Key result
Letter critiques prior nifedipine trial for nonrandomized design and unmonitored dosing in refractory angina.
Why the study?
A recent article discussing proposed pathophysiologic mechanisms of paradoxical myocardial ischemia with nifedipine in refractory angina contained several methodological flaws, including an uncontrolled open design and an apparent lack of nifedipine titration.
Answers are grounded in this paper and cite their sources.
Prior study flaws limit nifedipine add-on conclusions; challenges reliance on nonrandomized data for refractory angina.
To the Editor.— There are several scientific flaws in the recent article by Boden et al1discussing the proposed pathophysiologic mechanisms of paradoxical myocardial ischemia in the treatment of patients with refractory angina who are taking nifedipine coadministered with β-blockers or long-acting nitrates. The first problem is the basic study design. The authors studied a subset of patients who had experienced recurrent episodes of angina pectoris following nifedipine administration and, in an uncontrolled, nonrandomized, open fashion, evaluated each patient's response to study medications. Although the study attempted to investigate the pathophysiologic mechanisms of paradoxical angina, this uncontrolled design introduces both patient and investigator bias. Certainly, the patients' psychological and physiological response to a regimen that they expect will cause them pain must confound the validity of any results obtained from the trial. A second major problem is the apparent lack of nifedipine titration. Despite the fact that the patients
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Roger Sachs (1985) conducted a letter in Refractory angina pectoris. Nifedipine coadministered with beta-blockers or long-acting nitrates was evaluated on Paradoxical myocardial ischemia / angina response. Nifedipine coadministered with beta-blockers or nitrates for refractory angina was evaluated in a prior study critiqued here for its uncontrolled, nonrandomized, open design and lack of titration.
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