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Biomedical subjects

S S Jick

Publications and source records attributed to S S Jick.

At least 19 recordsLinked to original sources

Live attenuated polio vaccine and the risk of intussusception.

AIMS: Since suspicion has been raised that administration of an oral live attenuated rotavirus vaccine may increase the risk of intussusception in young children, there has been concern about the possible effects of oral polio vaccine. The aim of the study was to evaluate the relationship between oral attenuated polio vaccine and intussusception in children below the age of 1 year. METHODS: We conducted a nested case-control analysis based on data from the General Practice Research Database which encompassed 133 children who developed documented intussusception during the first year of life and 515 controls. RESULTS: The time from oral polio vaccine to the index date was similar in cases and controls. Relative risk estimates for intussusception ranged from 0.7 (95% CI 0.2, 2.1) for babies whose last oral polio vaccine was given 29-35 days before their index date to 1.0 (95% CI 0.4, 2.3) for those whose last oral polio vaccine was given 15-21 days before their index date (compared with babies vaccinated more than 43 days before their index date). CONCLUSIONS: There is no suggestion that oral polio vaccine increases the risk for intussusception.

Case-Control Studies↗

The risk of cataract among users of inhaled steroids.

Prolonged exposure to inhaled corticosteroids among adults over 49 years old has been reported to increase cataract risk. Small-scale studies of inhaled steroid users suggest that no increased risk for children and young adults exists. To describe cataract risk among people with asthma who use inhaled corticosteroids relative to patients with asthma with no history of corticosteroid use, we conducted a retrospective observational cohort study of patients identified from the United Kingdom-based General Practice Database with a nested case-control analysis. Relative to patients who do not use corticosteroids, all inhaled corticosteroid users were at a marginally increased risk of cataract (RR = 1.3). Among individuals 40 years of age or older, the risk ratio increased with use of increasing numbers of inhaled corticosteroid prescriptions after controlling for diabetes mellitus, hypertension, and smoking history. This trend was not evident in those under age 40.

Administration, Inhalation↗

Statins and the risk of dementia.

BACKGROUND: Dementia affects an estimated 10% of the population older than 65 years. Because vascular and lipid-related mechanisms are thought to have a role in the pathogenesis of Alzheimer's disease and vascular dementia, we did an epidemiological study of the potential effect of HMGCoA (3 hydroxy-3methylglutaryl-coenzyme A) reductase inhibitors (statins) and other lipid-lowering agents on dementia. METHODS: We used a nested case-control design with information derived from 368 practices which contribute to the UK-based General Practice Research Database. The base study population included three groups of patients age 50 years and older: all individuals who had received lipid-lowering agents (LLAs); all individuals with a clinical diagnosis of untreated hyperlipidaemia; and a randomly selected group of other individuals. From this base population, all cases with a computer-recorded clinical diagnosis of dementia were identified. Each case was matched with up to four controls derived from the base population on age, sex, practice, and index date of case. FINDINGS: The study encompassed 284 cases with dementia and 1080 controls. Among controls 13% had untreated hyperlipidaemia, 11% were prescribed statins, 7% other LLAs, and 69% had no hyperlipidaemia or LLA exposure. The relative risk estimates of dementia adjusted for age, sex, history of coronary-artery disease, hypertension, coronary-bypass surgery and cerebral ischaemia, smoking and body mass index for individuals with untreated hyperlipidaemia (odds ratio 0.72 [95% CI 0.45-1.14]), or treated with nonstatin LLAs (0.96 [0.47-1.97], was close to 1.0 and not significant compared with people who had no diagnosis of hyperlipidaemia or exposure to other lipid-lowering drugs. The adjusted relative risk for those prescribed statins was 0.29 (0.13-0.63; p=0.002). INTERPRETATION: Individuals of 50 years and older who were prescribed statins had a substantially lowered risk of developing dementia, independent of the presence or absence of untreated hyperlipidaemia, or exposure to nonstatin LLAs. The available data do not distinguish between Alzheimer's disease and other forms of dementia.

Aged↗

Risk of venous thromboembolism among users of third generation oral contraceptives compared with users of oral contraceptives with levonorgestrel before and after 1995: cohort and case-control analysis.

