SUMMARYPurpose: To investigate the comparative effects of carbamazepine (CBZ) and lamotrigine (LTG) on electrocardiography (ECG) parameters in elderly patients with newly diagnosed epilepsy. Methods: The study was conducted in the Norwegian subcohort (n = 108) of an international randomized double-blind 40-week trial, which compared the efficacy and tolerability of LTG and sustained-release CBZ in patients aged 65 and older with newly diagnosed epilepsy. Target maintenance doses were 400 mg/day for CBZ and 100 mg/day for LTG, with adjustments based on clinical response. Patients with significant unpaced atrioventricular (AV) conduction defect were excluded. Resting 12-lead ECG recordings were made under standardized conditions at pretreatment (baseline) and at the 40-week study visit (treatment visit). Changes in QRS interval (primary endpoint), heart rate (HR), PQ, and QTc (HR-corrected QT) intervals were assessed and compared between groups. Results: Of the 108 patients randomized, 33 discontinued prematurely because of adverse events (n = 24, none of which was cardiac) or other reasons (n = 9), and 15 were nonevaluable due to incomplete ECG data. None of the assessed ECG parameters differed significantly between groups at baseline. No significant ECG changes were recorded between baseline and treatment visit for QRS duration and QTc intervals, whereas HR fell and PQ intervals increased slightly on both treatments. However, there were no differences between groups in changes from baseline to treatment visit. There were no significant relationships between individual ECG changes and serum drug concentrations, except for QTc intervals, which decreased slightly with increasing CBZ concentrations. The proportion of patients with ECG parameters outside the normal range at treatment visit was similar to that recorded at baseline. Discussion: Clinically significant ECG changes are not common during treatment with CBZ or LTG in elderly patients with no preexisting significant AV conduction defects.

Objective To compare the impact of 200 and 400 Ag oral misoprostol on pre-operative cervical priming in both primi-and multigravidae prior to first trimester termination of pregnancy. Pre-operative cervical dilatation and bleeding were assessed. Design Randomised controlled trial.Setting Norwegian university teaching hospital.Sample Five hundred and fifty-one women undergoing surgical termination of pregnancy between 7 and 12 weeks of gestation. Methods Patients were randomised to either 200 or 400 Ag of oral misoprostol 10 -16 hours before vacuum aspiration. The degree of cervical dilatation prior to abortion by vacuum aspiration was measured. Preoperative bleeding and pain were recorded and vaginal bleeding was measured. Main outcome measures Degree of pre-operative cervical dilatation and pre-operative bleeding.Results The mean cervical dilatation was 5.8 mm (SD 1.7) for the women who received 400 Ag misoprostol and 5.4 mm (SD 1.4) for those who received 200 Ag ( P ¼ 0.004). The pre-operative dilatation was larger in multigravidae than in primigravidae in both dosage groups. The odds ratio (OR) of pre-operative bleeding was 3.3 (95% confidence interval [CI] 2.1 -5.0) in the 400 Ag dosage group, as compared with the group receiving 200 Ag misoprostol. The occurrence of bleeding was dose-dependent. Frequency of bleeding was similar in multigravidae compared with primigravidae in the 400 Ag dosage group, whereas the occurrence of bleeding was less in primigravidae than multigravidae in the 200 Ag dosage group. Only 89 out of 551 patients bled one or more grams. The volumes measured were not statistically significantly different.Complications were minor, and were distributed equally between the two dosage groups. Conclusions The 200 Ag oral misoprostol compared with the 400 Ag oral misoprostol given 10-16 hours before first trimester surgical abortions results in less pre-operative vaginal bleeding and in a statistically, although not clinically significant reduction in cervical dilatation.