The Indian Practitioner

V. Parvatkar ¹, S. Tadvi ¹, T. Rizvi ², S. Das ³, J. Karankumar ⁴, N. Phadke ⁴, M. Fegade ⁴

Affiliations
1 Consultant Physician, Mumbai, IN
2 Consultant Physician, Ranchi, IN
3 Consultant Physician, Bhubaneshwar, IN
4 Medical Services, Ranbaxy Laboratories Limited., IN

Abstract

Background and Objective: Arterolane maleate (150 mg) and Piperaquine phosphate (750 mg) as a fixed dose combination was approved for the eTreatment of acute uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in adultsf. Arterolane is a synthetic trioxolane, which rapidly kills malarial parasites in blood and provides fast relief from symptoms of malaria like fever, chills and associated symptoms. Piperaquine has a long lasting effect than Arterolane and kills the residual malarial parasites. There was a need of a post marketing surveillance study to ascertain efficacy and to identify any safety concerns with the use of Arterolane- Piperaquine (AP) therapy in adult patients with uncomplicated P. falciparum malaria in India. Methods: This was a prospective, open-label, single arm, multi-center, post-marketing study. Patients with acute symptomatic uncomplicated malaria confirmed positive for P.falciparum malaria by Rapid Diagnostic Test (RDT) and presence of fever (. 99 ‹F) were included. Enrolled patients were on the study drug, Arterolane-Piperaquine therapy, one tablet once daily for 3 consecutive days. Patients with severe malaria, mixed infection, age 65 years, known allergy, significant renal or hepatic impairment; and pregnant and lactating women were excluded from the study. Efficacy was assessed in terms of percentage of patients being eafebrilef and blood smear negative for P. falciparum at end of 3 days of treatment and at the end of day 28 of the Observation period. Safety and tolerability was evaluated by the incidence and severity of adverse events (AEs), and abnormal laboratory values through the 3 days of treatment with AP therapy and day 28 of Observation period. Results: A total of 1681 patients were screened of which 336 patients were found to be febrile with RDT positive for P. falciparum and were enrolled in the study. Of the enrolled patients, 67.9% of patients were males and 32.1% were females, with the mean age of 33.0 years. In this study, the Primary Endpoint for the percentage of patients being eafebrilef at end of 3 days of treatment was almost 100%, confirming the efficacy of AP therapy. This was further confirmed by the absence of P. falciparum in thick blood smear examination at the end of 3 days of treatment. Regarding the Secondary Endpoint, 100% of patients were eaparasitemiaf on Day 28 of the observation period on thick blood smear examination; and there was no reported case of efeverf during 28 Days of the observation period. Arterolane-Piperaquine therapy was well tolerated and there was no new adverse event that was reported in this study compared to the earlier studies done with AP therapy. Conclusion: Arterolane-Piperaquine therapy provides rapid clearance of P. falciparum parasite, relief from most theramalaria related symptoms with good tolerability and patient compliance in acute uncomplicated falciparum malaria.

Keywords

Act: Artemisinin-based Combination Therapies; Ap Therapy / Arterolane-piperaquine: Fixed Dose Combination of Arterolane Maleate (150 Mg) And Piperaquine Phosphate (750 Mg); Al Therapy: Artemether- Lumefantrine; Sp Therapy: Artesunate – Sulfadoxine And Pyrimethamine; P. Falciparum: Plasmodium Falciparum Malaria; Rdt: Rapid Diagnostic Test For Malaria

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S. Dhandapani ¹, A. Gangadhar ², S. Das ²

Affiliations
1 Sakthi Hospital and Research Centre, IN
2 Abbott Healthcare Pvt Ltd, IN

Abstract

Primary dysmenorrhea (PD) is a common gynaecological disorder affecting nearly 50% of menstruating women. Camylofin combination with paracetamol has demonstrated superior efficacy than dicyclomine- paracetamol combination, in the treatment of colicky abdominal pain. However, comparative data on these two antispasmodics in combination with Mefenamic acid in PD is not available.

Aim: To compare the efficacy and tolerability of fixed dose combinations of Camylofin + Mefenamic acid and Dicyclomine + Mefenamic acid in patients with Primary Dysmenorrhea.

Methods: A randomised, open-label, comparative study, to evaluate the efficacy and tolerability of a fixed-dose combination of Camylofin 50 mg + Mefenamic acid 250 mg (Study Group) and Dicyclomine 10 mg + Mefenamic acid 250 mg (Control Group) in 50 PD patients.

Results: In the study group (Camylofin + Mefenamic Acid) the VAS scores reduced by 86% and 100% on day 3 and day 5 respectively as compared to a marginally less decrease in VAS scores by 82% and 95% on day 3 and day 5 respectively in the control group(P>0.05). Patients with complete pain relief (study end) were almost 96% and 88% patients in the study and control groups respectively (P>0.05). Global assessment of efficacy by the investigator showed that 73% of the patients in the study group were rated as 'Very Good' to 'Excellent' as compared to 54% of the patients in the control group (P>0.05).

Conclusion: These findings suggest that Camylofin + Mefenamic acid may be a better alternative to Dicyclomine + Mefenamic acid. However, the results did not attain statistical significance.

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