A prospective, multicentric study to determine the safety and effectiveness of fixed-dose combination of camylofin dihydrochloride and nimesulide in patients presenting with acute colicky abdominal pain in India

Kirankumar Jadhav; Vineet Shukla; Anil Kumar; Partha P. Kalita; Swapnav Borthakur

doi:10.18203/2349-3933.ijam20220743

Authors

Kirankumar Jadhav B. J. Government Medical College and Sassoon General Hospital, Pune, Maharashtra, India
Vineet Shukla KRM Hospital and Research Centre, Lucknow, Uttar Pradesh, India
Anil Kumar Gandhi Hospital, In Patient Block, Secunderabad, Telangana, India
Partha P. Kalita GNRC Hospital, Near IIT Sila Grant, North Guwahati, Assam, India
Swapnav Borthakur Down Town Hospital, Guwahati, Assam, India

DOI:

https://doi.org/10.18203/2349-3933.ijam20220743

Keywords:

Camylofin, Colicky pain, Nonsteroidal anti-inflammatory drugs, Spasmolytic, Nimesulide

Abstract

Background: Spasmolytics and NSAIDs are a therapy of choice in colic pain. However, the tolerability and effectiveness of this combination remains unexplored. The aim of this prospective, single-arm, open label, multicenter study was to evaluate the safety and effectiveness of Anafortan-N^® (fixed-dose combination of camylofin dihydrochloride 50 mg + nimesulide 100 mg) in patients with acute colicky abdominal pain.

Methods: In all, 295 patients with acute colicky abdominal pain and at least one episode of colicky pain in the last 24 hours were enrolled in this study. None of the patients were hospitalized. All patients were advised Anafortan-N^®tablets twice daily orally for 5 days. The safety of Anafortan-N^® was assessed by number and percentage of patients with adverse events (AEs) and change in the severity and frequency of AEs by the end of treatment. The tolerability was determined by number and percentage of patients who had to discontinue the treatment due to AEs. The effectiveness was evaluated as percentage change in the mean intensity of pain score (based on a 100-mm visual analog scale) from baseline to end of treatment.

Results: Overall, 14 (4.7%) patients reported 14 AEs, all of which were treatment-emergent and non-serious. Of the 14 AEs, 7 AEs were mild, 6 AEs were moderate, and 1 AE was severe. No serious adverse events (SAEs) were reported. No adjustment of the study medication was required in response to any of the AEs, and none of the AEs led to discontinuation of the study treatment. At end of treatment (EOT), the pain intensity significantly (p<0.0001) reduced to 1.7±5.49 with a mean change of -69.9±17.42 from baseline, and the daily pain intensity significantly (p<0.0001) reduced to 0.1±0.38 with a mean change of -3.5±1.77 from baseline.

Conclusions: Among Indian patients presenting with acute abdominal colicky pain, twice daily treatment with a FDC of camylofin dihydrochloride 50 mg and nimesulide 100 mg (Anafortan-N^®) showed significant reduction in pain intensity with very few side effects, thereby confirming its safety, tolerability, and effectiveness in acute colicky abdominal pain.

Metrics

Metrics Loading ...

References

Bates CM, Plevris JN. Clinical evaluation of abdominal pain in adults. Medicine. 2013;41:81-6.

Mayadeo N. Camylofin dihydrochloride injection: a drug monograph review. Int J Reprod Contracept Obstet Gynecol. 2019;8:359-67.

Tolba R, Shroll J, Kanu A, Rizk MK. The epidemiology of chronic abdominal pain, In: L. Kapural (ed.). Chronic Abdominal Pain: An evidence-based, comprehensive guide to clinical management. 2015.

Sandler RS, Stewart WF, Liberman JN, Ricci JA, Zorich NL. Abdominal pain, bloating, and diarrhea in the United States: prevalence and impact. Digest Dis Sci. 2000;45:1166-71.

Long T. Excessive infantile crying: a review of the literature. J Child Health Care. 2001;5:111-6.

Roberts DM, Ostapchuk M, O'Brien JG. Infantile colic. Am Fam Physician. 2004;70:735-40.

Porwal A, Mahajan AD, Oswal DS, Erram SS, Sheth DN, Balamurugan S et al. Efficacy and tolerability of fixed-dose combination of dexketoprofen and dicyclomine injection in acute renal colic. Pain Res Treat. 2012;2012:295926.

Goodman, Gillman AG. The Pharmacological Basis of Therapeutics (11th ed.). Mc Grew-Hill Publication. 2006;1009-19.

De los Santos AR, Zmijanovich R, Pérez Macri S, Martí ML, Di Girolamo G. Antispasmodic/analgesic associations in primary dysmenorrhea double-blind crossover placebo-controlled clinical trial. Int J Clin Pharmacol Res. 2001;21:21-9.

Mueller-Lissner S, Tytgat GN, Paulo LG, Quigley EMM, Bubeck J, Peil H et al. Placebo- and paracetamol-controlled study on the efficacy and tolerability of hyoscine butylbromide in the treatment of patients with recurrent crampy abdominal pain. Aliment Pharmacol Ther. 2006;23:1741-8.

Brock N. Pharmacology of Avacan. Dtsch Med Wochenschr. 1951;76:474-7.

Kruger HH, Krentz C. Clinical results with a new spasmolytic (Avacan).Arztl Wochensch. 1951;6:232-6.

Penzold FA. Contribution to spasmolysis (Clinical experiences with the new antispasmodic Avacan). Dtsch Med Wochenschr. 1951;76:479-81.

Pilz A. Clinical experience with a new spasmolytic (Avacan). Wien Med Wochenschr. 1955;105:438-9.

Gupta C. Use of anafortan intravenous injection for treatment of colicky pain. J Indian Med Assoc. 2000;98:479-82.

Clarke PM, Avery AB. Evaluating the costs and benefits of using combination therapies. Med J Aust. 2014;200:1-3.

Singla AK, Chawla M, Singh A. Nimesulide: Some pharmaceutical and pharmacological aspects-an update. J Pharm Pharmacol. 2000;52:467-86.

Dayama SS, Patil SS, Sambarey PW. A randomised controlled study of intramuscular camylofin dihydrochloride vs intravenous hyoscine butylbromide in augmentation of labour. Global J Med Res Gynecol Obstet. 2016;16:1-6.

Kaur S, Bajwa SK, Kaur P, Bhupal S. To compare the effect of camylofin dihydrochloride (anafortin) with combination of valethamate bromide (epidosin) and hyoscine butyl-n-bormide (buscopan) on cervical dilation. J Clin Diagn Res. 2013;7:1897-9.

Rajani U, Binu P. A randomized comparative study of intramuscular camylofin dihydrochloride and intravenous drotaverine hydrochloride on cervical dilatation in labor. Indian J Clinical Practice. 2015;26:558-563.

Sielaff HJ. Comparative experimental studies on the effect of spasmolytics and ganglion-blocking substances (atropin, avacan, pendiomid, buscopan, banthine) on motility of the human small intestine. Z Gesamte Exp Med. 1953;120:599-612.