Rafe Donahue - Academia.edu (original) (raw)
Papers by Rafe Donahue
Epilepsy is a significant comorbid condition in institutionalized persons with developmental disa... more Epilepsy is a significant comorbid condition in institutionalized persons with developmental disabilities and may contribute significant additional costs. This study was conducted to provide an estimate of the costs of epilepsy from the institutional perspective. Costs were measured retrospectively for 50 persons with epilepsy and 50 persons without epilepsy matched by severity of developmental disability. A time and motion study was employed to assign opportunity costs to documented nursing and physician activities. Two separate methods of attribution were used and incremental costs attributable to epilepsy were found to be approximately 825and825 and 825and918 per person over a 6-month period. The following categories accounted for costs: personnel (47.0%), drug (39.6%), hospitalization (9.4%), and laboratories/procedures (4.0%). Results are useful for describing the economic burden of epilepsy.
Eur Neuropsychopharmacol, 1998
Statistics & Probability Letters, 1995
Every second-order stationary process with index set {0, ±1, ±2, …} and zero autocorrelations at ... more Every second-order stationary process with index set {0, ±1, ±2, …} and zero autocorrelations at lags greater than one can be represented as a causal moving average of order one. On the other hand, there may not be a finite-order moving average representation of a stationary process which is indexed by the two-dimensional integer lattice and which has zero autocorrelations when at least one lag is greater than one. We investigate such processes.
Neuropsychopharmacology, 2001
Our objective was to determine if pretreatment anxiety levels were associated with preferential r... more Our objective was to determine if pretreatment anxiety levels were associated with preferential response to bupropion sustained release (n = 122) or sertraline (n = 126) during a 16-week randomized acute phase treatment study. Both agents had comparable antidepressant activity, and comparable anxiolytic effects using the intent-to-treat sample. Baseline anxiety levels were not related to antidepressant efficacy, and they did not differentiate responders to each agent. Time to clinically significant anxiolysis did not differentiate between treatment groups or between responders to each agent. These results contradict the commonly held, but unsubstantiated, belief that in clinically depressed anxious patients, serotonergic antidepressants are especially anxiolytic and that such patients preferentially benefit from the antidepressant or anxiolytic effects of selective serotonin reuptake inhibitors. Thus, the clinical decision to select between these two agents when treating depressed outpatients cannot rest on either levels of pretreatment anxiety or on anticipation of more rapid or more complete anxiolysis.
Journal of Surgical Research, 2008
reperfusion, but the effect on the inflammatory response in humans remains largerly unknown. The ... more reperfusion, but the effect on the inflammatory response in humans remains largerly unknown. The purpose of this study is to investigate the effect of enterally administered omega-3 fatty acid on subsequent immunity and complications. Methods: Serial bood samples were drawn (12 hrs, 24hrs and 7 days after injury) from patients enrolled in a prospective, randomized, double-blind trial of enteral omega-3 fatty acid supplementation versus placebo. Obtained whole blood was analyzed by flow cytometry for the surface expression of CD14 and CD16, and the intracellular cytokine expression of IL-6 and TNF-␣. Patient demographics and outcome variables were prospectively collected. Results: 36 traumatically injured patients were enrolled, with 17 patients recieving omega-3 fatty acid supplementation. No difference was noted between groups in regards age, sex, or injury severity. The precentage of CD14ϩCD16ϩ monocytes was significantly decreased in patients receiving omega-3 fatty acid only at day 7 following injury (16.8 Ϯ 1.8 vs. 21.4 Ϯ 1.5, pϽ0.001). CD16ϩ cells were more commonly associated with increased intracellular cytokine levels of both IL-6 and TNF-␣ compared to CD16-cells, suggesting CD14ϩCD16ϩ cells as pro-inflammatory. No difference in the rate of nosocomial infection was noted between omega-3 fatty acid supplementation and placebo (11 vs. 8, pϭ0.202). However, patients receiving omega-3 fatty acid supplemenation had more progression of MODS as defined by a Marshall MOD score (5.47 Ϯ 0.58 vs. 7.42 Ϯ 0.51, pϭ 0.016). Ventilator days (10.82 Ϯ 1.34 vs. 15.68 Ϯ 1.89, pϭ0.044) and ICU length of stay (12.06 Ϯ 1.31 vs. 16.68 Ϯ 1.87, pϭ0
