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A prospective study of lifestyle factors and bone health in breast cancer patients who received aromatase inhibitors in an integrated healthcare setting

Fracture and osteoporosis are known side effects of aromatase inhibitors (AIs) for postmenopausal hormone receptor positive (HR+) breast cancer (BC) patients. How modifiable lifestyle factors impact fracture risk in these patients is relatively unknown. We conducted a prospective cohort study…

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Usage of long-acting muscarinic antagonists and biologics as add-on therapy for patients in the United States with moderate-to-severe asthma

Many asthma patients remain uncontrolled on inhaled corticosteroids (ICS) and long-acting beta agonists (LABAs), but guidance for selecting add-on therapies, including long-acting muscarinic antagonists (LAMAs) or biologics, is limited. We describe how prescribing practices for add-on LAMA and biologic therapy…

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Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 in a Community Oncology Setting

This project will establish a prospective cohort of white and Black cancer patients treated with immune checkpoint inhibitors, leveraging the NCI Community Oncology Research Program network infrastructure, to investigate racial differences in immune-related adverse events and their predictors, treatment delay…

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Long-term effectiveness of BPH/LUTS pharmacological therapies and using machine learning based predictive analytics to tailor treatment.

This career development award project will compare the effectiveness of pharmacological therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia in preventing long-term disease progression; and develop and validate predictive models using demographic, clinical, and laboratory data available…

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A Pragmatic Randomized Controlled Trial of a Bundled, Pharmacist-Led Hyperpolypharmacy Deprescribing Intervention

This randomized controlled trial study is testing an intervention to reduce unsafe medication use in patients aged 75 years and older. The intervention uses collaborative drug therapy management between physicians and pharmacists, standard-of-care treatment protocols, shared decision-making, and the CEASE deprescribing protocol.…

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Clinical effectiveness of integrase strand transfer inhibitor-based antiretroviral regimens among adults with human immunodeficiency virus: a collaboration of cohort studies in the United States and Canada

Integrase strand transfer inhibitor (InSTI)-based regimens are now recommended as first-line antiretroviral therapy (ART) for adults with human immunodeficiency virus, but evidence on long-term clinical effectiveness of InSTI-based regimens remains limited. We examined whether InSTI-based regimens improved longer-term clinical outcomes.…

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Endophthalmitis prophylaxis failures in patients injected with intracameral antibiotic during cataract surgery

To estimate the association of cefuroxime and moxifloxacin in relation to the occurrence of endophthalmitis following phacoemulsification cataract surgery. Retrospective clinical cohort study. We studied patients with noncomplex phacoemulsification cataract surgery in Kaiser Permanente Northern California during 2014-2019. Data were…

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Prescription medications for sleep disturbances among midlife women during 2 years of follow-up: a SWAN retrospective cohort study

To examine the effects of prescription sleep medications on patient-reported sleep disturbances. Retrospective cohort. Longitudinal cohort of community-dwelling women in the USA. Racially and ethnically diverse middle-aged women who reported a sleep disturbance. New users of prescription sleep medications propensity…

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Adverse Pregnancy Outcomes and Cardiovascular Disease Risk: Unique Opportunities for Cardiovascular Disease Prevention in Women: A Scientific Statement From the American Heart Association

This statement summarizes evidence that adverse pregnancy outcomes (APOs) such as hypertensive disorders of pregnancy, preterm delivery, gestational diabetes, small-for-gestational-age delivery, placental abruption, and pregnancy loss increase a woman's risk of developing cardiovascular disease (CVD) risk factors and of developing…

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Rationale and Design of the Pragmatic Randomized Trial of Icosapent Ethyl for High Cardiovascular Risk Adults (MITIGATE)

The MITIGATE study aims to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), compared with usual care, on laboratory-confirmed viral upper respiratory infection (URI)-related morbidity and mortality in adults with established atherosclerotic cardiovascular disease (ASCVD). IPE is…

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Management of Renin-Angiotensin-Aldosterone System blockade in patients admitted to hospital with confirmed coronavirus disease (COVID-19) infection (The McGill RAAS-COVID- 19): A structured summary of a study protocol for a randomized controlled trial

The aim of the RAAS-COVID-19 randomized control trial is to evaluate whether an upfront strategy of temporary discontinuation of renin angiotensin aldosterone system (RAAS) inhibition versus continuation of RAAS inhibition among patients admitted with established COVID-19 infection has an impact…

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A Multicenter, Randomized, Placebo-controlled Pragmatic Phase 3 Study Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events in Medically Ill Outpatients with Acute Symptomatic COVID-19 (PRE

This virtual, pragmatic randomized clinical trial will evaluate whether rivaroxaban reduces the risk of a composite endpoint of major venous and arterial thrombotic events, all-cause hospitalization, and all-cause mortality compared with placebo in outpatients with acute, symptomatic COVID-19 infection.

