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53. Amiodarone in patients with congestive heart failure and asymptomatic ventricular arrhythmia

Author

Singh, Steven N., Fletcher, Ross D., Fisher, Susan Gross, Singh, Bramah N., Lewis, H. Daniel, Deedwania, Prakash C., Massie, Barry M., Colling, Cindy, and Lazzeri, Diane

Subjects
Amiodarone -- Evaluation, Congestive heart failure -- Drug therapy, Arrhythmia -- Drug therapy, Heart diseases -- Patient outcomes
Abstract

Amiodarone may not prevent sudden death or prolong life in patients with heart failure and arrythmias. Amiodarone is a drug that causes dilation of blood vessels in the heart and prevents irregular heart beats, or arrythmias. Doctors assigned 336 patients to receive amiodarone and 338 to receive a placebo to determine the effect of the drug on longterm survival. Amiodarone did not have a significant effect on survival. During the study 274 patients died including 131 (39%) patients taking amiodarone and 143 (42%) taking a placebo. Among patients taking amiodarone, 64 (49%) suffered a sudden death compared to 75 (52%) of those patients taking a placebo. Amiodarone did have some beneficial effects. After two weeks of therapy, the patients taking amiodarone had a significantly lower heart rate averaging 70 beats/minute. In addition, the average frequency of irregular heart beats decreased from about 254 per hour to 66 per hour at two weeks to 44 per hour after three months.

Published
1995

57. ADMISSION-TO-DISCHARGE WEIGHT CHANGE AND 30-DAY POST-DISCHARGE OUTCOMES IN OLDER PATIENTS WITH HEART FAILURE WITH PRESERVED AND REDUCED EJECTION FRACTION (HFPEF AND HFREF)

Author

Gill, Gauravpal S., primary, Malik, Awais, additional, Nazari, Matt, additional, Arundel, Cherinne, additional, Singh, Steven, additional, Panjrath, Gurusher, additional, Deedwania, Prakash, additional, Kanonidis, Ioannis, additional, Faselis, Charles, additional, Fonarow, Gregg C., additional, and Ahmed, Ali, additional

Published
2019
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61. Amiodarone in Congestive Heart Failure

Author

Silver, Mitchell J., Young, James, Topol, Eric J., Colli, Agostino, Sechi, Leonardo A., De Carli, Stefano, Bartoli, Ettore, Singh, Steven N., Fletcher, Ross D., and Fisher, Susan G.

Published
1995
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62. Veterans Affairs Congestive Heart Failure Antiarrhythmic Trial

Author

Singh, Steven N., Fletcher, Ross D., Fisher, Susan, Lazzeri, Diane, Deedwania, Prakash, Lewis, Daniel, Massie, Barry, Singh, Bramah N., and Colling, Cindy

Subjects
Congestive heart failure -- Patient outcomes, Anti-arrhythmia drugs -- Evaluation, Arrhythmia -- Drug therapy, Health
Published
1993

64. Long-term effect of mexiletine on left ventricular function and relation to suppression of ventricular arrhythmia

Author

Singh, Steven, Klein, Richard, Eisenberg, Brian, Hughes, Edward, Shand, Margaret, Doherty, Pat, and Sharon, Gerhard

Subjects
Mexiletine -- Health aspects, Heart ventricle, Left, Arrhythmia -- Care and treatment, Health
Abstract

