Key result
The addition of cisapride to oral sotalol significantly decreased the time to maximum serum concentration from 2.79 hours to 1.16 hours (P=0.009) compared to oral sotalol alone.
Why the study?
Does the addition of cisapride to oral sotalol or sublingual administration improve the absorption kinetics of sotalol in healthy male volunteers?
RCT (n=7)
Open-label
Crossover
Does the addition of cisapride to oral sotalol or sublingual administration improve the absorption kinetics of sotalol in healthy male volunteers?
Absolute Event Rate: 1.16% vs 2.79%
p-value: p=0.009
The addition of cisapride to oral sotalol significantly accelerates its absorption, suggesting potential utility for episodic treatment of supraventricular arrhythmias.
Cisapride accelerates sotalol absorption in healthy volunteers; extends pharmacokinetic options for acute use but leaves clinical efficacy and safety open in patients.
AIMS: To study the absorption kinetics of sotalol following administration of different formulations. A formulation which results in fast absorption might be useful in the episodic treatment of paroxysmal supraventricular tachycardia (SVT), atrial fibrillation (Afib) or atrial flutter (Afl). METHODS: In an open randomized crossover study seven healthy male volunteers were given an intravenous infusion of 20 mg sotalol, for assessing the absolute bioavailability, an oral solution containing 80 mg sotalol, an oral solution containing both 80 mg sotalol and 20 mg cisapride and an 80 mg sotalol tablet, which was taken sublingually. RESULTS: The addition of cisapride decreased the time at which maximum serum concentrations were reached (tmax) from 2.79 (1.85-4.34) h to 1.16 (0.68-2.30) h (P=0.009) [95% CI: -2.59, -0.55] and increased the absorption rate constant (ka) from 0.49 (0.31-0.69) h(-1) to 1.26 (0.52-5.61) h(-1) (P=0.017). The absolute bioavailability of sotalol was reduced by cisapride from 1.00+/-0.15 to 0.70+/-0.26 (P=0.006), while maximum serum concentrations of both oral solutions were not significantly different. Compared with the sublingually administered tablet with a median tmax of 2.12 (0.89-3.28) h, the sotalol/cisapride oral solution gave a smaller tmax (p=0.009) [95% CI: -1.64, -0.36]. The ka of the sotalol/cisapride solution was significantly (P=0.010) larger than the ka of 0.56 (0.33-0.75) h(-1) found after sublingual administration of the tablet. CONCLUSIONS: The sotalol/cisapride oral solution might be suitable for the episodic treatment of SVT, Afib or Afl.
No takes yet. Share an insight, caveat, or question.
Deneer et al. (1998) conducted an RCT in Healthy subjects (n=7). Sotalol combined with cisapride vs. 80 mg sotalol oral solution, 80 mg sublingual sotalol tablet, and 20 mg IV sotalol was evaluated on Time at which maximum serum concentrations were reached (tmax) (95% CI -2.59, -0.55, p=0.009). The addition of cisapride to oral sotalol significantly decreased the time to maximum serum concentration from 2.79 hours to 1.16 hours (P=0.009) compared to oral sotalol alone.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: