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Biomedical subjects

James A Kaye

Publications and source records attributed to James A Kaye.

At least 19 recordsLinked to original sources
PubMed2006

Risk of nonfatal venous thromboembolism with oral contraceptives containing norgestimate or desogestrel compared with oral contraceptives containing levonorgestrel.

CONTEXT: Previous studies have reported that users of the "third-generation" oral contraceptives (OCs) containing the progestins gestodene and desogestrel have about twice the risk for venous thromboembolism (VTE) compared to users of older OCs containing levonorgestrel. Estimates of the risk for VTE among users of norgestimate-containing OCs compared to other OCs, however, are lacking. OBJECTIVE: The purpose of this study is to obtain quantitative information on the risk of nonfatal VTE in women using OCs containing either norgestimate or desogestrel in comparison with women taking OCs containing levonorgestrel. DESIGN, SETTING AND PARTICIPANTS: Based on information from PharMetrics, a United States-based company that collects and records information on claims paid by managed care plans, we used a nested case-control study design to estimate relative risks of nonfatal VTE among 15- to 39-year-old current users of OCs containing norgestimate with 35 microg of ethinyl estradiol (EE), desogestrel with 30 microg of EE or levonorgestrel with 30 microg of EE, both monophasic and triphasic preparations, during the period January 2000 to March 2005. Cases were women with a well-documented VTE of uncertain origin that was diagnosed in current users of a study drug. Up to four controls were closely matched to each case by age and calendar time, and odds ratios (ORs) were calculated using conditional logistic regression comparing the risk of VTE among users of the three contraceptives. We also estimated and compared the incidence rates for all three OCs. RESULTS: Based on 281 newly diagnosed idiopathic cases of VTE and 1055 controls, we found that the adjusted ORs for nonfatal VTE comparing norgestimate- or desogestrel-containing OC users to users of levonorgestrel-containing OCs were 1.1 [95% confidence interval (CI), 0.8-1.6] and 1.7 (95% CI, 1.1-2.4), respectively. The incidence rates of VTE were 30.6 (95% CI, 25.5-36.5), 53.5 (95% CI, 42.9-66.0) and 27.1 (95% CI, 21.1-34.3) per 100,000 woman-years for users of norgestimate-, desogestrel- and levonorgestrel-containing OCs, respectively. The incidence rate ratios for norgestimate-containing OCs compared to levonorgestrel-containing OCs and desogestrel-containing OCs compared to levonorgestrel-containing OCs were 1.1 (95% CI, 0.8-1.5) and 2.0 (95% CI, 1.4-2.7), respectively. CONCLUSIONS: The risk of nonfatal VTE among users of desogestrel-containing OCs is significantly elevated compared to that of levonorgestrel-containing OCs. The risk of VTE in users of norgestimate-containing OCs was closely similar to that of users of levonorgestrel-containing OCs.

Adolescent↗
PubMed2006

Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol.

CONTEXT: There is concern that a new transdermal contraceptive patch containing ethinyl estradiol (EE) and the progestin norelgestromin increases the risk for venous thromboembolism (VTE) compared to previously marketed oral contraceptives (OCs). OBJECTIVE: Quantitative information was obtained on the risk of nonfatal VTE in women using the contraceptive patch in comparison to women using OCs, norgestimate (either monophasic or triphasic) and 35 microg EE (norgestimate-35), an OC that has been marketed for over a decade. DESIGN, SETTING AND PARTICIPANTS: Nested case-control design based on information from PharMetrics, a US-based company that collects and organizes information on claims paid by managed care plans. The study was nested among all women aged 15 to 44, who started either the contraceptive patch or norgestimate-35 after April 1, 2002. Cases were women with current use of one of these two study drugs and a documented diagnosis of VTE in the absence of identifiable clinical risk factors (idiopathic VTE). Up to four controls were matched to each case by age and calendar time. MAIN OUTCOME MEASURES: Odds ratios (ORs) comparing the risk of nonfatal VTE in new users of the two contraceptives and incidence rates of nonfatal VTE for new users of each of the study contraceptives. RESULTS: We identified 68 newly diagnosed, idiopathic cases of VTE in the study population. In the case-control analysis, the OR comparing the contraceptive patch to norgestimate-35 was 0.9 (95% CI 0.5-1.6). The overall incidence rate for VTE was 52.8 per 100,000 women-years (95% CI 35.8-74.9) among users of the contraceptive patch and 41.8 per 100,000 women-years among users of norgestimate-35 (95% CI 29.4-57.6), and the age-adjusted VTE incidence rate ratio (IRR) for current use of the contraceptive patch vs. norgestimate-35 was 1.1 (95% CI 0.7-1.8). CONCLUSIONS: The risk of nonfatal VTE for the contraceptive patch is similar to the risk for OCs containing 35 microg ethinylestradiol and norgestimate.

