Prophylactic nimodipine treatment improves hearing outcome after vestibular schwannoma surgery in men: a subgroup analysis of a randomized multicenter phase III trial.


Journal

Neurosurgical review
ISSN: 1437-2320
Titre abrégé: Neurosurg Rev
Pays: Germany
ID NLM: 7908181

Informations de publication

Date de publication:
Jun 2021
Historique:
received: 30 04 2020
accepted: 11 08 2020
revised: 29 07 2020
pubmed: 23 8 2020
medline: 30 6 2021
entrez: 23 8 2020
Statut: ppublish

Résumé

A 2016 published randomized multicenter phase III trial of prophylactic nimodipine treatment in vestibular schwannoma surgery showed only a tendency for higher hearing preservation rates in the treatment group. Gender was not included in statistical analysis at that time. A retrospective analysis of the trial considering gender, preoperative hearing, and nimodipine treatment was performed. The treatment group received parenteral nimodipine from the day before surgery until the seventh postoperative day. The control group was not treated prophylactically. Cochlear nerve function was determined by pure-tone audiometry with speech discrimination preoperatively, during in-patient care, and 1 year after surgery and classified according to the Gardner-Robertson grading scale (GR). Logistic regression analysis showed a statistically significant effect for higher hearing preservation rates (pre- and postoperative GR 1-4) in 40 men comparing the treatment (n = 21) and the control (n = 19) groups (p = 0.028), but not in 54 women comparing 27 women in both groups (p = 0.077). The results were also statistically significant for preservation of postoperative hearing with pre- and postoperative GR 1-3 (p = 0.024). There were no differences in tumor sizes between the treatment and the control groups in men, whereas statistically significant larger tumors were observed in the female treatment group compared with the female control group. Prophylactic nimodipine is safe, and an effect for hearing preservation in 40 men with preoperative hearing ability of GR 1-4 was shown in this retrospective investigation. The imbalance in tumor size with larger tumors in females of the treatment group may falsely suggest a gender-related effect. Further investigations are recommended to clarify whether gender has impact on nimodipine's efficacy.

Identifiants

pubmed: 32827307
doi: 10.1007/s10143-020-01368-2
pii: 10.1007/s10143-020-01368-2
pmc: PMC8121726
doi:

Substances chimiques

Nimodipine 57WA9QZ5WH

Types de publication

Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

1729-1735

Subventions

Organisme : BMBF
ID : 1315883

Références

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Auteurs

Christian Scheller (C)

Department of Neurosurgery, Martin Luther University Halle-Wittenberg, Ernst-Grube-Str. 40, 06097, Halle (Salle), Germany. christian.scheller@uk-halle.de.

Stefan Rampp (S)

Department of Neurosurgery, Martin Luther University Halle-Wittenberg, Ernst-Grube-Str. 40, 06097, Halle (Salle), Germany.

Sandra Leisz (S)

Department of Neurosurgery, Martin Luther University Halle-Wittenberg, Ernst-Grube-Str. 40, 06097, Halle (Salle), Germany.

Marcos Tatagiba (M)

Department of Neurosurgery, University of Tübingen, Tübingen, Germany.

Alireza Gharabaghi (A)

Department of Neurosurgery, University of Tübingen, Tübingen, Germany.

Kristofer F Ramina (KF)

Department of Neurosurgery, University of Tübingen, Tübingen, Germany.

Oliver Ganslandt (O)

Department of Neurosurgery, Stuttgart Hospital, Stuttgart, Germany.

Cordula Matthies (C)

Department of Neurosurgery, University of Würzburg, Würzburg, Germany.

Thomas Westermaier (T)

Department of Neurosurgery, University of Würzburg, Würzburg, Germany.

Gregor Antoniadis (G)

Department of Neurosurgery, University of Ulm, Ulm, Germany.

Maria T Pedro (MT)

Department of Neurosurgery, University of Ulm, Ulm, Germany.

Veit Rohde (V)

Department of Neurosurgery, University of Göttingen, Göttingen, Germany.

Kajetan von Eckardstein (K)

Department of Neurosurgery, Westpfalz-Klinikum Kaiserslautern, Kaiserslautern, Germany.

Konstanze Scheller (K)

Department of Oral and Maxillofacial and Facial Plastic Surgery, Martin Luther University Halle-Wittenberg, Halle, Germany.

Christian Strauss (C)

Department of Neurosurgery, Martin Luther University Halle-Wittenberg, Ernst-Grube-Str. 40, 06097, Halle (Salle), Germany.

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