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Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial

The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure…

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Kidney Function and Potassium Monitoring After Initiation of Renin-Angiotensin-Aldosterone System Blockade Therapy and Outcomes in 2 North American Populations

Clinical practice guidelines recommend routine kidney function and serum potassium testing within 30 days of initiating ACE (angiotensin-converting enzyme) inhibitor or angiotensin II receptor blocker therapy. However, evidence is lacking about whether follow-up testing reduces therapy-related adverse outcomes. We conducted…

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Angiotensin Receptor-Neprilysin Inhibition Based on History of Heart Failure and Use of Renin-Angiotensin System Antagonists

The PIONEER-HF (comParIson Of sacubitril/valsartaN versus Enalapril on Effect on nt-pRo-bnp in patients stabilized from an acute Heart Failure episode) trial demonstrated the efficacy and safety of sacubitril/valsartan (S/V) in stabilized patients with acute decompensated heart failure (HF) and reduced ejection…

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Cardiovascular Outcomes in Relation to Antihypertensive Medication Use in Women with and Without Cancer: Results from the Women’s Health Initiative

Recent clinical trials have evaluated angiotensin-converting enzyme (ACE) inhibitors (ACEis), angiotensin receptor blockers (ARBs), and beta blockers (BBs) in relation to cardiotoxicity in patients with cancer, typically defined by ejection fraction declines. However, these trials have not examined long-term, hard…

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Initiation of Angiotensin-Neprilysin Inhibition After Acute Decompensated Heart Failure: Secondary Analysis of the Open-label Extension of the PIONEER-HF Trial

In PIONEER-HF, among stabilized patients with acute decompensated heart failure (ADHF), the in-hospital initiation of sacubitril/valsartan was well tolerated and led to improved outcomes compared with enalapril. However, there are limited data comparing the strategies of in-hospital vs postdischarge initiation…

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Risk of Cardiovascular Events in Statin-Treated Patients with Type 2 Diabetes and Metabolic Dyslipidemia without Prevalent Atherosclerotic Cardiovascular Disease

The relationship between achieved low-density lipoprotein cholesterol (LDL-C) levels and risk of incident atherosclerotic cardiovascular disease events among patients with diabetes and metabolic dyslipidemia has not been well described. We conducted an observational cohort study of statin-treated adults (ages 21-90…

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LIFE EXPECTANCY DISPARITIES AMONG ADULTS WITH HIV IN THE UNITED STATES AND CANADA: THE IMPACT OF A REDUCTION IN DRUG- AND ALCOHOL-RELATED DEATHS USING THE LIVES SAVED SIMULATION (LISSO) MODEL

Improvements in life expectancy among people living with human immunodeficiency virus (PLWH) receiving antiretroviral treatment in the United States and Canada might differ among key populations. Given the difference in substance use among key populations and the current opioid epidemic,…

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Statins as a free pass: Body mass index and other cardiovascular risk factors among lipid-lowering medication users and nonusers in the California Men’s Health Study

To lower risk from cardiovascular disease (CVD), national guidelines recommend lifestyle changes followed by use of lipid-lowering medications when appropriate. Previous studies have questioned whether individuals taking these medications are less likely to modify their dietary intake and physical activity,…

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Treatment and Outcomes of Acute Pulmonary Embolism and Deep Venous Thrombosis: The Cardiovascular Research Network Venous Thromboembolism (CVRN VTE) Study

Few studies describe both inpatient and outpatient treatment and outcomes of patients with acute venous thromboembolism in the United States. A multi-institutional cohort of patients diagnosed with confirmed pulmonary embolism or deep venous thrombosis during the years 2004 through 2010…

