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Jay N. Cohn - One of the best experts on this subject based on the ideXlab platform.
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effect of fixed dose combined Isosorbide Dinitrate hydralazine in elderly patients in the african american heart failure trial
Journal of Cardiac Failure, 2012Co-Authors: Anne L Taylor, Susan Ziesche, Michael L Sabolinski, Manuel Worcel, Jalal K Ghali, Tad W Archambault, Jay N. CohnAbstract:Abstract Background Fixed-dose combined Isosorbide Dinitrate/hydralazine (FDC I/H) significantly improved outcomes in patients with advanced heart failure (HF) receiving background neurohormonal therapy in the African-American Heart Failure Trial (A-HeFT). In this analysis, we investigated treatment effects by age Methods and Results Time-to-event curves were produced by the Kaplan-Meier method. Hazard ratios were calculated with the Cox proportional hazards model. Baseline characteristics showed that patients ≥65 years old had less hypertensive and more ischemic HF, better quality of life (QoL) scores, higher plasma B-type natriuretic peptide and creatinine levels, and received less background neurohormonal therapy. Kaplan-Meier curves showed that FDC I/H improved mortality and event-free survival in elderly patients. The hazard ratios for mortality, first heart failure hospitalization, and event-free survival (both unadjusted and adjusted for baseline differences), were similar quantitatively and in direction of effect in both age groups. Conclusions In A-HeFT, FDC I/H improved outcomes in HF patients aged
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combination of Isosorbide Dinitrate and hydralazine reduces 30 day hospital readmissions and increases time to hospital readmission in blacks with heart failure
Journal of the American College of Cardiology, 2012Co-Authors: Inderjit Anand, Jay N. Cohn, Thomas S Rector, Howard Furst, Anne L TaylorAbstract:A fixed dose combination of Isosorbide Dinitrate plus hydralazine (FDC I/H) reduced mortality in black patients with moderate to severe heart failure in the African-American Heart Failure Trial (A-HeFT). We further examined its effect on hospital readmissions. A total of 1050 black patients with
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lack of bioequivalence between different formulations of Isosorbide Dinitrate and hydralazine and the fixed dose combination of Isosorbide Dinitrate hydralazine the v heft paradox
Clinical Pharmacokinectics, 2007Co-Authors: Michael L Sabolinski, Manuel Worcel, Milton Packer, Jay N. CohnAbstract:Objective To investigate whether the apparent discrepancy between the efficacy of the combination of Isosorbide Dinitrate (ISDN) and hydralazine demonstrated in the first V-HeFT trial (V-HeFT I) and that in V-HeFT II could be explained by pharmacokinetic differences in the study drug formulations, and to compare the pharmacokinetic profile of the fixed-dose combination of ISDN/hydralazine (FDC ISDN/HYD; BiDil®) formulation used in A-HeFT with that of the V-HeFT study drug formulations.
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Isosorbide Dinitrate and hydralazine in a fixed dose combination produces further regression of left ventricular remodeling in a well treated black population with heart failure results from a heft
Journal of Cardiac Failure, 2007Co-Authors: Jay N. Cohn, Inder S Anand, Anne L Taylor, Michael L Sabolinski, Manuel WorcelAbstract:Abstract Background Isosorbide Dinitrate combined with hydralazine therapy compared with placebo in patients with heart failure resulted in a sustained increase in left ventricular (LV) ejection fraction (EF) indicative of regression of LV remodeling in the first Vasodilator-Heart Failure Trial (V-HeFT-I) in patients receiving only digoxin and diuretic. In the African-American Heart Failure Trial (A-HeFT) a fixed-dose combination resulted in a 43% reduction in mortality in 1050 black patients with heart failure already treated with recommended neurohormonal inhibiting drugs. Whether the fixed-dose combination produces a further regression of LV remodeling when added to renin-angiotensin and sympathetic inhibitors has not been documented. Methods and Results Echocardiograms at baseline and 6 months after randomization to placebo or a fixed-dose combination of Isosorbide Dinitrate/hydralazine (FDC I/H) were analyzed in 678 A-HeFT participants in a core laboratory. LVEF rose by 2.8 EF units in the FDC I/H group versus 0.8% in the control group ( P 2 in the FDC I/H group versus an increase of 1.4 g/m 2 in the placebo group ( P P P = .05). Conclusions A fixed-dose combination of I/H produces regression of LV remodeling when added to background therapy with renin-angiotensin and sympathetic inhibitors in black patients with heart failure. This remodeling benefit may explain at least in part the mortality reduction in A-HeFT.
