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Biomedical subjects

B B Gerstman

Publications and source records attributed to B B Gerstman.

At least 19 recordsLinked to original sources

Steroidal contraceptive use update, United States, 1989-1994.

OBJECTIVE: To update United States steroidal contraceptive use data for the period 1989 to 1994. STUDY DESIGN: Pharmaceutical marketing data were used to examine trends in the utilization and distribution of oral contraceptives, Norplant, and Depo-Provera. RESULTS: There were 56.8 million prescriptions for oral contraceptives dispensed through retail pharmacies in 1994. Estrogen and progestin doses remained fairly stable over time. The average ethinyl estradiol dose of formulations was approximately 34 microg per pill. Mentions for oral contraceptives among 35- to 44-year-old women increased. Approximately 169,000 Norplant systems were distributed from 1991 through 1994. More than 1.5 million milliliters of Depo-Provera were distributed from 1993 to 1994. CONCLUSIONS: Oral contraceptives remain a popular form of contraception. Parenteral formulations have been rapidly accepted.

Journal Article↗

The incidence of depression in new users of beta-blockers and selected antihypertensives.

We studied the occurrence of depression in new users of propranolol (n = 704), other beta-blockers (n = 587), angiotensin-converting enzyme inhibitors (n = 976), calcium channel blockers (n = 742), and diuretics (n = 773) in the Harvard Community Health Plan population. The period of the study was from April 1988 to June 1991. All study subjects were followed for new or newly recurrent depression for up to 6 months after receiving their first study prescription. Case status was confirmed by blinded medical record review. We found 10 cases of depression that met DSM-III-R criteria ("major depression") and an additional 18 cases that had one or more symptoms consistent with depression ("minor depression"). Rates of major depression in users of beta-blockers and users of non-beta-blocker study drugs were 5.8 per 1000 person-years of exposure and 9.6 per 1000 person-years, respectively. None of the cases of major depression was propranolol associated. Rates of major or minor depression (combined) in users of beta-blockers and users of non-beta-blockers were 20.2 per 1000 person-years and 25.2 per 1000 person-years, respectively. The age- and sex-adjusted relative risk of major or minor depression associated with the use of beta-blockers compared to non-beta-blockers was 0.8 (95% CI, 0.3-1.9). The relative risk associated with propranolol compared to non-beta-blockers was also 0.8 (95% CI, 0.1-2.7). Therefore, depression occurred no more frequently in beta-blocker users than in other members of the study base.

Adrenergic beta-Antagonists↗

Baldness and coronary heart disease rates in men from the Framingham Study.

The authors assessed the relation between the extent and progression of baldness and coronary heart disease. Baldness was assessed twice, in 1956 and in 1962, in a cohort of 2,017 men from Framingham, Massachusetts. Extent of baldness was classified in terms of number of bald areas: no areas bald (n = 153), one area bald (n = 420), two areas bald (n = 587), and all areas bald (n = 857). Men who were assessed both times and who had two or fewer bald areas during the first evaluation were classified into one of three groups: "mild or no progression," "moderate progression," or "rapid progression." The cohort was followed for up to 30 years for new occurrences of coronary heart disease, coronary heart disease death, cardiovascular disease, and death due to any cause. The relations between the extent and progression of baldness and the aforementioned outcomes were assessed using a Cox proportional hazards model, adjusting for age and other known cardiovascular disease risk factors. Extent of baldness was not associated with any of the outcomes. However, the amount of progression of baldness was associated with coronary heart disease occurrence (relative risk (RR) = 2.4, 95% confidence interval (CI) 1.3-4.4), coronary heart disease mortality (RR = 3.8, 95% CI 1.9-7.7), and all-cause mortality (RR = 2.4, 95% CI 1.5-3.8). Rapid hair loss may be a marker for coronary heart disease.

Adult↗

Trends in the prevalence of asthma hospitalization in the 5- to 14-year-old Michigan Medicaid population, 1980 to 1986.

