Automated data bases used for pharmacoepidemiology research.
Explore the source record for details and available documents.
Aged↗
Biomedical subjects
B L Strom
Publications and source records attributed to B L Strom.
The epidemiology of the acute flank pain syndrome from suprofen.
Suprofen, a new nonsteroidal anti-inflammatory drug, was marketed in early 1986 as an analgesic agent. Until physicians began reporting an unusual acute flank pain syndrome to the spontaneous reporting system, 700,000 persons used the drug in the United States. Through August 1986, a total of 163 cases of this syndrome were reported. To elucidate the epidemiology of the syndrome, a case-control study was performed, comparing 62 of the case patients who had been reported to the spontaneous reporting system to 185 suprofen-exposed control subjects who did not have the syndrome. Case patients were more likely to be men (odds ratio, 3.8; 95% confidence interval, 1.2-12.1), suffer from hay fever and asthma (odds ratio, 3.4; 95% confidence interval, 1.0-11.9); to participate in regular exercise (odds ratio, 5.9; 95% confidence interval, 1.1-30.7), especially in the use of Nautilus equipment (p = 0.02); and to use alcohol (odds ratio, 4.4; 95% confidence interval, 1.1-17.5). Possible risk factors included young age, concurrent use of other analgesic agents (especially ibuprofen), preexisting renal disease, a history of kidney stones, a history of gout, a recent increase in activity, a recent increase in sun exposure, and residence in the Sunbelt. These were findings that were suggestive but did not reach conventional statistical significance. These findings are consistent with the postulated mechanism for this unusual syndrome: acute diffuse crystallization of uric acid in renal tubules.
Acute Kidney Injury↗
Oral contraceptives and vascular disease.
This update on the cardiovascular risks of oral contraceptives unfortunately adds little to our original 1982 review for the following reasons: 1) There are many different formulations on the market, and they keep changing; 2) Women often use different formulations, stopping and starting as well as switching; 3) The statistical power of the studies often does not permit analyses by specific formulations; 4) The required information (brand name) is sometimes not collected or not collected reliably; 5) Apparently few case-control studies are being conducted to address these issues. Data that are available, interpreted cautiously, suggest either a continuance of the previously observed risk or a small to modest diminution with the use of the newer oral contraceptive formulations. The earlier advice to physicians still seems prudent and is briefly stated: 1) Try to avoid prescribing oral contraceptives for women over 35 years of age; 2) Women who smoke cigarettes should avoid using oral contraceptives, and users should not smoke; 3) Prescribe the formulation with the lowest dose and/or potency of estrogen that is effective and that does not cause unacceptable "breakthrough" bleeding; 4) Women with hypertension should be carefully monitored, and women who develop hypertension while on oral contraceptives should be switched to another form of contraception, if possible. Although oral contraceptives are the most effective form of contraception currently widely available, all risks of a contraceptive method must be compared with corresponding measures of effectiveness and with the risks of unwanted pregnancy. In particular, oral contraceptive users can reduce their risk of myocardial infarction by a reduction or elimination of cigarette smoking.
Adult↗
The gastrointestinal side effects of the nonsteroidal anti-inflammatory drugs.
Explore the source record for details and available documents.
Anti-Inflammatory Agents, Non-Steroidal↗
Breast cancer in relation to the occurrence and time of induced and spontaneous abortion.
The authors evaluated whether an induced or spontaneous abortion during the first six months of gestation, particularly if it occurs before the first term pregnancy, increases the risk of breast cancer. Data from a case-control study of women under 70 years of age were used: 3,200 cases of breast cancer were compared with 4,844 controls with nonmalignant nongynecologic conditions. Among both nulliparous and parous women, the risk of breast cancer was not related to the number of induced or spontaneous abortions. After allowance for all identified potential confounding factors, the estimated relative risk for nulliparous women with an induced abortion relative to those who had never been pregnant was 1.3 (95% confidence interval (CI) 0.8-2.2), and for spontaneous abortion, the corresponding estimate was 0.9 (95% CI 0.5-1.5). Among parous women, the estimated relative risks were 1.2 (95% CI 0.9-1.6) for an induced abortion and 0.9 (95% CI 0.8-1.0) for a spontaneous abortion, relative to never having had an abortion of any type. The time of the abortion had little effect: The relative risk estimates were 0.9 (95% CI 0.5-1.4) for induced abortion before the first term birth, 1.4 (95% CI 1.0-1.9) for induced abortion first occurring after the first term birth, 0.9 (95% CI 0.7-1.2) for spontaneous abortion before the first term birth, and 0.9 (95% CI 0.7-1.0) for spontaneous abortion first occurring after the first term birth. Similar results were evident for women under age 40, among whom the frequency of induced abortion was relatively high. These data suggest that the risk of breast cancer is not materially affected by abortion, regardless of whether it occurs before or after the first term birth.
