Daily tesamorelin for 26 weeks decreased visceral fat and improved lipid profiles, effects that might be useful in HIV-infected patients who have treatment-associated central fat accumulation. (ClinicalTrials.gov number, NCT00123253 [ClinicalTrials.gov] .).
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Flupirtine has been on the market for about 30 years in several European countries as an analgesic. This use has not resulted in regulatory action concerning hepatotoxicity.
WHAT THIS STUDY ADDS• When used in a novel indication, hepatotoxicity was frequent with flupirtine, questioning the general assumption that the safety profile in one indication can be extrapolated to other indications.
AIMSTo determine efficacy of the analgesic flupirtine in the treatment of overactive bladder syndrome in a proof-of-concept study.
METHODSDouble-blind, double-dummy, three-armed comparison of flupirtine extended release (400 mg/day, titrated to 600 mg/day), tolterodine extended release (4 mg/day) and placebo for 12 weeks.
RESULTSWhen major elevations of liver enzymes (more than three times the upper normal limit) were detected in several flupirtine-exposed patients, the study was prematurely discontinued. Based on study-end data, hepatotoxicity was detected in 31% of patients receiving flupirtine for Ն6 weeks.
CONCLUSIONSUnexpected frequent and relevant toxicity can occur when testing an established drug for a new indication.
Two 'imported' cases of relapsing fever after a trip through Senegal are described. Two women developed a tick-borne relapsing fever after having slept outdoors on a terrace in Zinguichor, Senegal. The first patient was rapidly cured after a course of doxycycline. The second patient initially received erythromycin, but despite this treatment she developed neurological symptoms and Borrelia persisted in the thick-smear examination. After treatment with doxycycline she developed a Jarish-Herxheimer reaction. Treatment with doxycycline was continued and finally all symptoms disappeared within 36 hours after starting this treatment. A diagnosis of relapsing fever should be considered in all patients returning from the tropics with recurrent fever, especially if no malaria parasites are found.
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