JOURNAL OF EVIDENCE BASED MEDICINE AND HEALTHCARE

Table of Contents

2018 Month : June Volume : 5 Issue : 24 Page : 1818-1824

EFFICACY, SAFETY AND QUALITY OF LIFE OUTCOMES OF PALONOSETRON, RAMOSETRON AND GRANISETRON AS A PART OF ANTIEMETIC THERAPY IN PREVENTION OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING- A RANDOMISED COMPARATIVE TRIAL

Seema Gupta1, Aman Sharma2, Rahul Sharma3, Dinesh Kumar4, Nusrat Kreem Bhat5, Vijay Khajuria6

Corresponding Author:
Dr. Aman Sharma,
H. No. 85/3, Sanjay Nagar,
Jammu – 180010,
Jammu and Kashmir.
E-mail: amansharma1602@gmail.com
DOI: 10.18410/jebmh/2018/380

ABSTRACT
BACKGROUND
5-HT3 receptor antagonists have potent antiemetic effect in chemotherapy induced nausea and vomiting. The present study was conducted to study and compare the efficacy and safety of ramosetron, palonosetron and granisetron in preventing acute and delayed nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy, and the impact of these drugs on daily living of these patients.

MATERIALS AND METHODS
It was an open label, randomised, prospective, comparative, parallel study. A total of 59 patients were enrolled in the study. They were divided into 3 groups: palonosetron (0.25mg i.v and 0.5mg orally daily; n=18) group, ramosetron (0.3 mg i.v and 0.1 mg orally daily; n=22) group, and granisetron (1mg i.v and 2mg orally daily; n=19). The drugs were given for 5 days after chemotherapy cycle. In addition, all the three groups received inj. dexamethasone (16mg) prior to chemotherapy and tab. domperidone 10mg orally before chemotherapy and 3 times daily till day 5. The incidence and severity of nausea and vomiting, use of rescue antiemetics and the impact on daily living were evaluated for 7 days. Emetic episodes were recorded on a diary on a daily basis and nausea was measured on a visual analogue scale. Complete response rates (no emesis and no need of rescue antiemetics) were measured as the primary end point. The quality of life outcomes were measured using the functional life index – emesis (FLIE) questionnaire. Safety was evaluated by monitoring the adverse drug reactions of the test drugs.

RESULTS
The complete response rate in ramosetron group (72.7% in acute; 68.2% in delayed) were numerically better than palonosetron (66.7%; 61.1%) and granisetron (42.1%; 36.8%). The results didn’t achieve statistical significance. The impact on daily living was numerically better in ramosetron than palonosetron and granisetron but the results didn’t show a statistical significance. All the three drugs were well tolerated.

CONCLUSION
All the three drugs were effective and well tolerated. However, ramosetron showed numerically better complete response rates and better quality of life outcomes as compared to palonosetron and granisetron.

KEYWORDS
Emetogenic chemotherapy, nausea and vomiting, serotonin, quality of life, FLIE, CINV.