If the IMPROVE-IT Trial Was Positive, as Reported, Why Did the FDA Denied Expanded Approval for Ezetimibe and Simvastatin? An Explanation of the Tipping Point Analysis.

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

Who cites it

3 citing papers in PubMed.

1. Tipping Point Analysis: Assessing the Potential Impact of Missing Data.JAMA · 2025
   Article
2. A Benchmark, Expand, and Calibration (BenchExCal) Trial Emulation Approach for Using Real-World Evidence to Support Indication Expansions: Design and Process for a Planned Empirical Evaluation.Clinical pharmacology and therapeutics · 2025
   Article
3. Quantitative bias analysis for external control arms using real-world data in clinical trials: a primer for clinical researchers.Journal of comparative effectiveness research · 2024
   Review

Corrections and comments

• Comment on
  Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes.2015

Authors and funding

2 authors.

Funding

No grant is acknowledged in the PubMed record.

Abstract

PubMed holds no abstract for this paper.

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