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Biomedical subjects

Naomi V Dahl

Publications and source records attributed to Naomi V Dahl.

8 recordsLinked to original sources
PubMed2006

Oxybutynin transdermal system improves the quality of life in adults with overactive bladder: a multicentre, community-based, randomized study.

OBJECTIVE: To assess health-related quality-of-life (HRQoL) and safety with the oxybutynin transdermal system (OXY-TDS) (Oxytrol), Watson Pharma, Corona, CA, USA) in the Multicentre Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin (MATRIX) study, as HRQoL measurements are increasingly important in evaluating pharmacotherapy for overactive bladder (OAB). PATIENTS AND METHODS: This randomized, open-label, community-based study enrolled 2878 participants aged >/=18 years who had been given a diagnosis of OAB. The 327 study sites were representative of various practice types. All participants were treated with OXY-TDS 3.9 mg/day for </=6 months. HRQoL was assessed using the King's Health Questionnaire (KHQ); the primary endpoint was the change in KHQ scores from baseline to study end. RESULTS: Most enrolees (2052/2625; 78.2%) had moderate to severe OAB at baseline (Patient Perception of Bladder Condition score >/= 4 on a scale of 1-6), and most (1632/2859; 57.1%) had been given previous drug treatment for OAB. Of 2592 with evaluable baseline KHQ scores, 92.2% reported urgency and 88.2% reported urge urinary incontinence. The most impaired domains at baseline were Incontinence Impact (69.3), Symptom Severity (55.9), and Sleep/Energy (54.2). There were clinically meaningful and statistically significant improvements in nine of 10 domains at the study end; the greatest improvements were in Incontinence Impact (-13.5), Symptom Severity (-12.4), and Role Limitations (-13.3). The treatment was well tolerated, with low incidences of drug-related anticholinergic adverse effects such as dry mouth (75; 2.6%), constipation (44; 1.5%), and dizziness (21; 0.7%). There were drug-related application-site reactions, including pruritus, erythema, dermatitis and irritation, in 14.0% of participants. CONCLUSIONS: OXY-TDS treatment was well tolerated in this diverse, community-based population, and resulted in clinically significant improvements in HRQoL, regardless of baseline characteristics.

Administration, Cutaneous↗
PubMed2006

The impact of the overactive bladder syndrome on sexual function: a preliminary report from the Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin trial.

OBJECTIVE: The objective of the study was to determine the impact of overactive bladder on sexual function from a preliminary analysis of the Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin study. STUDY DESIGN: The Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin study was an open-label, prospective trial of 2878 subjects with overactive bladder, treated with transdermal oxybutynin for 6 months or less. The impact of overactive bladder on sexual function before and after treatment was assessed via item responses from the King's Health Questionnaire and Beck Depression Inventory-II (kappa-test). RESULTS: At baseline, 586 (23.1%) reported that overactive bladder had an impact on their sex life. Coital incontinence in 569 (22.8%) decreased after treatment to 438 (19.3%). Effects of overactive bladder on subjects' sex lives improved in 19.1% (worsened in 11.2%), and the effect on relationships with partners improved in 19.6% (worsened in 11.9%). Reduced interest in sex, reported by 52.1% at baseline, improved significantly. (all P < .0001). CONCLUSION: Overactive bladder negatively affects sexual function. Treatment with transdermal oxybutynin improved sexual function and marital relationships.

Administration, Cutaneous↗
PubMed2005

The nephrologist as a primary care provider for the hemodialysis patient.

The role of nephrologists as de facto primary care providers (PCP) for dialysis patients is of increasing interest. We sought to determine the proportion of patients who rely on nephrologists for primary care and to identify demographic variables associated with this primary care responsibility. We reviewed the charts of 158 patients receiving hemodialysis at a suburban, freestanding, teaching hospital affiliated outpatient unit from December 1999 through January 2001. In addition, each patient was interviewed and completed a survey. Non-nephrologists were considered to be a patient's PCP if there was chart, survey or interview evidence of such a relationship. Of the 158 patients, only 56 patients had a PCP. The nephrologist thus was the de facto PCP in 65% of hemodialysis patients, a responsibility that was 3.3-fold more likely for patients not enrolled in a health maintenance organization (HMO) or managed care organization (MCO). In the non-HMO/MCO group, patients with a PCP had been on dialysis for less time than those without a PCP [2.7 vs. 4.6 years (P=0.0006)]. Only 32% of patients on dialysis <1 year had nephrologists as de facto PCP vs. 71% of those on dialysis more than 1 year (P=0.0002). This association between time on dialysis and de facto use of nephrologists as PCP was not accounted for by the shorter time on dialysis of HMO/MCO enrollees. The extent to which the nephrologist fulfills the often unsought role as PCP needs further investigation.

Aged↗
PubMed2004

Iron therapy in the pediatric hemodialysis population.

Iron therapy maintains iron stores and optimizes the response to recombinant human erythropoietin (r-HuEPO) in patients with end-stage renal failure. Information is limited, however, regarding the preferential route of iron administration in pediatric patients receiving hemodialysis. Therefore, we prospectively randomized 35 iron-replete patients (aged >1 to <20 years) to receive up to 16 weeks of maintenance i.v. ( n=17) or daily oral ( n=18) iron. Eligible patients had received hemodialysis for >2 months, had a baseline transferrin saturation [TSAT] >20%, and were receiving maintenance r-HuEPO. Treatment arms were evenly distributed with respect to baseline demographic and clinical characteristics, with no statistically significant differences in baseline hemoglobin (Hb), hematocrit (Hct), reticulocyte Hb content (CHr), serum ferritin (SF), TSAT, or r-HuEPO dose. In the 35 patients, i.v. iron dextran and not oral iron was associated with a significant increase (138.5 to 259.1 ng/ml, P=0.003) in SF. A comparison of the change in SF between the i.v. iron group and the oral iron group was also significant ( P=0.001). Whereas only i.v. iron was associated with a significant decrease in the dose of r-HuEPO (234.0 to 157.6 U/kg per week, P=0.046) and an increase of the CHr (29.2 to 30.1 pg, P=0.049), these changes were not significantly different from those experienced by patients in the oral iron group. In both groups, the Hct remained stable and in neither group was there a significant change in the TSAT. In summary, although both oral and i.v. iron maintained patients in an iron-replete state in this short-term study, only i.v. therapy allowed for a significant improvement in iron stores.

Administration, Oral↗
PubMed2004

Sodium ferric gluconate complex in haemodialysis patients: a prospective evaluation of long-term safety.

BACKGROUND: A previous single dose placebo-controlled double-blinded trial showed an extremely low (0.4%) intolerance rate of sodium ferric gluconate complex (SFGC) in SFGC-naive haemodialysis patients. No large prospective trials have assessed the safety of SFGC during repeated exposure in the outpatient haemodialysis setting. METHODS: Chronic haemodialysis patients completing the single-dose trial of SFGC were eligible to participate in this prospective, multicentre, open-label, long-term evaluation of SFGC, designed to record adverse events occurring up to 72 h post-dose. Patients received as many as 20 ampules (1250 mg total) of SFGC at an investigator-determined dose and rate over a 9 month evaluation period. RESULTS: Among 1412 enrolled patients at 54 centres, 1321 received 13,151 infusions of SFGC. Most doses (94.8%) were < or =125 mg and the majority were given over 10 min. Infusion rates ranged from <5 to 125 mg/min. There were no life-threatening events. Fifty-one patients (3.9%) experienced an adverse event, possibly related to SFGC. Of these, one experienced a serious event (hypotension). Five patients (0.4%) experienced an event that precluded SFGC readministration: pruritus (three), vasodilatation (one) and loss of taste (one). Among 372 patients (28.2%) receiving angiotensin-converting enzyme inhibitor (ACEI) therapy, adverse events were neither more common nor more severe than in the other patients. CONCLUSIONS: Repeated doses of SFGC are very well tolerated in haemodialysis patients. No life-threatening events were observed in over 13,000 doses administered. Administration of SFGC to patients using ACEI is safe and does not increase the incidence or severity of adverse events to SFGC.

Aged↗
PubMed2004

Single-dose pharmacokinetics of sodium ferric gluconate complex in iron-deficient subjects.

STUDY OBJECTIVES: To determine the single-dose pharmacokinetics of intravenous sodium ferric gluconate complex in sucrose injection (SFGC) in iron-deficient human volunteers, and to assess iron transport. DESIGN: Open-label, randomized study. SETTING: Clinical research facility. SUBJECTS: Fourteen iron-deficient men and women. INTERVENTIONS: Subjects were randomized to receive a single intravenous dose of either SFGC 62.5 mg administered over 30 minutes or SFGC 125 mg over 60 minutes. Five days later, the same subjects were rerandomized to receive a second intravenous dose of SFGC, either 62.5 mg administered over 4 minutes or 125 mg over 7 minutes. MEASUREMENTS AND MAIN RESULTS: Blood samples were collected at predefined times before, during, and up to 72 hours after the infusion to determine the single-dose pharmacokinetics of SFGC. Assays were performed for both total iron and transferrin-bound iron, from which drug-bound iron could be calculated. Urine was collected over 24 hours before dosing and for 24 hours after the start of infusion to determine the renal elimination of iron. Clearance of SFGC from serum was rapid and far exceeded rates reported for iron dextran. Pharmacokinetic parameters were unaffected by dose or infusion rate. Serum iron derived from SFGC did not exceed the binding capacity of transferrin. Serum iron from SFGC became rapidly available (< 24 hrs) as transferrin-bound iron, but only after passage through another compartment, presumably the reticuloendothelial system (RES). At least 80% of the administered iron was transported to bone marrow within 24 hours after infusion. CONCLUSIONS: Iron derived from SFGC appears to be rapidly transferred to a bioavailable iron compartment as transferrin-bound iron after digestion in the RES. At the doses administered in this study, liberation of potentially toxic, free iron was not detectable.

Adult↗
PubMedDate not supplied

Herbs, menopause, and dialysis.

Women with chronic kidney disease (CKD) are at increased risk for menstrual disorders, early menopause, and osteoporosis, and rarely discuss gynecologic and reproductive issues with their nephrologist. Various complementary and alternative medicine (CAM) products are of interest to women with end-stage renal disease (ESRD) who have these disorders. However, very little is known about the specifics of using herbal medicines in patients on chronic dialysis, resulting in numerous problems when patients and providers try to ascertain the safety and efficacy of these products. This article reviews evidence regarding the safety and efficacy of black cohosh, ginseng, chastetree, dong quai, evening primrose oil, soy products, and the so-called natural hormones. Pharmacologic parameters important to evaluating the quality of botanical products are discussed, along with recommendations and information resources.

Female↗