The incidence of first provoked and unprovoked seizure in pediatric patients with and without psychiatric diagnosesAndrew T McAfee
i3 Drug Safety, Waltham, Massachusetts 02451, USA
Epilepsia 48:1075-82. 2007
..To estimate the rate of new-onset afebrile provoked and unprovoked seizure in a general pediatric population and subgroups of patients with and without psychiatric diagnoses other than attention deficit hyperactivity disorder (ADHD)...
Identification of esophageal cancer in the General Practice Research DatabaseAlexander M Walker
World Health Information Science Consultants, LLC, Newton, MA 02466, USA
Pharmacoepidemiol Drug Saf 20:1159-67. 2011
..The literature on the timing of cancer code appearance in general practice records is scanty but suggests that there may be substantial error by comparison with actual dates of clinical onset...
Orthogonal predictions: follow-up questions for suggestive dataAlexander M Walker
World Health Information Science Consultants, LLC, Newton, MA 02466, USA
Pharmacoepidemiol Drug Saf 19:529-32. 2010
..The Universal Data Warehouse will shortly render moot searches for new databases in which to test...
Signal detection for vaccine side effects that have not been specified in advanceAlexander M Walker
World Health Information Science Consultants, LLC, Newton, MA, USA
Pharmacoepidemiol Drug Saf 19:311-7. 2010
..The system is potentially much more sensitive to patterns with multiple features than are very large, high-dimension contingency tables...
Coronary heart disease outcomes in patients receiving antidiabetic agents in the PharMetrics database 2000-2007Alexander M Walker
World Health Information Science Consultants LLC, Wellesley, MA 02481, USA
Pharmacoepidemiol Drug Saf 17:760-8. 2008
..The risk of coronary heart disease (CHD) in users of antidiabetic agents must be quantified to permit reasoned therapeutic choices...
Coronary heart disease outcomes in patients receiving antidiabetic agentsAndrew T McAfee
i3 Drug Safety, Newton, Massachusetts 02451, USA
Pharmacoepidemiol Drug Saf 16:711-25. 2007
..There is conflicting evidence on the reduction of cardiovascular risk in diabetic patients treated with oral antidiabetic agents...
Paroxetine in the first trimester and the prevalence of congenital malformationsJ Alexander Cole
i3 Drug Safety, Auburndale, MA, USA
Pharmacoepidemiol Drug Saf 16:1075-85. 2007
..To refine a preliminary analysis identifying a possibly increased prevalence of malformations among infants born to women exposed to paroxetine in the first trimester...
Hospitalization for peptic ulcer and bleeding in users of selective COX-2 inhibitors and nonselective NSAIDs with special reference to celecoxibM Kay Patterson
i3 Drug Safety, Waltham, MA, USA
Pharmacoepidemiol Drug Saf 17:982-8. 2008
..To assess the relative incidence of peptic ulcer bleeding and perforation (PUBP) in users of selective cyclooxygenase-2 (COX-2) inhibitors and nonselective nonsteroidal anti-inflammatory drugs (NSAIDs)...
Achilles tendon rupture and its association with fluoroquinolone antibiotics and other potential risk factors in a managed care populationJohn D Seeger
i3 Drug Safety, Auburndale, MA, USA
Pharmacoepidemiol Drug Saf 15:784-92. 2006
..We sought to quantify the strength of association between exposure to fluoroquinolone antibiotics and the occurrence of ATR, accounting for other risk factors...
Bupropion in pregnancy and the prevalence of congenital malformationsJ Alexander Cole
i3 Drug Safety, Epidemiology, Auburndale, MA 02466, USA
Pharmacoepidemiol Drug Saf 16:474-84. 2007
..We conducted a study of congenital malformations among infants born to women exposed to bupropion during their first trimester...
An event-based approach for comparing the performance of methods for prospective medical product monitoringJoshua J Gagne
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, MA, USA
Pharmacoepidemiol Drug Saf 21:631-9. 2012
..Little attention has been given to how to compare methods in this setting...
