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9. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure

Author

Packer, Milton, Bristow, Michael R., Cohn, Jay N., Colucci, Wilson S., Fowler, Michael B., Gilbert, Edward M., and Shusterman, Neil H.

Subjects
Heart failure -- Drug therapy, Adrenergic beta blockers -- Evaluation
Abstract

Carvedilol appears to reduce mortality from heart failure. Carvedilol is a beta blocker that also affects alpha1 receptors. Of 1,094 people with chronic heart failure, 696 took approximately 45 milligrams of carvedilol every day and 398 took a placebo. Most of the participants were taking other heart medications. Treatment lasted up to 15 months. Three percent of the patients taking carvedilol died compared to 8% of those in the placebo group. Hospitalization rates were 27% less in the carvedilol group compared to the placebo group. Heart rate dropped significantly in those taking carvedilol but blood pressure remained the same in both groups. Dizziness was the most common side effect of carvedilol followed by fatigue and shortness of breath. Only 6% of those taking carvedilol had to stop taking the drug because of side effects. Other beta blockers may not have the same effect on mortality as carvedilol.

Published
1996

12. Fenoldopam, but not nitroprusside, improves renal function in severely hypertensive patients with impaired renal function

Author

Shusterman, Neil H., Elliott, William J., and White, William B.

Subjects
Dopamine -- Agonists, Sodium nitroferricyanide -- Physiological aspects, Antihypertensive drugs -- Evaluation, Hypertension -- Drug therapy, Chronic kidney failure -- Drug therapy, Health, Health care industry
Abstract

Purpose: Patients with hypertensive crises often experience reduced renal function that may worsen as the elevated blood pressure is treated. Fenoldopam, a novel, peripherally acting dopamine-1 agonist, lowers blood pressure through arteriolar vasolidation, with particularly prominent effects on the renal vascular bed. This study was conducted to examine the effects of fenoldopam on blood pressure and renal function compared to those of sodium nitroprusside in severely hypertensive patients with impaired renal function. Patients and methods: Renal function and systemic hemodynamics were studied in 19 severely hypertensive patients (diastolic blood pressure greater than or equal to 120 mm Hg) with impaired renal function (creatinine clearance less than or equal to 70 mL/min) enrolled in clinical trials of fenoldopam and sodium nitroprusside. For comparison, an additional 22 severely hypertensive patients with nonimpaired renal function were studied under the same conditions. Blood pressure and heart rate were measured at baseline before treatment and periodically during treatment. Renal function was determined before and during drug infusion by collection of timed urine specimens and blood samples. Creatinine clearance, urine flow rate, and sodium and potassium excretions were measured and compared. Results: In patients with impaired renal function, blood pressure (mean [+ or -] SEM) was reduced success in both groups (fenoldopam: 214 [+ or -] 8/139 [+ or -] 6 mm Hg to 176 [+ or -] 8/107 [+ or -] 3 mm Hg, p

Published
1993

14. Converting from Transdermal to Buccal Formulations of Buprenorphine: A Pharmacokinetic Meta-Model Simulation in Healthy Volunteers.

Author

Priestley, Tony, Chappa, Arvind K, Mould, Diane R, Upton, Richard N, Shusterman, Neil, Passik, Steven, Tormo, Vicente J, and Camper, Stephen

Subjects
BUPRENORPHINE, DRUG administration, DRUG labeling, MATHEMATICAL models, TRANSDERMAL medication, THEORY, BUCCAL administration
Abstract

Objective To develop a model to predict buprenorphine plasma concentrations during transition from transdermal to buccal administration. Design Population pharmacokinetic model-based meta-analysis of published data. Methods A model-based meta-analysis of available buprenorphine pharmacokinetic data in healthy adults, extracted as aggregate (mean) data from published literature, was performed to explore potential conversion from transdermal to buccal buprenorphine. The time course of mean buprenorphine plasma concentrations following application of transdermal patch or buccal film was digitized from available literature, and a meta-model was developed using specific pharmacokinetic parameters (e.g. absorption rate, apparent clearance, and volumes of distribution) derived from analysis of pharmacokinetic data for intravenously, transdermally, and buccally administered buprenorphine. Results Data from six studies were included in this analysis. The final transdermal absorption model employed a zero-order input rate that was scaled to reflect a nominal patch delivery rate and time after patch application (with decline in rate over time). The transdermal absorption rate constant became zero following patch removal. Buccal absorption was a first-order process with a time lag and bioavailability term. Simulations of conversion from transdermal 20 mcg/h and 10 mcg/h to buccal administration suggest that transition can be made rapidly (beginning 12 hours after patch removal) using the recommended buccal formulation titration increments (75–150 mcg) and schedule (every four days) described in the product labeling. Conclusions Computer modeling and simulations using a meta-model built from data extracted from publications suggest that rapid and straightforward conversion from transdermal to buccal buprenorphine is feasible. [ABSTRACT FROM AUTHOR]

