The Real-World Safety and Effectiveness of Prochlorperazine in Indian Patients with Dizziness.
Journal
The Journal of the Association of Physicians of India
ISSN: 0004-5772
Titre abrégé: J Assoc Physicians India
Pays: India
ID NLM: 7505585
Informations de publication
Date de publication:
Feb 2020
Feb 2020
Historique:
entrez:
4
2
2020
pubmed:
6
2
2020
medline:
18
2
2020
Statut:
ppublish
Résumé
Considering the prevailing concerns about extrapyramidal symptoms (EPS) associated with oral prochlorperazine, this study was conducted to assess the safety of oral prochlorperazine (in recommended dose/duration) in the management of acute dizziness. Effectiveness was also assessed in the Indian real-world setting. A prospective, multicentric, single-arm observational study was conducted across 20 centers in India. Data from 500 patients were analyzed. Patients presenting with a complaint of dizziness, receiving prochlorperazine (Stemetil® MD-5 mg, t.i.d.) as per the routine clinical practice were enrolled. Safety and effectiveness at Week-1, compared to baseline, were assessed. The mean (SD) age of the population was 43.3 (11.93) years with a marginally higher proportion of women (women: 52.2% Vs men 47.8%). The mean (SD) dose of prochlorperazine was 14.9 (0.24) mg/day. Only three patients (0.006%) reported adverse drug reactions (headache, asthenia, somnolence) during the conduct of the study, which were mild in severity and were completely resolved. Further, a significant reduction in the number of episodes of dizziness was noted at the end of Week-1(p<.0001). Moreover, improvement in the number of episodes from baseline to Week-1 was significant for nausea, vomiting, lightheadedness, and headache. Prochlorperazine was well-tolerated in the management of acute dizziness when administered at a mean dose of 14.9 mg/day, and mean duration of 7.2 days. Additionally, prochlorperazine was effective in providing significant symptomatic relief from dizziness and associated vomiting and nausea.
Sections du résumé
BACKGROUND
BACKGROUND
Considering the prevailing concerns about extrapyramidal symptoms (EPS) associated with oral prochlorperazine, this study was conducted to assess the safety of oral prochlorperazine (in recommended dose/duration) in the management of acute dizziness. Effectiveness was also assessed in the Indian real-world setting.
METHODS
METHODS
A prospective, multicentric, single-arm observational study was conducted across 20 centers in India. Data from 500 patients were analyzed. Patients presenting with a complaint of dizziness, receiving prochlorperazine (Stemetil® MD-5 mg, t.i.d.) as per the routine clinical practice were enrolled. Safety and effectiveness at Week-1, compared to baseline, were assessed.
RESULTS
RESULTS
The mean (SD) age of the population was 43.3 (11.93) years with a marginally higher proportion of women (women: 52.2% Vs men 47.8%). The mean (SD) dose of prochlorperazine was 14.9 (0.24) mg/day. Only three patients (0.006%) reported adverse drug reactions (headache, asthenia, somnolence) during the conduct of the study, which were mild in severity and were completely resolved. Further, a significant reduction in the number of episodes of dizziness was noted at the end of Week-1(p<.0001). Moreover, improvement in the number of episodes from baseline to Week-1 was significant for nausea, vomiting, lightheadedness, and headache.
CONCLUSION
CONCLUSIONS
Prochlorperazine was well-tolerated in the management of acute dizziness when administered at a mean dose of 14.9 mg/day, and mean duration of 7.2 days. Additionally, prochlorperazine was effective in providing significant symptomatic relief from dizziness and associated vomiting and nausea.
Substances chimiques
Antiemetics
0
Prochlorperazine
YHP6YLT61T
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
61-66Informations de copyright
© Journal of the Association of Physicians of India 2011.