Results of multivariable logistic regression, propensity matching, propensity adjustment, and propensity-based weighting under conditions of nonuniform effectTobias Kurth
Division of Preventive Medicine, Department of Medicine, Brigham and Women s Hospital, Harvard Medical School, Boston, MA, USA
Am J Epidemiol 163:262-70. 2006
..Researchers need to be clear about the population for which an overall treatment estimate is most suitable...
Cardiovascular risk of selective cyclooxygenase-2 inhibitors and other non-aspirin non-steroidal anti-inflammatory medicationsPriscilla Velentgas
Ingenix i3 Drug Safety, Auburndale, MA 02466, USA
Pharmacoepidemiol Drug Saf 15:641-52. 2006
..The purpose of this study was to estimate rates of acute coronary syndrome (ACS), and sudden cardiac death in relation to use of rofecoxib, celecoxib, naproxen, diclofenac, and ibuprofen...
Risk of Guillain-Barré syndrome after meningococcal conjugate vaccinationPriscilla Velentgas
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
Pharmacoepidemiol Drug Saf 21:1350-8. 2012
..We conducted a study to assess the risk of GBS after MCV4 vaccination using health plan administrative and claims data together with the review of primary medical records of potential cases...
Serum potassium monitoring for users of ethinyl estradiol/drospirenone taking medications predisposing to hyperkalemia: physician compliance and survey of knowledge and attitudesPatricia Mona Eng
i3 Drug Safety, Riverside Center 3 120, 275 Grove Street, Auburndale, MA 02466, USA
Contraception 75:101-7. 2007
..Product labeling recommends potassium monitoring in the first month of use for women concurrently receiving medication that may increase serum potassium...
The comparative safety of rosuvastatin: a retrospective matched cohort study in over 48,000 initiators of statin therapyAndrew T McAfee
i3 Drug Safety, Newton, MA 02466, USA
Pharmacoepidemiol Drug Saf 15:444-53. 2006
..The purpose of this study was to compare incidence rates of hospitalization associated with rhabdomyolysis, myopathy, renal, or hepatic dysfunction, and of in-hospital death, between initiators of rosuvastatin and other statins...
Severe vascular events in migraine patientsPriscilla Velentgas
Ingenix Epidemiology, Auburndale, MA 02466, USA
Headache 44:642-51. 2004
..Consistent with previous studies, migraineurs in general have an elevated risk of stroke, but not myocardial infarction, compared with nonmigraineurs...
The Zelnorm epidemiologic study (ZEST): a cohort study evaluating incidence of abdominal and pelvic surgery related to tegaserod treatmentJohn D Seeger
Brigham and Women s Hospital and Harvard Medical School, Boston, MA, USA
BMC Gastroenterol 12:171. 2012
..We sought to quantify the association between tegaserod use and the occurrence of abdominal or pelvic surgery, including cholecystectomy...
Active safety monitoring of new medical products using electronic healthcare data: selecting alerting rulesJoshua J Gagne
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, MA 02120, USA
Epidemiology 23:238-46. 2012
..These systems will rely on algorithms to generate alerts about potential safety concerns...
More lawyers. More bureaucrats. Less information on drug safetyAlexander M Walker
i3 Drug Safety, Riverside Center 3-120, Auburndale, MA 02466, USA
Pharmacoepidemiol Drug Saf 15:394-5. 2006
Temporal trends and drug exposures in pulmonary hypertension: an American experienceAlexander M Walker
Harvard School of Public Health, Boston, MA, USA
Am Heart J 152:521-6. 2006
..We also studied whether use of anorexigens and other drugs differed among patients with pulmonary hypertension of different etiologies...
Posttransplant lymphoproliferative disorder among renal transplant patients in relation to the use of mycophenolate mofetilDonnie P Funch
Ingenix Epidemiology, Auburndale, MA 02466, and Division of Nephrology, University of Alabama at Birmingham, Birmingham, AL, USA
Transplantation 80:1174-80. 2005
..This study assessed the risk of PTLD in relation to immunosuppression during a period that saw the introduction and eventual market dominance of mycophenolate mofetil (MMF)...
Epidemiology and outcomes in patients with atrial fibrillation in the United StatesAlexander M Walker
World Health Information Science Consultants, Wellesley, Massachusetts, USA
Heart Rhythm 5:1365-72. 2008
..Nonrheumatic atrial fibrillation (AF) is a common cause of embolic stroke. Warfarin therapy can reduce stroke risk by two-thirds in patients with AF, but therapy may not always be used or always be used optimally...