OBJECTIVE: To compare the risk of idiopathic venous thromboembolism among women taking third generation oral contraceptives (with gestodene or desogestrel) with that among women taking oral contraceptives with levonorgestrel. DESIGN: Cohort and case-control analyses derived from the General Practice Research Database. SETTING: UK general practices, January 1993 to December 1999. PARTICIPANTS: Women aged 15-39 taking third generation oral contraceptives or oral contraceptives with levonorgestrel. MAIN OUTCOME MEASURES: Relative incidence (cohort study) and odds ratios (case-control study) as measures of the relative risk of venous thromboembolism. RESULTS: The adjusted estimates of relative risk for venous thromboembolism associated with third generation oral contraceptives compared with oral contraceptives with levonorgestrel was 1.9 (95% confidence interval 1.3 to 2.8) in the cohort analysis and 2.3 (1.3 to 3.9) in the case-control study. The estimates for the two types of oral contraceptives were similar before and after the warning issued by the Committee on Safety of Medicines in October 1995. A shift away from the use of third generation oral contraceptives after the scare was more pronounced among younger women (who have a lower risk of venous thromboembolism) than among older women. Fewer cases of venous thromboembolism occurred in 1996 and later than would have been expected if the use of oral contraceptives had remained unchanged. CONCLUSIONS: These findings are consistent with previously reported studies, which found that compared with oral contraceptives with levonorgestrel, third generation oral contraceptives are associated with around twice the risk of venous thromboembolism.

Adolescent↗

Angiotensin-converting enzyme inhibitors, calcium channel blockers, and breast cancer.

BACKGROUND: The use of angiotensin-converting enzyme (ACE) inhibitors has been linked to a decreased risk of developing cancer, and longer-term use of calcium channel blockers (CCBs) has been associated with an increased risk of developing cancer in general and breast cancer in particular. METHODS: Using data from the General Practice Research Database, we conducted a large case-control analysis. Previous exposure to ACE inhibitors, CCBs, and beta-blockers was compared between 3706 postmenopausal women who were diagnosed with incident breast cancer between 1992 and 1997 and 14155 matched-control women. RESULTS: Compared with nonusers of antihypertensive drugs, women who used ACE inhibitors (odds ratio [OR], 1.0; 95% confidence interval [CI], 0.7-1.5), CCBs (OR, 0.9; 95% CI, 0.7-1.2), or beta-blockers (OR, 1.0; 95% CI, 0.8-1.2) for 5 or more years were not at an increased or decreased risk of developing breast cancer (adjusted for smoking and body mass index [calculated as weight in kilograms divided by the square of height in meters]). The risk of breast cancer did not differ between users of different ACE inhibitors or different CCBs (dihydropyridines, diltiazem hydrochloride, and verapamil hydrochloride) or between users of short-acting (OR, 1.0; 95% CI, 0.7-1.4) or sustained-release (OR, 1.0; 95% CI, 0.8-1.3) nifedipine preparations. CONCLUSION: The findings of this large case-control analysis do not support the hypothesis that longer-term use of ACE inhibitors or CCBs affects the risk of developing breast cancer.

Adrenergic beta-Antagonists↗

Isotretinoin use and risk of depression, psychotic symptoms, suicide, and attempted suicide.

BACKGROUND: It has been suggested that there is a causal association between isotretinoin therapy and the risk of depression, psychotic symptoms, suicide, and attempted suicide. OBJECTIVE: To further investigate the proposed association between isotretinoin therapy and the risk of depression, psychotic symptoms, suicide, and attempted suicide using a formal study design. DESIGN: Large population-based cohort studies. SETTING: The Canadian Saskatchewan Health Database and the United Kingdom General Practice Research Database. PATIENTS: Data were analyzed for 7195 isotretinoin users and 13,700 oral antibiotic users with acne from the Canadian Saskatchewan Health Database and for 340 isotretinoin users and 676 oral antibiotic users with acne from the United Kingdom General Practice Research Database. All subjects had computer-recorded histories of between 6 months and 5 years before, and at least 12 months after, their first isotretinoin or antibiotic prescription. OUTCOME MEASURE: Prevalence rates of neurotic and psychotic disorders, suicide, and attempted suicide were compared between isotretinoin and antibiotic users and within isotretinoin users as their own comparison (pretreatment vs posttreatment). The results were expressed as relative risks, calculated using multiple logistic regression analyses. RESULTS: Relative risk estimates, comparing isotretinoin use and oral antibiotic use with nonexposure to either drug for newly diagnosed depression or psychosis, were approximately 1.0 regardless of the data source. Similarly, relative risk estimates were all around 1.0 when comparing before with after isotretinoin use. The relative risk estimate for suicide and attempted suicide was 0.9 (95% confidence interval, 0.3-2.4) when comparing current isotretinoin exposure with nonexposure. CONCLUSION: This study provides no evidence that use of isotretinoin is associated with an increased risk for depression, suicide, or other psychiatric disorders.

