A double-blind trial of gabapentin monotherapy for newly diagnosed partial seizures. International Gabapentin Monotherapy Study Group 945-77.

BACKGROUND: Gabapentin is widely approved as add-on therapy for epilepsy treatment for partial seizures with and without secondary generalization. To investigate the efficacy of gabapentin administered as monotherapy in patients with newly diagnosed partial epilepsy, a randomized double-blind trial was performed. METHODS: Eligible patients were randomized to receive one of three masked doses of gabapentin (300, 900, or 1,800 mg/day) or open-label carbamazepine (600 mg/day) and kept daily seizure diaries throughout the study. After titration, patients entered a 24-week evaluation phase. Patients were required to exit the study if they experienced an exit event, defined as a total of three simple or complex partial seizures, one generalized tonic-clonic (GTC) seizure, or status epilepticus. Patients could be withdrawn for lack of efficacy, adverse events, or noncompliance. Kaplan-Meier statistics were used to estimate the probability that patients would continue in the study without having an exit event. RESULTS: Time to exit event was longer for patients on 900 mg/day (n = 72) or 1,800 mg/day (n = 74) of gabapentin than for patients receiving 300 mg/day (n = 72; p = 0.0395 and 0.0175, respectively). The most clinically relevant measure of retention on treatment (exit event plus adverse event withdrawal rate) was similar for carbamazepine (n = 74) and 1,800 mg/day gabapentin (54% versus 57%) but was lower (better) for 900 mg/day gabapentin (44%). No unexpected new adverse events emerged with gabapentin monotherapy. CONCLUSIONS: Gabapentin at 900 or 1,800 mg/day is effective and safe as monotherapy for patients with newly diagnosed partial epilepsy.

A study to assess the anticholinergic activity of rolipram in healthy elderly volunteers.

Rolipram is an antidepressant with a novel mechanism of action: enhanced noradrenaline (first messenger) synthesis and release, and inhibition of cAMP (second messenger) breakdown. This study was aimed at objectively assessing potential anticholinergic effects of rolipram in healthy elderly volunteers by measurement of saliva production and pupil size. Eight male volunteers between 67 and 77 years of age first received in a randomized manner either a single dose of 50 mg amitriptyline or a placebo control. After a minimum washout period of seven days, they then received a multiple dosing regimen of a) 0.75 mg and b) 1.5 mg rolipram given every eight hours over a 5-day period with a two day washout between a) and b). Whereas no changes at all in pupil size could be observed, amitripyline significantly reduced salivary flow. Rolipram however had no effect on saliva production after either single or repeated administration of 0.75 or 1.5 mg. The results are discussed in connection with pharmacokinetic parameters obtained in the study.

The effects of two sharpening methods on the strength of a periodontal scaling instrument.

Several different techniques exist for sharpening periodontal scalers each of which will yield a relatively sharp instrument; however, some techniques may decrease the strength of the instrument more rapidly than others. The purpose of this study was to evaluate the effect of two different sharpening techniques on the strength of a periodontal scaler. Sixty McCall No. 13-14 scalers (SCI-DENT) were divided into groups of ten. Each group was reduced in size from 0 to 50% of a standard original size in increments of 10% by reducing the face of the instrument using an RX Honing Machine. A second set of 60 scalers was treated in a similar fashion by reducing the lateral surfaces of the instrument. Original angles and blade clearances were maintained on all instruments. Strength was measured by applying a force at a positive rake angle of 15 degrees in an Instron Testing Machine with a head speed of 50 cm/min. There were no significant differences in strength from grinding on the face vs. the lateral surfaces of the scaler in contrast to the observations of other investigators. Moreover, a 10 to 20% reduction can be accomplished before a significant drop in strength is observed by sharpening either the side or face of the instrument.