Search PubMed⌕ Search

Biomedical subjects

S G Bryant

Publications and source records attributed to S G Bryant.

At least 19 recordsLinked to original sources
PubMed1995

Postmarketing surveillance by patient self-monitoring: preliminary data for sertraline versus fluoxetine.

BACKGROUND: There have been no published postmarketing reports comparing sertraline with another serotonin selective reuptake inhibitor (SSRI) in large-sample, parallel groups. As part of an ongoing postmarketing surveillance study, this paper presents preliminary data for a number of adverse clinical events reported by outpatients being treated with either fluoxetine or sertraline. METHOD: Using a well-validated method developed to signal possible adverse drug reactions, data were collected on 1577 fluoxetine-treated and 1209 sertraline-treated patients who filled a prescription for either of the two targeted drugs. Pharmacists gave these patients an announcement, part of which served as an entry form, that described the purpose and details of the study. Volunteers (highly selective) were requested to report during the next month via a toll-free telephone interview "any new or unusual symptoms or unexpected improvements" in their health since starting the designated medication. RESULTS: Almost 1 (31.4%) of every 3 sertraline-treated patients called at least once to report one or more adverse clinical events compared with only about 1 (19.7%) of every 5 fluoxetine-treated patients. Most of the reported adverse clinical events--but not all--are well-known adverse drug reactions that seem common to SSRIs. Adverse clinical events reported more frequently by sertraline-treated patients included urinary, sexual, psychological, neurologic, gastrointestinal, and dermatological complaints. Drug discontinuation was also reported more frequently by sertraline-treated patients. Fluoxetine-treated patients reported an increased frequency of weight gain and anger or aggression. CONCLUSION: These data indicate that many adverse reactions known to be induced by fluoxetine are being reported with even greater frequency by sertraline-treated patients. Possible interpretations of these differences are discussed.

1-Naphthylamine↗
PubMed1991

Effects of age on reporting of adverse clinical events: results from two postmarketing surveillance methods.

Two postmarketing surveillance methods were employed to determine the possible effects of age on reports by outpatients of adverse clinical events (ACEs) occurring shortly after treatment with targeted oral antibiotics or tricyclic antidepressants. One approach involved staff-initiated interviews of patients by telephone and the other involved patient-initiated telephone calls to report possible adverse drug reactions. Regardless of the method, the interviews obtained ACE reports both spontaneously and by review of organ systems. Both postmarketing methods confirmed monotonic relationships for age with treatment duration on the target drugs and with the number of concurrent medications. However, the expected positive correlation between age and spontaneously reported ACEs was evident only in the self-monitoring patients who initiated reports. Negative correlations between age and the number of reported valid ACEs were seen in six independent samples, whereas only two demonstrated a positive relationship. This disparity may elucidate a critical methodologic problem: careful attention must be paid to the means of eliciting information about possible adverse clinical events before attempting to study adverse drug reactions, which are necessarily a subset of ACEs.

Administration, Oral↗
PubMed1991

The diagnosis of intermittent explosive disorder in violent men.

In a study of violent men, 443 symptomatic adult male volunteers were evaluated for presence of intermittent explosive disorder (IED). Investigators first established presence of severe and frequent violent outbursts not readily explainable by another disorder. Seventy-nine violent men were so selected. Of these, 26 had excessive impulsivity, an exclusionary criterion for IED. Twenty-one were excluded because of other, exclusionary mental disorders. Violent behavior of five subjects was deemed proportionate to the provocation. Insufficient data were obtained for an accurate diagnoses of IED in 12 subjects. Fifteen subjects satisfied all criteria for IED, i.e., 18.9 percent of sufficiently violent men without other major psychopathology or 1.49 percent of all 443 men who complained of violence. Epidemiologic and validity aspects of IED are discussed.

Adult↗
PubMed1990

Postmarketing surveillance: accuracy of patient drug attribution judgments.

