Abstract | OBJECTIVES: METHODS: Individual patient data were used from a GXR trial; only published summary data were used from ATX trials. In a matching-adjusted indirect comparison, individual patients from the GXR trial were weighted such that their mean baseline characteristics matched those published for ATX trials. Placebo-arm outcomes were then compared to further assess balance between the matched populations. Changes in the Conners' Parent Rating Scale-Revised Short Form Oppositional Subscale from baseline to endpoint among GXR-treated and ATX-treated patients were then compared. RESULTS: Before matching, the GXR (n = 143) and ATX (n = 98) trial populations had significant differences in baseline characteristics and placebo-arm outcomes. After matching, baseline characteristics were well balanced across trials, and placebo-arm outcomes became nearly identical. Comparing active treatment arms across the matched populations, GXR was associated with a significantly greater reduction in mean Conners' Parent Rating Scale-Revised Short form oppositional subscale compared with ATX {-5.0 [95% confidence interval (CI): -6.6 to -3.4] vs. -2.4 [CI: -3.7 to -1.1], p = 0.01, effect size = 0.58}. CONCLUSIONS: In the absence of head-to-head randomized trials, matching-adjusted indirect comparisons can provide timely and reliable comparative evidence for decision makers and can be applied even when very few trials are available for the treatments of interest.
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Authors | James Signorovitch, M Haim Erder, Jipan Xie, Vanja Sikirica, Mei Lu, Paul S Hodgkins, Eric Q Wu |
Journal | Pharmacoepidemiology and drug safety
(Pharmacoepidemiol Drug Saf)
Vol. 21 Suppl 2
Pg. 130-7
(May 2012)
ISSN: 1099-1557 [Electronic] England |
PMID | 22552988
(Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2012 John Wiley & Sons, Ltd. |
Chemical References |
- Delayed-Action Preparations
- Propylamines
- Guanfacine
- Atomoxetine Hydrochloride
|
Topics |
- Adolescent
- Atomoxetine Hydrochloride
- Attention Deficit Disorder with Hyperactivity
(complications, drug therapy, epidemiology)
- Attention Deficit and Disruptive Behavior Disorders
(complications, drug therapy, epidemiology)
- Child
- Comparative Effectiveness Research
- Delayed-Action Preparations
- Guanfacine
(administration & dosage, therapeutic use)
- Humans
- Outcome and Process Assessment, Health Care
(statistics & numerical data)
- Pharmacoepidemiology
(methods, statistics & numerical data)
- Propylamines
(administration & dosage, therapeutic use)
- Randomized Controlled Trials as Topic
(standards, statistics & numerical data)
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