ENTERIC COATING REDUCES UPPER GASTROINTESTINAL ADVERSE REACTIONS TO DOXYCYCLINE

A new doxycycline formulation consisting of enteric-coated doxycycline hyclate pellets in capsules is aimed at reducing gastrointestinal adv erse reactions related to doxycycline therapy. In this randomised, dou ble-blind, 3-way crossover study, adverse reactions caused by short te rm treatment with enteric-coated doxycycline hyclate pellets in capsul es were compared with placebo and doxycycline monohydrate tablets. The latter are generally considered to be better tolerated than older for mulations of doxycycline hyclate. 111 healthy volunteers completed the study, They were given 150 mg of doxycycline once daily over 3 consec utive days with a washout of 4 to 10 days between the study periods. T he medication was administered after an overnight fast (10 hours) with 200 ml of tap water. An upright position was maintained for 1 hour an d no food was allowed for 2 hours after drug administration. Participa nts recorded adverse reactions daily. Adverse reactions were reported by 66% of the subjects during treatment with doxycycline monohydrate, while 43% reported adverse reactions during treatment with enteric-coa ted doxycycline hyclate and 30% during placebo. Compared with the 2 ot her groups, doxycycline monohydrate caused significantly more adverse reactions in general, and abdominal pain, nausea and vomiting in parti cular. It is concluded that enteric-coated doxycycline hyclate pellets in capsules have significantly better gastrointestinal tolerability c ompared with doxycycline monohydrate.