Clinical therapeutics
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Clinical therapeutics · May 1997
Review Case ReportsNonsteroidal anti-inflammatory drugs, traditional opioids, and tramadol: contrasting therapies for the treatment of chronic pain.
The treatment of chronic pain is an important function of physicians. In the United States, available drug treatments for chronic pain currently include simple analgesics such as acetaminophen, salicylates and other nonsteroidal anti-inflammatory drugs, traditional opioid drugs, and adjuvant agents (eg, antidepressants, anticonvulsants). ⋯ Tramadol is an effective analgesic that works through a combined mechanism of weak mu receptor binding and the inhibition of serotonin and norepinephrine reuptake. Tramadol has a favorable adverse-effect profile and therefore is likely to have an important role in the management of chronic pain syndromes.
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Clinical therapeutics · Mar 1997
ReviewThe use of claims databases for outcomes research: rationale, challenges, and strategies.
Health care payers and policy makers need information about the cost and effectiveness of medical treatments. While randomized controlled trials historically are the primary source of medical information, they are expensive and labor-intensive, and often have limited utility for answering questions about "real-world" patient populations. These problems have led to an increasing reliance on claims database research in making policy decisions about treatment options. ⋯ Recommendations for avoiding or minimizing threats to internal validity, construct validity, and external validity are: (1) use of a study design that includes comparisons; (2) ensuring that the study design and conclusions are consistent with the database; (3) a priori conceptual modeling of the research question; (4) use of appropriate constructs; (5) explicit examination of alternative explanations for study findings; (6) sensitivity analyses of key assumptions; (7) awareness of the distinction between statistical and practical significance of findings; (8) generalization only when appropriate; and (9) reporting of relevant information. Given that any study design or data source has limitations, we hope that this paper will encourage a philosophy of methodological pluralism in outcomes research. Awareness and accurate reporting of validity issues will strengthen and extend the information resources currently available to decision makers.
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Clinical therapeutics · Jan 1997
A pharmacoeconomic evaluation of the use of dexrazoxane in preventing anthracycline-induced cardiotoxicity in patients with stage IIIB or IV metastatic breast cancer.
A Markov model was developed to determine the cost of treating patients with stage IIIB or IV metastatic breast cancer with 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) and dexrazoxane (administered after six courses of FAC) versus FAC alone. The primary end point in our economic study was cost per cardiac event avoided. Cost per life-year saved was also calculated, even though the survival advantage needs to be confirmed in follow-up studies. ⋯ Analyses showed that therapy with dexrazoxane costs $5661.77 per cardiac event prevented. Sensitivity analyses on model variables were performed and showed that the basic results of the model did not change when parameters were varied. The clinical efficacy and cost-effectiveness of dexrazoxane as shown by the results of the current study encourage further investigation of the uses of dexrazoxane in other populations and against other comparators.
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Clinical therapeutics · Jan 1997
Cost-effectiveness of long-term intrathecal morphine therapy for pain associated with failed back surgery syndrome.
A decision analytic study was conducted using computer simulation to project the outcomes in a simulated cohort of patients whose treatment for back surgery had failed. The objective of this study was to estimate the direct cost of intrathecal morphine therapy (IMT) delivered via an implantable pump relative to alternative therapy (medical management) over a 60-month course of treatment. IMT administered by way of an implantable pump can provide effective pain relief for selected patients whose less invasive treatment modalities have failed. ⋯ In a sensitivity analysis, the best case (low adverse event rate, low cost) estimate was $53,468 ($891/mo), whereas the worst case (high adverse event rate, high cost) estimate was $125,102 ($2085/mo). Cost-effectiveness estimates ranged from $7212 (best case) to $12,276 (worst case) per year of pain relief. Results from a computer simulation designed to collect the costs not included in previous empiric research indicate that IMT appears to be cost-effective when compared with alternative (medical) management for selected patients when the duration of therapy exceeds 12 to 22 months.
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Clinical therapeutics · Jul 1996
Randomized Controlled Trial Comparative Study Clinical TrialEfficacy and tolerability of oral ondansetron versus prochlorperazine in the prevention of emesis associated with cyclophosphamide-based chemotherapy and maintenance of health-related quality of life.
This study compared the efficacy and tolerability of oral ondansetron (8 mg twice daily [BID] for up to 3 days) with those of phenothiazine prochlorperazine (10 mg BID for up to 3 days) in 133 cancer patients receiving cyclophosphamide-based chemotherapy. In addition, the study evaluated the impact of these treatments on patients' health-related quality of life, measured with both the Functional Living Index-Cancer and the Functional Living Index-Emesis questionnaires. The first dose of study drug was administered 30 minutes before initiation of chemotherapy. ⋯ Both treatments were well tolerated. The most common potentially drug-related adverse event was headache, which occurred in significantly more (16%) ondansetron-treated patients compared with prochlorperazine-treated patients (3%). The results of this study demonstrate that oral ondansetron 8 mg BID for up to 3 days is more effective than prochlorperazine 10 mg BID for up to 3 days in the prevention of emesis associated with moderately emetogenic chemotherapy.