|
Incidence in Study 119 Ð Add-On TherapyÐ Adults with Partial Onset Seizures Study 119 was a randomized, double-blind, placebo-controlled, parallel group study with 3 treatment arms: 1) placebo; 2) topiramate 200 mg/ day with a 25 mg/ day starting dose, increased by 25 mg/ day each week for 8 weeks until the 200 mg/ day maintenance dose was reached; and 3) topiramate 200 mg/ day with a 50 mg/ day starting dose, increased by 50 mg/ day each week for 4 weeks until the 200 mg/ day maintenance dose was reached. All patients were maintained on concomitant carbamazepine with or without another concomitant antiepileptic drug. The incidence of adverse events did not differ significantly between the 2 topiramate regimens. The cited frequencies of adverse events cannot be directly compared with data obtained in other studies using different patients with different titration rates and taking different com-binations of concomitant medications. Text Continues Below
Other Adverse Events Observed Other events that occurred in more than 1% of adults treated with 200 to 400 mg of topiramate in placebo-controlled trials but with equal or greater frequency in the placebo group were: headache, injury, anxiety, rash, pain, convulsions aggravated, coughing, fever, diarrhea, vomit-ing, muscle weakness, insomnia, personality disorder, dysmenorrhea, upper respiratory tract infection, and eye pain. Other Adverse Events Observed During All Clinical Trials Topiramate, initiated as adjunctive therapy, has been administered to 1,927 adults and 313 pediatric patients with epilepsy during all clinical studies. During these studies, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To pro-vide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using modified WHOART dictionary terminology. The frequencies presented represent the proportion of patients who experienced an event of the type cited on at least one occasion while receiving topiramate. Reported events are included except those already listed in the previous table or text, those too general to be informative, and those not reasonably associated with the use of the drug. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
