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Published on: February 28, 2012
Digitalis: a dangerous drug in atrial fibrillation? An analysis of the SPORTIF III and V data
K Gjesdal1, J Feyzi, S B Olsson
1Ullevål University Hospital, 0407 Oslo, Norway. knut.gjesdal@medisin.uio.no
Insights
Digitalis use in atrial fibrillation (AF) patients was linked to higher mortality, suggesting potential risks outweigh benefits. Further research is needed due to non-randomized digitalis use.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Digitalis is known to improve exercise capacity in heart failure but has no impact on survival.
- Concerns exist that digitalis's inotropic benefits may be offset by adverse effects.
- Atrial fibrillation (AF) patients may react differently to digitalis due to their specific condition.
Purpose of the Study:
- To investigate the impact of digitalis use on mortality in patients with atrial fibrillation (AF).
- To clarify whether the potential adverse effects of digitalis outweigh its benefits in AF patients.
- To analyze digitalis's role in a population primarily benefiting from its rate-controlling properties.
Main Methods:
- Analysis of data from the Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation (SPORTIF) III and V studies.
- Inclusion of 7329 moderate-to-high risk AF patients randomized to warfarin or ximelagatran.
- Comparison of survival rates between digitalis users and non-users, with multivariate risk factor adjustment.
Main Results:
- Over half (53.4%) of the study population used digitalis.
- Digitalis users exhibited significantly higher mortality rates at baseline (6.5% vs 4.1%, p<0.001).
- This increased mortality persisted after adjusting for baseline risk factors (HR = 1.53, p<0.001).
Conclusions:
- The findings suggest that digitalis, similar to other inotropic drugs, may be associated with increased mortality in AF patients.
- The rate-reducing effect of digitalis in AF might be beneficial, but this could be counteracted by increased mortality risks.
- Results require cautious interpretation as digitalis use was not randomized.
Objective:
In heart failure, digitalis increases exercise capacity and reduces morbidity, but has no effect on survival. This raises the suspicion that the inotropic benefits of digitalis may be counteracted by serious adverse effects. Patients with atrial fibrillation (AF) were studied to clarify this.
Design:
In the Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation (SPORTIF) III and V studies, 7329 patients with AF at moderate-to-high risk were randomised to preventive treatment of thromboembolism, either with warfarin or the oral direct thrombin inhibitor ximelagatran. The survival of users and non-users of digitalis was investigated.
Results:
At baseline, 53.4% of the study population used digitalis, and these patients had a higher mortality than non-users (255/3911 (6.5%) vs 141/3418 (4.1%), p<0.001; hazard ratio (HR) = 1.58 (95% CI 1.29 to 1.94)). Digitalis users also had more baseline risk factors. After multivariate risk factor adjustment, the increased mortality persisted (p<0.001; HR = 1.53 (95% CI 1.22 to 1.92 vs 1.23 to 1.92)).
Conclusions:
The results suggest that digitalis, like other inotropic drugs, may increase mortality. This may be concealed in heart failure, but be revealed in patients with AF, who need the rate-reducing effect of digitalis, but do not benefit much from an increased inotropy. Cautious interpretation of the data is mandatory since the patients were not randomised with respect to digitalis use.
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