JW, et al
European heart journal. 2016;(19):1504-13
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AIMS: The mechanistic basis of the symptoms and signs of myocardial ischaemia in patients without obstructive coronary artery disease (CAD) and evidence of coronary microvascular dysfunction (CMD) is unclear. The aim of this study was to mechanistically test short-term late sodium current inhibition (ranolazine) in such subjects on angina, myocardial perfusion reserve index, and diastolic filling. MATERIALS AND RESULTS Randomized, double-blind, placebo-controlled, crossover, mechanistic trial in subjects with evidence of CMD [invasive coronary reactivity testing or non-invasive cardiac magnetic resonance imaging myocardial perfusion reserve index (MPRI)]. Short-term oral ranolazine 500-1000 mg twice daily for 2 weeks vs. placebo. Angina measured by Seattle Angina Questionnaire (SAQ) and SAQ-7 (co-primaries), diary angina (secondary), stress MPRI, diastolic filling, quality of life (QoL). Of 128 (96% women) subjects, no treatment differences in the outcomes were observed. Peak heart rate was lower during pharmacological stress during ranolazine (-3.55 b.p.m., P < 0.001). The change in SAQ-7 directly correlated with the change in MPRI (correlation 0.25, P = 0.005). The change in MPRI predicted the change in SAQ QoL, adjusted for body mass index (BMI), prior myocardial infarction, and site (P = 0.0032). Low coronary flow reserve (CFR <2.5) subjects improved MPRI (P < 0.0137), SAQ angina frequency (P = 0.027), and SAQ-7 (P = 0.041). CONCLUSIONS In this mechanistic trial among symptomatic subjects, no obstructive CAD, short-term late sodium current inhibition was not generally effective for SAQ angina. Angina and myocardial perfusion reserve changes were related, supporting the notion that strategies to improve ischaemia should be tested in these subjects. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01342029.
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Recurrence of angina pectoris after percutaneous coronary intervention is reduced by statins in Japanese patients.
Tsunoda, R, Sakamoto, T, Kojima, S, Ogata, Y, Kitagwa, A, Ogawa, H
Journal of cardiology. 2011;(3):208-15
Abstract
BACKGROUND Statins have been reported to reduce cardiovascular events in patients with coronary artery disease (CAD). Percutaneous coronary intervention (PCI) is commonly used to relieve ischemic symptoms in patients with CAD. However, there is little information on the effect of statins on cardiovascular events after PCI, even in the era of coronary stent implantation. METHODS A total of 1019 patients with acute or chronic CAD and modest total cholesterol levels (180-240 mg/dl) were enrolled and randomly assigned to treatment with or without statins. We evaluated the effect of any available statin on the incidence of cardiovascular events after PCI. The primary endpoint was a composite of cardiovascular death, nonfatal acute myocardial infarction (MI), recurrent angina pectoris requiring emergency rehospitalization (rAP), heart failure, and stroke. RESULTS Indications for PCI were stable angina in 54%, ST-elevation MI in 41% and non-ST-elevation MI/unstable angina pectoris in 5%. After 2 years of statin treatment, low-density lipoprotein cholesterol (LDL-C) decreased from 133 to 96 mg/dl. Stents were implanted in 84% of all cases. The primary endpoint event rate was 9.5% in the statin group and 14.7% in the non-statin group (p=0.0292). Of all primary endpoint events, only rAP was significantly suppressed by statins (p=0.0027). In rAP patients, coronary angiography revealed that statins suppressed restenosis but not new lesions. CONCLUSIONS For Japanese CAD patients treated with PCI and stent implantation, statin therapy reduced the incidence of recurrent cardiovascular events, particularly rAP. Discretionary statin treatment to achieve LDL-C levels <100 mg/dl effectively reduced restenosis causing rAP.
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Characteristics and drug utilization patterns of new users of rosuvastatin and other statins in four countries.
