A cluster of reports of hypersensitivity reactions among patients who switched from carvedilol (immediate release formulation, referred to hereafter as carvedilol) to carvedilol extended release was received during the initial post-launch period of carvedilol extended release. In follow up to this observation, product labeling for both agents was updated and a nested case control study was subsequently conducted to examine the risk of serious hypersensitivity reactions i.e. anaphylactic reaction and/or angioedema among patients who used carvedilol extended release compared to carvedilol and separately compared to other long acting beta(β)-blockers. This proposed analysis is an update to the previously conducted analysis using the same database, LabRx, now containing 2 additional years of data, which should provide a larger number of carvedilol extended release exposed subjects.
Study Type
OBSERVATIONAL
Enrollment
1
All dosages of carvedilol immediate release
All dosages of carvedilol extended release
All dosages of LA propranolol and SA metoprolol
i.e., labetalol. All dosages. Excluding carvedilol immediate release and carvedilol extended release.
All dosages of short acting non-selective β-Blockers (Carteolol, Levobunolol, Metipranolol, Nadolol, Penbutolol, Pindolol, Sotalol, Timolol) and short acting β1-Selective agents (Acebutolol, Atenolol, Betaxolol, Bisoprolol, Nebivolol)
No β-blocker within the month prior to the index date
Hypersensitivity reactions (anaphylactic reaction/ angioedema)
Time frame: Hypersensitivity reactions among users in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009
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