ABSTRACT
OBJECTIVE: Rasagiline, a monoamine oxidase type B inhibitor, is indicated for both the initial treatment of Parkinson disease (PD) and as adjunctive (add-on) treatment for patients already taking dopaminergic therapy. This open-label prospective community-based clinical trial was designed to determine the time-to-onset and the magnitude of the beneficial effects of rasagiline in PD patients. METHODS: Patients received rasagiline of 1.0 mg once daily as monotherapy or 0.5 mg once daily as adjunct therapy (adjunct therapy dose could be increased to 1 mg/d if clinically indicated) for 12 weeks. Dietary restrictions and recommendations regarding concurrent antidepressant treatment consistent with the Food and Drug Administration (FDA) regulations were in keeping with typical usage. Effectiveness was measured as change from baseline in bradykinesia scores and physicians' and patients' global impression. Patients were prospectively monitored for treatment emergent dopaminergic side effects, tyramine reactions, and possible interactions with commonly used antidepressants. RESULTS: Objective and subjective measures of symptom severity improved at 1 week in 272 PD patients treated with once-daily rasagiline (n=123 monotherapy, n=149 adjunct therapy). The magnitude of beneficial effect was similar in monotherapy and adjunct therapy patients. No significant dopaminergic side effects, tyramine reactions, or interactions with antidepressants were observed in the 12-week trial. CONCLUSIONS: Rasagiline has a measurable beneficial effect on PD symptoms within 1 week of treatment. Rasagiline has a similar magnitude of benefit in monotherapy and adjunct therapy patients. Adverse interactions between antidepressants and rasagiline were not observed in patients in this trial. The usual use of rasagiline in community neurology practice, consistent with the FDA labeling, seems safe and effective.
Subject(s)
Antiparkinson Agents/therapeutic use , Drug Therapy, Combination , Indans/therapeutic use , Monoamine Oxidase Inhibitors/therapeutic use , Parkinson Disease/drug therapy , Adult , Aged , Aged, 80 and over , Antiparkinson Agents/adverse effects , Female , Humans , Hypokinesia/chemically induced , Indans/adverse effects , Male , Middle Aged , Monoamine Oxidase Inhibitors/adverse effects , Prospective Studies , Time FactorsABSTRACT
Administering items or subscales separately from the measure for which they were designed to be a part may have unintended consequences for research and practice in Parkinson's disease (PD). The current study tested the equivalence of the bradykinesia subscale when administered alone versus as a component of the full 14-item Unified Parkinson's Disease Rating Scale (UPDRS) motor examination, as well as examined the reliability and validity of the bradykinesia subscale. The study sample consisted of 112 patients with PD. Patients were randomly assigned to either the bradykinesia subscale alone group (n = 56), who were administered the bradykinesia subscale separately from the rest of the UPDRS motor examination, or the full scale group (n = 56), who were administered the UPDRS motor examination in its standard format. The two one-sided t-test (TOST) procedure was used to test for mean equivalency between the two administration groups. Additionally, reliability and validity analyses were performed. The bradykinesia subscale mean scores from the full scale group and the subscale alone group were not statistically equivalent. However, in both groups, the bradykinesia subscale had exceptional reliability and was strongly and similarly related to age, activities of daily living, disability, and other assessments of motor symptom severity. The bradykinesia subscale is a valid and reliable assessment when administered separately from the rest of the UPDRS motor examination; however, caution should be taken when comparing mean scores across studies or occasions when different administrations are used.
Subject(s)
Hypokinesia/diagnosis , Motor Skills Disorders/diagnosis , Parkinson Disease/diagnosis , Activities of Daily Living , Adult , Aged , Aged, 80 and over , Disability Evaluation , Female , Humans , Hypokinesia/etiology , Male , Middle Aged , Motor Skills Disorders/etiology , Neurologic Examination/methods , Parkinson Disease/complications , Reproducibility of Results , Severity of Illness IndexSubject(s)
Humans , Infant , Child , Adolescent , Adult , Middle Aged , Aged , Male , Female , Abdomen, Acute/etiologySubject(s)
Humans , Infant , Child , Adolescent , Adult , Middle Aged , Male , Female , Abdomen, Acute/etiologyABSTRACT
From September 1977, 11 general practitioners took part in a survey of 12 months' duration in which they recorded morbidity at every doctor-patient encounter. 35,143 patients made 53,094 encounters and a total of 62,932 problems were identified. The most common reason for going to the doctor was for examination with no disease detected. Acute upper respiratory tract infections, hypertension and pregnancy were the 3 most common specific problems with which the doctors dealt. The results demonstrated some features of general practice such as the abundance of the common diseases, the need to be alert to the infrequent occurrence of wide range major disease, pre-symptomatic screening of the healthy "at risk" patient and the problems of the ill-defined conditions. Comparisons with other surveys show some similarities in general practice morbidity, but also important differences that can be related to prevailing local conditions (AU)