Administration, Cutaneous↗
PubMed2006

Nonsteroidal antiinflammatory drugs and acute myocardial infarction in patients with no major risk factors.

STUDY OBJECTIVE: To assess the risk of long-term use of five nonsteroidal antiinflammatory drugs (NSAIDs)--rofecoxib, celecoxib, ibuprofen, naproxen, and diclofenac--in relation to acute myocardial infarction. DESIGN: Five separate nested case-control studies, one for each NSAID, designed to minimize important biases present in other observational studies. Setting. University-affiliated research program. Data Source. The United Kingdom General Practice Research Database (GPRD). MEASUREMENTS AND MAIN RESULTS: We identified all people in the GPRD aged 30-79 years who had a first recorded prescription for rofecoxib, celecoxib, ibuprofen, naproxen, or diclofenac after January 1, 1999. Cases of newly diagnosed, first-time acute myocardial infarction were then identified from the study population, along with matched control subjects. Relative risk estimates for acute myocardial infarction in patients with no recorded major clinical risk factors for acute myocardial infarction were determined for each NSAID according to receipt of 2-4, 5-9, 10-19, or 20 or more prescriptions compared with receipt of only 1 prescription. Results were adjusted for relevant variables possibly related to the risk for acute myocardial infarction. No material elevation of risk according to the number of prescriptions received for ibuprofen or naproxen was noted. However, a substantial increased risk similar to that found in clinical trials was noted in patients who received 10 or more prescriptions for rofecoxib, celecoxib, or diclofenac. CONCLUSION: Extensive use of rofecoxib, celecoxib, and diclofenac increases the risk of acute myocardial infarction, but similar use of ibuprofen and naproxen does not.

Acute Disease↗
PubMed2005

Tamoxifen-treated breast carcinoma patients and the risk of acute myocardial infarction and newly-diagnosed angina.

BACKGROUND: It is known that tamoxifen therapy favorably affects blood cholesterol levels and other cardiovascular disease risk factors; however, to our knowledge, few studies to date have reported a lower risk of heart disease for breast carcinoma patients who are treated with tamoxifen. METHODS: A nested, matched, case-control study design was used with data from the General Practice Research Database to examine whether patients with breast carcinoma who had been treated with tamoxifen were at reduced risk of having a first acute myocardial infarction (MI) or of developing angina compared with unexposed women. All women between age 30 years and age 85 years who had been diagnosed with breast carcinoma and treated with tamoxifen, or who had been diagnosed with carcinoma of the bladder or colorectum, or nonmelanoma skin cancer between January 1991 and December 1999 were identified. From this population, all women were identified who had newly diagnosed acute MI or angina that occurred at least 1 year after their cancer diagnosis. Four female control participants were matched to each case based on age (+/- 1 year), date of MI or angina diagnosis (corresponding date for matched controls), and date of cancer diagnosis (+/- 6 months). Odds ratios (ORs) and 95% confidence intervals (95% CIs) were generated using conditional logistic regression, controlling for the matching factors, and adjusting for important risk factors, including body mass index, use of hormone replacement therapy, smoking status, and treated hypertension. RESULTS: Current users of tamoxifen had a reduced rate ratio of acute MI or angina (adjusted OR, 0.4; 95% CI, 0.2-0.7) compared with nonusers. The effect persisted with increasing cumulative dose and length of use. CONCLUSIONS: The treatment of breast carcinoma with tamoxifen was found to reduce a woman's risk of acute MI or angina during the 5 years of recommended therapy.

Adult↗
PubMed2005

Obesity and the risk of prostate cancer (United States).

The role of obesity in prostate cancer etiology remains controversial. A recent report suggested that obese men younger than age 60 may have a lower risk of developing prostate cancer than men the same age who are not obese. The current study used a nested, matched case-control study design and data collected in the General Practice Research Database between January 1991 and December 2001 to assess the association between body mass index (BMI) and the risk of incident prostate cancer. Seven hundred and thirty cases of prostate cancer with adequate information on BMI were identified and matched to 2740 controls on age, sex, general practice, and index date. Obese men (BMI > or = 30.0 kilograms [kg]/square of height in meters [m(2)]) were at lower risk of developing prostate cancer (AOR=0.78, 95% CI: 0.56, 1.09) compared to normal weight men (BMI=23.0-24.9 kg/m(2)), and the data best fit an inverse quadratic model for the relation between BMI and the risk of prostate cancer. This study provides modest support for a protective association between obesity and the risk of incident prostate cancer.

Adult↗
PubMed2005

Cesarean delivery in the United Kingdom: time trends in the general practice research database.

OBJECTIVE: To estimate recent temporal trends in delivery by cesarean during the past decade and the proportion of vaginal deliveries after prior caesarean in the United Kingdom. METHODS: We conducted a cohort study using information from the General Practice Research Database. We identified all women with 1 or more deliveries between January 1990 and December 1999 and determined the method(s) of delivery. We estimated the proportion of women with vaginal delivery after cesarean in a subcohort who had at least 3 years of follow-up. RESULTS: We identified 39,938 cesareans among 271,663 deliveries (14.7%), with an increase from 12.5% in 1990 to 18.3% in 1999. The proportion of cesarean deliveries increased with age and increased over time in all age groups except women aged younger than 20 years. Among 26,480 women with a caesarean delivery between 1990 and 1996, 7,649 (28.9%) had a subsequent delivery. The proportion of vaginal delivery after prior cesarean decreased from 45% in 1991 to 37% in 1999. CONCLUSION: Cesarean deliveries increased as a proportion of all deliveries in the United Kingdom during the past decade, and the proportion of vaginal delivery after prior cesarean decreased. Still, the proportion of cesarean deliveries is lower and the proportion of vaginal deliveries after prior cesarean is higher in the United Kingdom than in the United States. LEVEL OF EVIDENCE: II-2.

Adult↗
PubMed2005

Antibiotics and the risk of breast cancer.

BACKGROUND: Two recent studies found a positive association between antibiotic use and the risk of breast cancer. METHODS: Using information from the U.K. General Practice Research Database, we identified 1268 cases of incident breast cancer (40- to 79-year-old women diagnosed in 1987 to 2002 who had at least 6 years of history recorded in the General Practice Research Database) and 6291 female controls matched to the cases on age, general practice, and duration of history recorded in the General Practice Research Database. We ascertained antibiotic prescriptions (penicillins, cephalosporins, sulfonamides, macrolides, tetracyclines, quinolones, metronidazole, and nitrofurantoin) recorded up to 1 year before the index date. RESULTS: Odds ratios (95% confidence intervals) of breast cancer for 0, 1-50, 51-100, 101-500, and 501 or more cumulative days of antibiotic use were 1.0 (reference), 1.0 (0.9-1.2), 0.9 (0.7-1.2), 0.9 (0.7-1.3), and 1.2 (0.6-2.4). CONCLUSIONS: These data do not support the hypothesis that antibiotic use is associated with an increased risk of breast cancer.

Adult↗
PubMed2005

Risk of cholestatic liver disease associated with flucloxacillin and flucloxacillin prescribing habits in the UK: cohort study using data from the UK General Practice Research Database.

AIMS: To provide additional quantification of the risk of flucloxacillin-related liver disease and to describe time trends in flucloxacillin prescribing in the UK. METHODS: This was a cohort study using data from the UK General Practice Research Database. We identified patients with a first-time prescription for flucloxacillin or, for comparison, oxytetracycline from 1992 to 2002 and cases who developed clinically documented cholestatic liver disease of uncertain origin after first-time use of these drugs. We also determined the annual frequency of first-time use of flucloxacillin from 1991 to 2000. RESULTS: We identified 283 097 and 131 189 first-time users of flucloxacillin and oxytetracycline, respectively. The risk of cholestatic liver disease per 100 000 first-time users was 8.5 (95% CI 5.4, 12.6) in the 1-45 days and 1.8 (95% CI 0.6, 4.1) in the 46-90 days after starting flucloxacillin, and 0.8 (95% CI 0.02, 4.3) in the 1-45 days after starting oxytetracycline. The frequency of first-time use of flucloxacillin remained stable between 1991 and 2000. CONCLUSIONS: Flucloxacillin is now established as an important cause of cholestatic liver disease. Warnings about the risk have not had an impact on prescribing practices in the UK, where it remains the predominantly prescribed antistaphylococcal oral antibiotic. This situation in the UK is in sharp contrast to regulatory actions and changes in prescribing habits in Australia after identification of the risk of cholestasis associated with flucloxacillin, and to the predominant use of the alternative drug dicloxacillin in the USA.

Aged↗
PubMed2004

Antidepressants and the risk of suicidal behaviors.

CONTEXT: The relation between use of antidepressants, especially selective serotonin reuptake inhibitors (SSRIs), and suicidal ideation and behaviors has received considerable public attention recently. The use of such drugs among teenagers has been of particular concern. OBJECTIVE: To estimate the relative risks (RRs) of nonfatal suicidal behavior in patients starting treatment with 1 of 3 antidepressant drugs compared with patients starting treatment with dothiepin. DESIGN AND SETTING: Matched case-control study of patients treated in UK general practices using the UK General Practice Research Database for 1993-1999. PARTICIPANTS: The base population included 159,810 users of the 4 antidepressant drugs. Participants could have used only 1 of these antidepressants and had to have received at least 1 prescription for the study antidepressant within 90 days before their index date (the date of suicidal behavior or ideation for cases and the same date for matched controls). MAIN OUTCOME MEASURES: Frequency of first-time exposure to amitriptyline, fluoxetine, paroxetine, and dothiepin of patients with a recorded diagnosis of first-time nonfatal suicidal behavior or suicide compared with comparable patients who did not exhibit suicidal behavior. RESULTS: After controlling for age, sex, calendar time, and time from first antidepressant prescription to the onset of suicidal behavior, the relative risks for newly diagnosed nonfatal suicidal behavior in 555 cases and 2062 controls were 0.83 (95% confidence interval, [CI] 0.61-1.13) for amitriptyline, 1.16 (95% CI, 0.90-1.50) for fluoxetine, and 1.29 (95% CI, 0.97-1.70) for paroxetine compared with those using dothiepin. The RR for suicidal behavior among patients first prescribed an antidepressant within 1 to 9 days before their index date was 4.07 (95% CI, 2.89-5.74) compared with patients who were first prescribed an antidepressant 90 days or more before their index date. Time since first antidepressant prescription was not, however, a confounder of the relation between specific antidepressants and suicidal behavior since its relation to suicidal behavior was not materially different among users of the 4 study drugs. Similarly for fatal suicide, the RR among patients who were first prescribed an antidepressant within 1 to 9 days before their index date was 38.0 (95% CI, 6.2-231) compared with those who were first prescribed an antidepressant 90 days or more before their index date. There were no significant associations between the use of a particular study antidepressant and the risk of suicide. CONCLUSIONS: The risk of suicidal behavior after starting antidepressant treatment is similar among users of amitriptyline, fluoxetine, and paroxetine compared with the risk among users of dothiepin. The risk of suicidal behavior is increased in the first month after starting antidepressants, especially during the first 1 to 9 days. A possible small increase in risk (bordering statistical significance) among those starting the newest antidepressant, paroxetine, is of a magnitude that could readily be due to uncontrolled confounding by severity of depression. Based on limited information, we also conclude that there is no substantial difference in effect of the 4 drugs on people aged 10 to 19 years.

