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Annual Meeting Abstracts 2004 FEATURE paroxetine or placebo. Methods: Acute-phase data obtained from four 8-week, double-blind studies, with patients randomized to duloxetine (20–60 mg BID; N = 736), paroxetine (20 mg QD; N = 359), or placebo (N = 371). Long-term data obtained from extension phases, in which acute treatment responders received duloxetine (40 or 60 mg BID; N = 297), paroxetine (20 mg QD; N = 140), or placebo (N = 129) for 26 additional weeks. Sexual function evaluated using the Arizona Sexual Experience Scale (ASEX). Results: In patients without initial sexual dysfunction, the probability of acute phase sexual dysfunction onset was significantly lower for duloxetine-treated patients compared with those receiving paroxetine (P = .015), although both rates were significantly higher than placebo (P = .007 and P < .001, respectively). Long-term data revealed that sexual function improved (ASEX total score reduced) in 70.9% of duloxetine-treated patients between baseline and end point, compared with 57.6% for paroxetine (P = .060). For ASEX questions 1 and 2, a significantly greater proportion of duloxetine-treated patients reported improvement compared with paroxetine (P = .050 and P = .037, respectively). No significant differences were found in Questions 3, 4, or 5. Conclusions: In these studies, the incidence of acute phase sexual dysfunction development among patients receiving duloxetine across its dose range (40–120 mg/day) was significantly lower than that of paroxetine at the low end of its dose range (20 mg/day). On certain ASEX questions, a significantly higher percentage of duloxetine-treated patients reported improvement in sexual functioning compared with paroxetine. Original Citation: American Psychological Association, May 2003. 189—DULOXETINE FOR THE TREAT- MENT OF MAJOR DEPRESSIVE DISORDER: SAFETY AND EFFICACY ASSOCIATED WITH RAPID DOSE ESCALATION (60–120 MG QD). Gonzales J, Wohlreich M, Mallinckrodt C, Watkin J, Prakash A, Eli Lilly and Company. E- mail: mvmd@lilly.com Objective: Duloxetine, a dual reuptake inhibitor of serotonin/norepinephrine (5-HT/NE), has demonstrated efficacy for the treatment of emotional and painful physical symptoms of major depressive disorder (MDD) in double-blind, placebo-controlled trials at 60 mg QD. While the expected starting and therapeutic dose is 60 mg QD, we further investigated duloxetine’s pharmacologic profile by examining its safety and tolerability during dose escalation from 60 mg QD to 120 mg QD. Methods: Patients with MDD (N = 128), blinded to timing of dose escalations, received placebo for 1 week followed by duloxetine (60 mg QD) titrated after 1 week to 90 mg QD and after a further week to 4 weeks of 120 mg QD. Efficacy measures included 17-item Hamilton Rating Scale for Depression (HAMD17) total score, Clinical Global Impression of Severity (CGI-S) scale, Patient Global Impression of Improvement (PGI-I) scale, and Visual Analog Scales (VAS) for pain. Safety was assessed using spontaneously reported treatment-emergent adverse events, changes in vital signs, and laboratory analytes. Results: Significant improvements were observed in all efficacy measures at end point (P < .001). The rate of discontinuation due to adverse events (16.3%) was comparable to rates observed in previous placebo-controlled trials. The most frequently reported treatment-emergent adverse events (TEAEs) were nausea, headache, dry mouth, dizziness, and decreased appetite. The majority of TEAEs were associated with initial duloxetine dosing—escalations in dose produced few additional TEAEs. Mean changes from baseline to end point in supine systolic and diastolic blood pressure were 1.2 and 0.6 mmHg, respectively, with no reports of sustained hypertension. Mean change in heart rate was 1.7 bpm, while mean changes in QTcB and QTcF were 1.8 and –5.4 msec, respectively. Conclusions: These results establish the safety and tolerability of duloxetine at once-daily doses above 60 mg, and demonstrate that rapid dose escalation can be achieved without incurring additional adverse events. Original Citation: European College of Neuropsychopharmacology, Prague, Czech Republic, September 2003. 