JONA: The Journal of Nursing Administration, 2000
To compare results obtained from a time-and-motion study with those obtained using self-reporting... more To compare results obtained from a time-and-motion study with those obtained using self-reporting. Nurse executives are often required to provide additional patient care services with limited personnel resources. As a result, nurse executives must evaluate the appropriate allocation of nursing personnel resources. Work measurement may be used to evaluate personnel allocation. Multiple measurement approaches are available, but few studies have compared these methods. Eight nurses were observed by a single observer during five shifts (or approximately 40 hours per nurse). After completion of the time-and-motion study, participants were to self-report their work activities during their ensuing five shifts. Mixed-effects analysis of variance was used to determine the significance of the work measurement method on percentage of total time, number of activities, and mean time per activity by activity category. Two hundred ninety hours of time-and-motion study observations and 338 hours of self-report data were available for analysis. Comparable amounts of total time were reported within the various activity categories using time-and-motion and self-reporting methods. In terms of number of activities reported, a significantly higher number of activities were reported using time-and-motion. As a result, mean activity times were significantly longer using the self-reporting method compared with time-and-motion. Nurse executives should consider continuous self-reporting as a low-cost means of quantifying allocation of time among nursing personnel. Self-reporting, however, is not recommended for estimating the total number of activities or the mean time per activity because of perceptual differences between participants of what constitutes an activity.
Journal of Clinical Psychopharmacology, 2000
... MD*; Kavoussi, Richard MD; Hughes, Arlene R. PhD; Batey, Sharyn R. PharmD; Johnston, J. An... more ... MD*; Kavoussi, Richard MD; Hughes, Arlene R. PhD; Batey, Sharyn R. PharmD; Johnston, J. Andrew PharmD; Donahue, Rafe PhD; Ascher ... Two hundred forty-eight patients who had received a diagnosis of moderate to severe major depression were randomly assigned ...
The Journal of Clinical Psychiatry, 2001
The Journal of Clinical Psychiatry, 2000
Depression is a serious and widespread emotional disorder among the elderly. This study compared ... more Depression is a serious and widespread emotional disorder among the elderly. This study compared the efficacy and safety of bupropion sustained release (SR) with the selective serotonin reuptake inhibitor paroxetine in the treatment of major depression in elderly outpatients. Elderly (> or = 60 years) outpatients with major depressive disorder (DSM-IV criteria) were evaluated in this 6-week multicenter, randomized, double-blind study comparing bupropion SR, 100-300 mg/day, and paroxetine, 10-40 mg/day. Efficacy was assessed by changes in scores on the Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A) and the Clinical Global Impressions-Severity of Illness and -Improvement scales. Safety was assessed by monitoring adverse events, vital signs, and body weight. A total of 100 patients ranging in age from 60 to 88 years were randomly assigned to treatment with bupropion SR (N = 48) or paroxetine (N = 52). Measurements of efficacy were similar between the 2 treatment groups, with both groups showing improved scores on all depression rating scales. Headache, insomnia, dry mouth, agitation, dizziness, and nausea occurred in > 10% of patients in both groups; somnolence, diarrhea, constipation, and anorexia occurred in > 10% of patients in the paroxetine group. No statistically significant differences between groups in vital signs or weight were found. Both bupropion SR and paroxetine were safe and effective for the treatment of depression in the elderly. Because of its favorable side effect profile, bupropion SR may provide a safe and effective nonserotonergic treatment alternative that is well suited as an antidepressant for the elderly.