Serious cardiovascular events and mortality among patients with schizophreniaCheryl Enger
Ingenix Epidemiology, Riverside Center, Suite 3-120, 275 Grove Street, Auburndale, MA 02466, USA
J Nerv Ment Dis 192:19-27. 2004
..This risk was most pronounced in persons with more intense exposure to drugs and appeared to be indistinguishable in users of typical antipsychotics, of atypical products, or of both...
Incidence of colonic ischemia, hospitalized complications of constipation, and bowel surgery in relation to use of alosetron hydrochlorideDavid P Miller
Ingenix, Epidemiology Division, Newton, Massachusetts 02466, USA
Am J Gastroenterol 98:1117-22. 2003
..On June 7, 2002, the Food and Drug Administration approved alosetron for reintroduction in the U.S. market for women with severe diarrhea-related IBS...
The impact of wording in "Dear doctor" letters and in black box labelsLisa Bianchi Weatherby
Epidemiology Division, Ingenix, Newton, MA 02466, USA
Clin Pharmacol Ther 72:735-42. 2002
....
Precautions for proactive surveillanceAlexander M Walker
Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA
Pharmacoepidemiol Drug Saf 11:17-20. 2002
..The resolution for proactive surveillance is sen/cen: high sensitivity to signals and vigorous censoring to filter out the noise...
Studies of diabetes, thiazolidinediones, and coronary heart diseaseAlexander M Walker
Pharmacoepidemiol Drug Saf 16:1313-4; author reply 1314-6. 2007
Anemia as a predictor of cardiovascular events in patients with elevated serum creatinineAlexander M Walker
i3 Drug Safety, Auburndale, Massachusetts, Thousand Oaks, California, USA
J Am Soc Nephrol 17:2293-8. 2006
..0 to 12.9 g/dl. The risk for progression to dialysis was only slightly elevated (7 to 34%) in anemic patients. Anemia raises the risk for cardiovascular disease in patients with elevated serum creatinine...
A propensity score-matched cohort study of the effect of statins, mainly fluvastatin, on the occurrence of acute myocardial infarctionJohn D Seeger
Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, USA
Am J Cardiol 92:1447-51. 2003
..Serum low-density lipoprotein levels were reduced by statin therapy, and there were fewer incidents of AMI in statin initiators than in noninitiators...
Inhibition of clinical benefits of aspirin on first myocardial infarction by nonsteroidal antiinflammatory drugsTobias Kurth
Division of Preventive Medicine, Department of Medicine, Brigham and Women s Hospital, 900 Commonwealth Ave E, Boston, Mass 02215 1204, USA
Circulation 108:1191-5. 2003
..Recent data also suggest that other nonsteroidal anti-inflammatory drugs (NSAIDs) may interfere with this benefit of aspirin...
Analgesic use and change in kidney function in apparently healthy menTobias Kurth
Division of Preventive Medicine, Brigham and Women s Hospital, Harvard Medical School, Boston, MA 02215 1204, USA
Am J Kidney Dis 42:234-44. 2003
..Studies using a single creatinine measurement have yielded inconsistent results regarding analgesic use and kidney function...
Drug copayment and adherence in chronic heart failure: effect on cost and outcomesJ Alexander Cole
Division of Epidemiology, i3 Drug Safety, Auburndale, Massachusetts 02466, USA
Pharmacotherapy 26:1157-64. 2006
..To measure the association among prescription copayment, drug adherence, and subsequent health outcomes among patients with chronic heart failure (CHF)...
The effect of zanamivir treatment on influenza complications: a retrospective cohort studyJ Alexander Cole
Epidemiology and Safety Research Division, Riverside Center, Ingenix, Inc, Auburndale, Massachusetts 02466, USA
Clin Ther 24:1824-39. 2002
..Complications of influenza are a major cause of morbidity and mortality during the influenza season. Clinical trials of zanamivir have reported a reduced incidence of influenza complications among high-risk patients...
Risk for respiratory events in a cohort of patients receiving inhaled zanamivir: a retrospective studyJeanne E Loughlin
Epidemiology and Safety Research Division, Ingenix, Inc, Auburndale, Massachusetts 02466, USA
Clin Ther 24:1786-99. 2002
..Inhaled zanamivir is indicated for treatment of uncomplicated acute illness due to influenza A and B viruses in patients aged > or = 12 years who have been symptomatic for no more than 2 days...
Dopamine antagonists and the development of breast cancerPhilip S Wang
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, 221 Longwood Ave, Boston, MA 02115, USA
Arch Gen Psychiatry 59:1147-54. 2002
..In light of the small hazards and the possibility of residual confounding, these findings should lead to follow-up investigations but not to changes in treatment strategies...
Benzodiazepine use and hip fractures in the elderly: who is at greatest risk?Anita K Wagner
Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA 02215, USA
Arch Intern Med 164:1567-72. 2004
..It remains unclear whether benzodiazepine use increases hip fracture incidence. We studied this relationship in a large cohort, controlling for multiple potential confounders...
Supplementary data collection with case-cohort analysis to address potential confounding in a cohort study of thromboembolism in oral contraceptive initiators matched on claims-based propensity scoresP Mona Eng
Ingenix, i3 Drug Safety, Waltham, MA 02451, USA
Pharmacoepidemiol Drug Saf 17:297-305. 2008
..g., smoking and obesity) not captured in claims data in a claims-based cohort study of thromboembolism among matched oral contraceptive (OC) initiators...
Determinants of the differences in LDL-cholesterol after initiation of statin treatmentHerve Caspard
Department of US Medical Affairs, Sanofi Aventis, Bridgewater, NJ 08807 0977, USA
Ann Pharmacother 40:21-6. 2006
..Randomized clinical trials may not accurately predict drug benefit in clinical practice because the patients and conditions of therapy almost always differ between those settings...
Persistence and adherence with topical glaucoma therapyBeth L Nordstrom
Ingenix Epidemiology, Auburndale, Massachusetts 02466, USA
Am J Ophthalmol 140:598-606. 2005
..The present study describes the patterns and predictors of treatment persistence and adherence among patients who are diagnosed with glaucoma or as glaucoma suspects (based on claims codes)...
Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system usersJ Alexander Cole
i3 Drug Safety, Auburndale, Massachusetts, USA
Obstet Gynecol 109:339-46. 2007
....
Mortality of stroke patients treated with thrombolysis: analysis of nationwide inpatient sampleTobias Kurth
Neurology 68:710; author reply 711. 2007
Algorithms to identify colonic ischemia, complications of constipation and irritable bowel syndrome in medical claims data: development and validationBruce E Sands
Gastrointestinal Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA
Pharmacoepidemiol Drug Saf 15:47-56. 2006
..This report describes the development and validation of claims-based algorithms to identify colonic ischemia, hospitalized complications of constipation, and irritable bowel syndrome (IBS)...
An application of propensity score matching using claims dataJohn D Seeger
Ingenix Epidemiology, Auburndale, Massachusetts 02466, USA
Pharmacoepidemiol Drug Saf 14:465-76. 2005
..In such settings, there will typically be many more variables available for control as potential confounders than traditional epidemiologic techniques will allow...
Risk of thromboembolism in women taking ethinylestradiol/drospirenone and other oral contraceptivesJohn D Seeger
i3 Drug Safety, Ingenix, Waltham, Massachusetts 02451, USA
Obstet Gynecol 110:587-93. 2007
..We sought to estimate the association between ethinylestradiol/drospirenone and risk of thromboembolism relative to the association among other oral contraceptives...
Use of propensity score technique to account for exposure-related covariates: an example and lessonJohn D Seeger
Ingenix i3 Drug Safety, Waltham, Massachusetts, USA
Med Care 45:S143-8. 2007
..Although propensity scores are used increasingly often, their limitations in settings without complete data may not be recognized...
Aprotinin during coronary-artery bypass grafting and risk of deathSebastian Schneeweiss
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, MA 02120, USA
N Engl J Med 358:771-83. 2008
..Aprotinin (Trasylol) is used to mitigate bleeding during coronary-artery bypass grafting (CABG). Accumulating evidence suggests that this practice increases mortality...