Using negative control outcomes to assess the comparability of treatment groups among women with osteoporosis in the United States

Autor: Vera Ehrenstein, Diane Reams, M. Alan Brookhart, Leah J. McGrath, Henrik Toft Sørensen, Leslie Spangler, Sara N. Levintow, Jeffrey R. Curtis, Bradley Saul, Brian D. Bradbury
Rok vydání: 2020
Předmět:
bisphosphonate
medicine.medical_specialty
negative control
pharmacoepidemiology
Drug-Related Side Effects and Adverse Reactions
Epidemiology
medicine.medical_treatment
Injections
Subcutaneous
comparative analyses
Osteoporosis
Administration
Oral
Lower risk
030226 pharmacology & pharmacy
Sensitivity and Specificity
Zoledronic Acid
law.invention
zoledronic acid
03 medical and health sciences
residual confounding
0302 clinical medicine
Randomized controlled trial
law
Internal medicine
medicine
Humans
Pharmacology (medical)
030212 general & internal medicine
Infusions
Intravenous
Osteoporosis
Postmenopausal
Aged
Aged
80 and over
Bone Density Conservation Agents
Diphosphonates
business.industry
Confounding
denosumab
Confounding Factors
Epidemiologic
Bisphosphonate
Pharmacoepidemiology
Middle Aged
medicine.disease
osteoporosis
United States
Denosumab
Zoledronic acid
Female
business
medicine.drug
Zdroj: McGrath, L J, Spangler, L, Curtis, J R, Ehrenstein, V, Sørensen, H T, Saul, B, Levintow, S N, Reams, D, Bradbury, B D & Brookhart, M A 2020, ' Using negative control outcomes to assess the comparability of treatment groups among women with osteoporosis in the United States ', Pharmacoepidemiology and Drug Safety, vol. 29, no. 8, pp. 854-863 . https://doi.org/10.1002/pds.5037
ISSN: 1099-1557
Popis: Purpose: In contrast to randomized clinical trials, comparative safety and effectiveness assessments of osteoporosis medications in clinical practice may be subject to confounding by indication. We used negative control outcomes to detect residual confounding when comparing osteoporosis medications. Methods: Using MarketScan Commercial and Supplemental claims, we identified women aged ≥55 years who initiated an oral bisphosphonate (BP) (risedronate, alendronate, or ibandronate), denosumab (an injected biologic), or intravenous zoledronic acid (ZA) from October 1, 2010 to September 30, 2015. Women with Paget's disease or cancer were excluded. We compared individual oral BPs to each other, denosumab to ZA, denosumab to oral BPs, and ZA to oral BPs, with respect to 11 negative control outcomes identified by subject matter experts. We estimated the 12-month cumulative risk difference (RD) using inverse probability of treatment and censoring weights. Results: Among 148 587 women, most initiated alendronate (57%), followed by ibandronate (12%), ZA (11%), risedronate (10%), and denosumab (10%). Compared with denosumab, patients initiating ZA had similar risks of all negative control outcomes. Compared with oral BPs, patients initiating denosumab had a higher risk of a wellness visit (RD = 1.2%, 95% CI: 0.4, 1.9) and a lower risk of receiving herpes zoster vaccine (RD = −0.6%, 95% CI: −1.1, −0.2). Comparing ZA with oral BP initiators resulted in two outcomes with positive associations. Conclusions: Caution is warranted when comparing injectable vs oral osteoporosis medications, given the potential for unmeasured confounding. Evaluating negative control outcomes could be a standard validity check prior to conducting comparative studies.
Databáze: OpenAIRE
Externí odkaz: