Safety and efficacy of intracoronary nicorandil as hyperaemic agent for invasive physiological assessment: a patient-level pooled analysis.

AIMS: Our aim was to evaluate the safety and efficacy of intracoronary (IC) nicorandil as an alternative choice of hyperaemic agent for invasive physiologic studies. METHODS AND RESULTS: A total of 480 intermediate coronary lesions from 429 patients enrolled from six Japanese and Korean centres were analysed. IC nicorandil showed earlier achievement of hyperaemia (time to the lowest FFR: 18.0 s [1st and 3rd quartile value 15.6-21.5] vs. 44.0 s [36.0-60.0], p<0.001) with similar hyperaemic efficacy, compared with intravenous (IV) adenosine/ATP (FFR 0.82 [0.75-0.87] vs. 0.82 [0.74-0.88], p=0.207). FFR measurements with both agents showed excellent correlation and classification agreement (CA) for FFR ≤0.80 (r=0.941, ICC 0.980, CA 90.8%, kappa=0.814, AUC of nicorandil 0.980, all p<0.001). Only three patients (0.7%) showed changes in classification across the grey zone (0.75-0.80). IC nicorandil produced fewer changes in blood pressure (BP) and heart rate (HR) and showed less chest pain than IV adenosine/ATP (all p<0.001). When comparing ΔFFR according to ΔBP or ΔHR between IV adenosine/ATP and IC nicorandil, there were no correlations, either between ΔFFR and ΔBP (r=-0.114, p=0.091), or between ΔFFR and ΔHR (r=1.000, p=0.151). CONCLUSIONS: Nicorandil IC bolus injection is a simple, safe and effective hyperaemic method for FFR measurement and can be used as a substitute for adenosine.

[Efficacy assessment of azithromycin 1.5% eye drops versus tobramycin 0.3% on clinical signs of purulent bacterial conjunctivitis]. / Evaluation de l'efficacité d'un collyre azithromycine 1,5% versus tobramycine 0,3% sur les signes cliniques de la conjonctivite bactérienne purulente.

INTRODUCTION: Bacterial conjunctivitis is characterized by hyperemia and discharge of one or both eyes. These clinical signs appear quickly and are contagious. This study compares the clinical efficacy (signs and symptoms) and safety of azithromycin 1.5% eye drops with tobramycin 0.3%. PATIENTS AND METHODS: This was a multicenter, randomized, investigator-masked study including 1,043 patients with purulent bacterial conjunctivitis. Patients received either azithromycin twice daily for 3 days or tobramycin, 1 drop every 2 hours for 2 days, then four times daily for 5 days. The primary variable was clinical cure at the test-of-cure (TOC) visit (D9) on the worst eye. The cure was defined as bulbar conjunctival injection and discharge scores of 0. Clinical signs were evaluated at D0, D3, and D9. RESULTS: In the azithromycin group 87.8% of patients and in the tobramycin group 89.4% were clinically cured at D9. Clinical cure with azithromycin was not inferior to tobramycin at D9: discharge was absent in 96.3% of patients treated with azithromycin and 95.1% with tobramycin. Azithromycin was well tolerated. CONCLUSIONS: Azithromycin 1.5% for 3 days (six drops) was as effective as tobramycin for 7 days (36 drops). Furthermore, patients on azithromycin presented earlier clinical cure on Day 3 than patients on tobramycin. Azyter, with its convenient dosing (bid for 3 days), is a step forward in the management of purulent bacterial conjunctivitis.