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Metformin Initiation and Early Adherence among Kaiser Permanente Northern California Members with Newly Diagnosed Type 2 Diabetes

Aim 1: Identify patient-level predictors of metformin treatment during the year following type 2 diabetes diagnosis. Examined factors will include: demographics, such as age, race/ethnicity, gender, and rural versus urban; clinical characteristics, such as A1c at diagnosis, diabetes-related comorbidities (hypertension,…

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Enhanced Recovery After Surgery to Change Process Measures and Reduce Opioid Use After Cesarean Delivery: A Quality Improvement Initiative

To evaluate implementation of an enhanced recovery after surgery (ERAS) program for patients undergoing elective cesarean delivery by comparing opioid exposure, multimodal analgesia use, and other process and outcome measures before and after implementation. An ERAS program was implemented among…

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Initiation of antidepressant medication and risk of incident stroke: using the Adult Changes in Thought cohort to address time-varying confounding

Depression strongly predicts stroke incidence, suggesting that treating depression may reduce stroke risk. Antidepressant medications, however, may increase stroke risk via direct pathways. Previous evidence on antidepressant medication and stroke incidence is mixed. We evaluated associations between antidepressant use and…

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Comparison of Patient-Reported Care Satisfaction, Quality of Warfarin Therapy, and Outcomes of Atrial Fibrillation: Findings From the ORBIT – AF Registry

Background Patient satisfaction with therapy is an important metric of care quality and has been associated with greater medication persistence. We evaluated the association of patient satisfaction with warfarin therapy to other metrics of anticoagulation care quality and clinical outcomes…

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Comparative effectiveness of treatment of actinic keratosis with topical fluorouracil and imiquimod in the prevention of keratinocyte carcinoma: a cohort study

The effectiveness of 5-fluorouracil compared with that of imiquimod for preventing keratinocyte carcinoma is unknown. To compare the effectiveness of 5-fluorouracil and that of imiquimod in preventing keratinocyte carcinoma in a real-world practice setting. We identified 5700 subjects who filled…

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Comparison of msp genotyping and a 24 SNP molecular assay for differentiating Plasmodium falciparum recrudescence from reinfection

Current World Health Organization guidelines for conducting anti-malarial drug efficacy clinical trials recommend genotyping Plasmodium falciparum genes msp1 and msp2 to distinguish recrudescence from reinfection. A more recently developed potential alternative to this method is a molecular genotyping assay based…

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Brief Report: Maternal Opioid Prescription from Preconception Through Pregnancy and the Odds of Autism Spectrum Disorder and Autism Features in Children

Opioid use during pregnancy is associated with suboptimal pregnancy outcomes. Little is known about child neurodevelopmental outcomes. We examined associations between maternal opioid prescriptions preconception to delivery (peri-pregnancy) and child's risk of ASD, developmental delay/disorder (DD) with no ASD features,…

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Medical and non-medical marijuana use in depression: Longitudinal associations with suicidal ideation, everyday functioning, and psychiatry service utilization

Marijuana use is clinically problematic in depression, and non-medical and medical use may both contribute to barriers to care in this population. Among outpatients with depression, we examined the differential impact of medical or non-medical marijuana use, relative to no-use,…

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Early therapeutic persistence on dabigatran versus warfarin therapy in patients with atrial fibrillation: results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry

Anticoagulation is highly effective for the prevention of stroke in patients with atrial fibrillation (AF) but it is dependent on patients continuing therapy. While studies have demonstrated suboptimal therapeutic persistence on warfarin, few have studied persistence rates with non vitamin…

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Reducing risk of Clostridium difficile infection and overall use of antibiotic in the outpatient treatment of urinary tract infection

Risk of community-acquired Clostridium difficile infection (CA-CDI) following antibiotic treatment specifically for urinary tract infection (UTI) has not been evaluated. We conducted a nested case-control study at Kaiser Permanente Northern California, 2007-2010, to assess antibiotic prescribing and other factors in…

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Risk of Incident Atherosclerotic Cardiovascular Disease Events by Achieved Atherogenic Lipid Levels Among 62,428 Statin-Treated Individuals With Diabetes Mellitus

