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Biomedical subjects

T E Delea

Publications and source records attributed to T E Delea.

7 recordsLinked to original sources
PubMed1990

The risks and benefits of an Rx-to-OTC switch. The case of over-the-counter H2-blockers.

In recent years, many new over-the-counter (OTC) medications have resulted from the granting of OTC status by the U.S. Food and Drug Administration to drug entities that previously were available only by prescription (Rx). While the benefits to consumers of Rx-to-OTC switches may be substantial, they also involve some degree of risk, as usage typically expands and physician supervision diminishes. This study explores the potential utility of techniques of decision analysis in evaluating the balance of these benefits and risks. Histamine H2 receptor antagonists (H2-blockers), which are currently available only by prescription, are presented as a case study and were examined to determine how OTC availability of these agents would alter the patterns, effectiveness, and risks of self-treatment for acid-peptic disorders. Currently, about 5.7 million persons experience an episode of dyspepsia during any given quarter, of whom 3.5 million self-medicate with antacids. Study results indicate that OTC availability of H2-blockers would: 1) increase the proportion of persons with dyspepsia who self-medicate from 61.8% currently to 64.1%; 2) increase the proportion of persons who experience complete relief of their symptoms while self-medicating from 37.9% currently to 43.2%; 3) result in 14 additional cases of serious hematologic disorders and an additional 22,000 instances of minor side effects per quarter, but cause the overall rate of side effects among persons who self-medicate to decline; 4) cause an additional 300 persons per quarter with gastric cancer to self-medicate before seeking professional care, but cause no change in the median time between onset of symptoms and the decision to seek such care; and 5) decrease by 277,000 the number of persons per quarter who seek professional care for dyspepsia. On balance, results suggest that OTC H2-blockers may be a relatively safe and effective means of self-care for acid-peptic disorders, and may substantially reduce the number of patient encounters with the medical care system for minor gastrointestinal complaints. This study also illustrates the potential utility of the techniques of decision analysis to the formulation of drug regulatory policy.

Aged↗
PubMed1989

Cimetidine and adverse reactions: a meta-analysis of randomized clinical trials of short-term therapy.

PURPOSE: We pooled data from randomized, double-blind, placebo-controlled trials to determine the frequency of adverse reactions among patients treated with cimetidine for acute acid-peptic disorders. METHODS: Meta-analysis was used to analyze data obtained from a search of English language reports of trials of cimetidine in the ambulatory treatment of acute acid-peptic disorders that were published between January 1982 and April 1987. RESULTS: Of 161 trials of cimetidine that we identified, 84 provided complete reporting of data on adverse reactions and, of these, 24 employed a randomized, double-blind, placebo-controlled design. Across these 24 trials, the overall rate of reported adverse reactions among 622 patients randomly assigned to receive cimetidine was 10.9%; the corresponding rate among 516 patients randomly assigned to receive placebo was 10.1%. This difference was not statistically significant (p greater than 0.10), nor were any significant differences noted in the frequencies of reported central nervous system or gastrointestinal adverse reactions (p greater than 0.10). Rates of adverse reactions also did not differ by dosage or trial duration. The overall rate of adverse reactions reported in the 60 trials that did not utilize a randomized, double-blind, placebo-controlled design was similar to the rate reported in those that did. CONCLUSIONS: Our findings suggest that the frequency of adverse reactions among patients receiving cimetidine for acute acid-peptic disorders is not significantly different from that of patients receiving placebo.

Acute Disease↗
PubMed1987

Cost effectiveness of labetalol and propranolol in the treatment of hypertension among blacks.

The cost effectiveness of labetalol and propranolol in the treatment of black adults with mild to moderate hypertension was assessed using published reports from US clinical trials of these agents among such patients. Data from these studies suggest that labetalol and propranolol lower diastolic blood pressure among black hypertensive adults by 11.2 mmHg and 8.4 mmHg, respectively. Results indicate that, for a hypothetical cohort of 1,000 patients on monotherapy, patients treated with labetalol would experience two to seven fewer strokes over a ten-year period, depending upon age and sex, and annual drug costs would be reduced by $190. For stepped care, annual costs would be $205 and $212 lower for those treated initially with labetalol. Labetalol therefore may be more cost effective than propranolol among black adults with mild to moderate hypertension.

Aged↗
PubMed1986

Cost-effectiveness of nicotine gum as an adjunct to physician's advice against cigarette smoking.

A nicotine chewing gum has recently become available for use as an aid in giving up cigarette smoking. Although its efficacy has been demonstrated in clinic-based smoking cessation programs, its value in a primary care setting is uncertain. We examined the cost-effectiveness of nicotine gum as an adjunct to physician's advice and counseling against smoking during routine office visits. Our findings indicate that the cost per year of life saved with this intervention ranges from $4113 to $6465 for men and from $6880 to $9473 for women, depending on age. This compares favorably with other widely accepted medical practices, eg, treatment of hypertension or hyperlipidemia. Our study, therefore, suggests that nicotine gum is a cost-effective adjunct to physician's advice against cigarette smoking in a primary care setting.

Adult↗
PubMedDate not supplied

Maternal smoking during pregnancy and expenditures on neonatal health care.

Cigarette smoking during pregnancy substantially increases the risk of low-weight birth, and infants born to smokers weigh less, on average, than those born to nonsmokers. Low birth weight is an important predictor of neonatal morbidity and death, and the intensity of neonatal care is significantly higher for low-birth-weight infants. In this study, we estimate expenditures on neonatal care based on the relation between maternal smoking during pregnancy and the incidence of low-weight births. Our results indicate that maternal smoking during pregnancy was responsible for 35,816 low-weight births in the U.S. in 1983, or about 14.5% of all low-weight births. We also estimate that 14,977, or 6.6%, of all admissions to neonatal intensive care units were a result of maternal smoking and that these admissions cost approximately $272 million, representing 8.5% of total national expenditures on neonatal intensive care services. We estimate that the average cost of neonatal care was $288 higher for infants born to smokers than for those born to nonsmokers.

Birth Weight↗