Literature DB >> 24911392

User-only design to assess drug effectiveness in clinical practice: application to bisphosphonates and secondary prevention of fractures.

Giovanni Corrao1, Arianna Ghirardi, Giulia Segafredo, Antonella Zambon, Gianluca Della Vedova, Francesco Lapi, Francesco Cipriani, Achille Caputi, Alberto Vaccheri, Dario Gregori, Rosaria Gesuita, Annarita Vestri, Tommaso Staniscia, Giampiero Mazzaglia, Mauro Di Bari.   

Abstract

PURPOSE: Different strategies applicable to control for confounding by indication in observational studies were compared in a large population-based study regarding the effect of bisphosphonates (BPs) for secondary prevention of fractures.
METHODS: The cohort was drawn from healthcare utilization databases of 13 Italian territorial units. Patients aged 55 years or more who were hospitalized for fracture during 2003-2005 entered into the cohort. A nested case-control design was used to compare BPs use in cohort members who did (cases) and who did not experience (controls) a new fracture until 2007 (outcome). Three designs were employed: conventional-matching (D1 ), propensity score-matching (D2 ), and user-only (D3 ) designs. They differed for (i) cohort composition, restricted to patients who received BPs straight after cohort entry (D3 ); (ii) using propensity score for case-control matching (D2 ); and (iii) compared groups of BPs users versus no users (D1 and D2 ) and long-term versus short-term users (D3 ).
RESULTS: Bisphosphonate users had odds ratios (95% confidence interval) of 1.20 (1.01 to 1.44) and 0.95 (0.74 to 1.24) by applying D1 and D2 designs, respectively. Statistical evidence that long-term BPs use protects the outcome onset with respect to short-term use was observed for user-only design (D3 ) being the corresponding odds ratio (95% confidence interval) 0.64 (0.44 to 0.93).
CONCLUSIONS: User-only design yielded closer results to those seen in RCTs. This approach is one possible strategy to account for confounding by indication.
Copyright © 2014 John Wiley & Sons, Ltd.

Entities:  

Keywords:  bisphosphonates; confounding; fracture; pharmacoepidemiology; propensity score; user-only design

Mesh:

Substances:

Year:  2014        PMID: 24911392     DOI: 10.1002/pds.3650

Source DB:  PubMed          Journal:  Pharmacoepidemiol Drug Saf        ISSN: 1053-8569            Impact factor:   2.890


  10 in total

1.  Effectiveness of oral bisphosphonates for primary prevention of osteoporotic fractures: evidence from the AIFA-BEST observational study.

Authors:  Arianna Ghirardi; Mauro Di Bari; Antonella Zambon; Lorenza Scotti; Gianluca Della Vedova; Francesco Lapi; Francesco Cipriani; Achille P Caputi; Alberto Vaccheri; Dario Gregori; Rosaria Gesuita; Annarita Vestri; Tommaso Staniscia; Giampiero Mazzaglia; Giovanni Corrao
Journal:  Eur J Clin Pharmacol       Date:  2014-06-22       Impact factor: 2.953

Review 2.  The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?

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Journal:  Drug Saf       Date:  2019-03       Impact factor: 5.606

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Journal:  Clin Drug Investig       Date:  2018-07       Impact factor: 2.859

5.  Calcium Channel Blockers in Secondary Cardiovascular Prevention and Risk of Acute Events: Real-World Evidence from Nested Case-Control Studies on Italian Hypertensive Elderly.

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Journal:  Clin Drug Investig       Date:  2017-12       Impact factor: 2.859

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Authors:  Federico Rea; Giulia Calusi; Matteo Franchi; Davide Liborio Vetrano; Giuseppe Roberto; Stefano Bonassi; Ursula Kirchmayer; Alessandro Chinellato; Alessandra Bettiol; Janet Sultana; Alessandro Mugelli; Giovanni Corrao
Journal:  Drugs Aging       Date:  2018-12       Impact factor: 3.923

7.  Do patterns of mental healthcare predict treatment failure in young people with schizophrenia? Evidence from an Italian population-based cohort study.

Authors:  Giovanni Corrao; Davide Soranna; Luca Merlino; Emiliano Monzani; Caterina Viganò; Antonio Lora
Journal:  BMJ Open       Date:  2015-06-03       Impact factor: 2.692

Review 8.  Eight Good Reasons for Careful Monitoring and Evaluation of the Vaccine Campaign against COVID-19: Lessons Learned through the Lombardy Experience for Dealing with Next Challenges.

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Journal:  Int J Environ Res Public Health       Date:  2022-01-19       Impact factor: 3.390

9.  Cardiovascular Outcomes and Mortality Associated With Discontinuing Statins in Older Patients Receiving Polypharmacy.

Authors:  Federico Rea; Annalisa Biffi; Raffaella Ronco; Matteo Franchi; Simona Cammarota; Anna Citarella; Valeria Conti; Amelia Filippelli; Carmine Sellitto; Giovanni Corrao
Journal:  JAMA Netw Open       Date:  2021-06-01

10.  Persistent erectile dysfunction in men exposed to the 5α-reductase inhibitors, finasteride, or dutasteride.

Authors:  Tina Kiguradze; William H Temps; Steven M Belknap; Paul R Yarnold; John Cashy; Robert E Brannigan; Beatrice Nardone; Giuseppe Micali; Dennis Paul West
Journal:  PeerJ       Date:  2017-03-09       Impact factor: 2.984

  10 in total

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