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Isosorbide Dinitrate and hydralazine in a fixed dose combination produces further regression of left ventricular remodeling in a well treated black population with heart failure results from a heft
Journal of Cardiac Failure, 2007Co-Authors: Jay N. Cohn, Inder S Anand, Anne L Taylor, Michael L Sabolinski, William S Tam, Manuel WorcelAbstract:Abstract Background Isosorbide Dinitrate combined with hydralazine therapy compared with placebo in patients with heart failure resulted in a sustained increase in left ventricular (LV) ejection fraction (EF) indicative of regression of LV remodeling in the first Vasodilator-Heart Failure Trial (V-HeFT-I) in patients receiving only digoxin and diuretic. In the African-American Heart Failure Trial (A-HeFT) a fixed-dose combination resulted in a 43% reduction in mortality in 1050 black patients with heart failure already treated with recommended neurohormonal inhibiting drugs. Whether the fixed-dose combination produces a further regression of LV remodeling when added to renin-angiotensin and sympathetic inhibitors has not been documented. Methods and Results Echocardiograms at baseline and 6 months after randomization to placebo or a fixed-dose combination of Isosorbide Dinitrate/hydralazine (FDC I/H) were analyzed in 678 A-HeFT participants in a core laboratory. LVEF rose by 2.8 EF units in the FDC I/H group versus 0.8% in the control group ( P 2 in the FDC I/H group versus an increase of 1.4 g/m 2 in the placebo group ( P P P = .05). Conclusions A fixed-dose combination of I/H produces regression of LV remodeling when added to background therapy with renin-angiotensin and sympathetic inhibitors in black patients with heart failure. This remodeling benefit may explain at least in part the mortality reduction in A-HeFT.
Clyde W Yancy - One of the best experts on this subject based on the ideXlab platform.
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response to letter regarding article hydralazine and Isosorbide Dinitrate in heart failure historical perspectives mechanisms and future directions
Circulation, 2011Co-Authors: Robert T Cole, Andreas P Kalogeropoulos, Vasiliki V Georgiopoulou, Arshed A Quyyumi, Javed Butler, Mihai Gheorghiade, Clyde W YancyAbstract:We appreciate the careful review by Drs Taylor, Hare, and Mann of our article1 and their thoughtful letter in response to it. The importance of studying the combination of hydralazine and Isosorbide Dinitrate in heart failure has been highlighted both by our review and by their letter. It is not uncommon for drug research and development to fall into either of the 2 following scenarios. Some drugs may enter phase III trials without a comprehensive understanding of their systemic and organ-specific mechanistic effects. In …
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hydralazine and Isosorbide Dinitrate in heart failure historical perspective mechanisms and future directions
Circulation, 2011Co-Authors: Robert T Cole, Clyde W Yancy, Andreas P Kalogeropoulos, Vasiliki V Georgiopoulou, Arshed A Quyyumi, Mihai Gheorghiade, Javed ButlerAbstract:Until the 1970s, treatment options for heart failure were limited to digitalis and diuretics.1 Although effective for symptoms, there was no evidence of mortality benefit with this combination, and it was an inadequate option for many patients with advanced symptoms. The search for more effective options led to strategies that modulated hemodynamics.1 Numerous physiological studies showed the dependence of ventricular function on vascular resistance, and drugs that reduced systemic vascular resistance improved cardiac performance.2,–,5 A pivotal study by Franciosa et al6 showed that sodium nitroprusside in patients with heart failure in the setting of acute myocardial infarction reduced left ventricular filling pressures from 22.7±2.0 to 11.3±1.6 mm Hg and led to a modest increase in cardiac output. A subsequent study revealed more striking improvements in patients with refractory heart failure, in whom nitroprusside reduced systemic vascular resistance by 50%, increased cardiac output by 56%, and reduced left ventricular filling pressure by 47%.7 These hemodynamic benefits with nitroprusside led to studies with oral agents, including hydralazine, Isosorbide Dinitrate (ISDN), prazosin, phentolamine, and minoxidil. Although these drugs did affect hemodynamics, none was as effective as nitroprusside individually.8,–,12 In 1977, Massie et al13 studied the combination of 2 oral agents, hydralazine and ISDN (H-ISDN) in class III to IV heart failure patients, proposing that simultaneously reducing preload with ISDN and afterload with hydralazine would result in a better response than with either drug individually. They found that H-ISDN reduced left ventricular filling pressure by 36%, increased cardiac index by 58%, and reduced systemic vascular resistance by 34%. Later, Pierpont et al14 compared H-ISDN with nitroprusside and showed that the 2 therapies had similar effects on wedge pressure reduction and cardiac index increase. Considering these hemodynamic benefits with …
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Isosorbide Dinitrate hydralazine combination therapy in african americans with heart failure
Vascular Health and Risk Management, 2006Co-Authors: Melvin R Echols, Clyde W YancyAbstract:Despite significant improvement in therapy and management, heart failure remains a worrisome disease state that is especially problematic in special populations. African Americans suffer a disproportionately higher prevalence of heart failure when compared to other populations. It has been recently demonstrated that vasodilator therapy using the combination of Isosorbide Dinitrate (ISDN) and hydralazine (HYD) as an adjunct to background evidence-based therapy appears to display the strongest signal of benefit in reducing mortality and morbidity in the African American population. Through review of the retrospective and more recent prospective data, we will focus on the benefit of ISDN-HYD as adjunctive therapy for use in African Americans with systolic heart failure on concomitant appropriate evidence based therapy. This review also closely examines some of the potential contributions to endothelial dysfunction in African Americans, and the relationship of vascular homeostasis and nitric oxide. The role of oxidative stress in left ventricular dysfunction will also be explored as a reduction of oxidative stress offers particular promise in the management of heart failure. Although neurohormonal blockade has been responsible for notable event reductions in patients with systolic heart failure, the addition of ISDN-HYD, vasodilator therapy that enhances nitric oxide and reduces oxidative stress, further improves quality of life and survival in African American patients with heart failure. These findings strongly imply that nitric oxide enhancement and/or oxidative stress reduction may be important new therapeutic directions in the management of heart failure.
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combination of Isosorbide Dinitrate and hydralazine in blacks with heart failure
The New England Journal of Medicine, 2004Co-Authors: Anne L Taylor, Susan Ziesche, Clyde W Yancy, Peter E Carson, Keith C Ferdinand, Malcolm Taylor, Kirkwood F Adams, Michael L Sabolinski, Manuel Worcel, Jay N. CohnAbstract:background We examined whether a fixed dose of both Isosorbide Dinitrate and hydralazine provides additional benefit in blacks with advanced heart failure, a subgroup previously noted to have a favorable response to this therapy. methods A total of 1050 black patients who had New York Heart Association class III or IV heart failure with dilated ventricles were randomly assigned to receive a fixed dose of Isosorbide Dinitrate plus hydralazine or placebo in addition to standard therapy for heart failure. The primary end point was a composite score made up of weighted values for death from any cause, a first hospitalization for heart failure, and change in the quality of life. results The study was terminated early owing to a significantly higher mortality rate in the placebo group than in the group given Isosorbide Dinitrate plus hydralazine (10.2 percent vs. 6.2 percent, P = 0.02). The mean primary composite score was significantly better in the group given Isosorbide Dinitrate plus hydralazine than in the placebo group (i0.1±1.9 vs. i0.5±2.0, P=0.01; range of possible values, –6 to +2), as were its individual components (43 percent reduction in the rate of death from any cause [hazard ratio, 0.57; P=0.01] 33 percent relative reduction in the rate of first hospitalization for heart failure [16.4 percent vs. 22.4 percent, P=0.001], and an improvement in the quality of life [change in score, i5.6±20.6 vs. i2.7±21.2, with lower scores indicating better quality of life; P=0.02; range of possible values, 0 to 105]). conclusions The addition of a fixed dose of Isosorbide Dinitrate plus hydralazine to standard therapy for heart failure including neurohormonal blockers is efficacious and increases survival among black patients with advanced heart failure.