The relevance of low-density lipoprotein cholesterol (LDL-C) or non-high-density lipoprotein cholesterol (non-HDL-C) goals for primary prevention of atherosclerotic cardiovascular disease (ASCVD) among patients with diabetes was assessed. This retrospective cohort study included patients with type 2 diabetes, age 21 to…

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Stroke Risk and Treatment in Patients with Atrial Fibrillation and Low CHA2DS2-VASc Scores: Findings From the ORBIT-AF I and II Registries

Background Current American College of Cardiology/American Heart Association guidelines suggest that for patients with atrial fibrillation who are at low risk for stroke (CHA2DS2VASc=1) (or women with CHA2DS2VASc=2) a variety of treatment strategies may be considered. However, in clinical practice,…

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Risk of diabetes complications among those with diabetes receiving androgen deprivation therapy for localized prostate cancer

Androgen deprivation therapy (ADT), used increasingly in the treatment of localized prostate cancer, is associated with substantial long-term adverse consequences, including incident diabetes. While previous studies have suggested that ADT negatively influences glycemic control in existing diabetes, its association with…

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HIV Infection, Use of Tenofovir and Other Antiretrovirals, and Risk of Fatal and Non-Fatal Comorbidities: Cohort Study in Kaiser Permanente

Although the benefits of combination antiretroviral therapy (ART) for reducing HIV-related morbidity and mortality are well-recognized, toxicity from some ART may potentially contribute to excess age-related comorbidities. Certain antiretrovirals, including tenofovir, have known renal toxicity, but recent formulations may be…

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Association of Initiation of Basal Insulin Analogs vs Neutral Protamine Hagedorn Insulin With Hypoglycemia-Related Emergency Department Visits or Hospital Admissions and With Glycemic Control in Patients With Type 2 Diabetes

In clinical trials of patients with type 2 diabetes, long-acting insulin analogs modestly reduced the risk of nocturnal hypoglycemia compared with human neutral protamine Hagedorn (NPH) insulin, but cost 2 to 10 times more. Outcomes in clinical practice may differ…

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Influence of smoking, body mass index and other factors on the preventive effect of nonsteroidal anti-inflammatory drugs on colorectal cancer risk

Nonsteroidal anti-inflammatory drugs (NSAIDs) use has consistently been associated with lower risk of colorectal cancer (CRC); however, studies showed inconsistent results on which cohort of individuals may benefit most. We performed multivariable logistic regression analysis to systematically test for the…

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Adherence to Cardio-protective Medications Prescribed for Secondary Prevention after an Acute Coronary Syndrome Hospitalization Compared to Usual Care

Secondary prevention after an acute coronary syndrome (ACS) hospitalization is critical to prevent additional morbidity and mortality. While poor adherence to prescribed cardio-protective medications is a known problem;1;2 it is unknown whether an ACS event might motivate patients to achieve…

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Mineralocorticoid Receptor Antagonism in Patients With Atrial Fibrillation: Findings From the ORBIT-AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) Registry

Mineralocorticoid receptor antagonist (MRA) therapy may be beneficial to patients with atrial fibrillation (AF), but little is known about their use in patients with AF and subsequent outcomes. In order to better understand MRA use and subsequent outcomes, we performed…

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Effect of Out-of-Pocket Cost on Medication Initiation, Adherence, and Persistence among Patients with Type 2 Diabetes: The Diabetes Study of Northern California (DISTANCE)

To estimate the effect of out-of-pocket (OOP) cost on nonadherence to classes of cardiometabolic medications among patients with diabetes. Electronic health records from a large, health care delivery system for 223,730 patients with diabetes prescribed 842,899 new cardiometabolic medications during…

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Association of Inflammatory Markers with Disease Progression in Patients with Metastatic Melanoma Treated with Immune Checkpoint Inhibitors

We investigated the effect of inflammatory biomarkers (neutrophil, platelet, and lymphocyte counts) on risk of progression in patients with metastatic melanoma treated with an immune checkpoint inhibitor targeting programmed cell death protein-1 (PD-1). This retrospective cohort study included 108 patients…

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How Fast is Fast Enough? Assessing Door-to-Needle Times and Outcomes of Stroke Patients Receiving Acute Thrombolysis Therapy Under the Kaiser Permanente Northern California Stroke EXPRESS Program

With stroke treatment, there is a general belief that "time is brain." However, there has been no published data examining specifically the association between door-to-needle times for acute treatment with intravenous alteplase in stroke patients and 90-day outcomes. In 2016,…

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The role of angiotensin receptor-neprilysin inhibitors in cardiovascular disease-existing evidence, knowledge gaps, and future directions.