190—EFFECT OF LANSOPRAZOLE ON IL-6 IN HEALTHY WOMEN. Rue K, UHS- COM, MSIV, Marinac J, The University of Health Sciences, Mathews T, University of Health Sciences, Herndon B, University of Missouri–Kansas City, Williams C, Sun C, University of Health Sciences. E-mail: kchristopher@uhs.edu Objective: Determine the effect of 14 days of lansoprazole 30 mg (Prevacid) on serum interleukin-6 (IL-6) concentrations in healthy women. Background: Lansoprazole, a commonly prescribed proton pump inhibitor (PPI), has been shown to modulate the inflammatory response. Previous work has shown that PPIs possess antiinflammatory activity. PPIs may attenuate the oxidative burst of neutrophils (PMNs), downregulate the expression of adherence molecules on both PMNs and endothelial cells, as well as decrease circulating monocyte concentrations. Because lansoprazole modulates the inflammatory response, we hypothesized its usage may produce effects in IL-6, a cytokine that reflects inflammation. An increase in circulating IL-6 is indicative of an acute systemic inflammatory response. The effect of long-term lansoprazole administration on circulating plasma IL-6 concentrations is unknown. Methods: Twenty-one healthy, premenopausal women (mean age 30.6 years) were enrolled. Women taking hormones, those with acute infection, diabetes, or immunosuppressed conditions or who were taking confounding immune-modulating medications were excluded. Blood samples were obtained at baseline (V1) after 7 (V2) and 14 (V3) days of lansoprazole, and at washout (V4), 14 days after lansoprazole was discontinued. Human IL-6 concentrations were determined using ELISA. Data are reported as mean (± SD) pg/mL. Results: A significant depression of IL-6 concentrations was found at V4 as compared with V1: 2.2 (2.6) versus 1.6 (1.9); P = .02. IL-6 concentrations were similar at V1, V2, and V3: 2.2 (2.6), 2.3 (1.9) and 2.9 (3.6) pg/mL, respectively. Conclusions: Following discontinuation of drug given to healthy women for 14 days, IL-6 concentrations were significantly lower than before drug therapy. However, administration of lansoprazole results in no acute change in IL-6 concentrations. This finding suggests a delayed reduction in one marker of inflammation. Further work is needed to determine the causal relationship and clinical importance of this finding. 191—EFFECT OF LANSOPRAZOLE ON PMN ACTIVITY AND CHEMOKINES IN HEALTHY WOMEN. Rue K, UHS-COM, MSIV, Marinac J, The University of Health Sciences, Mathews T, University of Health Sciences, Herndon B, University of Missouri–Kansas City, Williams C, Sun C, University of Health Sciences. E-mail: kchristopher@uhs.edu Objective: Determine the effect of 14 days lansoprazole 30 mg on serum interleukin-8 (IL-8) concentrations, PMN chemotaxis, and PMN superoxide production in healthy women. Background: Lansoprazole is well known to modulate extracellular and intracellular acid in gastric mucosa. Neutrophils (PMNs) use similar ionic processes. Lansoprazole binds within PMN lysosomes, attenuating free radical production from activated PMNs. We hypothesized lansoprazole may also act indirectly by attenuating chemokines activating PMNs. IL-8 serum concentrations were measured in subjects’ whose PMNs were isolated and evaluated. Methods: Twenty-one healthy, premenopausal women (mean age 30.6 years) were enrolled. Women taking hormones, with acute infection, taking confounding medications, diabetics, and otherwise immune suppressed were excluded. Blood samples were obtained at baseline (V1), after 7 (V2) and 14 (V3) days of lansoprazole, and at washout (V4), 14 days after lansoprazole discontinuation. Human IL-8 ELISA was performed on the serum while PMN chemotaxis to fMLP and sod-cyto c assays were performed on PMNs isolated from the subjects’ blood. Data are reported as mean (± SD) pg/mL. Results: A significant increase in IL-8 concentrations was demonstrated at V4 as compared with both V1 and V3: V1 13.7 (11.0), V4 17.9 (24.4) P = .04; V3 15.0 (12.3), V4 17.9 (24.4) P =.04. However, no significant change in IL-8, chemotaxis to fMLP, nor superoxide production was demonstrated by subject PMNs while taking lansoprazole. V1, V2, and V3 IL-8 concentrations were similar: 13.7 (11.0), 21.1 (22.2), 15.0 (12.3) pg/mL respectively. Conclusions: Upon discontinuation of lansopra- 2004 Abstracts of Contributed Papers Vol. 44, No. 2 March/April 2004 www.japha.org Journal of the American Pharmacists Association 273 Downloaded From: http://japha.org/ on 01/25/2014
FEATURE Annual Meeting Abstracts 2004 zole given to healthy women for 14 days, IL-8 concentrations were significantly higher than before or during drug therapy. However, subjects’ PMNs showed no attenuation of free radical production nor a decrease in chemotaxis to fMLP. This is the first study to relate chemokines to PMN activity in subjects treated with a proton-pump inhibitor. Further work is needed to determine the causal relationship and clinical importance of these findings. 192—EXAMINATION OF A SERVICE- LEARNING–BASED PHARMACEUTICAL CARE PROGRAM DELIVERED BY THE PHARMACEUTICAL ACCESS PROJECT OF THE NESBITT SCHOOL OF PHARMACY. McManus M, Nesbitt School of Pharmacy and Nursing–Wilkes University, Graham B, Nesbitt School of Pharmacy and Nursing–Wilkes University. E-mail: mcmanus@wilkes.edu Objective: Examination of the impact of pharmacy student involvement on the delivery of pharmaceutical care to indigent and underserved patient populations and reflection on the impact of the service learning experience on the student’s perception of the professional role of the pharmacist. Methods: Data has been collected from three independent, free health care clinics. Each clinic has a distinct patient population and mission. Clinic data collection includes identification of the number of pharmaceutical care interventions by the students, patient diagnosis, tracking of the total number and type of medications prescribed. A student survey has been designed to assess student perception of the professional roles of pharmacists both before and after the service-learning experience. Final analysis of the data will be accomplished using SPSS. Results: Pharmaceutical care (as measured by number of direct patient contacts and medication dispensed) for indigent patients has steadily increased. The patient diagnoses that appear to have the most improved access are associated with asthma, hypertension and diabetes. Student perceptions of the professional role of the pharmacist demonstrated an increased appreciation for the skills and expertise the pharmacist brings to the health care team. Conclusions: The Pharmaceutical Access Project has evolved into a premier service-learning outreach program and research opportunity for the Nesbitt School of Pharmacy. It has rapidly grown over the past 3 years, from four free clinics to six. The program provides pharmaceutical services and medications (with the school of pharmacy acting as a restricted formulary warehouse) to the local indigent rural community. All of the services are provided by the students and faculty of the School of Pharmacy. Over the past 3 years, 40 students have had the unique experience of active involvement in ambulatory-based, collaborative efforts to improve health care delivery to the homeless and undeserved. The almost universal response of the students to the service-learning experience is one of compassion, increased confidence in professional skills, enhanced pride in the practice of pharmacy, and increased delivery of pharmaceutical care to the underserved individuals of the area. 193—INCIDENCE AND MANAGEMENT OF ANTIDEPRESSANT-INDUCED NAUSEA: EXPERIENCE WITH DULOXETINE. Gonzales J, Eli Lilly and Company, Greist J, Healthcare Technology Systems, Mallinckrodt C, Rayamajhi J, Eli Lilly and Company, Raskin J, Eli Lilly Canada. E-mail: jgreist@healthtechsys.com Objective: Gastrointestinal disturbances, particularly nausea, are the most frequently reported adverse events for many antidepressants. Consequently, management of nausea is important for patient adherence. We investigated the incidence of nausea in patients with major depressive disorder (MDD) who were treated with the new antidepressant