Malarone (Atovaquone / Proguanil Hydrochloride) - Summary

MALARONE SUMMARY

MALARONE^®

MALARONE (atovaquone and proguanil hydrochloride) is a fixed-dose combination of the antimalarial agents atovaquone and proguanil hydrochloride.

Prevention of Malaria: MALARONE is indicated for the prophylaxis of P. falciparum malaria, including in areas where chloroquine resistance has been reported (see CLINICAL STUDIES).

Treatment of Malaria: MALARONE is indicated for the treatment of acute, uncomplicated P. falciparum malaria. MALARONE has been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.

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NEWS HIGHLIGHTS

Published Studies Related to Malarone (Atovaquone / Proguanil)

Randomized, double-blind, placebo-controlled study of Malarone for malaria prophylaxis in non-immune Colombian soldiers. [2006.09]
Malarone was compared with placebo in a double-blind, randomized, placebo-controlled trial of prophylaxis of malaria in predominately Plasmodium vivax areas of Colombia. The study population consisted of 180 completely non-immune Colombian soldiers, male, average age 19 years, and average weight 63 kg.

Atovaquone-proguanil for treating uncomplicated malaria. [2005.10.19]
CONCLUSIONS: Data are limited but appear to suggest that atovaquone-proguanil is more effective than chloroquine, amodiaquine, and mefloquine. There are insufficient data for comparisons against sulfadoxine-pyrimethamine, halofantrine, artesunate plus mefloquine, quinine plus tetracycline, and dihydroartemisinin-piperaquine-trimethoprim-primaquine in treating malaria. There are not enough data to assess safety, but a number of adverse events were identified with all drugs. Large trials comparing atovaquone-proguanil with other new combination therapies are needed.

A randomized comparison of artesunate-atovaquone-proguanil versus quinine in treatment for uncomplicated falciparum malaria during pregnancy. [2005.09.01]
BACKGROUND: There is no safe, practical, and effective treatment for pregnant women infected with multidrug-resistant Plasmodium falciparum... CONCLUSION: AAP is a well-tolerated, effective, practical, but expensive treatment for multidrug-resistant falciparum malaria during the second or third trimesters of pregnancy. Despite the small number of subjects, our results add to the growing body of evidence that AAP is safe for the mother and the fetus.

Short report: no evidence of cardiotoxicity of atovaquone-proguanil alone or in combination with artesunate. [2005.08]
Combinations are set to become the mainstay in treatment and prophylaxis of malaria due to Plasmodium falciparum.We conclude that atovaquone-proguanil shows no evidence of cardiotoxicity either alone or when combined with artesunate.

Malaria prophylaxis for aircrew: safety of atovaquone/proguanil in healthy volunteers under aircraft cabin pressure conditions. [2005.07]
BACKGROUND: Because malaria in endemic areas presents a serious threat to the health of aircrew, optimal prevention is important. An effective and safe prophylactic antimalarial drug is needed. The combination of 250 mg atovaquone with 100 mg proguanil HCl (atovaquone/proguanil, or A/P) has shown good prophylactic efficacy and tolerance for prevention of falciparum malaria. However, medication for use by aircrew on duty is subject to approval by national and international aviation authorities, who require convincing evidence that the treatment has no negative effects on the flight performance of crews. The purpose of the present study was to evaluate the risk of detrimental effects of atovaquone/proguanil on flight-related performance and alertness in healthy subjects under conditions of aircraft cabin pressure... CONCLUSIONS: In-flight performance and alertness of aircrew will not be affected by the prophylactic use of A/P during a period of 14 days.

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Clinical Trials Related to Malarone (Atovaquone / Proguanil)

Weekly Dosing of Malarone ® for Prevention of Malaria [Recruiting]
The purpose of this study is to determine whether Malarone ®, which is a drug approved to prevent malaria when taken daily, will still effectively prevent malaria if taken weekly.

Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function [Recruiting]

Chloroquine Alone or in Combination for Malaria in Children in Malawi [Recruiting]
Malaria is a sickness caused by a parasite that people can get from mosquito bites. If it is not treated, malaria can make people very sick and even cause death, especially in children. The purpose of this study is to find out if it is better to use chloroquine alone or in combination with another drug to most effectively treat malaria. About 640 children with malaria, aged 6 months to 5 years of age, from the Blantyre Malaria Project Research Clinic at the Ndirande Health Center in Malawi will be in the study. They will be treated with either chloroquine alone or a combination of chloroquine plus another medication (azithromycin or artesunate or atovaquone-proguanil) every time they get malaria for a year. Blood samples will be collected and tested at least every 4 weeks Participants will be involved in the study for 1 year.

Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America [Completed]

Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients [Recruiting]
Malarone® (atovaquone/proguanil) is frequently used in malaria prophylaxis. Unfortunately, there are indications that certain anti-HIV agents may decrease atovaquone plasma levels by induction of atovaquone metabolism.

For travelling HIV patients, the clinical consequences of these possible drug drug interactions are serious, since a diminished exposure to the anti-malarial drug will result in suboptimal prophylaxis of malaria and potential development of drug resistant strains of Plasmodium falciparum.

The purpose of this study is to find out if HIV patients using HAART regimes with either lopinavir/ritonavir, atazanavir/ritonavir or efavirenz have lower atovaquone plasma levels than healthy volunteers after a single dose of atovaquone/proguanil.

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PATIENT REVIEWS / RATINGS / COMMENTS

Malarone review by 37 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Malaria prevention
Dosage & duration:		1 pill a day taken once a day for the period of 5-6 days
Other conditions:		none, preventative only
Other drugs taken:		Modicon (birth control pill)
		Reported Results
Benefits:		The benefits if I had continued to take the Malarone for the entire two weeks would have been to not contract Malaria. But the side effects were severe enough that I discontinued treatment and followed other preventative measures.
Side effects:		I had an overall sense of unwellness. Nausea was constant even when the drug was taken separate from other drugs and with food/on a full stomach etc. I felt almost flu like; ie the beginning of flu onset when you are not yet fully sick.
Comments:		When I discontinued use (while still in a Malaria risk area) I relied soley on preventative measures. I was in a night biting mosquito area (Thailand, Laos and Cambodia) so slept under a mosquito net. Used mosquito spray in the room and used a special spray for one set of clothing for higher risk environments (ie jungle). Also spoke with an Asian doctor at length about the Western philosphy vs Eastern for treatment. His take was that Eastern doctors choose to treat malaria when it is contracted but Western take higher and higher levels of drugs to prevent contraction. This may lead to drug resistant strains...