McAfee, AT, Rodríguez, LA, Goettsch, WG, González-Pérez, A, Johansson, S, Ming, EE, Wallander, MA, Herings, RM
Minerva cardioangiologica. 2010;(6):611-22
Abstract
AIM: This study was undertaken to increase understanding of the utilization of a newly introduced statin through evaluation of characteristics of 'real-life' patients in a pharmacoepidemiology program in the USA, the Netherlands, the UK and Canada. METHODS This was an observational analysis of prospectively collected data from primary care patients classified as new users of rosuvastatin or any other statin. New users (naïve or switched initiators) of rosuvastatin were compared with initiators of other statins, as identified from automated healthcare databases in the first 1 to 2 years of rosuvastatin availability. Demographics, statin doses, previous statin use and other lipid-lowering therapies, and relevant comorbidities were recorded. The main outcome measure was proportion of naïve and non-naïve statin users in patients prescribed rosuvastatin or 'other statins'. RESULTS Among 346.547 new statin users identified in the cohorts, 46.838 (13.5%) were new users of rosuvastatin and most (84.1%) were statin-naïve. Patients receiving rosuvastatin were more likely to have been previously treated with another statin or non-statin lipid-lowering therapy and tended to be younger, compared with first users of other statins. CONCLUSION These findings suggest that rosuvastatin is preferentially prescribed to patients who have not responded satisfactorily to established treatment.
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Potent anti-ischaemic effects of statins in chronic stable angina: incremental benefit beyond lipid lowering?
Deanfield, JE, Sellier, P, Thaulow, E, Bultas, J, Yunis, C, Shi, H, Buch, J, Beckerman, B
European heart journal. 2010;(21):2650-9
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AIMS: The DoUble-blind Atorvastatin AmLodipine (DUAAL) trial investigated whether atorvastatin decreases ischaemia by a vascular benefit, independent of low-density lipoprotein cholesterol lowering, in patients with coronary artery disease (CAD), both alone and in combination with the traditional anti-anginal therapy, amlodipine. METHODS AND RESULTS Randomized, double-blind, parallel-group, multicountry trial (2 weeks run-in and 24 weeks active therapy) comparing three treatments: amlodipine, atorvastatin, and amlodipine + atorvastatin; in 311 patients (78% male; mean age 62 years) with stable angina (≥ 2 attacks/week), CAD history, ≥ 3 transient myocardial ischaemia (TMI) episodes, and/or ≥ 15 min ischaemia on 48 h ambulatory electrocardiographic (AECG) monitoring. Efficacy variables were change in TMI by AECG, exercise ischaemia, angina diary data, and inflammatory biomarkers at Week 26. There was a comparable, highly significant decrease in TMI with amlodipine and atorvastatin, but no additional benefit for the combination. More than 50% of patients became TMI-free in all three groups and this was accompanied by a comparable, marked reduction in angina and nitroglycerin consumption. High-sensitivity C-reactive protein fell by 40% in patients receiving atorvastatin but there was no change with amlodipine. Adverse events were comparable among groups. CONCLUSION Atorvastatin was as potent an anti-ischaemic agent as amlodipine. Future studies of combination therapies will be instructive. CLINICAL TRIAL REGISTRATION INFORMATION National clinical trial number: NCT00159718, protocol number A0531031 listed on http://clinicaltrials.gov/.
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Sodium-hydrogen exchange inhibition by cariporide to reduce the risk of ischemic cardiac events in patients undergoing coronary artery bypass grafting: results of the EXPEDITION study.
Mentzer, RM, Bartels, C, Bolli, R, Boyce, S, Buckberg, GD, Chaitman, B, Haverich, A, Knight, J, Menasché, P, Myers, ML, et al
The Annals of thoracic surgery. 2008;(4):1261-70
Abstract
BACKGROUND The EXPEDITION study addressed the efficacy and safety of inhibiting the sodium hydrogen exchanger isoform-1 (NHE-1) by cariporide in the prevention of death or myocardial infarction (MI) in patients undergoing coronary artery bypass graft surgery. The premise was that inhibition of NHE-1 limits intracellcular Na accumulation and thereby limits Na/Ca-exchanger-mediated calcium overload to reduce infarct size. METHODS High-risk coronary artery bypass graft surgery patients (n = 5,761) were randomly allocated to receive either intravenous cariporide (180 mg in a 1-hour preoperative loading dose, then 40 mg per hour over 24 hours and 20 mg per hour over the subsequent 24 hours) or placebo. The primary composite endpoint of death or MI was assessed at 5 days, and patients were followed for as long as 6 months. RESULTS At 5 days, the incidence of death or MI was reduced from 20.3% in the placebo group to 16.6% in the treatment group (p = 0.0002). Paradoxically, MI alone declined from 18.9% in the placebo group to 14.4% in the treatment group (p = 0.000005), while mortality alone increased from 1.5% in the placebo group to 2.2% with cariporide (p = 0.02). The increase in mortality was associated with an increase in cerebrovascular events. Unlike the salutary effects that were maintained at 6 months, the difference in mortality at 6 months was not significant. CONCLUSIONS The EXPEDITION study is the first phase III myocardial protection trial in which the primary endpoint was achieved and proof of concept demonstrated. As a result of increased mortality associated with an increase in cerebrovascular events, it is unlikely that cariporide will be used clinically. The findings suggest that sodium hydrogen exchanger isoform-1 inhibition holds promise for a new class of drugs that could significantly reduce myocardial injury associated with ischemia-reperfusion injury.
