CORRESPONDENCE: LETTER TO THE EDITOR
Noninferiority of Pitavastatin in Intravascular Ultrasound Findings
Hideaki Kaneda, MD, PhD*,
Ji Ma, MD and
Toshihiro Morita, MD, PhD
* Tokyo Heart Center, 5-4-12 Kita-shinagawa, Tokyo 141-0001, Japan (Email: hdkaneda{at}gmail.com).
We read with interest the paper by Hiro et al. (1) comparing the regressive effect of pitavastatin on coronary plaque volume in acute coronary syndrome patients with that of atorvastatin using intravascular ultrasound (IVUS). The authors demonstrated that the upper limit of the 95% confidence interval of the difference in the mean percentage of change in plaque volume between the 2 groups (mean 1.11%, 95% confidence interval: –2.27% to 4.48%) did not exceed the pre-defined noninferiority margin of 5% and concluded that the noninferiority of pitavastatin compared with atorvastatin.
However, although an IVUS study comparing pravastatin with atorvastatin demonstrated a similar result (the difference in the mean percentage of change in atheroma volume was 1.3%, 5.4% in the pravastatin group and 4.1% in the atorvastatin group) (2), a clinical end point study (n = 4,162) using the same drugs demonstrated a significant difference in death or major cardiovascular event rates (26.3% in the pravastatin group and 22.4% in the atorvastatin group) (3). Therefore, it remains uncertain whether the noninferiority of pitavastatin in IVUS findings would translate to clinical noninferiority (4). Even such a small difference in IVUS findings may lead to a significant difference in clinical event rates in a large clinical trial.
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References
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1. Hiro T, Kimura T, Morimoto T, et al. Effect of intensive statin therapy on regression of coronary atherosclerosis in patients with acute coronary syndrome: a multicenter randomized trial evaluated by volumetric intravascular ultrasound using pitavastatin versus atorvastatin (JAPAN-ACS [Japan assessment of pitavastatin and atorvastatin in acute coronary syndrome] study) J Am Coll Cardiol 2009;54:293-302.[Abstract/Free Full Text]2. Nissen SE, Tuzcu EM, Schoenhagen P, et al. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial JAMA 2004;291:1071-1080.[Abstract/Free Full Text] 3. Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes N Engl J Med 2004;350:1495-1504.[CrossRef][Web of Science][Medline] 4. Tobis JM, Perlowski A. Atheroma volume by intravascular ultrasound as a surrogate for clinical end points J Am Coll Cardiol 2009;53:1116-1118.[Free Full Text]
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