The effects of oral mexiletine on left ventricular (LV) election fraction (EF) and ventricular arrhythmias--and a possible relation between these effects--were evaluated during 3 months of therapy in 29 patients with chronic ventricular premature complexes VPCS) and a moderately reduced to normal LVEF by 24-hour Holter monitoring and by radionuclide ventriculography at rest and during maximum tolerable exercise testing. After an average titration period of 13 days, a mean daily mexiletine dose of 739 mg was maintained throughout the treatment. At the end of titration and after 3 months of treatment, patients with a baseline LVEF [is less than or equal to] 40% (group 2) responded with a median reduction of the hourly VPC rate by 90 and 81%, respectively, compared with 79 and 72% in those with a baseline LVEF >40% (group 1). Couplets and runs of ventricular tachycardia were almost completely suppressed in nearly all patients. A single patient had a proarrhythmic increase in VPCs during treatment. Compared with baseline, there were no significant changes in resting or exercise LVEF after 1 or 3 months of treatment in either of the 2 groups of patients. No correlation was found between treatment-induced changes in arrhythmia frequency and in resting EF. No symptoms of congestive heart failure developed. The study confirms that long-term use of mexiletine is efficacious and relatively free of cardiac depressant effects even in patients with diminished LV function. (Am J Cardiol 1990;66:1222-1227), Treatment of ventricular arrhythmias, abnormal heartbeats originating in the ventricles, are very difficult to treat if the patients have poor left ventricle function or chronic congestive heart failure. These patients do not respond well to antiarrhythmic drugs and are more likely to experience drug-induced worsening of the arrhythmia. However, mexiletine, an antiarrhythmic drug, has not demonstrated adverse effects on patients with a history of heart attack, left ventricular dysfunction, or congestive heart failure. This study of 29 men assessed the effects of mexiletine on left ventricular function and the suppression of ventricular premature complexes (VPCs), a type of abnormal heart rhythm. The results confirmed that left ventricular ejection fraction (LVEF), the proportion of blood that is ejected by contraction of the left ventricle, was not significantly affected by mexiletine. Of the six antiarrhythmic drugs recently tested, mexiletine had the second lowest incidence (after lorcainide) of new or worsened congestive heart failure. Those patients with a baseline LVEF below 35 percent (normal is 65 percent) did not develop symptoms or signs of congestive heart failure while taking mexiletine. Those patients who had more severely impaired left ventricles originally had more VPCs per hour, and had a greater than average reduction while taking mexiletine than patients with less damage. However, there was no relation between the magnitude of the treatment effect on left ventricular function and the degree of suppression of VPCs, which contradicts other studies. This study confirms that long-term oral mexiletine treatment works well, and has few heart depressant effects in men with diminished left ventricular function. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1990

65. Systolic Blood Pressure and Outcomes in Patients With Heart Failure With Preserved Ejection Fraction

Author

Tsimploulis, Apostolos, primary, Lam, Phillip H., additional, Arundel, Cherinne, additional, Singh, Steven N., additional, Morgan, Charity J., additional, Faselis, Charles, additional, Deedwania, Prakash, additional, Butler, Javed, additional, Aronow, Wilbert S., additional, Yancy, Clyde W., additional, Fonarow, Gregg C., additional, and Ahmed, Ali, additional

Published
2018
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71. Efficacy and safety of ACC-9358, a new antiarrythmic agent

Author

Singh, Steven N., Shand, Margaret, Feng, Liping, Chen, Yiwang, Woosley, Raymond L., and Fletcher, Ross D.

Subjects
Arrhythmia -- Drug therapy, Anti-arrhythmia drugs -- Evaluation, Health
Abstract

A new drug, ACC-9358, used to control of cardiac arrhythmia (irregular heart beat), was tested for its ability to regulate heart rhythm in six male cardiac patients. The men displayed high-density (more than 60 per 24 hours) ventricular premature complexes (VPCs), a wave pattern characterized on an electrocardiograph as an extra beat preceding the normal ventricular contraction. The patients' heart rates were recorded during a 24-hour period that included infusion of a placebo (inactive) drug or ACC-9358, administered on alternate days. Results showed a reduction in total VPCs from baseline (approximately 846 per hour) to 15 per hour with ACC-9358, as well as reductions in paired VPCs, and in ventricular tachycardia (regular but rapid beats). These effects continued until the third hour after discontinuation of the drug. One patient reported mild, well-tolerated side effects. Hemodynamic (blood flow) variables were unaffected. Overall, ACC-9358 suppressed 90 percent or more of the VPCs during the first four to six hours, and it seems likely that the drug works directly, rather than by means of an active metabolite. It appears to be an effective and promising drug for control of arrhythmias. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1990

73. Pulmonary Effect of Amiodarone in Patients With Heart Failure fn1fn1This study was supported by the Department of Veterans Affairs Cooperative Studies Program of the Medical Research Service (Washington, D.C.), Sanofi Winthrop Recherche (Paris, France) and Wyeth-Ayerst Laboratories (Philadelphia, Pennsylvania)

Author

Singh, Steven N., Fisher, Susan G., Deedwania, Prakash C., Rohatgi, Prashant, Singh, Bramah N., and Fletcher, Ross D.