The Journal of Clinical Psychiatry, 2001
To examine the effects of bupropion sustained release (SR) and sertraline on anxiety in outpatien... more To examine the effects of bupropion sustained release (SR) and sertraline on anxiety in outpatients with recurrent DSM-IV-defined major depressive disorder. This retrospective analysis was conducted using pooled data from 2 identical, 8-week, acute-phase, double-blind, placebo-controlled, parallel-group studies of bupropion SR (N = 234), sertraline (N = 225), and placebo (N = 233). Symptoms of anxiety and depression were measured using the 14-item Hamilton Rating Scale for Anxiety (HAM-A) and the 21-item Hamilton Rating Scale for Depression (HAM-D-21), respectively. Percentage reduction in baseline HAM-A total score for each treatment week was calculated to determine whether the time to onset of anxiolytic activity differed among antidepressant responders to each agent. Central nervous system (CNS) adverse events were tabulated. Bupropion SR and sertraline were comparably effective, both were superior to placebo in reducing depressive symptoms. and they did not differ in their effect on anxiety symptoms. Antidepressant responders (> 50% reduction in baseline HAM-D-21 score) in both groups showed marked and comparable reductions in HAM-A scores (baseline to exit). There were no differences between bupropion SR and sertraline in the median time (4 weeks) to reach a clinically significant anxiolytic effect (> or = 50% reduction in baseline HAM-A score). CNS adverse events were comparable for bupropion SR and sertraline, except for somnolence, which was more common in sertraline-treated patients. Bupropion SR and sertraline had comparable antidepressant and anxiolytic effects and an equally rapid onset of clinically significant anxiolytic activity. There was no difference in the activating effects between the 2 antidepressants. Selection between these 2 agents cannot be based on either anticipation of differential anxiolytic activity or differential CNS side effect profiles.
Journal of Affective Disorders, 2001
A common clinical belief is that more sedating and/or serotonin-selective antidepressants are pre... more A common clinical belief is that more sedating and/or serotonin-selective antidepressants are preferred for depressed patients with symptoms of anxiety compared with more activating and/or catecholamine-selective antidepressants. The purpose of this study was to determine whether higher baseline anxiety is associated with different antidepressant responses to bupropion sustained release (SR) or sertraline. A retrospective data analysis was conducted using pooled data from two identical 8-week, randomized, double-blind, placebo-controlled multicenter studies of bupropion SR (n=234), sertraline (n=225), and placebo (n=233) in adult outpatients with recurrent, major depressive disorder. Anxiety symptoms were measured using the 14-item Hamilton Anxiety Rating Scale scores. Baseline anxiety levels were not related to antidepressant response to treatment with either bupropion SR or sertraline, nor did they differentiate between responders to bupropion SR and responders to sertraline. Baseline anxiety levels do not appear to be a basis for selecting between bupropion SR and sertraline in the treatment of outpatients with major depressive disorder.
International Journal of Infectious Diseases, 2009
Background-Pakistan carries one of the world's highest burdens of chronic hepatitis and mortality... more Background-Pakistan carries one of the world's highest burdens of chronic hepatitis and mortality due to liver failure and hepatocellular carcinomas. However, national level estimates of the prevalence of and risk factors for hepatitis B and hepatitis C are currently not available.
European Neuropsychopharmacology, 2000
European Neuropsychopharmacology, 1999
European Neuropsychopharmacology, 1998
European Neuropsychopharmacology, 1998
Clinical Therapeutics, 1999
Sexual dysfunction, a frequently reported side effect of many antidepressants, may result in pati... more Sexual dysfunction, a frequently reported side effect of many antidepressants, may result in patient dissatisfaction and noncompliance with treatment regimens. This paper describes the results of the first placebo-controlled comparison of the efficacy, safety, and effects on sexual functioning of sustained-release bupropion (bupropion SR) and the selective serotonin reuptake inhibitor sertraline. This randomized, double-masked, double-dummy, parallel-group, multicenter trial enrolled 360 patients with moderate-to-severe recurrent major depression. Patients were treated with bupropion SR 150 to 400 mg/d, sertraline 50 to 200 mg/d, or placebo for up to 8 weeks. Patients' depression and sexual functioning were assessed at weekly or biweekly clinic visits; safety was assessed by regular monitoring of adverse events, vital signs, and body weight. Treatment groups were similar at baseline in terms of age, sex, and race, and most patients had a diagnosis of moderate uncomplicated depression. Patients treated with bupropion SR or sertraline showed similar improvements on all efficacy measures; both active treatments were superior to placebo in improving scores on all rating scales for depression at various time points. Significantly more patients treated with sertraline experienced orgasmic dysfunction throughout the study than did patients treated with bupropion SR or placebo (P < 0.001). Headache was the most frequently reported adverse event in all 3 treatment groups and occurred with similar frequency in each group (30% to 40%). Nausea (31%), diarrhea (26%), insomnia (18%), and somnolence (17%) occurred in significantly more patients in the sertraline group than in the bupropion SR group (18%, 7%, 13%, and 3%, respectively) and the placebo group (10%, 11%, 4%, and 6%, respectively). Dry mouth occurred more frequently with bupropion SR (19%) than with sertraline (14%) or placebo (12%), although the differences were not significant. Changes in vital signs were similar in all groups. Similar (small, but not statistically significant) decreases in mean body weight were seen in both the bupropion SR (-1.06 kg) and sertraline (-0.79 kg) groups, whereas the placebo group experienced a minor increase (0.21 kg). Although bupropion SR and sertraline were similarly well tolerated and effective in the treatment of depression, sertraline treatment was more often associated with sexual dysfunction and certain other adverse events compared with bupropion SR and placebo. Therefore, bupropion SR may be an appropriate choice as an antidepressant for the treatment of sexually active patients.
