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Clinical Trials

Albenza (albendazole)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved June 1996

Specific Treatments:

parasitic infections

General Information

Albenza has been approved for the treatment of two parasitic infections caused by worms:

  • Hydatid cyst disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus
  • Neurocysticercosis caused by larval forms of the pork tapeworm, Taenia solium

For hydatid disease, the recommended dose for Albenza is 400 mg twice daily with meals for three cycles (each cycle consists of 28 days of dosing followed by a 14-day albendazole-free interval). For neurocysticercosis, the recommended dose is 400 mg twice daily for eight to 30 days.

Albendazole was first marketed outside the United States in 1982 for human use where it is currently marketed under the trade names of Zentel and Eskazole.

Clinical Results

Subjects treated with Albenza have shown improvement in more than 80% of the neurocysticercosis subjects and cure or improvement in up to 70%of the hydatid subjects.

Side Effects

Side effects were usually mild and resolved without treatment. The most frequently reported side effects by hydatid disease subjects included abnormal liver function, abdominal pain, nausea and vomiting; those reported by neurocysticercosis subjects included headache, nausea, and vomiting.

Additional Information

E. granulosus is considered endemic in the Western US sheep-raising areas of Utah, Arizona, and Nevada, but the vast majority of cases occur in new immigrants who have been exposed to the infection years previously in their countries of origin, or in travelers from the United States to endemic areas. Most cysts are found in the liver where, after remaining asymptomatic for decades, they finally produce abdominal pain or a mass. The incidence of hydatid disease in the United States is estimated to be between 100 and 200 new cases diagnosed annually.

T. solium cysticercosis is rare in the United States except in immigrants from endemic areas. It is most common in Latin America, Asia, Russia, and Eastern Europe and is caused by inadequately cooked or raw infected pork. Infection with the adult worm is usually asymptomatic. Severe larval infection, a result of ingestion of contaminated material, may cause muscle pains, weakness, or fever. It can also cause epileptic seizures. The incidence of neurocysticercosis is estimated to be less than 1,000 new cases diagnosed annually.

Worldwide, the prevalence of hydatid disease is estimated to be about one million people mostly found in herding and animal-raising countries and regions of North West China, parts of Northern and Southern Africa, East Africa, Iraq, the Mediterranean basin, Uruguay, Argentina, and Chile. It also occurs occasionally in other countries including the United States, Great Britain, South and East Europe, Australia, and New Zealand. The prevalence of neurocysticercosis is estimated to be about 1.5 million people worldwide. In both diseases, infection with the larva is accidental and transmission from human-to-human does not normally occur.

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