In: Disease23 Apr 2010
Eleven treated patients (25%) and nine control patients (20.5%) did not complete the study. Among the treated patients, five (11.3%) withdrew because of suspected ADEs from generic bisoprolol: weakness, dizziness, and dyspnea. No severe hypotension occurred in either group. Fourteen patients were excluded from the evaluation at follow-up. Seven patients had echocardiographic or 24-hour ECG data of insufficient quality, and seven patients withdrew because of telephone-connection difficulties. Their withdrawal from this study did not affect our conclusions because these patients were equally distributed in the treated and control groups.
Among all patients, 67 (76.1%) fulfilled complete clinical, ECG, and echocardiographic data and six to 12 months of follow-up data. The follow-up period was similar for the controls (263 ± 56 days, or 207-319 days) and for the treated patients (247 ± 74 days, or 173-321 days). There were no significant differences in age, sex, NYHA class, disease duration, or the use of diuretics and nitrates (Table 1).
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Table 1 Fundamental Characteristics of Patients with Heart Failure (Mean ± SD)
|Parameter||Control Patients (n = 34)||Treated Patients(n = 33)||P Value|
43.5 ± 7.4
|40.6 ± 6.8||P = .120 (t = 1.671)|
|12/21 (36.4%)||P > .200 (x2 = 0.015)|
|Resting ventricular rate at admission (beats/minute)||
105 ± 19
|110 ±21||P = .32 (t = 1.210)|
|24-hour average ventricular rate at hospital|
95 ± 14
|80 ± 14*||P < .001 (t = 4.385)|
|Left ventricular end-diastolic dimension (mm)||
57 ± 21
|55 ± 19||P > .200 (t = 0.409)|
|Average left atrial diameter (mm)||
|43 ± 5||P = .182 (t = 1.484)|
|Six-minute walking distance at hospital|
309 ± 28
|391 ± 32*||P < .001 (t = 11.149)|
|Systolic pressure at discharge (mm Hg)||
121 ± 14
|115 ±12||P = .008 (t = 1.885)|
|NYHA Class at hospital discharge (score)||
2.2 ± 0.6
|2.1 ± 0.8||P > .200 (t = 0.577)|
|* P < .05 compared with the control group of patients.mm = millimeters; Hg = mercury; NYHA = New York Heart Association; SD = standard deviation.|
The severity of mitral or aortic lesions did not differ in either group: (1) two treated patients (6.1%) and one control patient (2.9%) had mitral valve regurgitation of at least moderate severity and/or mild stenosis; (2) six treated patients (18.2%) and eight control patients (23.5%) had combined mitral stenosis of at least moderate severity and mitral valve regurgitation; and (3) 21 treated patients (63.6%) and 22 control patients (64.7%) had combined mitral and aortic valve disease.
Sixteen treated patients (48.5%) and 17 control patients (50.0%) had significant mitral stenosis. In both groups, approximately 50% of patients had pure and non-pure (predominant) mitral stenosis. The LVEF was higher than 40% in all patients in the two groups and was below 45% in three patients (two patients in the treatment group and one in the control group). All patients had combined mitral and aortic valve disease.
During follow-up, the use of ACE-inhibitors/ARBs and was similar for all patients. Thirteen treated patients (39.4°%) and 16 controls (47.1°%) received ACE-inhibitors/ARBs, and 30 treated patients (90.9%) and 32 controls (94.1%) received digoxin. The average maximum bisoprolol dose was 6.52 ±2.7 mg/day in the treatment group; 54.5% of the patients tolerated at least 5 mg of once daily. Nineteen treated patients (55.9%) and 20 controls (60.6%) received nitrates.
Short-Term Clinical Effects
At hospital admission, the resting ventricular rate was similar in both treated and control patients. Both groups had a similar NYHA class from admission to discharge. However, the treatment group showed a significantly lower 24-hour average ventricular rate at discharge (80 ± 14 beats/minute, 95 ± 14 beats/minute; P < .001). The length of hospital stay for the treated patients (6.8 ± 3.4 days) was significantly shorter than that for the control patients (9.5 ±4.3 days, P = 0.046). Further, the treated patients had better exercise capacity at discharge (391 ± 32 meters, 309 ± 28 meters; P< .001) (see Table 1).
At discharge, although the treated group had a mild higher systolic blood pressure than the controls, the LV end-diastolic dimension and the average LA diameter did not differ between the two groups (see Table 1).
Long-Term Clinical Effects
During follow-up, the combined endpoint accounted for 11 cases of HF in the controls (32.4%) and four cases in the treated patients (12.1%, P = .048) (Table 2). Ten controls and three treated patients were hospitalized for complaints associated with chronic HF; one treated patient and one control were admitted with these complaints.
Table 2 Clinical Characteristics for the Follow-up Period in Patients with Heart Failure (Mean ± SD)
|Control Patients||Treated Patients|
|Parameter||(n = 34)||(n = 33)||PValue|
|Combined endpoint (%)||11 (32.4%)||4 (12.1%)*||P = .048 (x2 = 3.944)|
|NYHA Class (score)||3.2 ± 0.8||2.2 ± 0.7*||P < .001 (t = 5.445)|
|24-hour average ventricular rate (beats/minute)||110 ±27||68 ± 17*||P < .001 (t = 7.645)|
|Decreased left atrial diameter (mm)||2.2 ± 0.5||-3.9 ± 0.6*||P < .001 (t = 45.138)|
|Six-minute walking distance (meters)||290 ± 23||423 ± 25*||P < .001 (t = 22.644)|
|Systolic (mm Hg)||118 ±16||105 ± 15*||P < .001 (t = 3.453)|
Also at follow-up, NYHA class in the treated patients remained stable. The condition of only two patients deteriorated to NYHA class IV, and 75.8% of patients were in class I or II. However, NYHA class in the controls worsened to some degree; the health of nine patients deteriorated to class IV, and 50% were in class III. NYHA class scores of the treated patients were significantly lower than those of the controls (2.2 ± 0.7 score, 3.2 ± 0.8 score; P < .001). In addition, compared with the controls, the treated patients receiving the study regimen had lower 24-hour average heart ventricular rates, decreased systolic blood pressure readings (P < .001), and longer six-minute walking distances (see Table 2).
Compared with the findings at discharge, the LV end-diastolic dimension in both groups did not differ significantly at follow-up. For all patients in the two groups, the LVEF was higher than 40%. The LVEF was below 45% in four patients (one treated patient and three controls). Thus, no significant changes in EF or LV end-diastolic dimension were found in either group during the follow-up evaluation. However, the treated patients did show a significantly decreased LA diameter compared with the control group at follow-up.
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