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Biomedical subjects

Jay S Cohen

Publications and source records attributed to Jay S Cohen.

11 recordsLinked to original sources
PubMed2006

Duloxetine in the treatment of women with stress urinary incontinence: results from DESIRE (Duloxetine Efficacy and Safety for Incontinence in Racial and Ethnic populations).

OBJECTIVE: To evaluate the effectiveness and safety of duloxetine for the treatment of African-American and Hispanic women with stress urinary incontinence. RESEARCH DESIGN AND METHODS: The 10-week (a 2-week lead in period followed by 8 weeks of active treatment), open-label, multicenter study of duloxetine 40 mg twice daily included women with stress urinary incontinence or stress predominant mixed incontinence. Efficacy was measured by the median percent change from baseline to endpoint of weekly incontinence episode frequency. The primary objective assessed the treatment response in a pre-specified group of women (n = 2960; 2321 Caucasian, 271 African-American, and 368 Hispanic) with similar baseline incontinence and comorbidity characteristics as the subjects enrolled in the placebo-controlled trials of duloxetine for the treatment of stress urinary incontinence. The efficacy in African-American and Hispanic women was compared with Caucasians using a predefined non-inferiority subpopulation analysis. Safety measures included adverse events, laboratory test results, and vital signs. RESULTS: All three subgroups reported significant (all p < 0.001) median percent decreases in weekly incontinence episode frequency: -65.7% (African-American), -73.0% (Hispanic), and -75.0% (Caucasian). Non-inferior efficacy was demonstrated for African-American and Hispanic women compared to the Caucasian women. Common adverse events included nausea (21.8%, 28.0%, 25.3%), dry mouth (7.7%, 11.4%, 11.9%), and fatigue (9.2%, 5.7%, 11.6%) for the African-American, Hispanic, and Caucasian groups, respectively. CONCLUSION: Duloxetine was efficacious and well tolerated for the treatment of African-American, Hispanic, and Caucasian women with stress urinary incontinence. The trial design was successful in enrolling a diverse population of patients. The most important limitations include the lack of placebo control, the short study duration, and the exclusion of patients with less than seven incontinence episodes per week.

Adult↗
PubMed2005

How celecoxib could be safer, how valdecoxib might have been.

Following the actions of the Food and Drug Administration (FDA) in April 2005, celecoxib became the only generally available cyclooxygenase-2 inhibiting antiinflammatory drug. The FDA instituted new precautions regarding the use of celecoxib and encouraged the use of "the lowest effective dose." This dose, as defined by the FDA and the package insert, is 200 mg/day for all patients; 200 mg/day of celecoxib is a strong dosage, equivalent to naproxen 500 mg twice daily. However, many patients receiving naproxen benefit from much lower, safer dosages. With celecoxib, studies have shown that a 50% lower dosage is effective and causes fewer adverse effects. Because nonsteroidal antiinflammatory drug-related events involving the gastrointestinal, renal, and cardiovascular systems are dose-related, it is essential to define the very lowest effective dosages of celecoxib and to make these dosages available for use. This article discusses the increasing trend of drug companies to market new drugs with one-size-fits-all or limited dosages, thereby making it difficult or impossible to individualize treatment based on patients' age, size, state of health, or use of concomitant medications. Imagine if naproxen had been marketed only at 500 mg twice daily or ibuprofen at 800 mg 4 times daily. Flexible, individualized dosing is required to provide optimal therapeutics. If celecoxib and valdecoxib had been marketed with a range of doses, many serious adverse effects might have been avoided. The marketing of strong, one-size-fits-all dosages places patients, physicians, and even manufacturers at unnecessary risk of unwanted events.

Cardiovascular Diseases↗
PubMed2003

Why aren't lower, effective, OTC doses available earlier by prescription?