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Efficacy of zoniporide, an Na/H exchange ion inhibitor, for reducing perioperative cardiovascular events in vascular surgery patients.
Fleisher, LA, Newman, MF, St Aubin, LB, Cropp, AB, Billing, CB, Bonney, S, Mackey, WC, Poldermans, D, Corbalan, R, Pereira, AH, et al
Journal of cardiothoracic and vascular anesthesia. 2005;(5):570-6
Abstract
OBJECTIVES To determine whether a novel Na+/H+ exchange ion inhibitor, zoniporide, is associated with reduced perioperative myocardial ischemic injury in high-risk surgery patients. DESIGN Randomized double-blind placebo-controlled multidose trial. SETTING Multicenter worldwide (105 centers) trial. PARTICIPANTS Patients with known or multiple risk factors for coronary artery disease undergoing noncardiac vascular surgery. INTERVENTIONS Four parallel groups received 1 of 3 doses of zoniporide or placebo, delivered as a 60-minute loading dose immediately before surgery, and followed by a continuous intravenous infusion for up to 7 days. MEASUREMENTS AND MAIN RESULTS A total of 824 subjects were randomized into the study from 105 centers worldwide. Of these, 784 subjects received study drug infusion in the 3-mg/kg/d, 6-mg/kg/d, and 12-mg/kg/d groups and the placebo group, and 769 satisfied the criteria for the primary efficacy analysis population. This is 68% of the planned sample size of 1125 subjects. Anesthetic management and perioperative cardiac medications were at the discretion of the attending anesthesiologists, surgeons, and cardiologists. The proportion of subjects who experienced the composite endpoint event (death, myocardial infarction, congestive heart failure, arrhythmia) by postsurgical day 30 was 18.5% in the 12-mg/kg/d group, compared with 15.7% in the placebo group, resulting in a relative risk (RR) of 1.17% (95% confidence interval [CI], 0.80-1.72; p = NS) favoring placebo. The proportions in the lower 2 zoniporide dose groups were slightly lower than in the placebo group, although the sample size is inadequate to reach any firm conclusions. CONCLUSIONS The results fail to demonstrate the efficacy of zoniporide in reducing the proportion of patients at high risk undergoing noncardiac vascular surgery who experience a composite cardiovascular endpoint, which led the corporate sponsor to stop enrollment early on the basis of a futility analysis of the chance of demonstrating efficacy with a larger sample size.
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Cardiovascular risk assessment and treatment to target low density lipoprotein levels in hospitalized ischemic heart disease patients: results of the HOLEM study.