BACKGROUND: Despite advances in therapy, morbidity and mortality rates as a result of pediatric asthma appear to have increased during the past decade. Epidemiologic evidence suggests that these increases disproportionately affected black children and the urban poor. METHODS: With use of data from the Medicaid Management Information System, we estimated the prevalence of asthma hospitalization in the 5- to 14-year-old Michigan Medicaid population for the period 1980 to 1986. RESULTS: Large increases were seen between 1980 and 1984, with leveling off or a slight decline thereafter. In 5- to 9-year-old children, the prevalence of asthma hospitalization increased from 2.3 per 1000 persons in 1980 to 4.5 per 1000 in 1984. Ten- to 14-year-old children demonstrated an increase of 2.2 per 1000 in 1980 to 3.2 per 1000 in 1984. Comparable trends occurred in all strata defined by age, race, residency, and gender. However, the largest increases were noted in urban black children, in which the rate more than doubled from 3.2 per 1000 in 1980 to 7.1 per 1000 in 1984. The adjusted relative risk for asthma hospitalization associated with being male was 1.6 (95% CI: 1.5, 1.7), with being black was 2.2 (95% CI: 2.1, 2.4), and with living in an urban county was 1.1 (95% CI: 1.04, 1.4). CONCLUSIONS: Within this relatively homogeneous low socioeconomic population, black race remained a strong predictor for asthma hospitalization, whereas urban residence was only minimally associated with this outcome.

Adolescent↗

Variations in the use of medication for the treatment of childhood asthma in the Michigan Medicaid population, 1980 to 1986.

Asthma is a leading cause of morbidity in the United States and is a leading cause of disability in children. Prevalence has been shown to be highest in male children, blacks, and urban residents. Racial and residential differences have been attributed to economics. Medicaid claims data allow for the comparison of asthma morbidity and treatment of patients with different demography but of low socioeconomic status. Michigan Medicaid claims data for recipient children between 5 and 14 years of age were used to ascertain demographic factors associated with asthma treatment from 1980 through 1986. A cross-sectional analysis was used. Black asthmatics were found to receive medical care more frequently, but to obtain asthma drugs less frequently than other groups. The prevalence of different prescription asthma preparations also varied by race and residence. Black, urban residents obtained fixed-combination drugs more frequently and steroids less frequently than other groups. Rural patients, in general, had fewer medical contacts but obtained more prescription products per provider contact, whether black or white. Possible reasons for this variation are discussed.

Adolescent↗

Clustering of adverse drug events: analysis of risk factors for cerebellar toxicity with high-dose cytarabine.

BACKGROUND: Cerebellar toxicity is a severe, therapy-limiting adverse reaction of cytarabine given in high doses. The Food and Drug Administration received a report of an increased frequency of cerebellar toxicity at the University of Wisconsin Hospital and Clinics after a switch from the product (Cytosar-U) manufactured by The Upjohn Co., Kalamazoo, Mich., to the generic form made by Quad Pharmaceuticals, Inc., Indianapolis, Ind. PURPOSE: To compare the incidence of cerebellar toxicity in Quad-treated patients with Upjohn-treated patients, a record-based cohort study was conducted at the University of Wisconsin Hospital and Clinics between January 1986 and August 1989. METHODS: The incidence of cerebellar toxicity was studied in 63 leukemia patients according to the manufacturer of the product received (34 Upjohn only, 25 Quad only, and four both manufacturers). The relative risk of cerebellar toxicity was adjusted for other known risk factors. RESULTS: Patients in the manufacturer-defined treatment groups did not differ significantly with respect to age, sex, type of leukemia, disease stage, calculated creatinine clearance, presence of abnormal liver function tests, or total dose received. The crude relative risk of cerebellar toxicity comparing the Quad product with the Upjohn product was 5.0 (95% confidence interval = 1.8-13.7). Adjustment for potential confounders did not alter the association. Other risk factors for cerebellar toxicity, independent of manufacturer, were age greater than 50 years, type of leukemia, disease stage, total dose greater than or equal to 20 g/m2, abnormal pretreatment liver function, and reduced creatinine clearance. CONCLUSION: This study found a significantly higher incidence of cerebellar toxicity with high-dose cytarabine manufactured by Quad Pharmaceuticals when compared with the incidence of cerebellar toxicity with the Upjohn product. Further research at independent institutions would be necessary to allow generalization of this finding. In addition, our findings suggest that a dose reduction in high-dose cytarabine therapy may be indicated for patients with reduced glomerular filtration rates.

Adolescent↗

Intestinal necrosis associated with postoperative orally administered sodium polystyrene sulfonate in sorbitol.

We estimated the incidence of intestinal necrosis in 752 hospitalized patients who had received sodium polystyrene sulfonate (SPS). Of these 752 patients, 117 were exposed within 1 week of surgery. Two cases of intestinal necrosis were discovered, both in patients who had received orally administered SPS in sorbitol within 1 week of surgery. Based on these two cases, the postoperative incidence of intestinal necrosis associated with SPS was 1.8%. For comparative purposes, we identified 862 patients who had undergone hemodialysis, renal transplantation, or cardiac transplantation, but did not receive SPS. No cases of idiopathic intestinal necrosis were found in this second group (P = 0.014). These data suggest that SPS in sorbitol-associated intestinal complications may be a relatively common occurrence in postoperatively exposed patients.