Abortion, Induced↗
Use of computerized databases to survey drug utilization in relation to diagnoses.
Many studies of drug utilization have suffered from the absence of information on the indications for therapy. A few data sets on drug utilization are available which include indication information. In addition, a number of computerized collections of medical billing data now exist in North America which can be used for such studies. These include data from the Kaiser Permanente Medical Plan; the Group Health Cooperative of Puget Sound; the Commission on Professional and Hospital Activities' Professional Activity Study; the U.S. state of Rhode Island; the Saskatchewan Health Plan in Canada; and Medicaid, the state run but federally financed health insurance plan for economically or medically needy individuals in the United States. These databases have a number of general advantages and disadvantages, which are reviewed. In addition, the differences among these databases are also explored. Finally, examples are presented demonstrating how these databases can be used for: 1) descriptive research on drug utilization, 2) evaluating the appropriateness of drug utilization, and 3) interventions designed to improve the appropriateness of prescribing.
Anti-Inflammatory Agents, Non-Steroidal↗
Overview of different logistical approaches to postmarketing surveillance.
The study designs used for postmarketing surveillance are those of epidemiology, but very large sample sizes are needed. Therefore, a number of specific logistical approaches have been developed. One can use spontaneous reports of adverse reactions, aggregate population based data, computerized collections of data from organized medical care programs, data collected for postmarketing surveillance on an ongoing basis, existing data collected as part of other ad hoc studies, or data collected de novo for the study being conducted. Each is described in more detail, along with its advantages and disadvantages.
Data Collection↗
The effect of indication on the risk of hypersensitivity reactions associated with tolmetin sodium vs other nonsteroidal antiinflammatory drugs.
A retrospective cohort study using 1980-1984 Medicaid billing data from 3 US states was performed to assess the relative risk of hypersensitivity reactions from different nonsteroidal antiinflammatory drugs (NSAID). Comparing tolmetin sodium to other NSAID, pooling the data across the 3 US states using the Mantel-Haenszel procedure, gave an overall relative risk (95% confidence interval) of 1.1 (0.8-1.4). After adjusting for multiple potential confounding variables using logistic regression, an odds ratio (95% confidence interval) of 0.9 (0.6-1.2) was observed. These data do not confirm previous suggestions that use of tolmetin is associated with a higher risk of hypersensitivity reactions than use of other NSAID.
Anti-Inflammatory Agents, Non-Steroidal↗
Generic drug substitution revisited.
Explore the source record for details and available documents.
Humans↗
Effects of dexamethasone in primary supratentorial intracerebral hemorrhage.
To evaluate the efficacy of dexamethasone for treatment of primary supratentorial intracerebral hemorrhage, we studied 93 patients 40 to 80 years old, using a double-blind randomized block design. After the subjects were stratified according to their level of consciousness (Glasgow Coma Scale), those with objectively documented primary supratentorial intracerebral hemorrhage were randomly assigned to either dexamethasone or placebo. For ethical reasons, three interim analyses were planned, to permit early termination of the trial if one study group did better than the other. During the third interim analysis, the death rate at the 21st day was identical in the two groups (dexamethasone vs. placebo, 21 of 46 vs. 21 of 47; chi-square = 0.01, P = 0.93). In contrast, the rate of complications (mostly infections and complications of diabetes) was much higher in the dexamethasone group (chi-square = 10.89, P less than 0.001), leading to early termination of the study. In the light of the absence of a demonstrable beneficial effect and the presence of a significant harmful effect, current practices of using dexamethasone for treatment of primary supratentorial hemorrhage should be reconsidered.
Adult↗
The effect of indication on hypersensitivity reactions associated with zomepirac sodium and other nonsteroidal antiinflammatory drugs.