Although traditional renin-angiotensin system antagonists including angiotensin-converting enzyme inhibitors and angiotensin receptor blockers have revolutionized the treatment of cardiovascular disease (CVD), the pivotal PARADIGM-HF trial demonstrated that sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), was superior to an angiotensin-converting enzyme inhibitor…

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Rationale and design of the comParIson Of sacubitril/valsartaN versus Enalapril on Effect on nt-pRo-bnp in patients stabilized from an acute Heart Failure episode (PIONEER-HF) trial.

OBJECTIVE: The objective is to assess the safety, tolerability, and efficacy of sacubitril/valsartan compared with enalapril in patients with heart failure (HF) with a reduced ejection fraction (EF) stabilized during hospitalization for acute decompensated HF.BACKGROUND: Sacubitril/valsartan, a first-in-class angiotensin receptor-neprilysin…

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Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study

The cardiovascular safety of saxagliptin, a dipeptidyl-peptidase 4 inhibitor, compared with other antihyperglycemic treatments is not well understood. We prospectively examined the association between saxagliptin use and acute myocardial infarction (AMI). We identified patients aged ≥18 years, starting from the…

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A real-world, community-based cohort study comparing the effectiveness of topical fluoruracil vs. topical imiquimod for the treatment of actinic keratosis

The most widely used topical agents for the field-based treatment of multiple actinic keratoses (AKs) are 5-fluorouracil and imiquimod, but their comparative effectiveness has not been assessed in a real-world setting. We compared the effectiveness of 5-fluorouracil and imiquimod in…

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Prevalence of Drug-Resistant Minority Variants in Untreated HIV-1-Infected Individuals With and Those Without Transmitted Drug Resistance Detected by Sanger Sequencing

Minority variant human immunodeficiency virus type 1 (HIV-1) nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance mutations are associated with an increased risk of virological failure during treatment with NNRTI-containing regimens. To determine whether individuals to whom variants with isolated NNRTI-associated drug…

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Estimating outcomes and cost effectiveness using a single-arm clinical trial: ofatumumab for double-refractory chronic lymphocytic leukemia.

BACKGROUND:Ofatumumab (Arzerra®, Novartis) is a treatment for chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab [double refractory (DR-CLL)]. Ofatumumab was licensed on the basis of an uncontrolled Phase II study, Hx-CD20-406, in which patients receiving ofatumumab survived for a median…

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High rates of severe hypoglycemia among African American patients with diabetes: the surveillance, prevention, and Management of Diabetes Mellitus (SUPREME-DM) network

Seven-year surveillance study (2005-2011) to evaluate race/ethnic differences in the trends in rates of severe hypoglycemia (SH) in a population of insured, at-risk adults with diabetes. SH events were identified via any primary or principal diagnosis from emergency department or…

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Effects of Ibudilast on the Subjective, Reinforcing, and Analgesic Effects of Oxycodone in Recently Detoxified Adults with Opioid Dependence.

Ibudilast, a nonselective phosphodiesterase inhibitor, is used clinically in Asia for the treatment of asthma and poststroke dizziness. Recent preclinical studies have suggested that it also inhibits glial cell activation in rodents, and may alter opioid-mediated effects, including analgesia and…

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Effect of Race and Ethnicity on Antihypertensive Medication Utilization Among Women in the United States: Study of Women’s Health Across the Nation (SWAN)

Antihypertensive medication use may vary by race and ethnicity. Longitudinal antihypertensive medication use patterns are not well described in women. Participants from the Study of Women's Health Across the Nation (SWAN), a prospective cohort of women (n=3302, aged 42-52), who…

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Pharmacogenomics of Statin Therapy

This study will recruit statin users with: 1) a major acute coronary event (n=150), 2) new onset type 2 diabetes (n=150), 3) statin-induced myopathy (n=150), and controls free of all 3 conditions (n=300). We will then conduct genetic, transcriptomic, proteomic…