Acne Vulgaris↗

The risk of gastrointestinal bleed, myocardial infarction, and newly diagnosed hypertension in users of meloxicam, diclofenac, naproxen, and piroxicam.

STUDY OBJECTIVE: To obtain formally quantified data on the relation of meloxicam to newly diagnosed gastrointestinal problems, myocardial infarction, or treated hypertension. DESIGN: Nested case-control study. SETTING: United Kingdom-based General Practice Research Database. PATIENTS: Patients who received prescriptions for meloxicam, diclofenac, naproxen, or piroxicam formed the study population. Cases were people who developed gastrointestinal problems, myocardial infarction, or hypertension. MEASUREMENTS AND MAIN RESULTS: Relative risk estimates for developing the study outcomes were provided for each study nonsteroidal antiinflammatory drug (NSAID), with diclofenac as the reference drug. In no instance was meloxicam associated with an increased risk for a study outcome. CONCLUSION: Compared with the other NSAIDs, meloxicam was not materially associated with any study outcomes. This study provides reassurance to those prescribing this newer class of NSAIDs.

Anti-Inflammatory Agents, Non-Steroidal↗

Antibiotics and risk of subsequent first-time acute myocardial infarction.

CONTEXT: Increasing evidence supports the hypothesis of a causal association between certain bacterial infections and increased risk of developing acute myocardial infarction. If such a causal association exists, subjects who used antibiotics active against the bacteria, regardless of indication, might be at lower risk of developing acute myocardial infarction than nonusers. OBJECTIVE: To determine whether previous use of antibiotics decreases the risk of developing a first-time acute myocardial infarction. DESIGN: Population-based case-control analysis. SETTING: The United Kingdom-based General Practice Research Database comprising 350 general practices. PATIENTS: A total of 3315 case patients aged 75 years or younger with a diagnosis of first-time acute myocardial infarction between 1992 and 1997 and 13139 controls without myocardial infarction matched to cases for age, sex, general practice attended, and calendar time. MAIN OUTCOME MEASURES: Use of antibiotics among those who did or did not have a first-time acute myocardial infarction. RESULTS: Cases were significantly less likely to have used tetracycline antibiotics (adjusted odds ratio [OR], 0.70; 95% confidence interval [CI], 0.55-0.90) or quinolones (adjusted OR, 0.45; 95% CI, 0.21-0.95). No effect was found for previous use of macrolides (primarily erythromycin), sulfonamides, penicillins, or cephalosporins. CONCLUSIONS: The findings from this large case-control analysis provide further, albeit indirect, evidence for an association between bacterial infections with organisms susceptible to tetracycline or quinolone antibiotics and the risk of acute myocardial infarction. These results of preliminary nature should stimulate more research to further explore the role of infections in the etiology of acute myocardial infarction.

4-Quinolones↗

The risk of venous thromboembolism in users of postcoital contraceptive pills.

Postcoital contraceptive pills (PCP) have recently been approved for use as emergency contraception in the United States. The objective of this study was to assess the risk of idiopathic venous thromboembolism (VTE) in relation to exposure to PCP, and to better quantify the risk of idiopathic VTE associated with current oral contraceptive (OC) use and pregnancy. A population-based cohort study with a nested case-control analysis was conducted using women from the General Practice Research Database. There were no women with an outcome of idiopathic VTE with current exposure to PCP. The incidence rates for various exposures were 3.0/100,000 person-years for the unexposed, 5.3/100,000 person-years for second generation OC, 10.7/100,000 person-years for third generation OC, and 15.5/100,000 person-years in pregnant (or postpartum) women. The relative risk estimates were 1.7 (95% CI 0.3-10.5) for second generation OC, 4.4 (95% CI 1.0-18.7) for third generation OC, and 6.3 (95% CI 1.2-33.5) for pregnancy. Short-term use of PCP is not associated with a substantially increased risk for developing VTE.

