Evid Based Med: first published as 10.1136/ebm.1996.1.150 on 1 August 1996. Downloaded from Pyronaridine was effective and well tolerated in African patients with acute, uncomplicated falcipamm malaria

RingwaldP, BickiiJ, Basco L. Random- symptoms of severe and complicated chloroquine) to have 1 additional treat- ised trial of pyronaridine versus malaria, recent self-medication, preg- ment success, 95% CI2 to 4; the rela- chloroquine for acute uncomplicated nancy, or mixed malaria infections. 81 tive risk improvement (RBI) was 71%, fakiparum malaria in Africa. Lancet. patients (84%) were included in the CI 36% to 128%.}* Pyronaridine led 1996 Jan 6;341:24~8. on-active-treatment analysis. to 100% parasite clearance by day 14 compared with 44% clearance in the intervention chloroquine group (? < 0.001) {ARI Objective 41 patients were allocated to 25 rag/kg 56%; NNT 2, CI 1 to 2; RRI128%, To compare the effectiveness of oral of chloroquine, and 40 patients were CI 69% to 231%}*. No significant dif- pyronaridine with chloroquine for allocated to 32 mg/kg of pyronari- ferences occurred in the fever- or para- acute, uncomplicated falciparum ma- dine; both treatments were given site-clearance times between patients laria in African adults. orally in divided doses for 3 days. Pa- with favourable responses in the pyro- Design tients were followed for 14 days on an naridine group and diose with favour- Randomised controlled trial with outpatient basis. able responses in the chloroquine 14-day follow-up. group. Mild gastrointestinal symptoms Main outcome measures were common with pyronaridine, but Treatment success at day 14 (defined Setting no serious adverse effects were noted. Urban outpatient clinic in Yaounde, as absence of clinical relapse), para- Cameroon, an area with a high rate site response (3 grades), fever clear- Conclusion of resistant malaria and of hypo- ance time, parasite clearance time, Pyronaridine was effective and well- endemic chloroquine-resistant fal- and adverse effects. tolerated in African patients with acute, ciparum malaria. uncomplicated falciparum malaria. Main results Source of funding: French Ministere de la Patients 40 patients (100%) in the pyronaridine Cooperation. 96 adult African patients (age range 15 group were considered a treatment to 64 y, 56% women) who had acute success at day 14 compared with 24 For article reprint: Dr. L. Basco, Centre de Ge'netique Mole'culaire, Centre National de falciparum malaria, defined as > 5000 patients (59%) in the chloroquine la Recherche Scientifique, 91198 Gif-sur- asexual parasites per jxL, and fever group (P < 0.001). {This absolute risk Yvette, France. FAX 33-1-69-82-43-86.http://ebm.bmj.com/ within the past 24 hours or a tempera- improvement (ART) of 41% means that ture > 37.5 °C at the time of consulta- 2 patients would need to be treated *Numbers calculated from data in article. tion. Exclusion criteria were signs and (NNT) with pyronaridine (rather than Commentary Pyronaridine was synthesized at the Chi- References

Malarial illness is common in areas where on September 29, 2021 by guest. Protected copyright. infection with Pksmodiumfalciparum malaria nese Academy of Preventive Medicine in 1. Winstanley P. Pyronaridine: a promising is widespread. Symptoms range from mild 1971, tested in China between 1971 and drug for Africa? (Editorial]. Lancet. 1996; and non-specific to acute life-threatening 1974, and has been widely available there 347:2-3. 2. Shao B. A review of antimalarial drug since 1980 (2,3). Elsewhere it is only used in episodes. Health care workers in endemic pyronaridine. Chinese Med j. I990;103: malarious areas often give antimalarial drugs experimental studies (4). More data on the 428-34. for any fever-related symptoms. This policy comparative effectiveness of pyronaridine in 3. Chen C, Tang LH, Jantanavivar. C. Stud- appeared effective when the parasite re- areas with a different pattern of antimalarial ies on a new antimalariiil compound: sponded to chloroquine, a cheap and safe drug resistance are required, and toxicity will pyronaridine. Trans R Soc Trop Med Hyg- antimakriai agent. However, with the spread need to be carefully researched and moni- 1992;8pyrimethamine, but parasite resistance to this (5), but a lot more work is required if 1995;73:S65-71. combination already exists. Alternative treat- pyronaridine is to be considered for interna- 5. Looareesuwan S, Olliaro P, Kyle D, ments have limitations (1). This study by tional registration. At U.S. $3 per dose, the Wernsdorfer W. Pyronaridine [Letter). Ringwald and coieagues shows the effective- cost of manufacturing pyronaridine will have Lancet. 1996;347:1 S89-9G. ness of pyronaridine compared with to be reduced for it ever to be an option in chloroquine in an African country. This study many African countries (1). is important for those concerned with evalu- ating new antimalarial drugs for the treat- Paul Garner, MD ment of disease in the face of existing and Liverpool School of Tropical Medicine potential resistance to current drugs. Liverpool, United Kingdom

150 Therapeutics Evidence-Based Medicine July/August 1996