Anne L Taylor - One of the best experts on this subject based on the ideXlab platform.
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effect of fixed dose combined Isosorbide Dinitrate hydralazine in elderly patients in the african american heart failure trial
Journal of Cardiac Failure, 2012Co-Authors: Anne L Taylor, Susan Ziesche, Michael L Sabolinski, Manuel Worcel, Jalal K Ghali, Tad W Archambault, Jay N. CohnAbstract:Abstract Background Fixed-dose combined Isosorbide Dinitrate/hydralazine (FDC I/H) significantly improved outcomes in patients with advanced heart failure (HF) receiving background neurohormonal therapy in the African-American Heart Failure Trial (A-HeFT). In this analysis, we investigated treatment effects by age Methods and Results Time-to-event curves were produced by the Kaplan-Meier method. Hazard ratios were calculated with the Cox proportional hazards model. Baseline characteristics showed that patients ≥65 years old had less hypertensive and more ischemic HF, better quality of life (QoL) scores, higher plasma B-type natriuretic peptide and creatinine levels, and received less background neurohormonal therapy. Kaplan-Meier curves showed that FDC I/H improved mortality and event-free survival in elderly patients. The hazard ratios for mortality, first heart failure hospitalization, and event-free survival (both unadjusted and adjusted for baseline differences), were similar quantitatively and in direction of effect in both age groups. Conclusions In A-HeFT, FDC I/H improved outcomes in HF patients aged
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combination of Isosorbide Dinitrate and hydralazine reduces 30 day hospital readmissions and increases time to hospital readmission in blacks with heart failure
Journal of the American College of Cardiology, 2012Co-Authors: Inderjit Anand, Jay N. Cohn, Thomas S Rector, Howard Furst, Anne L TaylorAbstract:A fixed dose combination of Isosorbide Dinitrate plus hydralazine (FDC I/H) reduced mortality in black patients with moderate to severe heart failure in the African-American Heart Failure Trial (A-HeFT). We further examined its effect on hospital readmissions. A total of 1050 black patients with
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Isosorbide Dinitrate and hydralazine in a fixed dose combination produces further regression of left ventricular remodeling in a well treated black population with heart failure results from a heft
Journal of Cardiac Failure, 2007Co-Authors: Jay N. Cohn, Inder S Anand, Anne L Taylor, Michael L Sabolinski, Manuel WorcelAbstract:Abstract Background Isosorbide Dinitrate combined with hydralazine therapy compared with placebo in patients with heart failure resulted in a sustained increase in left ventricular (LV) ejection fraction (EF) indicative of regression of LV remodeling in the first Vasodilator-Heart Failure Trial (V-HeFT-I) in patients receiving only digoxin and diuretic. In the African-American Heart Failure Trial (A-HeFT) a fixed-dose combination resulted in a 43% reduction in mortality in 1050 black patients with heart failure already treated with recommended neurohormonal inhibiting drugs. Whether the fixed-dose combination produces a further regression of LV remodeling when added to renin-angiotensin and sympathetic inhibitors has not been documented. Methods and Results Echocardiograms at baseline and 6 months after randomization to placebo or a fixed-dose combination of Isosorbide Dinitrate/hydralazine (FDC I/H) were analyzed in 678 A-HeFT participants in a core laboratory. LVEF rose by 2.8 EF units in the FDC I/H group versus 0.8% in the control group ( P 2 in the FDC I/H group versus an increase of 1.4 g/m 2 in the placebo group ( P P P = .05). Conclusions A fixed-dose combination of I/H produces regression of LV remodeling when added to background therapy with renin-angiotensin and sympathetic inhibitors in black patients with heart failure. This remodeling benefit may explain at least in part the mortality reduction in A-HeFT.
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Isosorbide Dinitrate and hydralazine in a fixed dose combination produces further regression of left ventricular remodeling in a well treated black population with heart failure results from a heft
Journal of Cardiac Failure, 2007Co-Authors: Jay N. Cohn, Inder S Anand, Anne L Taylor, Michael L Sabolinski, William S Tam, Manuel WorcelAbstract:Abstract Background Isosorbide Dinitrate combined with hydralazine therapy compared with placebo in patients with heart failure resulted in a sustained increase in left ventricular (LV) ejection fraction (EF) indicative of regression of LV remodeling in the first Vasodilator-Heart Failure Trial (V-HeFT-I) in patients receiving only digoxin and diuretic. In the African-American Heart Failure Trial (A-HeFT) a fixed-dose combination resulted in a 43% reduction in mortality in 1050 black patients with heart failure already treated with recommended neurohormonal inhibiting drugs. Whether the fixed-dose combination produces a further regression of LV remodeling when added to renin-angiotensin and sympathetic inhibitors has not been documented. Methods and Results Echocardiograms at baseline and 6 months after randomization to placebo or a fixed-dose combination of Isosorbide Dinitrate/hydralazine (FDC I/H) were analyzed in 678 A-HeFT participants in a core laboratory. LVEF rose by 2.8 EF units in the FDC I/H group versus 0.8% in the control group ( P 2 in the FDC I/H group versus an increase of 1.4 g/m 2 in the placebo group ( P P P = .05). Conclusions A fixed-dose combination of I/H produces regression of LV remodeling when added to background therapy with renin-angiotensin and sympathetic inhibitors in black patients with heart failure. This remodeling benefit may explain at least in part the mortality reduction in A-HeFT.
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effects of ace inhibitors or β blockers in patients treated with the fixed dose combination of Isosorbide Dinitrate hydralazine in the african american heart failure trial
American Journal of Cardiovascular Drugs, 2007Co-Authors: Jalal K Ghali, Anne L Taylor, Keith C Ferdinand, Michael L Sabolinski, Manuel Worcel, Joann Lindenfeld, Charles L Curry, Jay N. CohnAbstract:Background In the A-HeFT (African-American Heart Failure Trial), treatment of African-American patients with New York Heart Association (NYHA) class III/IV heart failure (HF) with fixed-dose combination (FDC) of Isosorbide Dinitrate/hydralazine (I/H) reduced mortality and morbidity and improved patient reported functional status compared with standard therapy alone.
Manuel Worcel - One of the best experts on this subject based on the ideXlab platform.
