Evaluating K-134 for Intermittent Claudication
Author Information
Author(s): Lewis Roger J, Connor Jason T, Teerlink John R, Murphy James R, Cooper Leslie T, Hiatt William R, Brass Eric P
Primary Institution: Harbor-UCLA Medical Center
Hypothesis
Can K-134, a phosphodiesterase inhibitor, improve walking performance in patients with intermittent claudication?
Conclusion
The trial found no concerning safety signals for K-134, allowing the continuation of higher doses while dropping the lowest dose.
Supporting Evidence
- No subjects in any treatment arms showed resting tachycardia or ischemic changes on ECG.
- The adaptive design allowed for efficient identification of safe dosing.
- Discontinuation rates were below the maximum tolerable limits for all K-134 doses.
Takeaway
This study tested a new medicine called K-134 to see if it helps people walk better when they have leg pain. They found it was safe to use at higher doses.
Methodology
The study was a double-blind, multi-dose, randomized trial comparing K-134 to placebo and cilostazol over 26 weeks.
Potential Biases
Potential bias from the adaptive design and the involvement of a Data Monitoring Committee.
Limitations
The study was limited by the need for adaptive design, which may complicate data interpretation.
Participant Demographics
Patients aged 40 and older with intermittent claudication.
Digital Object Identifier (DOI)
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