Biological Psychiatry, 2002
This was the first controlled continuation phase study (up to 1-year total treatment) to evaluate... more This was the first controlled continuation phase study (up to 1-year total treatment) to evaluate the safety and efficacy of bupropion SR for decreasing the risk for relapse of depression in patients who responded to bupropion SR. Patients with recurrent major depression were treated with bupropion SR 300 mg/day during an 8-week open-label phase. Responders (based on Clinical Global Impressions Scale for Improvement of Illness scores) entered a randomized, double-blind phase where they received bupropion SR 300 mg/day or placebo for up to 44 weeks. After randomization, relapse was defined as the point at which the investigator intervened by withdrawing the patient from the study to treat depression. Four hundred twenty-three patients were randomized. A statistically significant difference in favor of bupropion SR over placebo was seen in the time to treatment intervention for depression when survival curves were compared (log-rank test, p =.003). Statistically significant separation between bupropion SR and placebo began at double-blind week 12 (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;.05). Adverse events in bupropion SR-treated patients accounted for 9% and 4% of discontinuations from the open-label and double-blind phases, respectively. Bupropion SR was shown to be effective and well tolerated in decreasing the risk for relapse of depression for up to 44 weeks.
American Journal on Mental Retardation, 1999
Epilepsy is a significant comorbid condition in institutionalized persons with developmental disa... more Epilepsy is a significant comorbid condition in institutionalized persons with developmental disabilities and may contribute significant additional costs. This study was conducted to provide an estimate of the costs of epilepsy from the institutional perspective. Costs were measured retrospectively for 50 persons with epilepsy and 50 persons without epilepsy matched by severity of developmental disability. A time and motion study was employed to assign opportunity costs to documented nursing and physician activities. Two separate methods of attribution were used and incremental costs attributable to epilepsy were found to be approximately 825and825 and 825and918 per person over a 6-month period. The following categories accounted for costs: personnel (47.0%), drug (39.6%), hospitalization (9.4%), and laboratories/procedures (4.0%). Results are useful for describing the economic burden of epilepsy.
The Journal of bone and joint surgery. American volume, Jan 3, 2016
Nonunion, an important complication following foot and ankle arthrodesis, causes substantial morb... more Nonunion, an important complication following foot and ankle arthrodesis, causes substantial morbidity and disability. In patients undergoing hindfoot and ankle arthrodesis, autogenous bone graft (autograft) or a suitable alternative is often used to promote osseous fusion across the joint. This study assessed the importance of adequate graft material in the fusion space to achieve joint fusion during ankle and hindfoot arthrodesis. This study used data from a previously published clinical trial of grafting material (recombinant human platelet-derived growth factor-BB with beta-tricalcium phosphate [rhPDGF-BB/β-TCP] or autograft) for healing in hindfoot and ankle arthrodesis to correlate the amount of graft fill at 9 weeks with ultimate healing. Patients who received supplemental graft material for ankle or hindfoot arthrodesis for end-stage ankle or hindfoot arthritis were stratified according to nonunion risk factors and surgical fusion site. Patients underwent arthrodesis using s...