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effect of fixed dose combined Isosorbide Dinitrate hydralazine in elderly patients in the african american heart failure trial
Journal of Cardiac Failure, 2012Co-Authors: Anne L Taylor, Susan Ziesche, Michael L Sabolinski, Manuel Worcel, Jalal K Ghali, Tad W Archambault, Jay N. CohnAbstract:Abstract Background Fixed-dose combined Isosorbide Dinitrate/hydralazine (FDC I/H) significantly improved outcomes in patients with advanced heart failure (HF) receiving background neurohormonal therapy in the African-American Heart Failure Trial (A-HeFT). In this analysis, we investigated treatment effects by age Methods and Results Time-to-event curves were produced by the Kaplan-Meier method. Hazard ratios were calculated with the Cox proportional hazards model. Baseline characteristics showed that patients ≥65 years old had less hypertensive and more ischemic HF, better quality of life (QoL) scores, higher plasma B-type natriuretic peptide and creatinine levels, and received less background neurohormonal therapy. Kaplan-Meier curves showed that FDC I/H improved mortality and event-free survival in elderly patients. The hazard ratios for mortality, first heart failure hospitalization, and event-free survival (both unadjusted and adjusted for baseline differences), were similar quantitatively and in direction of effect in both age groups. Conclusions In A-HeFT, FDC I/H improved outcomes in HF patients aged
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lack of bioequivalence between different formulations of Isosorbide Dinitrate and hydralazine and the fixed dose combination of Isosorbide Dinitrate hydralazine the v heft paradox
Clinical Pharmacokinectics, 2007Co-Authors: Michael L Sabolinski, Manuel Worcel, Milton Packer, Jay N. CohnAbstract:Objective To investigate whether the apparent discrepancy between the efficacy of the combination of Isosorbide Dinitrate (ISDN) and hydralazine demonstrated in the first V-HeFT trial (V-HeFT I) and that in V-HeFT II could be explained by pharmacokinetic differences in the study drug formulations, and to compare the pharmacokinetic profile of the fixed-dose combination of ISDN/hydralazine (FDC ISDN/HYD; BiDil®) formulation used in A-HeFT with that of the V-HeFT study drug formulations.
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Isosorbide Dinitrate and hydralazine in a fixed dose combination produces further regression of left ventricular remodeling in a well treated black population with heart failure results from a heft
Journal of Cardiac Failure, 2007Co-Authors: Jay N. Cohn, Inder S Anand, Anne L Taylor, Michael L Sabolinski, Manuel WorcelAbstract:Abstract Background Isosorbide Dinitrate combined with hydralazine therapy compared with placebo in patients with heart failure resulted in a sustained increase in left ventricular (LV) ejection fraction (EF) indicative of regression of LV remodeling in the first Vasodilator-Heart Failure Trial (V-HeFT-I) in patients receiving only digoxin and diuretic. In the African-American Heart Failure Trial (A-HeFT) a fixed-dose combination resulted in a 43% reduction in mortality in 1050 black patients with heart failure already treated with recommended neurohormonal inhibiting drugs. Whether the fixed-dose combination produces a further regression of LV remodeling when added to renin-angiotensin and sympathetic inhibitors has not been documented. Methods and Results Echocardiograms at baseline and 6 months after randomization to placebo or a fixed-dose combination of Isosorbide Dinitrate/hydralazine (FDC I/H) were analyzed in 678 A-HeFT participants in a core laboratory. LVEF rose by 2.8 EF units in the FDC I/H group versus 0.8% in the control group ( P 2 in the FDC I/H group versus an increase of 1.4 g/m 2 in the placebo group ( P P P = .05). Conclusions A fixed-dose combination of I/H produces regression of LV remodeling when added to background therapy with renin-angiotensin and sympathetic inhibitors in black patients with heart failure. This remodeling benefit may explain at least in part the mortality reduction in A-HeFT.
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Isosorbide Dinitrate and hydralazine in a fixed dose combination produces further regression of left ventricular remodeling in a well treated black population with heart failure results from a heft
Journal of Cardiac Failure, 2007Co-Authors: Jay N. Cohn, Inder S Anand, Anne L Taylor, Michael L Sabolinski, William S Tam, Manuel WorcelAbstract:Abstract Background Isosorbide Dinitrate combined with hydralazine therapy compared with placebo in patients with heart failure resulted in a sustained increase in left ventricular (LV) ejection fraction (EF) indicative of regression of LV remodeling in the first Vasodilator-Heart Failure Trial (V-HeFT-I) in patients receiving only digoxin and diuretic. In the African-American Heart Failure Trial (A-HeFT) a fixed-dose combination resulted in a 43% reduction in mortality in 1050 black patients with heart failure already treated with recommended neurohormonal inhibiting drugs. Whether the fixed-dose combination produces a further regression of LV remodeling when added to renin-angiotensin and sympathetic inhibitors has not been documented. Methods and Results Echocardiograms at baseline and 6 months after randomization to placebo or a fixed-dose combination of Isosorbide Dinitrate/hydralazine (FDC I/H) were analyzed in 678 A-HeFT participants in a core laboratory. LVEF rose by 2.8 EF units in the FDC I/H group versus 0.8% in the control group ( P 2 in the FDC I/H group versus an increase of 1.4 g/m 2 in the placebo group ( P P P = .05). Conclusions A fixed-dose combination of I/H produces regression of LV remodeling when added to background therapy with renin-angiotensin and sympathetic inhibitors in black patients with heart failure. This remodeling benefit may explain at least in part the mortality reduction in A-HeFT.