Adult↗

Pregnancy outcomes after maternal exposure to fluconazole.

We evaluated pregnancy outcomes in 234 women exposed to fluconazole, 492 exposed to a topically administered azole preparation, 88 exposed to an oral azole preparation other than fluconazole, and 1629 not exposed to any of these agents during the first trimester of pregnancy Relative risks of having a baby with a congenital disorder for women exposed to fluconazole, oral azoles, and topical azoles in the first trimester of pregnancy compared with those who were unexposed were 1.1 (95% CI 0.4-3.3), 2.1 (95% CI 0.7-6.8), and 0.6 (95% CI 0.2-1.6), respectively These results provide reassurance that fluconazole exposure in the first trimester of pregnancy does not materially increase the risk of congenital disorders in infants.

Abnormalities, Drug-Induced↗

Frequency of liver disease in type 2 diabetic patients treated with oral antidiabetic agents.

OBJECTIVE: We evaluated liver disease in conventionally treated type 2 diabetic patients to provide a reference against which reports of liver disease related to novel oral antidiabetic treatments could be compared. RESEARCH DESIGN AND METHODS: In this follow-up study, patients with type 2 diabetes who were treated with oral antidiabetic agents were identified from the U.K.-based General Practice Research Database and were followed to determine whether they developed liver disease. The specific types and etiologies of liver disorders were determined. Incidence rates were calculated based on the accumulated exposure time to oral antidiabetic agents. RESULTS: Among 44,406 type 2 diabetic patients, 605 had a computer diagnosis of liver disease with an incidence rate of 53.2/10,000 person-years (95% CI 49.2-57.6). Of the 605 subjects, 186 had nonsymptomatic, mild, and transient liver disorders; 249 had a predisposing condition; and 113 had another cause for the disease. A total of 57 cases were possibly drug induced with an incidence rate of 5.0/10,000 person-years (3.9-6.5). Of the cases, 11 were attributed to other drugs, 8 were attributed to fatty liver disease of diabetes, and the remaining cases were attributed to uncertain causes. Oral antidiabetic agents were continued in 51 of these 57 cases, and we could not rule out oral antidiabetic agents as a cause of liver disease in 2 cases with an incidence rate of 0.2/10,000 person-years (< 0.1-0.6). CONCLUSIONS: In this population, the background incidence of liver disease was high. Most cases involved other systemic diseases that may cause liver disease.

Administration, Oral↗

A population-based study of appetite-suppressant drugs and the risk of cardiac-valve regurgitation.

BACKGROUND: Recent case reports suggest that a combination of the appetite suppressants fenfluramine and phentermine is associated with an increased risk of cardiac-valve regurgitation. There are also reports of valvular disorders in persons taking fenfluramine or dexfenfluramine alone, particularly for more than three months. METHODS: We conducted a population-based follow-up study and a nested case-control analysis of 6532 subjects who received dexfenfluramine, 2371 who received fenfluramine, and 862 who received phentermine to assess the risk of a subsequent clinical diagnosis of a valvular disorder of uncertain origin. For comparison, we identified a group of 9281 obese subjects who had not taken appetite suppressants who were matched to the treated subjects for age, sex, and weight. All subjects were free of diagnosed cardiovascular disease at the start of follow-up. The average duration of follow-up for all subjects was about four years. RESULTS: There were 11 cases of newly diagnosed idiopathic valvular disorders, 5 after the use of dexfenfluramine and 6 after the use of fenfluramine. There were six cases of aortic regurgitation, two cases of mitral regurgitation, and three cases of combined aortic and mitral regurgitation. There were no cases of idiopathic cardiac-valve abnormalities among the subjects who had not taken appetite suppressants or among those who took only phentermine. The five-year cumulative incidence of idiopathic cardiac-valve disorders was 0 per 10,000 subjects among those who had not taken appetite suppressants (95 percent confidence interval, 0 to 15.4) and among those who took phentermine alone (95 percent confidence interval, 0 to 76.6), 7.1 per 10,000 subjects among those who took either fenfluramine or dexfenfluramine for less than four months (95 percent confidence interval, 3.6 to 17.8; P=0.02 for the comparison with subjects who had not taken appetite suppressants), and 35.0 per 10,000 subjects among those who received either of these medications for four or more months (95 percent confidence interval, 16.4 to 76.2; P<0.001). CONCLUSIONS: The use of fenfluramine or dexfenfluramine, particularly for four months or longer, is associated with an increased risk of newly diagnosed cardiac-valve disorders, particularly aortic regurgitation.

