We compared the efficacy, safety, an tolerability of pramipexole, an aminobenzathiazol-derived dopamine agonist with novel properties, with those of placebo in advanced PD patients with motor fluctuations under levodopa treatment. Pramipexole improved motor function of patients during "on" and "off" periods, decreased the time spent in "off" periods, reduced the severity of "off" periods, decreased disability and PD severity during "on" and "off" periods, as assessed by the Unified Parkinson Disease Rating Scale, and permitted a reduction in levodopa dosage. Adverse effects related to the central nervous system were similar to those reported with other dopamine agonists, and the gastrointestinal and cardiovascular tolerability of the compound was satisfactory.
Clinical data on 3,911 patients were collected from 64 individual investigators to evaluate the safety of intravenous dipyridamole-thallium imaging as an alternative to exercise thallium imaging for the evaluation of coronary artery disease. There were two deaths because of myocardial infarctions, two nonfatal myocardial infarctions, and six cases of acute bronchospasm. Chest pain occurred in 770 patients (19.7%). Headache and dizziness were reported by 476 patients (12.2%) and 460 patients (11.8%), respectively. ST-T changes on the electrocardiogram were seen in 292 patients (7.5%). Use of parenteral aminophylline to treat adverse events associated with intravenous dipyridamole brought complete relief of symptoms in 439 of 454 patients (96.7%). There Although information was collected on the diagnostic usefulness (i.e., sensitivity and specificity) of dipyridamole-thallium scintigraphy as part of this study, this information is not presented here. The interpretation of the sensitivity-specificity data is complex because the data were collected retrospectively; there was no uniform protocol, no standard test procedures or equipment, and no uniform experience in conducting the test for all investigators (e.g., some investigators provided data from only one patient, whereas others provided data from more than 100 patients).Additionally, demographic and baseline data were not collected on all patients who underwent intravenous dipyridamole-thallium imaging. Thus, estimation of mortality or morbidity rates for select subgroups of patients is not possible (e.g., the mortality rate in patients without a history of unstable angina).Despite these problems in design, however, this study presents data for the largest collection of patients, to date, who have undergone dipyridamolethallium scintigraphy, which allows evaluation of the safety of the procedure. Patient Characteristics and Intravenous Dipyridamole DosageOf the 3,911 patients in this study, 1,096 (28.0%) were patients who had intravenous dipyridamolethallium scintigraphy and coronary angiography performed within a 1-year period and whose tests were interpreted in a blinded fashion. Patient characteristics and dosage information were collected for all these 1,096 patients. Approximately two thirds of these 1,096 patients were male. The mean age of the patients was 57.7 years (SD, 10.4 years), with a range of 26-88 years. Almost 88% of the patients had a history of chest pain before undergoing thallium imaging. Nineteen patients (1.7%) had a history of nonanginal pain, 420 (38.3%) had stable angina, 505 (46.1%) had a history of unstable angina (i.e., chest pain at rest or recent acceleration of chest pain), and 16 (1.5%) had a history of nonspecific chest pain. Approximately 42% of the patients had a history of myocardial infarction, 9.0% had previous coronary artery bypass graft surgery, and 3.0% had a previous coronary angioplasty. The two most frequently reported concurrent diseases other than CAD were hypertension and cardiovascular disease, which were repo...
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