Subjects
Cardiology and Cardiovascular Medicine
Published
1997
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74. Costs and clinical consequences of suboptimal atrial fibrillation management

Author

Singh, Steven

Subjects
ClinicoEconomics and Outcomes Research
Abstract

Steven N SinghDepartment of Cardiology, Veterans Affairs Medical Center, Washington, DC, USAAbstract: Atrial fibrillation (AF) places a considerable burden on the US health care system, society, and individual patients due to its associated morbidity, mortality, and reduced health-related quality of life. AF increases the risk of stroke, which often results in lengthy hospital stays, increased disability, and long-term care, all of which impact medical costs. An expected increase in the prevalence of AF and incidence of AF-related stroke underscores the need for optimal management of this disorder. Although AF treatment strategies have been proven effective in clinical trials, data show that patients still receive suboptimal treatment. Adherence to AF treatment guidelines will help to optimize treatment and reduce costs due to AF-associated events; new treatments for AF show promise for future reductions in disease and cost burden due to improved tolerability profiles. Additional research is necessary to compare treatment costs and outcomes of new versus existing agents; an immediate effort to optimize treatment based on existing evidence and guidelines is critical to reducing the burden of AF.Keywords: atrial fibrillation, pharmacoeconomics, stroke, health-related quality of life

Published
2012

76. Data and Safety Monitoring Board evaluation and management of a renal adverse event signal in TOPCAT.

Author

Bristow, Michael R., Sharma, Kavita, Assmann, Susan F., Linas, Stuart, Gersh, Bernard J., Grady, Christine, Rice, Madeline Murguia, Singh, Steven, Boineau, Robin, McKinlay, Sonja M., and Greenberg, Barry H.

Subjects
ADVERSE health care events, CLINICAL trials, SPIRONOLACTONE, PLACEBOS, HEART failure, ALDOSTERONE antagonists, PATIENT safety, QUESTIONNAIRES, KIDNEY failure, RESEARCH funding, HYPERKALEMIA
Abstract

Clinical trial Data and Safety Monitoring Boards (DSMBs) have a primary obligation of ensuring study participant safety, while maintaining trial integrity. The role of DSMBs is expanding, and ideally should include post-hoc reporting of deliberative processes related to clinically important safety issues or factors that could impact on future trial designs. We describe how the TOPCAT DSMB detected, investigated, and adjudicated an unexpectedly large renal adverse event signal midway through the trial, and offer general guidelines for dealing with similar unanticipated occurrences in future trials. The detection of a greater than expected incidence of deterioration in renal function, occurring in 6.1% of patients in the spironolactone arm compared with 3.9% in the placebo arm (P = 0.009), led to an in-depth DSMB review of associated study medication withdrawals and adverse events. The trial continued uninterrupted throughout the review, which reached the conclusions that spironolactone-associated renal dysfunction did not compromise overall patient safety or interfere with a perceived efficacy signal. Although no discrete mechanism for the spironolactone-associated renal adverse event signal was identified, likely possibilities are discussed. In clinical trials, DSMBs and co-ordinating centres should have the resources to detect, investigate, and adjudicate unexpected safety issues, with goals of ensuring patient safety and preserving the potential for detection of therapeutic effectiveness. In TOPCAT, spironolactone-associated renal dysfunction emerged as a potentially trial-threatening adverse event and, although clinically important, did not lead to compromise of patient safety, trial interruption, termination, or apparent loss of treatment effectiveness. [ABSTRACT FROM AUTHOR]

Published
2017
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78. Costs and clinical consequences of suboptimal atrial fibrillation management

Author

Singh,Steven N and Singh,Steven N

Abstract

Steven N SinghDepartment of Cardiology, Veterans Affairs Medical Center, Washington, DC, USAAbstract: Atrial fibrillation (AF) places a considerable burden on the US health care system, society, and individual patients due to its associated morbidity, mortality, and reduced health-related quality of life. AF increases the risk of stroke, which often results in lengthy hospital stays, increased disability, and long-term care, all of which impact medical costs. An expected increase in the prevalence of AF and incidence of AF-related stroke underscores the need for optimal management of this disorder. Although AF treatment strategies have been proven effective in clinical trials, data show that patients still receive suboptimal treatment. Adherence to AF treatment guidelines will help to optimize treatment and reduce costs due to AF-associated events; new treatments for AF show promise for future reductions in disease and cost burden due to improved tolerability profiles. Additional research is necessary to compare treatment costs and outcomes of new versus existing agents; an immediate effort to optimize treatment based on existing evidence and guidelines is critical to reducing the burden of AF.Keywords: atrial fibrillation, pharmacoeconomics, stroke, health-related quality of life