Administration, Oral↗

Oral contraceptive estrogen dose and the risk of deep venous thromboembolic disease.

Despite the well-recognized association between oral contraceptives and deep venous thromboembolism, little is known about the risks associated with currently marketed formulations containing less than 50 micrograms of estrogen. To assess the venous thrombogenicity of low-estrogen oral contraceptives (those containing less than 50 micrograms of estrogen) relative to intermediate-dose (50 micrograms of estrogen) and high-dose (greater than 50 micrograms of estrogen) formulations, we conducted a cohort study of oral contraceptive users between the ages of 15 and 44 years in the Michigan Medicaid population. The period of the study was from 1980 through the third quarter of 1986. A total of 2,739,400 oral contraceptive prescriptions received by 234,218 women were analyzed. Using the low-estrogen cohort as the referent group, the age and calendar period adjusted relative risk of venous thromboembolism in users of intermediate-dose formulations was 1.5 (95% confidence interval (CI) 1.0-2.1, p = 0.04), and the relative risk in users of high-dose formulations was 1.7 (95% CI 0.9-3.0, p = 0.06). These data provide evidence that the dose-response relation between oral contraceptive estrogen and venous thromboembolism extends from 50 to 30 micrograms of estrogen, the dose range of currently marketed formulations.

Chemistry, Pharmaceutical↗

Epidemiologic critique of the report on adverse reactions to ionic and nonionic media by the Japanese Committee on the Safety of Contrast Media.

The author takes a critical look at the findings of the Katayama study of adverse reactions to ionic and nonionic contrast media. The author suggests that although the relative risks appear to be large and favor the use of nonionic media, serious adverse reactions were infrequent with both media types and risks were small on an absolute scale. In addition, the study demonstrates the potential for several serious information and selection biases. The accuracy of risk estimates are therefore called into question. Nevertheless, this study is extremely important in clarifying the risks associated with ionic and nonionic media during venography.

Contrast Media↗

Trends in the content and use of oral contraceptives in the United States, 1964-88.

Drug marketing and physician survey data were used to examine trends in the use and hormonal content of oral contraceptives in the United States between 1964 and 1988. Retail prescriptions for oral contraceptives peaked at approximately 68 million in 1973 and have remained between 50 million and 60 million since 1981. Despite this relative consistency in the number of prescriptions, physician "mentions" of oral contraceptives have increased by approximately 75 percent. This increase may reflect closer monitoring of women on oral contraceptives. Use of multiphasic formulations has steadily risen, accounting for 37 percent of the oral contraceptive prescriptions in 1988. Mean estrogen and progestin doses in all types of formulations have steadily declined. A change in the type of estrogen and progestin used in preparations has coincided with this decline in dose. The association between age and use of high-dose formulations seen in the past was no longer evident in 1988. The data demonstrate that oral contraceptive formulations in wide use today differ in hormone content from those of the past, when most of the major studies addressing the risks associated with oral contraceptive use were completed. There is therefore a need to determine the risks and long-term effects associated with these newer formulations.

Adolescent↗

Mortality resulting from blood dyscrasias in the United States, 1984.

Blood dyscrasias are rare but serious diseases. We used national death certificate data for the year 1984 to estimate the number and rate of deaths caused by four blood dyscrasias. These diseases contributed to 4,490 deaths, corresponding to a mortality rate of 18.9 per million United States population. Aplastic anemia was the most frequent cause of death, followed by thrombocytopenia, agranulocytosis, and hemolytic anemia. Mortality rates varied by age, with a small peak in young children, lower rates for ages five through 34 years, and exponentially increasing rates beyond 35 years of age. Although drug relatedness could not be reliably ascertained from our data, other surveys have estimated that approximately 30% of fatal blood dyscrasias are caused by therapeutic drugs. Assuming that 30% drug attribution also applies to the U.S. population as a whole, approximately 1,350 blood dyscrasia deaths in the U.S. in 1984 may have been caused by drugs.

Adolescent↗

A method of pharmacoepidemiologic analysis that uses computerized Medicaid.