BACKGROUND: Many popular oral over-the-counter (OTC) drugs were originally available only by prescription, but not at the low doses contained in their OTC counterparts. Yet, if OTC doses are effective for treating mild symptoms, why weren't these low, often safer doses made available at least by prescription when the drugs were first approved? OBJECTIVE: To examine issues surrounding the delayed approval of OTC doses by the Food and Drug Administration (FDA). METHODS: Information reviewed included package inserts, data obtained from manufacturers, and articles published in MEDLINE (1966 to December 2001). Medications examined included presently available and potentially approved OTC antiinflammatory, gastrointestinal, and antihistamine drugs. RESULTS: Considerable data demonstrate the effectiveness of ibuprofen, naproxen, ranitidine, famotidine, nizatidine, diphenhydramine, and clemastine at OTC doses. Published studies also show the effectiveness of celecoxib, omeprazole, and fexofenadine at doses 33-50% lower than currently recommended for prescription use. CONCLUSIONS: OTC doses are effective for many patients with mild symptoms and for some with serious symptoms. However, OTC-like doses are usually not offered when drugs are approved for prescription use because new drugs are usually studied in patients with serious conditions requiring higher doses; manufacturers and the FDA seem to prefer a middle-dose approach; >75% of subjects in premarketing dose studies are male; and averaging the responses of study subjects may obscure a wide range of interindividual variation in drug response. Simplistic dosage guidelines make therapeutic decisions easier. Because dose-related adverse effects frequently diminish quality-of-life and reduce adherence, the early availability of OTC-like doses, at least by prescription, would allow healthcare professionals greater flexibility in matching medication doses to patients' widely differing needs.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2002

High-dose oral magnesium treatment of chronic, intractable erythromelalgia.

BACKGROUND: Previous studies with magnesium have shown beneficial effects in pain syndromes and in vascular disorders (hypertension, migraines, Raynaud's phenomenon). However, results have been variable, possibly because of the limited oral doses achievable due to frequent diarrhea. OBJECTIVE: To describe the case of a 53-year-old white man (the author) with disabling erythromelalgia (EM) who achieved modest improvement limited by adverse effects with calcium antagonists and then obtained remission with the use of magnesium. Intolerant of several standard magnesium products, he attained high doses of magnesium by taking intravenous-grade magnesium sulfate diluted in water orally (up to 24 mL/d of MgSO4 50% = 1166 mg/d of magnesium). METHODS: After 12 months of continued improvement, patient 1, a board member of The Erythromelalgia Association, notified other members of the success of this therapy via an Internet communication channel. He encouraged those interested in high-dose magnesium therapy to consult their physicians and to report their results to the Association. Twelve patients responded to this request, describing several standard oral magnesium products. RESULTS: Overall, 8 of 13 patients (61.5%) reported improvement (1, remission; 3, major improvement; 2, moderate improvement; 2, mild improvement). Four patients (30.8%) reported no response to magnesium therapy, and 1 patient's symptoms worsened. Two patients' magnesium dose was limited because of diarrhea. CONCLUSIONS: Despite recent progress in understanding and treating EM, this vascular disorder remains painful and life-altering for many patients. In this informal survey, the use of high oral doses of magnesium produced good and sometimes dramatic results in 8 of 13 patients who had been unresponsive to many other treatments. These results suggest a possible role for high-dose oral magnesium in the treatment of EM and, perhaps, other vascular disorders.

Administration, Oral↗
PubMed2002

Do standard doses of frequently prescribed drugs cause preventable adverse effects in women?

Adverse effects from prescription medications are a leading cause of disability and death in the United States, and more than 75% of these adverse effects are dose related. This analysis examines women's experience with dose-related adverse effects of several major medication groups, induding oral contraceptives, hormone replacement therapy, anti-inflammatory drugs, antihypertensives, statins, and others. The original recommended doses for oral contraceptives and conjugated estrogens were 100% to 800% higher than the doses recommended today. Unnecessarily high doses of ibuprofen and terfenadine were linked to serious and lethal dose-related adverse effects, and proven effective lower doses of celecoxib, fluoxetine, omeprazole, and many other medications were not initially marketed or recommended. Much of the data on effective low doses of drugs is not readily available to physicians or patients. The lack of information on or recommendations for the lowest, proven-effective doses of many major medications may in part explain the continued high incidence of dose-related adverse effects. The findings in this article suggest that women, especially elderly women, may be prone to adverse effects linked to unnecessarily high drug doses.

Adult↗