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effects of ace inhibitors or β blockers in patients treated with the fixed dose combination of Isosorbide Dinitrate hydralazine in the african american heart failure trial
American Journal of Cardiovascular Drugs, 2007Co-Authors: Jalal K Ghali, Anne L Taylor, Keith C Ferdinand, Michael L Sabolinski, Manuel Worcel, Joann Lindenfeld, Charles L Curry, Jay N. CohnAbstract:Background In the A-HeFT (African-American Heart Failure Trial), treatment of African-American patients with New York Heart Association (NYHA) class III/IV heart failure (HF) with fixed-dose combination (FDC) of Isosorbide Dinitrate/hydralazine (I/H) reduced mortality and morbidity and improved patient reported functional status compared with standard therapy alone.
Michael F Gerhards - One of the best experts on this subject based on the ideXlab platform.
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blinded randomized clinical trial of botulinum toxin versus Isosorbide Dinitrate ointment for treatment of anal fissure
British Journal of Surgery, 2009Co-Authors: Sebastiaan Festen, Suzanne S Gisbertz, F Van Schaagen, Michael F GerhardsAbstract:BACKGROUND: Nitric oxide donors such as Isosorbide Dinitrate (ISDN) are considered the first choice of treatment for anal fissure. After reports of the successful treatment of such fissures with botulinum toxin, this randomized blinded trial compared botulinum toxin with ISDN in the treatment of chronic anal fissure. METHODS: Patients were randomized to receive an injection of botulinum in the internal anal sphincter and a placebo ointment, or a placebo injection and ISDN ointment. The primary endpoint was macroscopic fissure healing after 4 months. RESULTS: After 4 months macroscopic healing of the fissures was noted in 14 of 37 patients in the botulinum group and 21 of 36 in the ISDN group. Pain scores were lower among patients who received ISDN, although the difference was not significant. Side-effects were similar in the two groups. CONCLUSION: In contrast with previous reports on botulinum toxin as a therapeutic agent for anal fissure, this study found no advantage over treatment with a nitric oxide donor as regards fissure healing and fissure-related pain.
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blinded randomized clinical trial of botulinum toxin versus Isosorbide Dinitrate ointment for treatment of anal fissure
British Journal of Surgery, 2009Co-Authors: Sebastiaan Festen, Suzanne S Gisbertz, F Van Schaagen, Michael F GerhardsAbstract:Background: Nitric oxide donors such as Isosorbide Dinitrate (ISDN) are considered the first choice of treatment for anal fissure. After reports of the successful treatment of such fissures with botulinum toxin, this randomized blinded trial compared botulinum toxin with ISDN in the treatment of chronic anal fissure. Methods: Patients were randomized to receive an injection of botulinum in the internal anal sphincter and a placebo ointment, or a placebo injection and ISDN ointment. The primary endpoint was macroscopic fissure healing after 4 months. Results: After 4 months macroscopic healing of the fissures was noted in 14 of 37 patients in the botulinum group and 21 of 36 in the ISDN group. Pain scores were lower among patients who received ISDN, although the difference was not significant. Side-effects were similar in the two groups. Conclusion: In contrast with previous reports on botulinum toxin as a therapeutic agent for anal fissure, this study found no advantage over treatment with a nitric oxide donor as regards fissure healing and fissure-related pain. Copyright © 2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.