A large, computerized database derived from Medicaid claims was used to evaluate the risk of allergy and/or anaphylaxis associated with the use of nonsteroidal antiinflammatory drugs (NSAIDs) as a class and the risk associated with the use of zomepirac relative to other NSAIDs. We compared 51,797 patients exposed to NSAIDs with 35,634 age- and sex-matched patients who had not been exposed. As a class, NSAIDs were associated with an adjusted relative risk (95% confidence interval) of hypersensitivity reactions of 2.0 (1.3-2.9). The increased risk was accentuated in those with a diagnosis compatible with acute pain (3.6 [2.2-5.9]) and absent in those without such a diagnosis (1.1 [0.6-1.9]). Comparison of those exposed to zomepirac with those exposed to other NSAIDs resulted in an age-adjusted relative risk of 2.0 (1.1-4.7). Stratification by the probable indication for NSAID use again suggested that the risk may be explained by the use of the NSAIDs for different indications. We concluded that NSAIDs are associated with an increased risk of allergy and/or anaphylaxis, and the use of zomepirac appears to be associated with an increased risk compared with the use of other NSAIDs. However, that increased risk may be a function of the primary indication for the drug or, more likely, the regimen associated with that indication, rather than an intrinsic property of the drug.
Adult↗
Risk factors and outcome of hospital-acquired acute renal failure. Clinical epidemiologic study.
In order to evaluate potential risk factors for the development of hospital-acquired acute renal failure, a case-control study was performed, comparing patients with hospital-acquired acute renal failure with control subjects matched on age, sex, hospital, service of admission, and baseline renal function. The same patients were then reanalyzed utilizing a cohort study design to investigate outcomes from this syndrome. The following elevated odds ratios (95 percent confidence interval) were found while simultaneously adjusting for possible confounding variables using logistic regression: volume depletion, 9.4 (2.1 to 42.8); aminoglycoside use, 5.6 (1.3 to 23.7); congestive heart failure 9.0 (2.1 to 38.9); radiocontrast exposure, 4.9 (1.2 to 19.7); and septic shock, approached infinity, p less than 0.0001. The effect of volume depletion was markedly accentuated in those with diabetes (odds ratio = 1.9) (p less than 0.05). The risk from aminoglycoside use markedly increased with increasing age (p less than 0.002). Finally, the development of hospital-acquired acute renal failure was associated with a marked increase in the risk of dying--the relative risk (95 percent confidence interval) was 6.2 (2.6 to 14.9)--and a marked increase in length of stay, from a median of 13 days in control subjects to a median of 23 days in case subjects (p = 0.005). In conclusion, hospital-acquired acute renal failure is a serious illness. Attempts to prevent it should focus on proved risk factors.
Acute Kidney Injury↗
The promise of pharmacoepidemiology.
Explore the source record for details and available documents.
Data Collection↗
Sexual activity, contraceptive use, and other risk factors for symptomatic and asymptomatic bacteriuria. A case-control study.
In a study to determine the risk factors for urinary tract infection in college-aged women, women who presented with acute urinary tract infection to the student health service were compared to women without bacteriuria who presented with complaints of other acute illnesses. Among women who were sexually active, the following multivariate adjusted odds ratios (95% confidence intervals) were found; intercourse in the previous 48 hours, 58.1 (11.9 to 284.1); intercourse only in the previous 3 to 7 days, 9.1 (1.9 to 44.1); diaphragm use in the previous 48 hours, 8.4 (3.4 to 21.1); urination after intercourse, 0.5 (0.3 to 0.9); and past history of urinary tract infection, 2.7 (1.5 to 5.0). Several other factors previously postulated to be related to urinary tract infection were found not to be associated, including oral contraceptive use, tampon use, and direction of wiping after a bowel movement. When the women with symptomatic bacteriuria were compared to women with asymptomatic bacteriuria, the results were similar, except diaphragm use and urination after intercourse were no longer associated with urinary tract infection. When the women with asymptomatic bacteriuria were compared to women without symptoms and without bacteriuria, diaphragm use remained the only statistically significant risk factor. These findings should be taken into account in attempts to prevent urinary tract infection, as well as in subsequent studies of this disease.
Adult↗
What is the cost of nephrotoxicity associated with aminoglycosides?