Epilepsy is a significant comorbid condition in institutionalized persons with developmental disa... more Epilepsy is a significant comorbid condition in institutionalized persons with developmental disabilities and may contribute significant additional costs. This study was conducted to provide an estimate of the costs of epilepsy from the institutional perspective. Costs were measured retrospectively for 50 persons with epilepsy and 50 persons without epilepsy matched by severity of developmental disability. A time and motion study was employed to assign opportunity costs to documented nursing and physician activities. Two separate methods of attribution were used and incremental costs attributable to epilepsy were found to be approximately 825and825 and 825and918 per person over a 6-month period. The following categories accounted for costs: personnel (47.0%), drug (39.6%), hospitalization (9.4%), and laboratories/procedures (4.0%). Results are useful for describing the economic burden of epilepsy.
Eur Neuropsychopharmacol, 1998
Statistics & Probability Letters, 1995
Every second-order stationary process with index set {0, ±1, ±2, …} and zero autocorrelations at ... more Every second-order stationary process with index set {0, ±1, ±2, …} and zero autocorrelations at lags greater than one can be represented as a causal moving average of order one. On the other hand, there may not be a finite-order moving average representation of a stationary process which is indexed by the two-dimensional integer lattice and which has zero autocorrelations when at least one lag is greater than one. We investigate such processes.
Neuropsychopharmacology, 2001
Our objective was to determine if pretreatment anxiety levels were associated with preferential r... more Our objective was to determine if pretreatment anxiety levels were associated with preferential response to bupropion sustained release (n = 122) or sertraline (n = 126) during a 16-week randomized acute phase treatment study. Both agents had comparable antidepressant activity, and comparable anxiolytic effects using the intent-to-treat sample. Baseline anxiety levels were not related to antidepressant efficacy, and they did not differentiate responders to each agent. Time to clinically significant anxiolysis did not differentiate between treatment groups or between responders to each agent. These results contradict the commonly held, but unsubstantiated, belief that in clinically depressed anxious patients, serotonergic antidepressants are especially anxiolytic and that such patients preferentially benefit from the antidepressant or anxiolytic effects of selective serotonin reuptake inhibitors. Thus, the clinical decision to select between these two agents when treating depressed outpatients cannot rest on either levels of pretreatment anxiety or on anticipation of more rapid or more complete anxiolysis.
Journal of Surgical Research, 2008
reperfusion, but the effect on the inflammatory response in humans remains largerly unknown. The ... more reperfusion, but the effect on the inflammatory response in humans remains largerly unknown. The purpose of this study is to investigate the effect of enterally administered omega-3 fatty acid on subsequent immunity and complications. Methods: Serial bood samples were drawn (12 hrs, 24hrs and 7 days after injury) from patients enrolled in a prospective, randomized, double-blind trial of enteral omega-3 fatty acid supplementation versus placebo. Obtained whole blood was analyzed by flow cytometry for the surface expression of CD14 and CD16, and the intracellular cytokine expression of IL-6 and TNF-␣. Patient demographics and outcome variables were prospectively collected. Results: 36 traumatically injured patients were enrolled, with 17 patients recieving omega-3 fatty acid supplementation. No difference was noted between groups in regards age, sex, or injury severity. The precentage of CD14ϩCD16ϩ monocytes was significantly decreased in patients receiving omega-3 fatty acid only at day 7 following injury (16.8 Ϯ 1.8 vs. 21.4 Ϯ 1.5, pϽ0.001). CD16ϩ cells were more commonly associated with increased intracellular cytokine levels of both IL-6 and TNF-␣ compared to CD16-cells, suggesting CD14ϩCD16ϩ cells as pro-inflammatory. No difference in the rate of nosocomial infection was noted between omega-3 fatty acid supplementation and placebo (11 vs. 8, pϭ0.202). However, patients receiving omega-3 fatty acid supplemenation had more progression of MODS as defined by a Marshall MOD score (5.47 Ϯ 0.58 vs. 7.42 Ϯ 0.51, pϭ 0.016). Ventilator days (10.82 Ϯ 1.34 vs. 15.68 Ϯ 1.89, pϭ0.044) and ICU length of stay (12.06 Ϯ 1.31 vs. 16.68 Ϯ 1.87, pϭ0