Adolescent↗
PubMed2004

Tamoxifen and cataracts: a null association.

BACKGROUND: Previous studies have reported an increased risk of cataract for breast cancer patients treated with tamoxifen. We assessed whether breast cancer patients treated with tamoxifen were at increased risk of developing cataracts compared to women not prescribed tamoxifen. METHODS: We used a nested, matched case-control study design and data collected in the General Practice Research Database. We identified all women 30-79 years old who were diagnosed with breast cancer and treated with tamoxifen within 6 months, or with bladder cancer, colorectal cancer or non-melanoma skin cancer between January 1991 and December 1999. From this population, we identified all newly diagnosed cases of cataract. We matched four female controls to each case on age (+/- 1 year), index date and study entry date (+/- 6 months). We assessed the risk of cataracts for current, past and ever users of tamoxifen and according to cumulative use of tamoxifen. We calculated adjusted odds ratios (AOR) and 95% confidence intervals (CI) controlling the matching factors and adjusting for important cataract risk factors. FINDINGS: Current tamoxifen users were at no increased risk of cataract (AOR = 1.0, 95% CI: 0.7, 1.4). There was no evidence of an increased risk with increasing cumulative dose. INTERPRETATION: We detected no increased risk of cataract among breast cancer patients who were treated with tamoxifen compared to women with other cancers who were not prescribed tamoxifen.

Adult↗
PubMed2004

Incidence of thrombotic thrombocytopenic purpura/hemolytic uremic syndrome.

BACKGROUND: Thrombotic thrombocytopenic purpura and hemolytic uremic syndrome are rare disorders characterized by platelet aggregation, microthrombi, and resulting tissue damage. We studied the incidence and possible risk factors for these diseases in 3 large populations in the United States, United Kingdom, and Canada. METHODS: Data were derived from a large health insurer in the United States, general practices in the United Kingdom, and the Province of Saskatchewan. We identified potential cases of thrombotic thrombocytopenia purpura and hemolytic uremic syndrome in computerized data and verified them by medical record review. We estimated incidence rates for thrombotic thrombocytopenia purpura and hemolytic uremic syndrome together and separately, and we conducted a case-control study to evaluate potential risk factors. RESULTS: The age-sex standardized incidence of thrombotic thrombocytopenia purpura and hemolytic uremic syndrome was higher than previously reported (6.5, 2.2, and 3.2 per million per year in the United States, United Kingdom, and Saskatchewan, respectively), but there was no secular trend. The incidence of thrombotic thrombocytopenia purpura and hemolytic uremic syndrome was higher in women than men. Most cases of hemolytic uremic syndrome occurred before 20 years of age. We confirmed several known risk factors for thrombotic thrombocytopenia purpura and hemolytic uremic syndrome (cancer, bone marrow transplantation, pregnancy). CONCLUSION: The incidence of thrombotic thrombocytopenia purpura and hemolytic uremic syndrome is higher than previously reported but does not appear to be rising. Apparent international differences in incidence could be the result of imprecision in identifying thrombotic thrombocytopenia purpura and hemolytic uremic syndrome in large research databases.

Adult↗
PubMed2004

Incidence and prevalence of drug-treated attention deficit disorder among boys in the UK.

BACKGROUND: Drug treatment for attention deficit disorder (ADD) was rare in the United Kingdom (UK) until in the mid-1990s. This contrasts with North America, where such treatment has been used to treat ADD for many decades. Since no quantitative data on the incidence and prevalence of drug-treated ADD are available in the UK, we used the general practice research database (GPRD) to obtain such information. AIMS: To provide estimates of incidence and prevalence of treated ADD in the UK for the years 1996-2001. DESIGN OF STUDY: Follow-up study of boys aged 5-14 years. SETTING: Data from UK general practices. METHODS: From the GPRD, we identified all boys aged 5-14 years who were prescribed methylphenidate for ADD. Based on the population in that age and sex category, we estimated incidence rates and the prevalence for treated ADD for the years 1996-2001. RESULTS: The incidence of first-time diagnosis of treated ADD increased among boys from the age of 5 years to reach a peak in boys aged 9-10 years, after which the incidence rate decreased. No material change in incidence was noted during the years 1996-2001. The prevalence of treated ADD was estimated to be 5.3 per 1000 boys in 1999. CONCLUSION: Drug treatment for ADD for boys treated for this disorder in the UK is substantially lower than the proportion of boys treated in North America.

