12 weeks prior the ORBITA randomization, medical therapy optimization of all antianginal medication was achieved.
Most importantly, optimization was well tolerated by all patients, with scarce adverse effects leading to therapy termination.
In clinical practice, there is skepticism towards achieving maximal dosage with a cost-effective therapy, good tolerance, adherence, and no drug-drug interaction.
The ORBITA did achieve optimization, so well as to raise questions around revascularization as the sole treatment capable of symptom relief.
It was the first study to compare PCI against placebo, without advantages. The optimization period was key to ensure that all patients were treated with guideline-directed truly optimal medical therapy.
Read also: Net Clinical Benefit of Long-Term Ticagrelor.
97.5% of the population achieved the prespecified target of 2 or more antianginal drugs in this period. In fact, the median number of antianginals was 3.
Amlodipine and bisoprolol were well tolerated, with only 2.3% and 5.4% of adverse effects reported. Ranolazine and ivabradine were also well tolerated, with 5% and 5.6% adverse effects, respectively.
Isosorbide mononitrate, the most conservative of antianginals, was not in luck: over 20% of the population reported adverse effects.
Read also: Revascularization Is Needed Before TAVR.
Statins were very well tolerated at high doses, closing the list of iconic drugs in the optimal medical therapy combo.
Conclusion
In the 12-week period prior randomization, the ORBITA successfully optimized medical therapy. This real optimization should be translating this into the clinical practice in the long-term.
JAHA-120-017381freeOriginal Title: Achieving Optimal Medical Therapy: Insights From the ORBITA Trial.
Reference: Michael Foley et al. J Am Heart Assoc. 2021;10:e017381. DOI: 10.1161/JAHA.120.017381.
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