Adult↗

Acute respiratory-tract infections and risk of first-time acute myocardial infarction.

BACKGROUND: There is growing interest in the role of infections in the aetiology of acute myocardial infarction (AMI). We undertook a large, population-based study to explore the association between risk of AMI and recent acute respiratory-tract infection. METHODS: We used data from general practices in the UK (General Practice Research Database). Potential cases were people aged 75 years or younger, with no history of clinical risk factors, who had a first-time diagnosis of AMI between Jan 1, 1994, and Oct 31, 1996. Four controls were matched to each case on age, sex, and the practice attended. The date of the AMI in the case was defined as the index date. For both cases and controls the date of the last respiratory-tract infection before the index date was identified. We also did a case-crossover analysis of cases who had an acute respiratory-tract infection either before the index date or before an arbitrarily chosen date (1 year before AMI). FINDINGS: In the case-control analysis of 1922 cases and 7649 matched controls, significantly more cases than controls had an acute respiratory-tract infection in the 10 days before the index date (54 [2.8%] vs 72 [0.9%]). The odds ratios, adjusted for smoking and body-mass index, for first-time AMI in association with an acute respiratory-tract infection 1-5, 6-10, 11-15, or 16-30 days before the index date (compared with participants who had no such infection during the preceding year) were 3.6 (95% CI 2.2-5.7), 2.3 (1.3-4.2), 1.8 (1.0-3.3), and 1.0 (0.7-1.6); (test for trend p<0.01). The case-crossover analysis showed a relative risk of 2.7 (1.6-4.7) for AMI in relation to an acute respiratory-tract infection in the 10 days before the index date. INTERPRETATION: Our findings suggest that in people without a history of clinical risk factors for AMI, acute respiratory-tract infections are associated with an increased risk of AMI for a period of about 2 weeks. We cannot, however, completely exclude the possibility of misdiagnosis bias, if prodromal symptoms of AMI were mistaken for respiratory-tract infection.

Acute Disease↗

A study of the relation of exposure to quinolones and suicidal behaviour.

AIMS: To investigate the concern, raised by spontaneous reports received by the German regulatory authorities, that use of quinolone antibiotics may increase the risk for suicide and other suicidal behaviours. METHODS: We carried out a nested case-control study using the General Practice Research Database (GPRD). We compared the risk of suicidal behaviours among users of quinolones, other antibiotics and no antibiotics. RESULTS: From January 1, 1991 through April 30, 1995 we identified 348 cases of suicide, attempted suicide, or suicidal ideation and 808 controls. Compared with controls, cases who had received a prescription for a quinolone in the 30 days prior to the event had an adjusted relative risk (RR) estimate of 1.5 (95% CI 0.4-6.3) for any suicidal behaviour. Cases who had filled a prescription for a quinolone in the 31 to 180 days prior to their event had an adjusted RR estimate of 0.8 (95% CI 0.4-1.7) compared with controls. Cases who used other antibiotics in the 30 days prior to the event conferred an adjusted RR estimate of 1.1 (95% CI 0.6-2.2), and 0.9 (95% CI 0.6-1.3) for exposure in the 31 to 180 days prior to the event. The results were not materially different when suicide, suicide attempt, and suicidal ideation were analyzed separately. CONCLUSIONS: We conclude that there is no material increased risk of suicidal behaviours for use of quinolone antibiotics compared with non-use or use of other antibiotics.

4-Quinolones↗