PubMed Health⌕ Search

Biomedical subjects

David Muram

Publications and source records attributed to David Muram.

8 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

Incidence of urinary incontinence in postmenopausal women treated with raloxifene or estrogen.

OBJECTIVE: Determine the effect of raloxifene or estrogen, as compared with placebo, on the reporting of urinary incontinence in postmenopausal women participating in an osteoporosis prevention trial. DESIGN: The current analysis is based on adverse event data that were collected as part of a double-blind, randomized, placebo-controlled trial designed to assess the efficacy and safety of raloxifene for osteoporosis prevention in postmenopausal women. Women were 40 to 60 years of age at study entry and had a prior hysterectomy. A total of 619 women were randomized to placebo, raloxifene 60 or 150 mg/d, or conjugated equine estrogen 0.625 mg/d and followed for up to 3 years. Urinary incontinence was self-reported and rated by participants as "mild," "moderate," or "severe." RESULTS: The prevalence of urinary incontinence as reported by patients at baseline was similar across treatment groups (3% to 6%, P = 0.46). During 3 years of follow-up, new or worsening urinary incontinence was reported with the following frequency: placebo (1.3%), raloxifene 60 mg/d (0.7%), raloxifene 150 mg/d (0.6%), and conjugated equine estrogen (7.0%). The percentage of estrogen subjects reporting urinary incontinence was significantly greater than that for placebo and both doses of raloxifene (P < or = 0.02). CONCLUSION: During 3 years of follow-up, conjugated equine estrogen was associated with an increased incidence of reports of urinary incontinence in women with a prior hysterectomy and this was significantly greater than both placebo and raloxifene.

Adult↗
PubMed2005

Validation of a two-item quantitative questionnaire for the triage of women with urinary incontinence.

OBJECTIVE: To evaluate the reproducibility, construct validity, and preferences for the 2-item Stress/Urge Incontinence Questionnaire. METHODS: The questionnaire asks a patient to recall the number of stress urinary incontinence and urge urinary incontinence episodes she experienced during the preceding week. The 4-week prospective study included 3 office visits and enrolled women with stress, urge, or mixed urinary incontinence symptoms. The test-retest reproducibility was assessed after 3 days, and the construct validity of the questionnaire was evaluated against a diary and other measures of incontinence severity and effect. The bother associated with completing (patients) or analyzing (physicians) the diary was assessed. Both groups also reported their time requirements and preferences for the questionnaire or diary. RESULTS: Reproducibility for the classification of symptoms was moderately strong (kappa = .536). Test-retest agreement was good (64-80%) for all but balanced mixed incontinence (38%). Intraclass correlations revealed good reproducibility for the number of stress (.694), urge (.703), and total (.726) incontinence episodes. Significant (P < .01) correlations with other measures of incontinence established construct validity. Patients and physicians reported it took less time to complete the questionnaire than the diary, but the majority said the completion or analysis of the diary was of little or no bother and preferred the diary. CONCLUSION: The Stress/Urge Incontinence Questionnaire is a valid tool that can be used in clinical practice to differentiate between symptoms of stress and urge urinary incontinence to make an initial diagnosis, especially in primary care where incontinence is not a focus of the practice.

Adult↗
PubMed2004

Rationale for a non-inferiority clinical trial design focused on subpopulations.

Although double-blind, placebo-controlled clinical trials are utilized extensively to characterize the efficacy and safety of new treatment options, the characteristics of the trial participants often do not reflect those of the wider patient population. In most cases, one or more patient subgroups (whether defined by race, ethnicity, co-morbidity, concomitant medication, age, or gender) will be under-represented. Understanding treatment responses in these subpopulations is a vital component of the overall therapeutic profile of a medication. Several different approaches to subgroup analyses within a single trial have been described. In addition, meta-analytic and data pooling approaches utilize results from multiple clinical trials of similar design to increase the number of patients within a targeted subgroup. If the results from exploratory analyses are suggestive of a clinically relevant difference in treatment response for a particular subgroup, then implementation of a prospectively designed clinical trial may be warranted. In this commentary, we discuss the design and results of various studies that include subgroup analyses. In addition, we describe a novel study design with a non-inferiority subpopulation analysis (NISA) that may provide new insights with respect to subgroup analyses. The NISA study design relies on characterization of the dominant group of patients recruited to date in placebo-controlled trials. In the NISA study, the group of patients with those same characteristics is referred to as the Core group. The other key features of the NISA design include non-inferiority analyses comparing subgroups to the Core group and study conditions closely aligned with routine clinical practice (heterogeneous study population and open-label drug administration without placebo). Limitations of the NISA design include the requirement of previously conducted placebo-controlled trials, the inability to compare treatment response to placebo, and that NISA has yet to be validated in practice. We also describe the implementation of the NISA study design in two ongoing clinical trials. After completion of these two studies, the practical value of the NISA design can be more thoroughly evaluated.

Clinical Trials as Topic↗
PubMed2003

Genital injuries.

Explore the source record for details and available documents.

Adolescent↗
PubMed2002

The effect of raloxifene on the incidence of ovarian cancer in postmenopausal women.

OBJECTIVE: The aim of this study was to determine the incidence of ovarian cancer in postmenopausal women treated with raloxifene compared with placebo. METHODS: This analysis comprises integrated data from seven randomized, placebo-controlled trials of raloxifene (N = 9837). Ovarian cancer cases were identified from the safety database and reviewed by a gynecologic adjudication review board. RESULTS: Sixteen cases of ovarian cancer were reported: 8 women (79.4/100,000 patient-years) on placebo and 8 (37.4/100,000 patient-years) on pooled raloxifene doses. The relative risk of ovarian cancer associated with raloxifene therapy was 0.50 (95% confidence interval, 0.19-1.35). CONCLUSION: Raloxifene use was not associated with an increased risk for ovarian cancer.

Aged↗