Effectiveness and Safety of Prochlorperazine in Indian Patients with Acute Vertigo: Results from a Large, Prospective, Post-marketing Observational Study

• Published in: Indian journal of otolaryngology, and head, and neck surgery and head, and neck surgery, 2023-12, Vol.75 (4), p.3152-3160
• Main Authors: Kameswaran, Mohan, Bharathi, M B, Periera, Carlton, Chandra, Sudipta, Reddy, Hari Krishna, Gupta, Manjeeta, Sholapuri, Deepa, Peethamabaran, Kartik
• Format: Article
• Language: English
• Subjects: Head and Neck Surgery; Medicine; Medicine & Public Health; Observational studies; Original Article; Otorhinolaryngology
• ISSN: 2231-3796; 0973-7707
• DOI: 10.1007/s12070-023-03831-0

Aim To assess the efficacy and safety of prochlorperazine in Indian patients with acute vertigo. Methods In this prospective, multicenter, open-label, post-marketing observational study, patients with acute peripheral vertigo of different etiologies received 5 mg prochlorperazine thrice a day for 5 days. The primary endpoints were percentage of patients with improvement in (1) vertigo symptoms and (2) clinical response as per scale for vestibular vertigo severity level and clinical response evaluation (SVVSLCRE) from baseline to end of treatment (Day 6). The key secondary endpoints were (1) improvement in nystagmus grading, and (2) safety and tolerability Efficacy of prochlorperazine by route of administration of first prochlorperazine dose (oral or intramuscular) was also assessed. Results Of 1716 enrolled patients (mean [standard deviation, SD]) age (42.0 [12.95] years; 53.6% men), 57.4% were diagnosed with Meniere’s disease, followed by vestibular neuritis (17.4%), labyrinthitis (16.7%), or ear surgery (8.5%). In the overall population, 91.1% of patients showed improvement in clinical response per SVVSLCRE grading at Day 6 (p