Estimating the National Population of Hospitalized Chronic Baclofen Users: A Cross-Sectional Analysis of a Commercial Claims Database.

Background: Baclofen is an effective treatment for spasticity. Abrupt cessation of intrathecal (IT) or oral baclofen risks the development of withdrawal symptoms; however, the magnitude of the problem is unknown.

Objectives: The aims for this study were as follows: (1) using an administrative claims database, estimate the number of patients in the United States on baclofen, and (2) estimate the annual percent hospitalized pediatric and adult populations consequently at risk for interruption of chronic baclofen therapy.

Characterizing Baclofen Withdrawal: A National Survey of Physician Experience.

Objective: We studied physicians' opinions and experiences concerning clinical concerns, perceived severity, occurrence, and management of baclofen withdrawal due to abrupt discontinuation.

Methods: A nationwide 26-question electronic survey was distributed via e-mail to physicians (N = 952) representing varying specialties who manage spasticity with baclofen. A total of 110 physicians provided responses to the survey (response rate = 11.

Technology assessment in healthcare: a review and description of a "best practice" technology assessment process.

Background: Technology assessment has become a rapidly growing component of the healthcare system. It has assumed a functional role in operational settings and is rapidly impacting decisions involving purchasing, coverage, and reimbursement. This review is intended to assist the healthcare decision maker in considering the application of technology assessment in healthcare, so as to maximize the efficiency of future purchasing decisions.

Relationship between practice guidelines, formulary management, and pharmacoeconomic studies.

Pharmacy and therapeutics committees can use pharmacoeconomic and outcome studies as tools to evaluate and implement clinical guidelines for patient care. Results of studies help optimize the clinical effects and control the costs of drug therapy. Such data also assist in positioning products in competitive environments.

Clinical experience with timolol maleate monotherapy of hypertension.

Beta-adrenergic blocking drugs are gaining acceptance as initial therapy for patients with mild to moderate hypertension. In a postmarketing surveillance study, 5,190 hypertensive patients received timolol maleate monotherapy and were evaluated by 1,355 physicians. A total of 1,057 patients did not complete the study: 28% of these patients experienced an adverse event.

Postmarketing study of timolol-hydrochlorothiazide antihypertensive therapy.

A postmarketing surveillance study was conducted to determine the safety and efficacy of a fixed-ratio combination containing 10 mg of timolol maleate and 25 mg of hydrochlorothiazide, administered twice daily for one month to hypertensive patients. Data on 9,037 patients were collected by 1,455 participating physicians. Mean systolic blood pressure decreased 25 mmHg and mean diastolic blood pressure declined 15 mmHg after one month of timolol-hydrochlorothiazide therapy (P less than 0.

Pharmacokinetic study of sisomicin in humans.

Detailed analyses of the pharmacokinetics of sisomicin administered at doses of 25, 50 and 100 mg intravenously and intramuscularly to healthy volunteers established that the drug is handled by a two-compartment open model system with a disposition (elimination) half-life of 2.6 hr. The kinetic estimates over this dose range are linear and independent of dose and were verified by a 60-min infusion experiment in which dose and the maximum serum concentration achieved (5 microgram/ml) were predicted correctly.

Pharmacology of enantiomers and (-) p-OH metabolite of indacrinone.

Indacrinone, a racemic mixture, is a loop-blocking diuretic with effects on uric acid elimination that differ from those of furosemide. A series of studies in healthy men was undertaken to characterize the pharmacologic activity of the positive (+) and negative (-) enantiomers (E) of indacrinone and its (-) p-OH metabolite, (-) MET. All subjects were on sodium- and potassium-controlled diet; each experiment was similar in design and included placebo and positive controls.

Comparison of oral indacrinone with furosemide.

The oral dose response and time course of action of indacrinone was compared with that of furosemide in six healthy men on a sodium and potassium-controlled diet. The single doses were 5, 10, 20, 40, and 80 mg indacrinone and 20, 40, and 80 mg furosemide. Diuretic, natriuretic, and kaliuretic effects revealed that indacrinone was more potent, had a longer duration of action, and induced a greater sodium for equivalent potassium loss during its period of peak activity than furosemide.

Effect of orally administered probenecid on the pharmacokinetics of cefoxitin.

To characterize the effect of orally administered probenecid on the pharmacokinetics of cefoxitin in healthy male volunteers, we administered to one group of six subjects 2 g of cefoxitin by intravenous (i.v.) bolus either alone, with 1 g of probenecid concomitantly, or when 1 g of probenecid was administered 1 h previously by using a crossover design.

Pharmacokinetics and comparative pharmacology of cefoxitin and cephalosporins.

Features of the distribution, metabolism, elimination, and pharmacokinetics of the cephalosporins and cefoxitin must be considered when concentrations of these drugs in biological fluids are interpreted. The extensive (approximately 86%) binding of cefazolin to plasma protein may account for the smaller volume of distribution and slower rate of renal clearance than are observed for cefoxitin, which is less extensively (73%) bound to protein. Results of microbiological assays of drug in urine may be influenced by the extent of metabolism of the drugs, which is 33% for cephalothin but less than 2% for cefoxitin.

The diuretic response in normal volunteers to a new benzylamine, 2-aminomethyl-4-(1,1-dimethylethyl)-6-iodophenol HCl.

A phase I dose-response study of 2-aminomethyl-4-(1,1-dimethylethyl)-6-iodophenol HCl (MK-447) was performed with the following oral doses: 6.25, 12.5, 25, 50, and 100 mg.

Evaluation of the prison inmate as a subject in drug assessment.

The reasons for exclusion of prisoners from research studies on drugs were based mostly on a relatively limited group of laboratory parameters which could have been detected using a simple battery of screening tests. The answers to a medical history form added little to the evaluation of either the prisoner or student groups, were probably very unreliable, and could be just as well confined to a few selected questions regarding drug history as a matter of record. Students gave appropriate responses to a mood scale measurement test while prisoners characteristically did not comply.

Effect of clonixin and aspirin on platelet aggregation in human volunteers.

The effect of clonixin and aspirin on platelet function was assessed in healthy volunteers. Both drugs inhibited secondary platelet aggregation and prolonged bleeding time, but the effect of clonixin was significantly less than that of aspirin. Hemorrhagic complications are less likely after clonixin than after aspirin.