We measured the economic impact of aminoglycoside-associated nephrotoxicity in a nested case-control study at six Philadelphia area hospitals. From the charts of 1756 patients who received aminoglycosides and met entry criteria, we collected data on patient demographics, clinical characteristics, and resource utilization for all patients with nephrotoxicity and for a sample of patients without nephrotoxicity. Of the 1756 patients, 129 (7.3%) developed aminoglycoside-associated nephrotoxicity. The component costs of nephrotoxicity were calculated by hospital accounting methods; room and board costs were enumerated with per diem rates. The additional cost of hospital ancillary services per case of nephrotoxicity was $446 (p less than 0.001); the additional cost of hospital stay was $825 for additional routine days (2.74 days) (p less than 0.02) and $1152 for intensive care days (1.50 days) (p less than 0.01). Additional consultations were $78 per patient. Therefore, the mean total additional cost of aminoglycoside-associated nephrotoxicity was $2501. The average additional cost per patient receiving aminoglycosides was $183.
Adult↗
The association of nonsteroidal anti-inflammatory drugs with upper gastrointestinal tract bleeding.
To evaluate the risk of developing upper gastrointestinal (UGI) bleeding from nonsteroidal anti-inflammatory drugs (NSAIDs), a retrospective (historical) cohort study was performed, using a computerized data base including 1980 billing data from all Medicaid patients in the states of Michigan and Minnesota. Comparing 47,136 exposed patients to 44,634 unexposed patients, the unadjusted relative risk for developing UGI bleeding 30 days after exposure to a NSAID was 1.5 (95% confidence interval 1.2 to 2.0). Univariate analyses demonstrated associations between UGI bleeding and age, sex, state, alcohol-related diagnoses, preexisting abdominal conditions, and use of anticoagulants. This association between NSAIDs and UGI bleeding was unchanged after adjusting for these potential confounding variables using logistic regression. A linear dose-response relationship and a quadratic duration-response relationship were demonstrated. Non-steroidal anti-inflammatory drugs are associated with UGI bleeding, although the magnitude of the increased risk is reassuringly small.
Anti-Inflammatory Agents, Non-Steroidal↗
Upper gastrointestinal tract bleeding from oral potassium chloride. Comparative risk from microencapsulated vs wax-matrix formulations.
A retrospective cohort study was performed to assess the relative risk of upper gastrointestinal (UGI) tract bleeding from two formulations of potassium chloride. Relevant information was obtained from 1980 through 1984 Medicaid billing data from the states of Michigan, Minnesota, Florida, and Ohio. After patients with a history of UGI tract bleeding prior to their first prescription for either of the two potassium chloride preparations under study were excluded, data were analyzed for 28,790 patients (143,512 patient-months) dispensed a microencapsulated formulation exclusively and 76,118 patients (560,341 patient-months) dispensed a wax-matrix formulation exclusively. The risk of UGI tract bleeding within 30 days after each prescription for the drug of interest was examined. After sampling from the undiseased study subjects and adjusting for multiple potential confounding variables using logistic regression, an odds ratio (95% confidence interval) of 0.67 (0.52 to 0.85) was observed.
Administration, Oral↗
The relative gastrointestinal toxicity of the nonsteroidal anti-inflammatory drugs.
To assess the relative rate or upper gastrointestinal (UGI) tract bleeding associated with nonsteroidal anti-inflammatory drugs (NSAIDs), we performed a retrospective cohort study using 1980 billing data from all Medicaid patients in the states of Michigan and Minnesota. The rate of UGI tract bleeding in the 30 days following each drug exposure was examined in the 88,044 patients dispensed only one of seven NSAIDs. The rate of UGI tract bleeding differed significantly among users of these drugs. Stratification and logistic regression were used to adjust for multiple potential confounding factors, without substantive changes in the results. An alcohol-drug interaction was found. Sulindac users had the highest rate of UGI tract bleeding, and it was the only drug statistically different from ibuprofen. When the average daily dose of sulindac received was divided by the maximum recommended daily dose, it was notably higher than those for other drugs. Repeated analyses using data from 1982 confirmed these results. We conclude that there are significant and consistent differences in the incidence of UGI tract bleeding associated with the use of NSAIDs in this population.
Anti-Inflammatory Agents, Non-Steroidal↗