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Retrospective Cohort Study of Risk of Hip Fractures Associated with High Dose, Long-term Proton Pump Inhibitor (HD-PPI) Use or H2 Receptor Antagonists (H2RA) and Cytochrome P450 Pharmacogenomics

This contract agreement with the FDA covers epidemiologic studies of drug safety questions identified by the FDA and led by KP researchers in Northern and Southern California. Examples of current studies include the cardiovascular safety of psychostimulant medications used for…

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Denosumab Global Safety Methodology and Background Rate Assessment and Global Safety Assessment Among Women with Postmenopausal Osteoporosis Using Multiple Observational Databases

This long term surveillance study has three primary goals: 1) to establish algorithms and identify women with postmenopausal osteoporosis; 2) to establish algorithms and identify the occurrence of adverse events of special interest, including osteonecrosis of the jaw, atypical fracture,…

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Depressive symptoms and adherence to cardiometabolic therapies across phases of treatment among adults with diabetes: the Diabetes Study of Northern California (DISTANCE)

Among adults with diabetes, depression is associated with poorer adherence to cardiometabolic medications in ongoing users; however, it is unknown whether this extends to early adherence among patients newly prescribed these medications. This study examined whether depressive symptoms among adults…

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Influence of Competing Risks on Estimating the Expected Benefit of Warfarin in Individuals with Atrial Fibrillation Not Currently Taking Anticoagulants: The Anticoagulation and Risk Factors in Atrial Fibrillation Study

To provide greater understanding of the "real world" effect of anticoagulation on stroke risk over several years. Cohort study. Anticoagulation and Risk Factors in Atrial Fibrillation Study community-based cohort. Adults with nonvalvular atrial fibrillation (AF) between 1996 and 2003 (13,559).…

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Influence of atrial fibrillation on post-discharge natriuretic peptide trajectory and clinical outcomes among patients hospitalized for heart failure: insights from the ASTRONAUT trial.

AIMS: Change in NT-proBNP level is a common surrogate endpoint in early phase heart failure (HF) trials, but whether this endpoint is influenced by atrial fibrillation/flutter (AFF) is unclear.METHODS AND RESULTS: This analysis included 1358 patients from the ASTRONAUT trial,…

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Risk of Serious Infection for Patients with Systemic Lupus Erythematosus Starting Glucocorticoids with or without Antimalarials

To compare serious infection risk for systemic lupus erythematosus (SLE) patients starting glucocorticoids (GC), antimalarials (AM), or their combination. We conducted a new-user, historical cohort study, Kaiser Permanente Northern California, 1997-2013. Cox proportional hazards analysis was used to calculate adjusted…

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Stability of High-Quality Warfarin Anticoagulation in a Community-Based Atrial Fibrillation Cohort: The Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study

Warfarin reduces ischemic stroke risk in atrial fibrillation (AF) but increases bleeding risk. Novel anticoagulants challenge warfarin as stroke-preventive therapy for AF. They are available at fixed doses but are more costly. Warfarin anticoagulation at a time in therapeutic range…

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A prospective cohort study of early discontinuation of adjuvant chemotherapy in women with breast cancer: the breast cancer quality of care study (BQUAL)

For many women with non-metastatic breast cancer, adjuvant chemotherapy prevents recurrence and extends survival. Women who discontinue chemotherapy early may reduce those benefits, but little is known about what predicts early discontinuation. We sought to determine prospectively the rate and…

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In-Hospital Diuretic Agent Use and Post-Discharge Clinical Outcomes in Patients Hospitalized for Worsening Heart Failure: Insights From the EVEREST Trial.

OBJECTIVES: The aim of this study was to characterize the association between decongestion therapy and 30-day outcomes in patients hospitalized for heart failure (HF).BACKGROUND: Loop diuretic agents are commonly prescribed for the treatment of symptomatic congestion in patients hospitalized for…

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Medication Adherence Does Not Explain Black-White Differences in Cardiometabolic Risk Factor Control among Insured Patients with Diabetes

Among patients with diabetes, racial differences in cardiometabolic risk factor control are common. The extent to which differences in medication adherence contribute to such disparities is not known. We examined whether medication adherence, controlling for treatment intensification, could explain differences…

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Use of Bevacizumab in Community Settings: Toxicity Profile and Risk of Hospitalization in Patients With Advanced Non-Small-Cell Lung Cancer

Little is known regarding toxicities and hospitalizations in community-based settings for patients with advanced non-small-cell lung cancer (NSCLC) who received commonly prescribed carboplatin-paclitaxel (CP) or carboplatin-paclitaxel-bevacizumab (CPB) chemotherapy. Patients with stages IIIB-IV NSCLC age ? 21 years diagnosed between 2005…

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​Variation in genes controlling warfarin disposition and response in American Indian and Alaska Native people: CYP2C9, VKORC1, CYP4F2, CYP4F11, GGCX.