Data from two samples of ambulatory patients participating in a postmarketing surveillance study, one receiving antibiotics and another receiving tricyclic antidepressant agents, are presented, indicating that patients appear to be capable of correctly discriminating probable adverse drug reactions from other adverse clinical events. However, attribution accuracy depended both on the surveillance method and on how reports of the adverse clinical events were obtained. Discrimination was better when patients were reporting adverse clinical events spontaneously than when the interviewer probed for recall in a systematic inquiry. Discrimination was also better when the adverse clinical events were obtained from a staff-initiated surveillance method than from a self-monitoring, patient-initiated telephone-reporting method--probably because the latter method generates an excessively strong tendency to report mainly those adverse clinical events suspected of being drug related.

Adult↗
PubMed1990

A drug utilization review of prescribing patterns for trazodone versus amitriptyline.

The second-generation antidepressant trazodone has been thought by some clinicians to exert a less robust antidepressant effect than do tricyclic agents. This impression differs from the findings of numerous published clinical trials. In an effort to determine whether this discrepancy may be due to possible inappropriate dosing or use of trazodone for different patient subtypes, a retrospective chart review of 138 depressed inpatients treated with amitriptyline and of 42 depressed inpatients treated with trazodone was performed to compare their respective prescribing patterns. While these two groups did not differ with regard to most demographic variables, results revealed that patient prescribed trazodone were older (trazodone, mean +/- SD age = 54.5 +/- 8.8 years versus amitriptyline, 43.2 +/- 12.9 years; p less than .001), more often had a recurrent depressive disorder (trazodone = 57.1%, amitriptyline = 39.1%, p less than .06), and more frequently had a history of unresponsiveness to other antidepressants (trazodone = 47.6%, amitriptyline = 11.6%; p less than .001). In addition, initially prescribed daily doses of trazodone were below the recommended starting dose of 150 mg/day (mean +/- SD starting dose = 113.7 +/- 42.1 mg/day), while starting daily doses for amitriptyline (mean +/- SD = 69.8 +/- 20.1 mg/day) were judged to be more adequate relative to the recommended daily dose of 75 mg/day. Final trazodone dosage (mean +/- SD final dose = 217.9 +/- 87.5 mg/day) could be judged to have been far short of optimal levels of 250 to 350 mg/day and of up to 600 mg/day for inpatients and 400 mg/day for outpatient.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1990

Death following suspected alprazolam withdrawal seizures: a case report.

This is a case report of severe psychosis and seizures following abrupt discontinuation of alprazolam and then the recurrence of seizures at the end of a gradual tapering schedule. The last of these seizures appeared to be a contributing factor in the patient's death. To the authors' knowledge, this is the first published report of a fatality associated with alprazolam withdrawal.

Alprazolam↗
PubMed1989

Blood platelet uptake of serotonin in episodic aggression.

Blood platelet uptake of 3H-serotonin (5HT uptake), a potential marker of serotonergic function, was determined in male outpatients with episodic aggression (n = 15) and in age- and sex-matched nonaggressive controls (n = 15). Correlations with rating scales of "impulsivity" (Barratt Impulsivity Scale, 10th revision) and "anger" (Spielberger Anger Expression Scale) were performed. Mean 5HT uptake was 18% lower in patients with episodic aggression. A significant negative correlation between % difference in platelet 5HT uptake and impulsivity score was observed, but the correlation between 5HT uptake and anger was not significant. These results support the hypothesis of disturbed serotonergic function in aggression and suggest that the primary relationship is in the "control" of aggression. The blood platelet may be useful in identifying impulsive subtypes.

Adolescent↗
PubMed1988

Monoamine oxidase inhibitors: safety and efficacy issues.

Controversy has historically centered on the use of monoamine oxidase inhibitors (MAOI) in the treatment of depression because of safety and efficacy issues. Hypertensive crisis following ingestion of foods containing tyramine is the most feared problem associated with MAOI therapy. The authors conclude that only four tyramine-containing foods clearly warrant absolute prohibition, but indicate situations where moderation should apply. Although MAOI remain second-line agents in the treatment of endogenous depression, it is unclear whether MAOI or tricyclic antidepressants should be the drugs of choice in atypical depression and this question necessitates future research.

Depressive Disorder↗
PubMed1988

Short- and long-term effects of auxiliary labels on patient knowledge of precautionary drug information.

The purpose of this study was to determine the efficacy of auxiliary prescription labels in educating outpatients about medicines at two different time periods. Five hundred fifty-nine patients were randomly assigned either to an experimental group or a control group; each person in the experimental group received a prescription bottle to which one study auxiliary label ("sticker") had been affixed, and those in the control group received bottles with no study sticker attached. Patients were interviewed by telephone approximately one week or two months after prescription pick up. Patients who had the study sticker affixed to their prescription bottle were significantly more knowledgeable after one week about precautionary information than those patients who did not receive stickers; however, sticker-group patients receiving the delayed interview incorrectly attributed many precautions to their medication. This is the first controlled study to document that auxiliary labels increase short-term knowledge about medications, and to suggest that the same labels may result in an inappropriate generalization over time.

Drug Labeling↗
PubMed1987

Patient-initiated postmarketing surveillance: a validation study.

A new patient-initiated, pharmacy-based postmarketing surveillance system is described. At the time a new prescription for a targeted drug was filled, 2705 outpatients (experimentals) randomly assigned to the new system had a printed notice attached to their medication bags: the information requested them to report any "new or unusual symptoms" during the next 2 weeks by a toll-free telephone number to a trained nonprofessional who conducted a standardized adverse drug reaction (ADR) interview. To help validate the new system, another sample of 1109 patients (controls) did not receive a request for self-monitoring but were interviewed by telephone 2 weeks later. Target drugs were chosen from two classes for which side effect profiles are well identified: oral antibiotics and tricyclic antidepressants. Results show that within both drug classes, all patient-initiated reports closely matched those obtained from controls; the experimental and control groups also reported predictably high relative frequencies for the most commonly expected ADRs. Additional analyses suggest that a patient-initiated monitoring system could prove to be a promising complement to existing physician-based surveillance systems.

Adult↗
PubMed1987

Increased frequency of doxycycline side effects.

As part of a study investigating new methods of detecting adverse drug reactions, adult outpatients receiving new prescriptions for 1 of 4 antibiotics (doxycycline, penicillin VK, ampicillin, or tetracycline) were assigned to 1 of 2 methods of monitoring adverse drug reactions. Data were collected from a total of 457 staff-initiated interviews and from 1467 patients who were asked to telephone to report possible adverse effects. Doxycycline is considered by authoritative sources to be generally comparable in side effects to other tetracyclines and penicillins, with the exception that it increases photosensitivity. Results from both monitoring methods consistently indicated at least a 3-fold higher frequency of nausea or vomiting with doxycycline relative to the other antibiotics. Complaints of skin rash also were at least 4 times more frequent with doxycycline, depending on the particular sample.

Adult↗
PubMed1987

Long-term versus short-term amitriptyline side effects as measured by a postmarketing surveillance system.

As part of a large-scale postmarketing surveillance study, the adverse clinical events (ACEs) reported by 85 outpatients taking amitriptyline were investigated. Two discrete groups of patients were identified based on their duration of amitriptyline treatment: 45 had started the drug within 2 weeks of their interview (mean = 10.1 days, SD = 1.6 days), while 40 were much longer term tricyclic antidepressant patients (mean = 227.2 days, SD = 135 days). Our analysis of amitriptyline side effects reported by each of these two discrete groups challenges the common clinical impression that tricyclic side effects, in general, abate with continued treatment. Shorter term patients were much better able to correctly attribute their adverse clinical events to their drug therapy. Anticholinergic side effects were reported as new symptoms by the long-term patients just as frequently with similar ratings of subjective severity. These reports of adverse drug reactions of recent onset by long-term amitriptyline users may reflect the fact that such symptoms fluctuate in their occurrence and may not be recognized as potentially drug-induced until some threshold for patient tolerance is exceeded.

Adult↗
PubMed1986

New approaches to postmarketing surveillance.

As part of a large-scale ongoing project exploring new pharmacy-based methods of postmarketing surveillance, we are comparing a patient-initiated monitoring system to a staff-initiated approach. Here we report data only from staff-initiated, computer-directed telephone interviews with 231 outpatients approximately 2 weeks after they had been prescribed a target drug chosen from two markedly different pharmacological classes for which adverse drug reactions (ADRs) are well-documented. Our results indicate that spontaneous patient reports of "new or unusual symptoms" obtained from a standardized staff-initiated telephone interview can be quite reliable, leading to accurate detection of known tricyclic antidepressant and antibiotic ADRs.

Anti-Bacterial Agents↗