OPC-8212 in the treatment of congestive heart failure: Results of a pilot study

Abstract

To characterize the effects of OPC-8212, a quinolone inotropic agent, in patients with heart failure, we utilized invasive hemodynamics, exercise testing, 24-hour ambulatory electrocardiograms, and two patient self-assessment questionnaires, before and after 1 month of treatment with OPC-8212, in 17 patients with moderate to severe congestive heart failure. There were no significant changes from baseline in heart rate (83 +/- 8 beats/min), mean arterial pressure (70 +/- 15 mmHg), pulmonary wedge pressure (18 +/- 7 mmHg), or cardiac index (2.3 +/- 0.4 L/min/m2) following treatment with OPC-8212. Both exercise duration (5.3 +/- 1.6 min) and peak oxygen consumption (12.0 +/- 2.9 mL/kg/min) were unchanged by OPC-8212. Two independent patient self-assessment scores, the Sickness Impact Profile and the Minnesota Living with Heart Failure Questionnaire, showed improvements from 6.8 to 5.4 and 49 to 38, respectively (both p less than .05), suggesting that the patients reported an improvement in daily functioning. The median ventricular premature contraction count and frequency were reduced from 1,118 beats to 243 beats (p less than 0.05) and 11/1,000 beats to 2.4/1,000 beats (0.05 less than p less than 0.10), respectively. Two patients developed agranulocytosis during longer-term treatment following this 1-month study. These data demonstrate that OPC-8212 did not have significant effects on hemodynamics or exercise tolerance. However, the improvement in patient self-assessment scores and the trend for improvement in ventricular arrhythmia profiles suggest that OPC-8212 may have some benefit for patients with congestive heart failure, but additional placebo-controlled, double-blind studies are necessary.

The Euro Cardio-QoL Project. An international study to develop a core heart disease health-related quality of life questionnaire, the HeartQoL

“…Heart Failure Questionnaire The instrument to be used is the Minnesota Living With Heart Failure Questionnaire (LHF), a valid, reliable, and responsive self-administered tool for patients with heart failure [18, 19]. Each item is preceded by the probe ‘Did your heart failure prevent you from…?’ and the LHF measures patient perceptions concerning the effects of heart failure on their lives in the last 4 weeks using 21 items in three domains: physical and symptoms (11 items), psychological (7 items), and socio-economic (3 items) [18].…”

“…The first is to start from the beginning and develop a core instrument by conducting qualitative interviews with patients, consulting with professionals, generating and then testing a large set of items. The second option is to start with psychometrically sound instruments already available in specific cardiac conditions such as the MacNew Heart Disease HRQL questionnaire [14, 15] for patients with MI, the Seattle Angina Questionnaire (SAQ) [16, 17], and the Minnesota Living With Heart Failure Questionnaire (LHF) [18, 19]. The second option was adopted since a substantial body of research already exists on the concepts of most concern to specific cardiac sub-groups.…”