​OBJECTIVES:Pharmacogenetic testing is projected to improve health outcomes and reduce the cost of care by increasing therapeutic efficacy and minimizing drug toxicity. American Indian and Alaska Native (AI/AN) people historically have been excluded from pharmacogenetic research and its potential benefits,…

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Effects of estrogen and venlafaxine on menopause-related quality of life in healthy postmenopausal women with hot flashes: a placebo-controlled randomized trial

This study aims to evaluate the effects of low-dose estradiol (E2) or venlafaxine on menopause-related quality of life and associated symptoms in healthy perimenopausal and postmenopausal women with hot flashes. A double-blind, placebo-controlled, randomized trial of low-dose oral 17?-E2 0.5…

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Preliminary Development and Evaluation of an Algorithm to Identify Breast Cancer Chemotherapy Toxicities Using Electronic Medical Records and Administrative Data

Breast cancer chemotherapy toxicity is not well documented outside of randomized trials. We developed and conducted preliminary evaluation of an algorithm to detect grade 3 and 4 toxicities using electronic data from a large integrated managed care organization. The algorithm…

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The Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans (SUGAR-MGH): Design of a pharmacogenetic Resource for Type 2 Diabetes

Genome-wide association studies have uncovered a large number of genetic variants associated with type 2 diabetes or related phenotypes. In many cases the causal gene or polymorphism has not been identified, and its impact on response to anti-hyperglycemic medications is…

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Comparison of Frequency and Outcome of Major Gastrointestinal Hemorrhage in Patients With Atrial Fibrillation on Versus Not Receiving Warfarin Therapy (from the ATRIA and ATRIA-CVRN Cohorts)

To date, there have been few studies evaluating outcomes of patients with atrial fibrillation (AF) who have experienced gastrointestinal (GI) hemorrhages. We examined short- and long-term mortality of major GI hemorrhage in patients with AF on and off warfarin in…

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Epidemiology, pathophysiology, and in-hospital management of pulmonary edema: data from the Romanian Acute Heart Failure Syndromes registry.

AIM: The objective of this study was to evaluate the clinical presentation, inpatient management, and in-hospital outcome of patients hospitalized for acute heart failure syndromes (AHFS) and classified as pulmonary edema (PE).METHODS: The Romanian Acute Heart Failure Syndromes (RO-AHFS) study…

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Use of leukotriene receptor antagonists are associated with a similar risk of asthma exacerbations as inhaled corticosteroids

Based on results of clinical trials, inhaled corticosteroids (ICS) are the most-effective controller medications for preventing asthma-related exacerbations, yet few studies in real-life populations have evaluated the comparative effectiveness of ICS. To determine the likelihood of asthma exacerbations among children…

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Associations Between Antidepressant Adherence and Shared Decision-Making, Patient-Provider Trust, and Communication Among Adults with Diabetes: Diabetes Study of Northern California (DISTANCE)

Depression and adherence to antidepressant treatment are important clinical concerns in diabetes care. While patient-provider communication patterns have been associated with adherence for cardiometabolic medications, it is unknown whether interpersonal aspects of care impact antidepressant medication adherence. To determine whether…

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Intensification of antihyperglycemic therapy among patients with incident diabetes: a Surveillance Prevention and Management of Diabetes Mellitus (SUPREME-DM) study

Antihyperglycemic medication intensification practices among patients with incident diabetes are incompletely understood. We characterized the first intensification the year after oral antihyperglycemic medication initiation among incident diabetes patients. This retrospective cohort study across 11 US health systems included adults identified…

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Comparative Effectiveness of Clopidogrel in Medically Managed Patients with Unstable Angina and non-ST Segment Elevation Myocardial Infarction