JONA: The Journal of Nursing Administration, 2000
To compare results obtained from a time-and-motion study with those obtained using self-reporting... more To compare results obtained from a time-and-motion study with those obtained using self-reporting. Nurse executives are often required to provide additional patient care services with limited personnel resources. As a result, nurse executives must evaluate the appropriate allocation of nursing personnel resources. Work measurement may be used to evaluate personnel allocation. Multiple measurement approaches are available, but few studies have compared these methods. Eight nurses were observed by a single observer during five shifts (or approximately 40 hours per nurse). After completion of the time-and-motion study, participants were to self-report their work activities during their ensuing five shifts. Mixed-effects analysis of variance was used to determine the significance of the work measurement method on percentage of total time, number of activities, and mean time per activity by activity category. Two hundred ninety hours of time-and-motion study observations and 338 hours of self-report data were available for analysis. Comparable amounts of total time were reported within the various activity categories using time-and-motion and self-reporting methods. In terms of number of activities reported, a significantly higher number of activities were reported using time-and-motion. As a result, mean activity times were significantly longer using the self-reporting method compared with time-and-motion. Nurse executives should consider continuous self-reporting as a low-cost means of quantifying allocation of time among nursing personnel. Self-reporting, however, is not recommended for estimating the total number of activities or the mean time per activity because of perceptual differences between participants of what constitutes an activity.
Journal of Clinical Psychopharmacology, 2000
... MD*; Kavoussi, Richard MD; Hughes, Arlene R. PhD; Batey, Sharyn R. PharmD; Johnston, J. An... more ... MD*; Kavoussi, Richard MD; Hughes, Arlene R. PhD; Batey, Sharyn R. PharmD; Johnston, J. Andrew PharmD; Donahue, Rafe PhD; Ascher ... Two hundred forty-eight patients who had received a diagnosis of moderate to severe major depression were randomly assigned ...
The Journal of Clinical Psychiatry, 2001
The Journal of Clinical Psychiatry, 2000
Depression is a serious and widespread emotional disorder among the elderly. This study compared ... more Depression is a serious and widespread emotional disorder among the elderly. This study compared the efficacy and safety of bupropion sustained release (SR) with the selective serotonin reuptake inhibitor paroxetine in the treatment of major depression in elderly outpatients. Elderly (> or = 60 years) outpatients with major depressive disorder (DSM-IV criteria) were evaluated in this 6-week multicenter, randomized, double-blind study comparing bupropion SR, 100-300 mg/day, and paroxetine, 10-40 mg/day. Efficacy was assessed by changes in scores on the Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A) and the Clinical Global Impressions-Severity of Illness and -Improvement scales. Safety was assessed by monitoring adverse events, vital signs, and body weight. A total of 100 patients ranging in age from 60 to 88 years were randomly assigned to treatment with bupropion SR (N = 48) or paroxetine (N = 52). Measurements of efficacy were similar between the 2 treatment groups, with both groups showing improved scores on all depression rating scales. Headache, insomnia, dry mouth, agitation, dizziness, and nausea occurred in > 10% of patients in both groups; somnolence, diarrhea, constipation, and anorexia occurred in > 10% of patients in the paroxetine group. No statistically significant differences between groups in vital signs or weight were found. Both bupropion SR and paroxetine were safe and effective for the treatment of depression in the elderly. Because of its favorable side effect profile, bupropion SR may provide a safe and effective nonserotonergic treatment alternative that is well suited as an antidepressant for the elderly.