Harats, D, Leibovitz, E, Maislos, M, Wolfovitz, E, Chajek-Shaul, T, Leitersdorf, E, Gavish, D, Gerber, Y, Goldbourt, U, ,
The Israel Medical Association journal : IMAJ. 2005;(6):355-9
Abstract
BACKGROUND Hypercholesterolemia control status is lacking throughout the western world. OBJECTIVES To examine whether the treatment recommendations given to ischemic heart disease patients at hospital discharge are compatible with the guidelines of the Israeli medical societies and the U.S. National Cholesterol Education Program for coronary artery disease prevention; and to study the effects of brief educational sessions on the adherence of physicians with the guidelines. METHODS We included consecutive IHD patients admitted to four central hospitals in Israel between 1998 and 2000. The study was conducted in two phases. In phase 1, we reviewed discharge letters to document treatment recommendations given to each patient. In phase 2 we educated the practitioners by reviewing the Israeli medical societies and the NCEP guidelines and the quality of their recommendations in phase 1, after which we reevaluated the discharge letters. RESULTS The study included 2,994 patients: 627 in phase 1 and 2,367 in phase 2. Of the patients who needed cholesterol-lowering according to their low density lipoprotein levels, 37.4% were not prescribed such drugs at discharge (under-treatment group). This proportion was reduced by education to 26.6% (P < 0.001) in phase 2. Of the treated patients, 65.6% did not reach the target LDLgoal in phase 1 (under-dosage group) as compared to 60.2% in phase 2 (P = 0.23). In phase 2 there was an increase in the percent of patients reaching LDL levels <130 mg/day (69.3% vs. 63.8% of patients prescribed medication, P = 0.01), but the percent of patients reaching' LDL levels <100 was not different in phase 2 after adjusting for age and gender (the odds ratio for reaching target LDL was 1.16, with 95% confidence interval of 0.95-1.43). CONCLUSIONS Physician recommendations to IHD patients discharged from hospital were suboptimal. We documented a high proportion of under-treated and under-dosaged patients. Brief educational sessions have a beneficial effect on the usage of statins; however, additional effort in guideline implementations is needed.
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Role of oral blockade of platelet glycoprotein IIb/IIIa on neutrophil activation in patients with acute coronary syndromes.
Serrano, CV, Nicolau, JC, Venturinelli, M, Baracioli, LM, Anders, RJ, Cannon, CP, Ramires, JA
Cardiovascular drugs and therapy. 2003;(2):129-32
Abstract
Orbofiban is a unique antiplatelet agent that inhibits the binding of fibrinogen to gycoprotein (GP) IIb/IIIa integrin receptors and thus prevents platelet aggregation induced by various agents. However, recent studies indicate that treatment with orbofiban does not reduce the incidence of recurrent ischemic events. The mechanisms underlying the lack of benefit of orbofiban in patients with acute coronary syndromes are not completely clear. The purpose of this study was to characterize the effects of orbofiban on cellular activation (neutrophil superoxide generation) and surface expression of adhesion molecules of circulating neutrophils (CD18, CD11b, and L-selectin) and platelets (P-selectin and GP IIb/IIIa) in patients with acute coronary syndromes. After 5-7 days, orbifiban (50 mg BID) did not reduce PMN adhesion molecule expression and ex vivo-stimulated PMN superoxide generation--as was observed in the placebo group, without orbofiban. In contrast, orbofiban induced marked reductions in GP IIb/IIIa and P-selectin expressions after 5-7 days of treatment. The sustained neutrophil activation observed with orbofiban may have a role on the recurrent thrombotic events observed with orbofiban treatment in the OPUS-TIMI 16 trial.
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The Extensive Lifestyle Management Intervention (ELMI) following cardiac rehabilitation trial.
Lear, SA, Ignaszewski, A, Linden, W, Brozic, A, Kiess, M, Spinelli, JJ, Haydn Pritchard, P, Frohlich, JJ
European heart journal. 2003;(21):1920-7
Abstract
AIM: Previous studies have reported lifestyle and risk factor deterioration following completion of a cardiac rehabilitation program (CRP). We report the results of a one-year Extensive Lifestyle Management Intervention (ELMI) aimed at preventing these adverse changes. METHODS AND RESULTS A total of 302 men and women with ischaemic heart disease were recruited following completion of a CRP and randomized to either the ELMI (consisting of exercise sessions, telephone follow-ups and risk factor and lifestyle counselling) or usual care. The primary outcome was global cardiovascular risk using the Framingham and Procam risk scores. Secondary outcomes included risk factors and lifestyle behaviours. Baseline characteristics were similar between the two groups. Adherence to the ELMI was high. There was a non-significant trend in favour of the ELMI between for both the Framingham (6.6+/-3.1 to 6.2+/-2.9 vs 6.6+/-3.2 to 6.7+/-3.2, P=0.138) and Procam (20.0+/-20.0 to 20.6+/-19.5 vs 19.1+/-18.7 to 21.8+/-19.1, P=0.089) scores. There were no differences in secondary outcomes. CONCLUSIONS A one-year multi-factorial post-CRP intervention results in modest, non-significant benefits to global risk compared to usual care. The absence of deterioration in the usual care group may be due to improved practices in usual care.