Malarone (Atovaquone / Proguanil Hydrochloride) - Summary

MALARONE SUMMARY

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 [Completed]
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 the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria [Active, not recruiting]
Riamet® or Malarone® are both recommended as the first line treatment for uncomplicated malaria in France, according to the French consensus Conference revised in 2007 on the treatment of imported malaria. The aim of the study is to compare both tolerance and efficacy of Malarone® and Riamet® in the treatment of uncomplicated imported malaria and to determine clinical and parasitological predictive factors associated with a less effectiveness. It's a multicentric, randomised study in adults with uncomplicated malaria. Treatment will be administered for 3 days, and patients will be followed for 28 days, to evaluate the therapeutic evolution. 640 patients will be included among 15 centres.

The ASAP Study - Therapeutic Efficacy of Atovaquone-proguanil vs. Artesunate-atovaquone-proguanil in Cambodia [Recruiting]
This is a two-arm, randomized, open label Treatment Study evaluating the therapeutic efficacy, safety, tolerability and pharmacokinetics of a three-day course of Atovaquone-Proguanil (AP) or a three-day course of Atovaquone-Proguanil combined with 3 days of Artesunate (ASAP) in patients with uncomplicated Plasmodium falciparum malaria at selected sites in Cambodia. Atovaquone-proguanil, soon to adopted as a first line antimalarial agent by the National Malaria Control Program (CNM) in Cambodia in provinces with confirmed multidrug resistance, will be given with or without artesunate (AS) as a directly observed, standard three-day fixed dose combination treatment to all volunteers enrolled. The efficacy and safety of both drug combination as well as evidence for in vivo and in vitro resistance to their components will be monitored during the treatment period. All volunteers will receive a single dose of 15mg of primaquine as recommended by WHO with the first dose of AP or ASAP to block the transmission of malaria to mosquitoes. Resistance to AP and ASAP will be assessed by a combination of clinical, pharmacologic, and parasitological parameters including genomic signatures of selection during careful weekly follow-up visits for 6 weeks. Investigators will also be able to evaluate the effects of primaquine on the sexual stages of malaria (gametocytes).

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

Chloroquine Alone or in Combination for Malaria in Children in Malawi [Completed]
Malaria is a sickness caused by a germ that can get into a person's body when a mosquito bites them. It can cause fever, headache, body aches and weakness. It can even cause death, especially in children. When malaria is treated with the appropriate medicine(s), it can be cured completely. 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.

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Reports of Suspected Malarone (Atovaquone / Proguanil) Side Effects

Drug Interaction (12),  Hallucination (12),  Nausea (10),  Anxiety (10),  Dermatitis Acneiform (9),  Vomiting (9),  Dizziness (8),  Thrombocytopenia (8),  Diarrhoea (8),  Headache (7), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Malarone review by 27 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		malaria prevention
Dosage & duration:		1 pill per day taken once a day for the period of ten days
Other conditions:		none
Other drugs taken:		no
		Reported Results
Benefits:		Malaria prevention. Also patient did not intcounter any mosquito bites.
Side effects:		The patient felt mild headeaches, in addition there were mild symptoms of nausea
Comments:		The pills were taken three days before the flight to South Africa, specifically one pill a day for ten days or duration of trip. Upon arrival home to the United States the pills were taken for a few more days.

Malarone review by 64 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		preventing malaria
Dosage & duration:		100 mg. taken 1 a day for the period of 9 days
Other conditions:		not applicable
Other drugs taken:		Aenonol, thryozine
		Reported Results
Benefits:		None
Side effects:		First few days (i.e. 2 days before leaving for South Africa) and 7 days whilst on a 18 days holiday. Severe vomiting and diarrohea. Bad nightmares. Decided this was going to spoil my holiday, as I could not eat having extreme nausea.
Comments:		Stopped taking Malarone whilst still on holiday.

Malarone review by 64 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		preventing malaria
Dosage & duration:		100 mg. taken 1 a day for the period of 9 days
Other conditions:		not applicable
Other drugs taken:		Aenonol, thryozine
		Reported Results
Benefits:		None
Side effects:		First few days (i.e. 2 days before leaving for South Africa) and 7 days whilst on a 18 days holiday. Severe vomiting and diarrohea. Bad nightmares. Decided this was going to spoil my holiday, as I could not eat having extreme nausea.
Comments:		Stopped taking Malarone whilst still on holiday.