This study sought to examine the effectiveness of clopidogrel in real-world, medically managed patients with unstable angina (UA) or non-ST-segment elevation myocardial infarction (NSTEMI). Although clinical trials have demonstrated the efficacy of clopidogrel to reduce cardiovascular (CV) morbidity and mortality…

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Low Socioeconomic Status is Associated with Increased Risk for Hypoglycemia in Diabetes Patients: The Diabetes Study of Northern California (DISTANCE)

Social risk factors for hypoglycemia are not well understood. Cross-sectional analysis from the DISTANCE study, a multi-language, ethnically-stratified random sample of adults in the Kaiser Permanente Northern California diabetes registry, conducted in 2005-2006 (response rate 62%). Exposures were income and…

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Characteristics of Diabetic Patients associated with Achieving and Maintaining Blood Pressure Targets in the Adherence and Intensification of Medications Program

To determine patient characteristics associated with achieving and sustaining blood pressure (BP) targets in the Adherence and Intensification of Medications program, a program led by pharmacists trained in motivational interviewing and authorized to make BP medication changes. We conducted a…

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‘The chief of the service is very enthusiastic about it’: A qualitative study of the adoption of buprenorphine for opioid addiction treatment

Qualified physicians may prescribe buprenorphine to treat opioid dependence, but medication use remains controversial. We examined adoption of buprenorphine in two not-for-profit integrated health plans, over time, completing 101 semi-structured interviews with clinicians and clinician-administrators from primary and specialty care.…

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Brief report: risk of adverse fetal outcomes associated with immunosuppressive medications for chronic immune-mediated diseases in pregnancy

To assess the risk of adverse fetal outcomes following exposure to individual immunosuppressive drugs in pregnant women with chronic immune-mediated diseases. Health plan data were obtained from the Tennessee Medicaid and Kaiser Permanente Northern California and Southern California claims databases,…

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Initial Antihyperglycemic Drug Therapy Among 241 327 Adults With Newly Identified Diabetes From 2005 Through 2010: A Surveillance, Prevention, and Management of Diabetes Mellitus (SUPREME-DM) Study

Among adults with incident diabetes, data are lacking about first antihyperglycemic initiation and whether medication choice aligns with recommendations. To identify predictors of initiating any antihyperglycemic, and specifically sulfonylurea versus metformin. This retrospective cohort study included 241 327 patients from…

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Standardizing terminology and definitions of medication adherence and persistence in research employing electronic databases

OBJECTIVE: To propose a unifying set of definitions for prescription adherence research utilizing electronic health record prescribing databases, prescription dispensing databases, and pharmacy claims databases and to provide a conceptual framework to operationalize these definitions consistently across studies. METHODS: We…

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Initiation of Tumor Necrosis Factor Alpha (TNFalpha) antagonists and risk of fractures in patients with selected rheumatic and autoimmune diseases

OBJECTIVE: We tested the hypothesis that initiation of tumor necrosis factor alpha (TNFalpha) antagonists reduced the risk of fractures compared to nonbiologic comparators in patients with autoimmune diseases. METHODS: Using 4 large administrative databases, we assembled retrospective cohorts of patients…

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Near real-time adverse drug reaction surveillance within population-based health networks: methodology considerations for data accrual

PURPOSE: This study describes practical considerations for implementation of near real-time medical product safety surveillance in a distributed health data network. METHODS: We conducted pilot active safety surveillance comparing generic divalproex sodium to historical branded product at four health plans…

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Comparison of Medication Practices in Patients With Heart Failure and Preserved Versus Those With Reduced Ejection Fraction (from the Cardiovascular Research Network [CVRN])

Limited data exist describing the differences in the medical treatment of patients with heart failure with preserved ejection fraction (HF-PEF) from those with heart failure with reduced ejection fraction (HF-REF) in more generalizable population-based cohorts. We studied patients with incident…

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Health Literacy and Antidepressant Medication Adherence Among Adults with Diabetes; The Diabetes Study of Northern California (DISTANCE)

Previous studies have reported that health literacy limitations are associated with poorer disease control for chronic conditions, but have not evaluated potential associations with medication adherence. To determine whether health literacy limitations are associated with poorer antidepressant medication adherence. Observational…

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