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Safety and Long-Term Efficacy of Transition from Sildenafil to Tadalafil due to Side Effects in Patients with Pulmonary Arterial Hypertension

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Abstract

Introduction

Two phosphodiesterase-type 5 (PDE-5) inhibitors, sildenafil and tadalafil, are approved for treatment of pulmonary arterial hypertension (PAH). It has not yet been observed if transition from sildenafil to tadalafil is beneficial in patients suffering from adverse reactions. Aim of this study was to analyze safety and long-term effects in PAH patients whose treatment was transitioned from sildenafil to tadalafil due to intolerable side-effects.

Methods

A retrospective analysis of PAH-patients who were stable on sildenafil for >3 months and transitioned to tadalafil due to adverse events was performed. Data collected included demographics, PAH-etiology, WHO-functional class, 6 min walking distance (6MWD), echocardiography, lung function tests, and NTproBNP pre-transition and 3, 6, and 12 months post-transition.

Results

Included were 13 PAH patients (8 females mean age 64 ± 10 years) who had been on sildenafil for a mean of 12 ± 8.4 months. In six patients (46.1 %) a switch to tadalafil was feasible and resulted in tolerable side effects and a stable clinical course with improvement of symptoms, 6MWD, stable echocardiographic findings, and NTproBNP-levels during a follow-up of 11 ± 3 months. In 5 out of 13 patients (38.5 %) adverse events occurred under tadalafil as well and therapy with PDE-5 inhibitors was discontinued. In two patients (15.4 %) sildenafil-treatment could be successfully restarted after an intermittent switch to tadalafil.

Conclusions

The observations of this study indicate that a transition of sildenafil to tadalafil in case of intolerable side effects is a reasonable therapy option in about 50 % of the patients. These results should be verified by a larger prospective study.

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Abbreviations

6MWD:

6 min walking distance

NO:

Nitric oxide

NTproBNP:

N-terminal prohormone of brain natriuretic peptide

PAH:

Pulmonary arterial hypertension

PASP:

Systolic pulmonary arterial pressures

PDE-5:

Phosphodiesterase-type 5

PH:

Pulmonary hypertension

q.d.:

Quaque die

TAPSE:

Tricuspid annular plane systolic excursion

t.i.d.:

Ter in die

WHO:

World Health Organization

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Acknowledgments

This study was funded by Eli Lilly and Company.

Conflict of interest

ML: receives consultancy fees from Actelion. DH: nothing to disclose. NE: receives speaker fees from Bayer HealthCare, Pfizer, Actelion, Lilly. AM: nothing to disclose. FP: nothing to disclose. EG: receives consultancy/speaker fees from Bayer HealthCare, Pfizer, Actelion, Lilly, Encysive, Alexion, United Therapeutics, GlaxoSmithKline, Miltenyi, Sinoxa Pharma and Novartis. BE: nothing to disclose.

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Authors and Affiliations

  1. Centre for Pulmonary Hypertension, Thoraxklinik of University Hospital Heidelberg, Amalienstrasse 5, 69126, Heidelberg, Germany

    Mona Lichtblau, Dominik Harzheim, Nicola Ehlken, Alberto Marra, Fabiola Pena Pinado, Ekkehard Grünig & Benjamin Egenlauf

  2. Department of Translational Medical Sciences, “Federico II” University, Naples, Italy

    Alberto Marra

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  1. Mona Lichtblau
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  2. Dominik Harzheim
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  3. Nicola Ehlken
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  4. Alberto Marra
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  5. Fabiola Pena Pinado
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  6. Ekkehard Grünig
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  7. Benjamin Egenlauf
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Correspondence to Mona Lichtblau.

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Mona Lichtblau and Dominik Harzheim made an equal contribution to the study.

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Lichtblau, M., Harzheim, D., Ehlken, N. et al. Safety and Long-Term Efficacy of Transition from Sildenafil to Tadalafil due to Side Effects in Patients with Pulmonary Arterial Hypertension. Lung 193, 105–112 (2015). https://doi.org/10.1007/s00408-014-9657-7

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  • DOI: https://doi.org/10.1007/s00408-014-9657-7

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