A method of pharmacoepidemiologic data analysis that utilizes computerized Medicaid data is presented. A cohort design in which Medicaid enrollees receiving drugs that are normally used to treat similar underlying conditions is described. A period of time in which Medicaid service transactions are evident is required before an individual is eligible for selection into a cohort. Selection of study subjects and descriptions of cohorts are based on Medicaid service histories occurring during the preliminary, prerequisite period. Time at risk is considered to begin after a prescription for a study drug is dispensed and continues until either a refill is dispensed, a prescription for an alternative drug within the same therapeutic class is dispensed, or a predetermined number of days has passed. Subjects are followed forward in time and relevant health care transactions that are suggestive of suspected adverse drug reactions are noted. Incidence densities associated with sequentially ranked prescriptions within sequential courses of therapy are compared. Methods to increase the accuracy of case ascertainment are briefly discussed. Separate validation studies may be used to evaluate the validity of computerized case ascertainment methods and to compensate for misclassification of outcome. The proposed method is intended to provide timely estimates of risk for selected outcomes. For outcomes that cannot be accurately ascertained from computerized data, this method may be useful in determining the feasibility of more customized studies.

Age Factors↗

Oral contraceptive oestrogen and progestin potencies and the incidence of deep venous thromboembolism.

To assess possible differences in the incidence of venous thrombosis and pulmonary embolism associated with oral contraceptives of varying hormonal potencies, the authors conducted a retrospective cohort study in the 15-44 year old Michigan Medicaid population. Cohorts were defined by the progestin- and oestrogen-potencies of oral contraceptives in use at the time of follow-up as classified by an oral contraceptive potency scheme. Using the low-oestrogen-/low-progestin-potency formulations for reference (rate ratio = 1), adjusted rate ratios of 0.8 (95% CI: 0.5 to 1.3, P = 0.41) and 0.6 (95% CI 0.4 to 1.2, P = 0.13) were observed for intermediate-progestin-potency and high-progestin-potency formulations, respectively. Adjusted rate ratios of 1.4 (95% CI: 0.8 to 2.3, P = 0.21) and 2.6 (95% CI: 1.2 to 5.5, P = 0.01) were observed for intermediate- and high-oestrogen-potency formulations. These data suggest a dose-response relationship between oral contraceptive oestrogen potency and venous thromboembolism, whereas no such evidence for a dose-response relationship between oral contraceptive progestin potency and venous thrombo-embolism was found.

Adolescent↗

Use of subsequent anticoagulants to increase the predictive value of Medicaid deep venous thromboembolism diagnoses.

Linked data bases that derive their information from health care administrative sources are increasingly being used to conduct pharmacoepidemiologic research. Computerized case ascertainment using these data would be highly advantageous in terms of time and cost considerations. For a study of oral-contraceptive-associated deep venous thromboembolism, we evaluated the utility of using anticoagulant treatment codes to validate diagnostic codes suggestive of deep venous thrombosis and pulmonary embolism. By requiring evidence of outpatient anticoagulant use within six months of hospitalization, the predictive value of case ascertainment increased from 42% to 65% for "probable" deep venous thromboembolism and from 70% to 97% for "possible" deep venous thromboembolism. In addition, use of anticoagulant treatment codes as a second marker of disease resulted in nondifferential outcome misclassification when the study base was restricted to current oral-contraceptive users. Use of confirmatory treatment claims may provide a rapid, cost-effective alternative to medical-record-based case ascertainment for pharmacoepidemiologic studies of selected outcomes conducted in Medicaid and other linked universal health care coverage populations.

Adolescent↗

Prevalence and treatment of asthma in the Michigan Medicaid patient population younger than 45 years, 1980-1986.

The prevalence and outpatient treatment of asthma were studied in the Michigan Medicaid patient population by use of computerized physician, hospital, and pharmacy reimbursement data to mark and track asthma-related medical transactions. Asthma cases were defined as patients with evidence of at least two diagnoses and prescription drug transactions consistent with asthma. More than 52,000 cases were thus identified. The period prevalence of asthma was estimated on a year-by-year basis. The prevalence of asthma in the population increased from 2.0 per 100 Medicaid patients in 1980 to 2.8 per 100 Medicaid patients in 1986. Prevalence decreased with age until the age of 20 years and increased thereafter, and was higher in male children than in female children. In contrast, asthma was more prevalent in female adults than in male adults. Prevalence was higher in black subjects than in other races and higher in urban residents than in rural residents. The total number of reimbursements for antiasthma medications increased from 60,000 per year to 120,000 per year, and the average number of antiasthma prescriptions per Michigan Medicaid asthma case increased at the rate of 6.6% per year during the study interval. Changes in the preferred types of asthma treatment consistent with changes that have occurred in the general population were observed. These data suggest that the relative and absolute occurrence of asthma and asthma treatment in the Michigan Medicaid population is increasing.

Adolescent↗