Clinical Investigations
Tolerability to β-blocker therapy among heart failure patients in clinical practice*,**

https://doi.org/10.1054/jcaf.2003.34Get rights and content

Abstract

Background: Although β-blockers were well-tolerated by heart failure (HF) patients in clinical trials, tolerability of these drugs in a general population of HF patients is not well-described. Methods: We studied a total of 308 encounters with β-blockers therapy in 268 ambulatory HF patients. Side effects and frequency and predictors of discontinuation of therapy were studied. Independent predictors of discontinuation were assessed. Results: Weight gain (59%), fatigue (56%), dizziness (41%), and dyspnea (29%) were the most common side effects. Fifty-one patients (19%) were discontinued on therapy with any 1 particular β-blocker. Fatigue (30%) and hypotension (28%) were the most common reasons for discontinuation. Forty (78%) of these were given a trial with a different β-blocker. Of these, 22 (55%) attempts with a different β-blocker were tolerated. Thus the overall absolute discontinuation rate was only 7% for patients who were given a trial with different β-blockers or 11% for the entire study population. Independent predictors of discontinuation of therapy included advanced symptoms, nonischemic etiology, history of pulmonary disease, and higher diuretic doses. Conclusion: Side effects with β-blockers in a general population of HF patients are common; however, with changes in medical management, most patients can tolerate them eventually. In case of intolerance to one kind, a trial with a different β-blocker is indicated.

Section snippets

Patient population

A total of 360 consecutive patients treated at either the Vanderbilt University Medical Center or the Nashville Veterans Administration Medical Center's HF Programs between January 1999 and June 2000 who either died or had a documented follow-up visit at least 1 month after initiation of β-blocker therapy were identified. To study typical HF patients with systolic dysfunction, we excluded 43 patients with an ejection fraction >40%; 18 patients with any of the following: aortic stenosis,

Outcomes

The primary outcome was the proportion of patients with an absolute intolerance to β-blockers. Other outcomes included assessment of side effects profile, frequency of patients who were successfully switched to another β-blocker if one was not tolerated, and predictors of discontinuation of β-blockers.

Results

The mean age of the study population was 59 ± 11 years and 71% of the patients were males. Mean ejection fraction was 24 ± 8%. Other demographic, clinical characteristics, histories, and baseline HF treatments are presented in Table 1.

. Patient characteristics

CharacteristicsOverallTolerated n = 217Discontinued n = 51P
Age (mean ± SD)59 ± 1159 ± 1258 ± 10NS
Male gender (%)717268NS
NYHA class (%)
 I-II374120.01
 III-IV635980
Etiology (%)
 Ischemic555939.02
 Nonischemic454161
Ejection fraction (mean ± SD)24 ± 8

Discussion

Several clinical trials have now shown that β-blockers reduce mortality and hospitalization rate and improve left ventricular ejection fraction among HF patients, and that these drugs were well-tolerated in clinical trials.1, 2, 3, 4 Previous studies have, however, shown a difference in drug tolerability between patients in clinical trials vs. practice setting.7 In the case of β-blockers, this disparity may be important as untreated worsening congestion can be life-threatening. On the other

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    *

    Reprint requests: Javed Butler MD, Cardiology Division, 383 PRB, Vanderbilt University Medical Center, Nashville, TN 37232.

    **

    1071-9164/03/0903-0008$30.00/0

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