Eileen M. Grace

Evaluating Health-Related Quality of Life Outcomes in Clinical Trials of Antiepileptic Drug Therapy

Summary: Purpose: To provide an overview of condition‐specific health‐related quality of life (HRQL) assessment in clinical trials of antiepileptic drug (AED) therapy in adults. We describe the key measurement issues in HRQL evaluation, identify the instruments that have been used in this population, summarize the psychometric characteristics of these instruments, propose areas of HRQL most likely to change with treatment, and offer recommendations for further research.

Controlled, double-blind, randomized trial of amitriptyline in relieving articular pain and tenderness in patients with rheumatoid arthritis

Thirty-six patients with definite or classical rheumatoid arthritis participated in a double-blind, randomized, placebo-controlled trial to assess the effectiveness of adding amitriptyline to the treatment regimen for the relief of pain not adequately controlled by non-steroidal anti-inflammatory drugs. Dosage of amitriptyline was increased gradually up to 25 mg 3-times daily and patients were followed up for 12 weeks. Assessments were made of joint pain and tenderness every 4 weeks. The results showed no difference between the amitriptyline and placebo-treated patients for either parameter.

The pharmacokinetics of flurbiprofen in younger and elderly patients with rheumatoid arthritis.

The pharmacokinetics of flurbiprofen (Ansaid Tablets, Upjohn Company of Canada, Don Mills, Ontario) were evaluated in both younger (40 to 60 years) and elderly (65 to 83 years) rheumatoid arthritic patients after both a 100‐mg single‐dose administration and at steady state during a 100‐mg twice‐a‐day dosage regimen. Both flurbiprofen plasma concentration‐time profiles and the urinary excretion of flurbiprofen and its major metabolites were evaluated. The results indicate that the pharmacokinetics of flurbiprofen are linear in both age groups based on only minor changes between single‐dose and steady‐state parameter determinations and the agreement between calculated and predicted accumulation values in plasma concentrations. Only minor differences in the pharmacokinetic parameters were observed between the younger and elderly patients. Only free flurbiprofen clearance was found to have a significant but variable correlation to patient age. The effect of flurbiprofen on the urinary excretion of two prostaglandins were also evaluated throughout this study. In both age groups, the maximum decrease in urinary excretion was observed after the first dose, and this effect was maintained throughout the remainder of the study. Percent decreases from baseline in urinary excretion during drug administration were similar for both age groups. Similar side‐effect profiles were observed between age groups.

The pharmacokinetics of isoxicam in elderly patients with rheumatoid arthritis

Nineteen patients, aged 60 years and over, with rheumatoid arthritis participated in a clinical trial to investigate the pharmacokinetics of isoxicam (a new non-steroidal anti-inflammatory drug) in this age group. The purpose of the study was to determine if the pharmacokinetics are different compared to a younger healthy population. The half-lives were independent of dosage, indicating linearity of pharmacokinetics. Furthermore, the half-lives after repeated dosing were not different from those found after single doses of 400 mg. This shows that there is neither undue accumulation of the drug nor induction of its own metabolism. These results are similar to the results obtained in other centres when isoxicam was administered to healthy subjects between 18 and 32 years.

Computerized Cheirometer for Assessing Grip-Strength Indices and Classification of Rheumatoid Patients

A computerized Cheirometer has been developed to objectively assess grip strength indices (GSI) of normals and rheumatoid arthritis (RA) patients. The instrument consists of a hand-grip bladder, an LVDT pressure transducer (Schaevitz) interfaced through a 12 bit A/D converter to an Apple II + computer. Software has been developed for data acquisition, display and classification of measured GSI into moderately diseased and severely diseased and normal classes.During the developmental phase of the instrument, it was noted that maximum pressure (PM) and rate-of-rise (ROR) of pressure during the squeezing of the bladder were the most sensitive indices to distinguish and classify normal and patient hand-grip waveforms. The reproducibility of PM and ROR as useful GS indices was tested in 13 chronic RA patients in the morning, with two measurements per patient, within half-hour intervals. The results indicate that PM and ROR are stable indices with no significant variation between two measurements (p < 0.05). A ...