Published
2018
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19. Effect of gender on the outcome of patients with severe heart failure treated with carvedliol: results of the COPERNICUS study

Author

Tendera, Michal P., primary, Coats, Andrew J., additional, Fowler, Michael B., additional, Katus, Hugo A., additional, Mohacsi, Paul, additional, Rouleau, Jean L., additional, Krum, Henry, additional, Amann-Zalan, Ildiko, additional, Shusterman, Neil H., additional, Roecker, Ellen B., additional, and Packer, Milton, additional

Published
2002
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21. The PRESTO (Prevention of Restenosis with Tranilast and its Outcomes) protocol: A double-blind, placebo-controlled trial

Author

Gheorghiade, Mihai D., primary, Holmes, David D., additional, Fitzgerald, Peter D., additional, Goldberg, Sheldon D., additional, LaBlanche, J-M D., additional, Lincoff, A. Michael, additional, Savage, Michael Michael, additional, Serruys, P. W., additional, Willerson, James W., additional, Granett, Jeffrey R., additional, Chan, Robert R., additional, and Shusterman, Neil H., additional

Published
2000
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24. Double-Blind, Placebo-Controlled Study of the Effects of Carvedilol in Patients With Moderate to Severe Heart Failure

Author

Packer, Milton, primary, Colucci, Wilson S., additional, Sackner-Bernstein, Jonathan D., additional, Liang, Chang-seng, additional, Goldscher, David A., additional, Freeman, Israel, additional, Kukin, Marrick L., additional, Kinhal, Vithal, additional, Udelson, James E., additional, Klapholz, Marc, additional, Gottlieb, Stephen S., additional, Pearle, David, additional, Cody, Robert J., additional, Gregory, John J., additional, Kantrowitz, Nikki E., additional, LeJemtel, Thierry H., additional, Young, Sarah T., additional, Lukas, Mary Ann, additional, and Shusterman, Neil H., additional

Published
1996
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25. Carvedilol Produces Dose-Related Improvements in Left Ventricular Function and Survival in Subjects With Chronic Heart Failure

Author

Bristow, Michael R., primary, Gilbert, Edward M., additional, Abraham, William T., additional, Adams, Kirkwood F., additional, Fowler, Michael B., additional, Hershberger, Ray E., additional, Kubo, Spencer H., additional, Narahara, Kenneth A., additional, Ingersoll, Henry, additional, Krueger, Steven, additional, Young, Sarah, additional, and Shusterman, Neil, additional

Published
1996
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30. Factors Influencing Erythrocyte Sedimentation in Patients With Chronic Renal Failure

Author

Shusterman, Neil, Kimmel, Paul L., Kiechle, Frederick L., Williams, Susan, Morrison, Gail, and Singer, Irwin

Abstract

• Erythrocyte sedimentation was studied in stable patients with chronic renal failure free of complicating illnesses. The mean (±SD) Westergren erythrocyte sedimentation rate was 49±26 mm/hr in patients not receiving dialysis and 60±33 mm/hr in patients receiving hemodialysis. Both values are significantly higher than normal. Because anemia accelerates the Westergren determination, we restudied the patients with the zeta sedimentation ratio (ZSR), a method unaffected by hematocrit. In nine patients not receiving dialysis and 49 patients receiving hemodialysis, the ZSR was significantly higher than normal. The ZSR correlated positively with plasma fibrinogen concentration. Recombination experiments showed that the abnormal factor accelerating erythrocyte sedimentation was a constituent of plasma. Thus, erythrocyte sedimentation is accelerated in stable patients with chronic renal failure and a plasma factor, probably fibrinogen, is responsible. An elevated erythrocyte sedimentation rate in this population lacks diagnostic usefulness.(Arch Intern Med 1985;145:1796-1799)

Published
1985
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33. Cardiorenal disorders and diseases

Author

Shusterman, Neil H.

Subjects
Cardiorenal Disorders and Diseases (Book) -- Book reviews, Books -- Book reviews
Published
1987

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