Published
2012

79. Abstract 18446: Receipt of Implantable Cardioverter-Defibrillator Among HIV+ and HIV- Veterans With Cardiomyopathy

Author

Fatemi, Omid, primary, Karasik, Pamela, additional, Singh, Steven, additional, Chang, Chung-Chou, additional, Tate, Janet P, additional, Gibert, Cynthia, additional, Benator, Debra, additional, Amdur, Richard, additional, Rimland, David, additional, Gottlieb, Stephen, additional, Budoff, Matthew, additional, McGinnis, Kathleen, additional, and Freiberg, Matthew, additional

Published
2013
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80. Blood Pressure Control Among US Veterans

Author

Fletcher, Ross D., primary, Amdur, Richard L., additional, Kolodner, Robert, additional, McManus, Chris, additional, Jones, Ronald, additional, Faselis, Charles, additional, Kokkinos, Peter, additional, Singh, Steven, additional, and Papademetriou, Vasilios, additional

Published
2012
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88. Exercise Capacity and Mortality in Black and White Men

Author

Kokkinos, Peter, primary, Myers, Jonathan, additional, Kokkinos, John Peter, additional, Pittaras, Andreas, additional, Narayan, Puneet, additional, Manolis, Athanasios, additional, Karasik, Pamela, additional, Greenberg, Michael, additional, Papademetriou, Vasilios, additional, and Singh, Steven, additional

Published
2008
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89. Abstract 3786: Exercise Capacity is Associated with Lower Mortality Risk in African-Americans than Caucasians with Type 2 Diabetes

Author

Kokkinos, Peter, primary, Myers, Jonathan, additional, Kokkinos, John Peter, additional, Pittaras, Andreas, additional, Manolis, Athanasios, additional, Nylen, Eric, additional, Abella, Joshua, additional, Hsu, Leon, additional, Narayan, Puneet, additional, Jacob, Roshney, additional, and Singh, Steven, additional

Published
2007
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93. Reply

Author

Kokkinos, Peter F., primary, Singh, Steven, additional, and Narayan, Puneet, additional

Published
2006
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94. Cost Effectiveness of Cardiac Resynchronization Therapy in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Trial

Author

Feldman, Arthur M., primary, de Lissovoy, Gregory, additional, Bristow, Michael R., additional, Saxon, Leslie A., additional, De Marco, Teresa, additional, Kass, David A., additional, Boehmer, John, additional, Singh, Steven, additional, Whellan, David J., additional, Carson, Peter, additional, Boscoe, Audra, additional, Baker, Timothy M., additional, and Gunderman, Matthew R., additional

Published
2005
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96. Exercise capacity and heart rate recovery as predictors of coronary heart disease events, in patients with heterozygous Familial Hypercholesterolemia

Author

Pitsavos, Christos H, primary, Chrysohoou, Christina, additional, Panagiotakos, Demosthenes B, additional, Kokkinos, Peter, additional, Skoumas, John, additional, Papaioannou, Ioanna, additional, Michaelides, Andreas P, additional, Singh, Steven, additional, and Stefanadis, Christodoulos I, additional

Published
2004
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97. Comparison of sotalol versus amiodarone in maintaining stability of sinus rhythm in patients with atrial fibrillation (Sotalol-Amiodarone Fibrillation Efficacy Trial [Safe-T])

Author

Singh, Steven N., primary, Singh, Bramah N., additional, Reda, Domenic J., additional, Fye, Carol L., additional, Ezekowitz, Michael D., additional, Fletcher, Ross D., additional, Sharma, Satish C., additional, Atwood, J.Edwin, additional, Jacobson, Alan K., additional, Lewis, H.Daniel, additional, Antman, Eliott M., additional, Falk, Rodney H., additional, Lopez, Becky, additional, and Tang, X.Charlene, additional

Published
2003
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98. Meta-analysis of antiarrhythmic therapy in the prevention of postoperative atrial fibrillation and the effect on hospital length of stay, costs, cerebrovascular accidents, and mortality in patients undergoing cardiac surgery

Author

Zimmer, Jennifer, primary, Pezzullo, John, additional, Choucair, Wassim, additional, Southard, Jeffrey, additional, Kokkinos, Peter, additional, Karasik, Pamela, additional, Greenberg, Michael D., additional, and Singh, Steven N., additional

Published
2003
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