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A placebo-controlled, randomized, double-blind study of OPC-8212 in patients with mild chronic heart failure.
Abstract:
OPC-8212 is a newly synthesized, orally effective inotropic agent. Previous studies have shown short-term hemodynamic and symptomatic improvement in patients with congestive heart failure. However, the long-term efficacy of this agent remains to be established. Eighty-three patients with chronic heart failure were randomly assigned to treatment with either OPC-8212 (n = 45) or matching placebo (n = 38). Of the placebo-treated patients, two patients died and another six patients were withdrawn from the study because of a deterioration of heart failure, while only 1 out of 45 OPC-8212-treated patients were withdrawn because of increased congestive symptoms. After 12 weeks of treatment, the OPC-8212 group showed a significant improvement in their numerical scores in sense of well-being as judged by the patients subscale A (p less than 0.01) and their physicians' general impression of the patients' status (p less than 0.01). The ejection fraction obtained from echocardiography increased from a mean (+/- SEM) baseline value of 42.8 +/- 2.6% to 46.6 +/- 2.9% (p less than 0.05) in the OPC-8212 group and 44.4 +/- 3.7% to 45.5 +/- 4.1% in the placebo group. These effects were not associated with an increase in the heart rate. The treatment was well tolerated without any limiting side effects. Thus, OPC-8212 is effective in patients with chronic heart failure, providing significant hemodynamic and symptomatic benefit in chronic treatment, together with a possible improvement of the prognosis of patients with heart failure.
Insights
Long-term treatment with OPC-8212 significantly improved well-being and ejection fraction in chronic heart failure patients. This oral inotropic agent demonstrated efficacy and tolerability, suggesting a potential to improve heart failure prognosis.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Congestive heart failure (CHF) management requires effective long-term therapies.
- OPC-8212, an oral inotropic agent, has shown short-term benefits in CHF patients.
- Long-term efficacy of OPC-8212 in chronic heart failure (CHF) needed further investigation.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of OPC-8212 in patients with chronic heart failure.
- To assess the impact of OPC-8212 on patient well-being, physician's general impression, and hemodynamic parameters.
Main Methods:
- A randomized, placebo-controlled trial involving 83 patients with chronic heart failure.
- Patients received either OPC-8212 (n=45) or a matching placebo (n=38) for 12 weeks.
- Efficacy was assessed using patient-reported well-being scores, physician's general impression, and echocardiographic ejection fraction.
Main Results:
- OPC-8212 treatment led to significant improvements in patient well-being (p<0.01) and physician's general impression (p<0.01).
- Ejection fraction increased significantly in the OPC-8212 group (42.8% to 46.6%, p<0.05), but not in the placebo group.
- Fewer patients in the OPC-8212 group were withdrawn due to heart failure deterioration compared to the placebo group.
- Treatment was well-tolerated with no limiting side effects and no increase in heart rate.
Conclusions:
- OPC-8212 is an effective oral agent for the chronic treatment of heart failure.
- It provides significant hemodynamic and symptomatic benefits.
- OPC-8212 may offer a potential improvement in the prognosis for patients with heart failure.