The Journal of Clinical Psychiatry, 2001
To examine the effects of bupropion sustained release (SR) and sertraline on anxiety in outpatien... more To examine the effects of bupropion sustained release (SR) and sertraline on anxiety in outpatients with recurrent DSM-IV-defined major depressive disorder. This retrospective analysis was conducted using pooled data from 2 identical, 8-week, acute-phase, double-blind, placebo-controlled, parallel-group studies of bupropion SR (N = 234), sertraline (N = 225), and placebo (N = 233). Symptoms of anxiety and depression were measured using the 14-item Hamilton Rating Scale for Anxiety (HAM-A) and the 21-item Hamilton Rating Scale for Depression (HAM-D-21), respectively. Percentage reduction in baseline HAM-A total score for each treatment week was calculated to determine whether the time to onset of anxiolytic activity differed among antidepressant responders to each agent. Central nervous system (CNS) adverse events were tabulated. Bupropion SR and sertraline were comparably effective, both were superior to placebo in reducing depressive symptoms. and they did not differ in their effect on anxiety symptoms. Antidepressant responders (> 50% reduction in baseline HAM-D-21 score) in both groups showed marked and comparable reductions in HAM-A scores (baseline to exit). There were no differences between bupropion SR and sertraline in the median time (4 weeks) to reach a clinically significant anxiolytic effect (> or = 50% reduction in baseline HAM-A score). CNS adverse events were comparable for bupropion SR and sertraline, except for somnolence, which was more common in sertraline-treated patients. Bupropion SR and sertraline had comparable antidepressant and anxiolytic effects and an equally rapid onset of clinically significant anxiolytic activity. There was no difference in the activating effects between the 2 antidepressants. Selection between these 2 agents cannot be based on either anticipation of differential anxiolytic activity or differential CNS side effect profiles.
Journal of Affective Disorders, 2001
A common clinical belief is that more sedating and/or serotonin-selective antidepressants are pre... more A common clinical belief is that more sedating and/or serotonin-selective antidepressants are preferred for depressed patients with symptoms of anxiety compared with more activating and/or catecholamine-selective antidepressants. The purpose of this study was to determine whether higher baseline anxiety is associated with different antidepressant responses to bupropion sustained release (SR) or sertraline. A retrospective data analysis was conducted using pooled data from two identical 8-week, randomized, double-blind, placebo-controlled multicenter studies of bupropion SR (n=234), sertraline (n=225), and placebo (n=233) in adult outpatients with recurrent, major depressive disorder. Anxiety symptoms were measured using the 14-item Hamilton Anxiety Rating Scale scores. Baseline anxiety levels were not related to antidepressant response to treatment with either bupropion SR or sertraline, nor did they differentiate between responders to bupropion SR and responders to sertraline. Baseline anxiety levels do not appear to be a basis for selecting between bupropion SR and sertraline in the treatment of outpatients with major depressive disorder.
International Journal of Infectious Diseases, 2009
Background-Pakistan carries one of the world's highest burdens of chronic hepatitis and mortality... more Background-Pakistan carries one of the world's highest burdens of chronic hepatitis and mortality due to liver failure and hepatocellular carcinomas. However, national level estimates of the prevalence of and risk factors for hepatitis B and hepatitis C are currently not available.
European Neuropsychopharmacology, 2000
European Neuropsychopharmacology, 1999
European Neuropsychopharmacology, 1998
European Neuropsychopharmacology, 1998
Clinical Therapeutics, 1999
Sexual dysfunction, a frequently reported side effect of many antidepressants, may result in pati... more Sexual dysfunction, a frequently reported side effect of many antidepressants, may result in patient dissatisfaction and noncompliance with treatment regimens. This paper describes the results of the first placebo-controlled comparison of the efficacy, safety, and effects on sexual functioning of sustained-release bupropion (bupropion SR) and the selective serotonin reuptake inhibitor sertraline. This randomized, double-masked, double-dummy, parallel-group, multicenter trial enrolled 360 patients with moderate-to-severe recurrent major depression. Patients were treated with bupropion SR 150 to 400 mg/d, sertraline 50 to 200 mg/d, or placebo for up to 8 weeks. Patients' depression and sexual functioning were assessed at weekly or biweekly clinic visits; safety was assessed by regular monitoring of adverse events, vital signs, and body weight. Treatment groups were similar at baseline in terms of age, sex, and race, and most patients had a diagnosis of moderate uncomplicated depression. Patients treated with bupropion SR or sertraline showed similar improvements on all efficacy measures; both active treatments were superior to placebo in improving scores on all rating scales for depression at various time points. Significantly more patients treated with sertraline experienced orgasmic dysfunction throughout the study than did patients treated with bupropion SR or placebo (P < 0.001). Headache was the most frequently reported adverse event in all 3 treatment groups and occurred with similar frequency in each group (30% to 40%). Nausea (31%), diarrhea (26%), insomnia (18%), and somnolence (17%) occurred in significantly more patients in the sertraline group than in the bupropion SR group (18%, 7%, 13%, and 3%, respectively) and the placebo group (10%, 11%, 4%, and 6%, respectively). Dry mouth occurred more frequently with bupropion SR (19%) than with sertraline (14%) or placebo (12%), although the differences were not significant. Changes in vital signs were similar in all groups. Similar (small, but not statistically significant) decreases in mean body weight were seen in both the bupropion SR (-1.06 kg) and sertraline (-0.79 kg) groups, whereas the placebo group experienced a minor increase (0.21 kg). Although bupropion SR and sertraline were similarly well tolerated and effective in the treatment of depression, sertraline treatment was more often associated with sexual dysfunction and certain other adverse events compared with bupropion SR and placebo. Therefore, bupropion SR may be an appropriate choice as an antidepressant for the treatment of sexually active patients.
