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Objective: To examine nonvertebral fracture risk in relation to inhaled corticosteroid (ICS) exposure among adults with respiratory disease. Design and patients: Nested case-control study within a cohort of 89,877 UnitedHealthcare [...]

Background: The risk factors for postherpetic neuralgia (PHN), the most common complication of herpes zoster, have not been well established. Objective: To elucidate the risk factors for PHN. Methods: Automated medical, claims, and pharmacy records of a health maintenance organization were used to identify cases of PHN and obtain data on risk factors. A case-base design was used to assess the impact of various patient, disease, and treatment factors on the prevalence of PHN 1 and 2 months after developing zoster. Results: There were 821 cases of herpes zoster that met all eligibility criteria. The prevalence of PHN more than 30 days after onset of zoster was 8.0% (95% confidence interval [CI], 6.3%-10.1%) and 4.5% (95% CI, 3.2%-6.2%) after 60 days. Compared with patients younger than 50 years, individuals aged 50 years or older had a 14.7-fold higher prevalence (95% CI, 6.8-32.0) 30 days and a 27.4-fold higher prevalence (95% CI, 8.8-85.4) 60 days after developing zoster. Prodromal sensory symptoms and certain conditions associated with compromised immunity were also associated with PHN. Systemic corticosteroids before zoster and treatment of zoster with acyclovir or corticosteroids did not significantly affect the prevalence of PHN. Conclusions: Increased age and prodromal symptoms are associated with higher prevalence of PHN 1 and 2 months after onset of zoster. Overall, systemic acyclovir appears not to confer any protection against PHN, although benefit among elderly patients cannot be excluded.

Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with an elevated risk of peptic ulcer and upper gastrointestinal hemorrhage, but published reports have lacked information on rates of outpatient disease, have concentrated on the elderly, and have not provided comparisons of rates for specific types of NSAIDs. Methods: We compared incidence rates of peptic ulcer and upper gastrointestinal hemorrhage in 68 028 people younger than 65 years who used diclofenac sodium, naproxen, piroxicam, or sulindac, and who were members of a network of health maintenance organizations. We reviewed automated insurance claims data and medical records to ascertain cases and included conditions treated on an outpatient basis. Results: Medical claims data were adequate for crude identification of potential cases, but review of medical records led to rejection of 63% of these, representing either no abnormality or diseases other than peptic ulcer or upper gastrointestinal hemorrhage. Of the total 112 cases, 64 (57%) were treated as outpatients. The crude incidence rate per 1000 person-years in users of any current, recent, or past NSAID was 2.2 and in distant-past users of NSAIDs was 0.75. For diclofenac, naproxen, piroxicam, and sulindac, we found a consistent pattern of decreasing NSAID effects from current to recent to past exposure. The risk of peptic ulcer or upper gastrointestinal hemorrhage was 1.6 cases per 1000 people using NSAIDs. Conclusions: Combining use of automated claims records with review of medical records promotes efficiency while maintaining specificity of case ascertainment. This study, with 57% of cases treated as outpatients, had results consistent with other published reports that were based on hospitalized patients. Within the limits of statistical error, the incidence rates of peptic ulcer and upper gastrointestinal hemorrhage appeared to be similar for the various NSAIDs studied.

Abstract Objective--To investigate the association between use of non-steroidal anti-inflammatory drugs and serious, acute non-infectious liver injury. Design--Retrospective cohort study, cross over design. Setting--Health records from provincial database in Saskatchewan, [...]

* Background.--Considerable differences in the estimates of the risk of upper gastrointestinal tract disease associated with treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) have been observed. We conducted a meta-analysis of epidemiologic studies of upper gastrointestinal tract disease related to NSAIDs to answer the following research questions: Are study characteristics (study design and quality) associated with different estimates of risk, for both aspirin and nonaspirin NSAIDs? Does the risk increase for particular groups of patients, such as women and the elderly? Methods.--Thirty-four studies addressing severe upper gastrointestinal tract disease associated with NSAIDs (including aspirin and nonaspirin NSAIDs) were examined and scored according to a quality checklist that we designed for this review. Results.--Only 44% of the studies controlled for major confounding variables (age and sex). While exposure was defined as current in 40% and 78% of the studies for nonaspirin NSAIDs and aspirin, respectively, few investigations checked for history of ulcer disease and concurrent diseases or other comedications known to be risk factors for upper gastrointestinal tract bleeding. The overall risk ratio, by means of a random-effects regression model, was 3.0 (95% confidence interval, 1.9 to 4.7). The individual estimates for aspirin and nonaspirin NSAIDs were similar. Both with and without control for quality, cohort studies provided a lower risk ratio estimate than did case-control studies. Conclusions.--The design and quality of the studies appear to be strong independent predictors of the risk estimate; cohort studies were associated with lower risk estimates than case-control studies, and satisfactory studies were associated with lower risk estimates than unsatisfactory studies. (Arch Intern Med. 1992;152:1289-1295)

OBJECTIVE: We tested the hypothesis that multiphasic, low-dose monophasic, and high-dose monophasic oral contraceptives share a common protective effect against functional ovarian cysts. STUDY DESIGN: We conducted a cohort study using the automatic files of Maine Medicaid to assemble a population of 7462 women between the ages of 15 and 44 who were prescribed an oral contraceptive between Jan. 1, 1987, and Dec. 31, 1988. We included as cases 32 women with a principal diagnosis of a functional ovarian cyst confirmed by medical records as being >20 mm in diameter. RESULTS: At comparison with the absence of an oral contraceptive prescription, we observed decreasing rates of functional ovarian cysts among women prescribed multiphasic pills (rate ratio 0.91, 95% confidence interval 0.3000 to 2.31), low-dose monophasic pills with [is less than or equal to] 35 [Mu] g estrogen (rate ratio 0.52, 95% confidence interval 0.17 to 1.33), and high-dose monophasic pills with >35 [Mu] g estrogen (rate ratio 0.24, 95% confidence interval 0.01 to 1.34). CONCLUSIONS: The protective effect of oral contraceptives against functional ovarian cysts reported previously for high-dose monophasic pills may be attenuated with newer pills of lower hormonal potency. (Am J Obstet Gynecol 1992;166:956-61.)

Results From the Surveillance of North American Pulmonary Hypertension Background: The use of appetite suppressants in Europe has been associated with the development of primary pulmonary hypertension (PPH). Recently, fenfiuramine [...]

PURPOSE: Serious, although rare, ventricular arrhythmias and deaths have been reported in patients taking cisapride monohydrate. Without quantification of the risk involved, it is impossible to develop rational therapeutic guidelines. SUBJECTS AND METHODS: Arrhythmic events (sudden deaths and other events compatible with serious ventricular arrhythmias) were sought among 36,743 patients prescribed cisapride in the United Kingdom and Saskatchewan, Canada. Prescriptions and cases were identified from computerized medical claims data and physicians' office records. We compared rates of events between periods of recent cisapride use and nonrecent use, using cohort analysis. Potential confounding factors, including concomitant treatment with agents that inhibit CYP3A4 metabolism or that prolong the QT interval, were assessed in a nested case-control study. RESULTS: In the cohort analysis, the incidence of the arrhythmic events was 1.6 times greater (95% confidence interval [CI]: 0.9 to 2.9) in periods of recent use. With adjustment for clinical history, use of CYP3A4 inhibitors, and use of drugs that prolong the QT interval, the odds ratio for cisapride and cardiac outcomes was 1.0 (95% CI: 0.3 to 3.7). There was no identifiable increase in risk when cisapride was dispensed at about the same time as QT-prolonging drugs or CYP3A4 inhibitors. QT- prolonging agents were associated with a 2.5-fold increase in the risk of arrhythmic events (95% CI: 1.1 to 5.8). CONCLUSIONS: Serious rhythm disorders were not associated with cisapride use, although the upper confidence bounds do not rule out an increase in risk. Am J Med. 1999;107: 356-362. [C] 1999 by Excerpta Medica, Inc.

Acute pulmonary illness compatible with previously described nitrofurantoin toxicity and requiring hospitalization occurred three times among 16,101 first courses of therapy with nitrofurantoia. One case of fatal pulmonary fibrosis was [...]