Adolescent↗
PubMed2003

MMR vaccine and idiopathic thrombocytopaenic purpura.

AIMS: To estimate the relationship between idiopathic thrombocytopaenic purpura (ITP) and the measles, mumps and rubella (MMR) vaccination in children; calculating the relative risk estimate for ITP with in 6 weeks after MMR vaccination and the attributable risk of ITP within 6 weeks after MMR vaccination. METHODS: Using the General Practice Research Database we identified children with a first-time diagnosis of ITP from a base population of children aged less than 6 years between January 1988 and December 1999. After describing the characteristics of all the children identified with ITP, we focused on cases aged 13-24 months to perform a population-based, case-control analysis to estimate the relative risk of developing ITP within 6 weeks after MMR vaccination. We also calculated the risk of ITP attributable to the MMR vaccination. RESULTS: Sixty-three children with a first time diagnosis of ITP were identified; 23 cases were between 13 and 24 months old. The relative risk estimate for ITP within 6 weeks after MMR vaccination, compared to the combined group of unvaccinated children and children vaccinated with MMR more than 26 weeks previously was 6.3 (95% CI 1.3-30.1). The attributable risk of developing ITP within 6 weeks after MMR vaccination was estimated to be 1 in 25,000 vaccinations (95% confidence interval 21,300, 89,400). CONCLUSION: This study confirms the increased risk of ITP within 6 weeks after MMR vaccination. However, the attributable risk of ITP within 6 weeks after MMR vaccination is low.

Case-Control Studies↗
PubMed2003

Changes in antipsychotic drug prescribing by general practitioners in the United Kingdom from 1991 to 2000: a population-based observational study.

AIM: To estimate changes in the frequency of use of various antipsychotic drugs in the UK from 1991 to 2000 and to relate these changes to patients' characteristics. METHODS: We conducted a population-based observational study using data from general practices that contribute information to the General Practice Research Database (GPRD). The study population comprised men and women 10-99 years old. We estimated annual use, first-time use, duration of use and, in a sample of 200 patients, indications for use of various antipsychotic drugs, and we observed how these measures had changed over the past decade. RESULTS: The annual use of antipsychotic drugs increased from 10.5 per thousand in 1991 to 12.2 per thousand in 2000, an overall increase of 16%. The increase was greater in men (25.2%) than women (2.7%). At the same time, the rate of new use of antipsychotic drugs was stable in men and decreased by 21% in women. The difference between patterns of annual use and rates of new use is attributable to the increasing average annual duration of treatment in both men and women during the past decade. Thioridazine, which the UK Committee on the Safety of Medicines (CSM) recently recommended should be used only for second-line treatment of schizophrenia in adults, was the most commonly prescribed antipsychotic throughout the study period. Its use increased as a proportion of all antipsychotic drug use from 1991 to 2000 in men and women aged 10-69 years, but decreased in older users. More than half of all first-time use of antipsychotic drugs in the sample of patients we evaluated was for treatment of depression, anxiety states, and panic disorders, while less than 10% was for treatment of schizophrenia and other psychoses. CONCLUSION: The use of antipsychotic drugs has increased in the UK during the past decade, primarily due to increased average annual duration of use rather than higher rates of new use. Most antipsychotic drug use appears to have been prescribed to treat nonpsychotic disorders. It will be of interest to see whether the use of thioridazine, which was the most widely prescribed antipsychotic during 1991-2000, decreases during the next decade in response to the recent CSM recommendation.

Adolescent↗