Acute Adrenal Insufficiency Precipitated by the Discontinuation of a Betamethasone and Dextrochlorpheniramine Combination: The Diagnostic Utility of an Echocardiographic Assessment of Systemic Vascular Resistance.

A 72-year-old woman with primary biliary cholangitis was admitted to our hospital with heart failure with a preserved ejection fraction. An accidental right ventricular perforation that occurred during an endomyocardial biopsy precipitated cardiogenic shock. Despite successful surgical treatment, she demonstrated progressive hemodynamic deterioration, which was resistant to the administration of high-dose catecholamines. She was diagnosed with acute adrenal insufficiency, which was attributed to the discontinuation of Celestamine® (betamethasone/dextrochlorpheniramine combination) just after the perforation. Prompt intravenous administration of hydrocortisone (150 mg/day) led to hemodynamic stabilization. The serial noninvasive assessment of systemic vascular resistance using transthoracic echocardiography was instrumental in detecting acute adrenal insufficiency in this case.

Quantitative benefit-risk assessment using only qualitative information on utilities.

BACKGROUND: Utilities of pertinent clinical outcomes are crucial variables for assessing the benefits and risks of drugs, but numerical data on utilities may be unreliable or altogether missing. We propose a method to incorporate qualitative information into a probabilistic decision analysis framework for quantitative benefit-risk assessment. OBJECTIVE: To investigate whether conclusive results can be obtained when the only source of discriminating information on utilities is widely agreed upon qualitative relations, for example, ''sepsis is worse than transient headache'' or ''alleviation of disease is better without than with complications.'' METHOD: We used the structure and probabilities of 3 published models that were originally evaluated based on the standard metric of quality-adjusted life years (QALYs): terfenadine versus chlorpheniramine for the treatment of allergic rhinitis, MCV4 vaccination against meningococcal disease, and alosetron for irritable bowel syndrome. For each model, we identified clinically straightforward qualitative relations among the outcomes. Using Monte Carlo simulations, the resulting utility distributions were then combined with the previously specified probabilities, and the rate of preference in terms of expected utility was determined for each alternative. RESULTS: Our approach conclusively favored MCV4 vaccination, and it was concordant with the QALY assessments for the MCV4 and terfenadine versus chlorpheniramine case studies. For alosetron, we found a possible unfavorable benefit-risk balance for highly risk-averse patients not identified in the original analysis. CONCLUSION: Incorporation of widely agreed upon qualitative information into quantitative benefit-risk assessment can provide for conclusive results. The methods presented should prove useful in both population and individual-level assessments, especially when numerical utility data are missing or unreliable, and constraints on time or money preclude its collection.

Model for outcomes assessment of antihistamine use for seasonal allergic rhinitis.

BACKGROUND: Drug selection for optimal treatment of common medical conditions may be difficult and involve many diverse factors. OBJECTIVE: The efficacy, safety, quality of life, and cost of treatment of seasonal allergic rhinitis with cetirizine, chlorpheniramine, or terfenadine were compared in a prospective, two-phase, randomized, single-blind clinical trial conducted in a managed care setting. METHODS: In phase I, which lasted 2 weeks, patients were randomized to receive one of the study drugs. In phase II, which lasted 4 weeks, the initial treatment was continued unless patients were dissatisfied, in which case they could be randomly assigned to receive another study drug. In both phases pseudoephedrine could be taken as needed. Patients kept daily diaries of symptoms and costs, and study drugs were evaluated at the end of each phase for efficacy, safety, and effect on quality of life by means of a validated questionnaire. A multiattribute outcomes assessment model for formulary decision making was used to rank the antihistamines. RESULTS: Physicians' and patients' assessments in phases I and II indicated that cetirizine and chlorpheniramine were significantly more effective than terfenadine (p < 0.05). Incidence of sedation in phase I and phase II was 40.5% and 16.7% for chlorpheniramine, 11.6% and 9.8% for cetirizine, and 6.7% and 5.1% for terfenadine, respectively. At the end of phase I, 28.9% of the patients treated with chlorpheniramine, 50% of the patients treated with terfenadine, and 69.4% of the patients treated with cetirizine were satisfied with their therapy and chose not to switch their medication. Quality of life scores improved most after treatment with cetirizine and least after treatment with terfenadine. CONCLUSION: The result of this trial indicate that antihistamine selection is best made with the use of a multiattribute evaluation that includes quality of life. In this study cetirizine was favored by patients and physicians most often, followed by chlorpheniramine and then terfenadine.