Biological Psychiatry, 2002
This was the first controlled continuation phase study (up to 1-year total treatment) to evaluate... more This was the first controlled continuation phase study (up to 1-year total treatment) to evaluate the safety and efficacy of bupropion SR for decreasing the risk for relapse of depression in patients who responded to bupropion SR. Patients with recurrent major depression were treated with bupropion SR 300 mg/day during an 8-week open-label phase. Responders (based on Clinical Global Impressions Scale for Improvement of Illness scores) entered a randomized, double-blind phase where they received bupropion SR 300 mg/day or placebo for up to 44 weeks. After randomization, relapse was defined as the point at which the investigator intervened by withdrawing the patient from the study to treat depression. Four hundred twenty-three patients were randomized. A statistically significant difference in favor of bupropion SR over placebo was seen in the time to treatment intervention for depression when survival curves were compared (log-rank test, p =.003). Statistically significant separation between bupropion SR and placebo began at double-blind week 12 (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;.05). Adverse events in bupropion SR-treated patients accounted for 9% and 4% of discontinuations from the open-label and double-blind phases, respectively. Bupropion SR was shown to be effective and well tolerated in decreasing the risk for relapse of depression for up to 44 weeks.
American Journal on Mental Retardation, 1999
Epilepsy is a significant comorbid condition in institutionalized persons with developmental disa... more Epilepsy is a significant comorbid condition in institutionalized persons with developmental disabilities and may contribute significant additional costs. This study was conducted to provide an estimate of the costs of epilepsy from the institutional perspective. Costs were measured retrospectively for 50 persons with epilepsy and 50 persons without epilepsy matched by severity of developmental disability. A time and motion study was employed to assign opportunity costs to documented nursing and physician activities. Two separate methods of attribution were used and incremental costs attributable to epilepsy were found to be approximately 825and825 and 825and918 per person over a 6-month period. The following categories accounted for costs: personnel (47.0%), drug (39.6%), hospitalization (9.4%), and laboratories/procedures (4.0%). Results are useful for describing the economic burden of epilepsy.
The Journal of bone and joint surgery. American volume, Jan 3, 2016
Nonunion, an important complication following foot and ankle arthrodesis, causes substantial morb... more Nonunion, an important complication following foot and ankle arthrodesis, causes substantial morbidity and disability. In patients undergoing hindfoot and ankle arthrodesis, autogenous bone graft (autograft) or a suitable alternative is often used to promote osseous fusion across the joint. This study assessed the importance of adequate graft material in the fusion space to achieve joint fusion during ankle and hindfoot arthrodesis. This study used data from a previously published clinical trial of grafting material (recombinant human platelet-derived growth factor-BB with beta-tricalcium phosphate [rhPDGF-BB/β-TCP] or autograft) for healing in hindfoot and ankle arthrodesis to correlate the amount of graft fill at 9 weeks with ultimate healing. Patients who received supplemental graft material for ankle or hindfoot arthrodesis for end-stage ankle or hindfoot arthritis were stratified according to nonunion risk factors and surgical fusion site. Patients underwent arthrodesis using s...