Global benefit-risk analysis of adjunctive aripiprazole in the treatment of patients with major depressive disorder.

Abstract:

OBJECTIVE:This study quantified the overall merit of adjunctive aripiprazole in major depressive disorder (MDD). METHODS:Global benefit-risk (GBR) analysis quantified the benefit and risk differences between adjunctive aripiprazole and antidepressant (ADT) monotherapy. Three hundred and fifty six patients receiving ADT monotherapy and 366 patients receiving ADT and adjunctive aripiprazole (2-20 mg/day) were included. Efficacy measures included the Montgomery-Asberg depression rating scale (MADRS) Total score response (> or =50% reduction) and remission (response plus Total score < or = 10). Treatment-emergent adverse events were classified by severity. GBR ratio measures evaluated the relative benefit of adjunctive aripiprazole. Logistic regression models tested the effect of adjunctive aripiprazole on GBR and were used to identify predictors of net benefit and potential factors affecting the adjunctive aripiprazole treatment effect. RESULTS:For MADRS-defined response and remission, the relative gain of adjunctive aripiprazole versus ADT monotherapy was 1.46 (p = 0.044) and 1.43 (p = 0.085), respectively. Gender, current escitalopram, duration of current episode, and baseline body mass index are potential factors affecting the adjunctive aripiprazole treatment effect. CONCLUSIONS:Compared with ADT monotherapy, adjunctive aripiprazole was associated with an improved benefit-risk profile in MDD.

authors

Wisniewski SR,Chen CC,Kim E,Kan HJ,Guo Z,Carlson BX,Tran QV,Pikalov A

doi

10.1002/pds.1805

subject

Has Abstract

pub_date

2009-10-01 00:00:00

pages

965-72

issue

10

eissn

1053-8569

issn

1099-1557

journal_volume

18

pub_type

杂志文章
  • Development and validation of a 5-year mortality prediction model using regularized regression and Medicare data.

    abstract:PURPOSE:De-implementation of low-value services among patients with limited life expectancy is challenging. Robust mortality prediction models using routinely collected health care data can enhance health care stakeholders' ability to identify populations with limited life expectancy. We developed and validated a claim...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4769

    authors: Lund JL,Kuo TM,Brookhart MA,Meyer AM,Dalton AF,Kistler CE,Wheeler SB,Lewis CL

    更新日期:2019-05-01 00:00:00

  • The positive predictive value of a hyperkalemia diagnosis in automated health care data.

    abstract:PURPOSE:Our objectives were to determine performance of coded hyperkalemia diagnosis at identifying (1) clinically evident hyperkalemia and (2) serum potassium>6 mmol/L. METHODS:This retrospective observational study included 8722 patients with diabetes within an integrated healthcare system who newly initiated an ang...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.2030

    authors: Raebel MA,Smith ML,Saylor G,Wright LA,Cheetham C,Blanchette CM,Xu S

    更新日期:2010-11-01 00:00:00

  • Use of health insurance claim patterns to identify patients using nonsteroidal anti-inflammatory drugs for rheumatoid arthritis.

    abstract:PURPOSE:To determine healthcare claim patterns associated using nonsteroidal anti-inflammatory drugs (NSAIDs) for rheumatoid arthritis (RA). METHODS:The CADEUS study randomly identified NSAID users within the French health insurance database. One-year claims data were extracted, and NSAID indication was obtained from ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/pds.3221

    authors: Bernard MA,Bénichou J,Blin P,Weill A,Bégaud B,Abouelfath A,Moore N,Fourrier-Réglat A,CADEUS Team.

    更新日期:2012-06-01 00:00:00

  • Provider risk factors for medication administration error alerts: analyses of a large-scale closed-loop medication administration system using RFID and barcode.

    abstract:PURPOSE:To determine the risk factors and rate of medication administration error (MAE) alerts by analyzing large-scale medication administration data and related error logs automatically recorded in a closed-loop medication administration system using radio-frequency identification and barcodes. METHODS:The subject h...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4068

    authors: Hwang Y,Yoon D,Ahn EK,Hwang H,Park RW

    更新日期:2016-12-01 00:00:00

  • National trends in long-term use of prescription opioids.

    abstract:PURPOSE:This study examined recent trends and correlates of prescription opioid use and long-term use in the United States. METHODS:Data were from 47 356 adult participants of National Health and Nutrition Survey from 1999-2000 to 2013-2014. Participants were asked about prescription medications used in the past 30 da...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4278

    authors: Mojtabai R

    更新日期:2018-05-01 00:00:00

  • Validation of The Health Improvement Network (THIN) database for epidemiologic studies of chronic kidney disease.

    abstract:PURPOSE:Chronic kidney disease (CKD) is a prevalent and important outcome and covariate in pharmacoepidemiology. The Health Improvement Network (THIN) in the UK represents a unique resource for population-based studies of CKD. We compiled a valid list of Read codes to identify subjects with moderate to advanced CKD. M...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.2203

    authors: Denburg MR,Haynes K,Shults J,Lewis JD,Leonard MB

    更新日期:2011-11-01 00:00:00

  • What is the quality of drug safety information for patients: An analysis of REMS educational materials.

    abstract:BACKGROUND:Poor-quality patient drug information has been identified as a major cause of preventable medication errors in the United States. The US Food and Drug Administration (FDA) has the authority to require marketing authorization holders of medicinal products to implement risk evaluation and mitigation strategies...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4614

    authors: Chan HW,Russell AM,Smith MY

    更新日期:2018-09-01 00:00:00

  • Regional variation in the use of medications by older Canadians--a persistent and incompletely understood phenomena.

    abstract:BACKGROUND:We have previously reported on regional variability in medication consumption by older Canadians. In this study, we used longitudinal data to determine whether regional differences in commonly consumed medications persisted and to explore potential explanatory factors for observed differences. METHODS:We ut...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.803

    authors: Hogan DB,Maxwell CJ,Fung TS,Ebly EM

    更新日期:2003-10-01 00:00:00

  • Characterization of new users of cilostazol in the UK, Spain, Sweden, and Germany.

    abstract:PURPOSE:To describe the characteristics of new users of cilostazol in Europe with the aim to support the evaluation of its benefit/risk as used in regular clinical practice before the implementation of labeling changes recommended by the European Medicines Agency. METHODS:New users of cilostazol were identified in pop...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4167

    authors: Castellsague J,Perez-Gutthann S,Calingaert B,Bui C,Varas-Lorenzo C,Arana A,Prados-Torres A,Poblador-Plou B,Gonzalez-Rubio F,Giner-Soriano M,Roso-Llorach A,Linder M,Citarella A,Scholle O,Blenk T,Garbe E

    更新日期:2017-06-01 00:00:00

  • Time trends in the use of anti-hypertensive medications: results from the Multi-Ethnic Study of Atherosclerosis.

    abstract:BACKGROUND:Previous reports have suggested that new evidence of the comparative effectiveness of different medication classes from randomized controlled trials (RCTs) does not always alter treatment decisions for first-line anti-hypertensive therapy. OBJECTIVES:To evaluate the association of RCT evidence in December 2...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1788

    authors: Delaney JA,McClelland RL,Furberg CD,Cooper R,Shea S,Burke G,Psaty BM

    更新日期:2009-09-01 00:00:00

  • Changes in use of disease-modifying anti-rheumatic drugs in Australia over the period 1992-2004.

    abstract:PURPOSE:Evidence is growing that early use of disease-modifying anti-rheumatic drugs (DMARDs) and combinations of these drugs provide optimal care for people with rheumatoid arthirits. The aim of this study was to describe objectively the pattern of consumption of DMARDs in the Australian community (community-based pre...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1256

    authors: Chan V,Tett SE

    更新日期:2006-07-01 00:00:00

  • Measures to quantify the abuse of prescription opioids: a review of data sources and metrics.

    abstract:PURPOSE:The abuse and nonmedical use of prescription opioids and its subsequent consequences are an important public health concern. This phenomenon has paralleled the increase in the therapeutic use of opioids for pain management. There is thus a need to measure prescription opioid abuse to understand trends over time...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,评审

    doi:10.1002/pds.3711

    authors: Secora AM,Dormitzer CM,Staffa JA,Dal Pan GJ

    更新日期:2014-12-01 00:00:00

  • Trends in the use of maintenance immunosuppressive drugs among liver transplant recipients in Taiwan: a nationwide population-based study.

    abstract:PURPOSE:During the past two decades, many novel immunosuppressive drugs have been approved for transplant recipients. Trends in the use of maintenance immunosuppressants after liver transplantation in Asia are unclear. Thus, we aimed to analyze the prescription trends in maintenance immunosuppressive drugs among liver ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3964

    authors: Huang YY,Hsu CC,Chou CL,Loong CC,Wu MS,Chou YC

    更新日期:2016-06-01 00:00:00

  • Development of a minimal set of prescribing quality indicators for diabetes management on a general practice level.

    abstract:OBJECTIVE:To identify the relevant prescribing quality domains of type 2 diabetes mellitus care as a basis for the selection of a minimal set of prescribing quality indicators from a set of previously validated indicators. METHODS:We used the principal factor analysis to identify the underlying dimensions or domains o...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.2248

    authors: Martirosyan L,Haaijer-Ruskamp FM,Braspenning J,Denig P

    更新日期:2012-10-01 00:00:00

  • Use of direct oral anticoagulants in patients with atrial fibrillation in Scotland: Applying a coherent framework to drug utilisation studies.

    abstract:PURPOSE:To report the use of direct oral anticoagulants (DOACs) for stroke prevention in patients with atrial fibrillation in Scotland and advocate the standardisation of drug utilisation research methods. METHODS:Retrospective cohort study using linked administrative data. Patients included those with a diagnosis of ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4272

    authors: Mueller T,Alvarez-Madrazo S,Robertson C,Bennie M

    更新日期:2017-11-01 00:00:00

  • How (not) to inform patients about drug use: use and effects of negations in Dutch patient information leaflets.

    abstract:PURPOSE:Under EU regulations, patient information leaflets (PILs) are required to be clear and understandable. Negations (e.g., not, no) are a linguistic aspect that may impact PIL comprehension, yet go unmentioned in these regulations. We conducted two studies to determine (1) how negations are used in Dutch PILs (stu...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3679

    authors: Burgers C,Beukeboom CJ,Sparks L,Diepeveen V

    更新日期:2015-02-01 00:00:00

  • Using claims data to predict dependency in activities of daily living as a proxy for frailty.

    abstract:PURPOSE:Estimating drug effectiveness and safety among older adults in population-based studies using administrative health care claims can be hampered by unmeasured confounding as a result of frailty. A claims-based algorithm that identifies patients likely to be dependent, a proxy for frailty, may improve confounding...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3719

    authors: Faurot KR,Jonsson Funk M,Pate V,Brookhart MA,Patrick A,Hanson LC,Castillo WC,Stürmer T

    更新日期:2015-01-01 00:00:00

  • Increased risk of digoxin toxicity following hospitalization.

    abstract:PURPOSE:Adverse drug events (ADEs) are an important cause of preventable hospitalizations among elderly individuals taking high-risk medications. The objective of the study was to identify health care system factors that affect the risk of digoxin toxicity for older adults on digoxin. METHODS:We conducted a prospectiv...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1680

    authors: Haynes K,Hennessy S,Localio AR,Cohen A,Leonard CE,Kimmel SE,Feldman HI,Strom BL,Metlay JP

    更新日期:2009-01-01 00:00:00

  • Assessing strength of evidence for regulatory decision making in licensing: What proof do we need for observational studies of effectiveness?

    abstract::Before a medicine can be recommended for a marketing authorization research must be provided to regulators that convincingly supports the benefit-risk of the product in the claimed indication. The established criteria for such research are usually expressed in terms of evidence from randomized controlled trials (RCT)....

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.5005

    authors: Slattery J,Kurz X

    更新日期:2020-10-01 00:00:00

  • The use of angiotensin converting enzyme inhibitors in general practice--appropriate or inappropriate?

    abstract:AIMS:To evaluate the pattern of prescribing of angiotensin-converting enzyme (ACE) inhibitors in general practice, related to the primary clinical diagnosis and concomitant medication. DESIGN:A descriptive survey of general practitioners' prescribing habits, presumptive diagnosis and patient demography over a period o...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/(SICI)1099-1557(199809/10)7:5<331::AID-PDS

    authors: Connolly JP,Silke B,McGavock H,Wilson-Davies K

    更新日期:1998-09-01 00:00:00

  • Association between drug-specific indicators of prescribing quality and quality of drug treatment: a validation study.

    abstract:PURPOSE:To evaluate the concurrent validity of three European sets of drug-specific indicators of prescribing quality METHODS:In 200 hip fracture patients (≥65 years), consecutively recruited to a randomized controlled study in Sahlgrenska University Hospital in 2009, quality of drug treatment at study entry was asses...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/pds.3827

    authors: Wallerstedt SM,Belfrage B,Fastbom J

    更新日期:2015-09-01 00:00:00

  • Use of antibiotics at hospitals in Stockholm: a benchmarking project using internet.

    abstract:PURPOSE:To evaluate the internet way of feedback to prescribing physicians, providing data on antimicrobial use and to assess the applicability of the DU90% (i.e. Drug Utilisation 90%--the number of drugs accounting for 90% of the volume of usage in defined daily doses, (DDDs)) methodology in the hospital setting. MET...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.898

    authors: Bergman U,Risinggård H,Vlahović-Palcevski V,Ericsson O

    更新日期:2004-07-01 00:00:00

  • The role of 5α-reductase inhibitors in gastro-oesophageal cancer risk: A nested case-control study.

    abstract:PURPOSE:The strong male predominance of gastro-oesophageal cancer suggests that sex hormones play an important role. 5α-Reductase (5AR) inhibitors have antiandrogen effects and have been shown to decrease cancer cell proliferation and metastasis. We conducted the first epidemiologic investigation into the association b...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4909

    authors: Busby J,Karasneh R,Murchie P,McMenamin Ú,Gadalla SM,Camargo MC,Iversen L,Lee AJ,Spence AD,Cardwell CR

    更新日期:2020-01-01 00:00:00

  • Trends in the long-term use of benzodiazepine anxiolytics and hypnotics: A national register study for 2006 to 2014.

    abstract:PURPOSE:Long-term benzodiazepine (BZD) treatment continues to be a debated topic. Because individual BZDs have different clinical profiles, we assessed the nationwide trends of long-term BZD use at active substance level during years 2006 to 2014. METHODS:This study covered all reimbursed BZD purchases (n = 408 572-52...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4551

    authors: Kurko T,Saastamoinen LK,Tuulio-Henriksson A,Taiminen T,Tiihonen J,Airaksinen M,Hietala J

    更新日期:2018-06-01 00:00:00

  • Descriptive epidemiology of acute liver enzyme abnormalities in the general population of central Massachusetts.

    abstract:OBJECTIVES:This study quantifies the incidence of liver enzyme abnormalities in the general population of central Massachusetts. METHODS:Computerized data files from a health maintenance organization were used to ascertain potential subjects during the study period of 1 July 1992-30 June 1993. Medical records and labo...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/(SICI)1099-1557(199907)8:4<275::AID-PDS427

    authors: Duh MS,Walker AM,Kronlund KH Jr

    更新日期:1999-07-01 00:00:00

  • Controlling confounding of treatment effects in administrative data in the presence of time-varying baseline confounders.

    abstract:PURPOSE:Confounding, a concern in nonexperimental research using administrative claims, is nearly ubiquitous in claims-based pharmacoepidemiology studies. A fixed-length look-back window for assessing comorbidity from claims is common, but it may be advantageous to use all historical claims. We assessed how the strengt...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3922

    authors: Gilbertson DT,Bradbury BD,Wetmore JB,Weinhandl ED,Monda KL,Liu J,Brookhart MA,Gustafson SK,Roberts T,Collins AJ,Rothman KJ

    更新日期:2016-03-01 00:00:00

  • Bayesian hierarchical methods in the detection of potentially teratogenic first-trimester medications.

    abstract:PURPOSE:Bayesian hierarchical models (BHMs) have been used to identify adverse drug reactions, allowing information sharing amongst adverse reactions and drugs expected to have similar properties. This study evaluated the use of BHMs in the routine signal detection analyses of potential first-trimester teratogens, wher...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4948

    authors: Cavadino A,Prieto-Merino D,Morris JK

    更新日期:2020-03-01 00:00:00

  • Refill adherence and polypharmacy among patients with type 2 diabetes in general practice.

    abstract:BACKGROUND AND AIMS:Non-adherence is considered a major barrier to better outcomes of diabetes care. A relationship has been established between polypharmacy and patients' adherence. This study aims to investigate the occurrence of polypharmacy and non-adherence in general practice, their mutual relationship and the as...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/pds.1810

    authors: van Bruggen R,Gorter K,Stolk RP,Zuithoff P,Klungel OH,Rutten GE

    更新日期:2009-11-01 00:00:00

  • Herbal products use during pregnancy: prevalence and predictors.

    abstract:PURPOSES:(1) Measure the prevalence of herbal product (HP) use, alone, and concomitantly with prescribed medications during pregnancy, (2) identify the most frequently consumed HP during gestation and (3) determine predictors of HP use at the beginning of pregnancy, and during the third trimester. METHODS:A questionna...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,评审

    doi:10.1002/pds.1731

    authors: Moussally K,Oraichi D,Bérard A

    更新日期:2009-06-01 00:00:00

  • Statin and NSAID use and prostate cancer risk.

    abstract:PURPOSE:Some studies have reported reduced risks of advanced, but not early, prostate cancer among statin users, and one study found a reduced risk only among statin users who had also used non-steroidal anti-inflammatory drugs (NSAIDs). We have previously reported no association between statin use and prostate cancer ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1970

    authors: Coogan PF,Kelly JP,Strom BL,Rosenberg L

    更新日期:2010-07-01 00:00:00