duloxetine, a potent dual reuptake inhibitor of serotonin and norepinephrine. Methods: Data were from eight double-blind, randomized, placebo- and active comparator-controlled trials of patients with MDD. The treatment arms were: placebo (N = 777), duloxetine 40 mg/day (N = 177), duloxetine 60 mg/day (N = 251), duloxetine 80 mg/day (N = 363), duloxetine 120 mg/day (N = 348), paroxetine 20 mg/day (N = 359), and fluoxetine 20 mg/day (N = 70). Results: In acute (8–9 week) placebo-controlled trials of duloxetine (40–120 mg/day), treatmentemergent nausea was reported by 19.9% of duloxetine-treated patients and 6.9% of patients receiving placebo (P < .001). Onset of duloxetine-induced nausea occurred primarily within the first 2 days of treatment with a median duration of 7 days. The incidence of nausea did not differ from placebo rates after 1 week. In paroxetine-controlled and fluoxetine-controlled studies, the incidence of treatmentemergent nausea in patients receiving duloxetine did not differ significantly from paroxetine (14.1% versus 12.0%) or fluoxetine (17.1% versus 15.7%). Most duloxetine-treated patients reported nausea to be mild (52.9%) or moderate (41.4%) in intensity. Treatment discontinuation secondary to nausea occurred in 1.4% of duloxetine-treated patients and 0.1% of patients receiving placebo. The incidence of treatment-emergent nausea during 6-month continuation of duloxetine treatment (80 mg/day: 2.1%; 120 mg/day: 1.3%) was similar to placebo (1.6%). Conclusions: These data indicate the new antidepressant duloxetine induces mild-to-moderate nausea in a subset of patients during treatment initiation. Nausea resolved rapidly with continued treatment. The incidence of duloxetine-induced nausea resembled that produced by the SSRIs paroxetine and fluoxetine. Duloxetine-induced nausea should have little impact on patient satisfaction and adherence. 194—LEVEL OF DEPRESSIVE SYMP- TOMS AMONG PATIENTS WITH A PRIOR HISTORY OF DEPRESSION TREATED WITH VERAPAMIL SR-LED VERSUS ATENOLOL-LED TREATMENT STRATE- GIES. Ried L, University of Florida/Department of Veterans Affairs, Tueth M, Department of Veterans Affairs, Handberg E, Pepine C, University of Florida. E-mail: ried@cop.ufl.edu Objective: INVEST demonstrated equivalence for clinical outcomes between a verapamil SR (Ve)- led strategy and an atenolol (At)-led strategy in 17,131 U.S. patients with hypertension and coronary artery disease. The study objective was to compare depressive symptoms between strategies among those with a previous diagnosis of depression. Methods: A subset of consecutively randomized INVEST patients living in the United States (N =2,317) were enrolled between April 1, and October 31, 1999. Patients were mailed a survey within 24 hours of randomization and 1 year later. The surveys contained a depression (CES-D) scale and questions about self-reported prior diagnosis of depression. Nearly 50.2% of patients returned both the randomization and follow-up surveys. Results: Among patients with a prior diagnosis of depression, the difference in CES-D scores between the At-led and Ve-led strategies after 1 year was 1.85 points (22.03 versus 20.18, t = 1.01, P = .31). Among patients without a prior diagnosis of depression, the difference was 1.43 points (12.12 versus 10.69, t =2.29, P = .02). The baseline CES-D scores were similar when the two treatment groups were compared. Baseline (23.5 versus 12.0, P < .001) and follow-up (21.0 versus 11.4, P < .001) depressive symptoms were significantly higher among those with a prior diagnosis of depression (N = 201) when compared with those without a prior diagnosis of depression (N = 951). Patients with a prior diagnosis of depression improved by 2.5 points after 1 year (t = 3.45, P = .001), whereas those without a prior history of depression improved by 0.6 points (t = 2.33, P = .02). Conclusions: Prior history of depression is consistently one of the most significant predictors of future depression. In INVEST, the treatment choice effected patients’ depressive symptoms similarly whether or not they had a prior diagnosis of depression, although the verapamil SR strategy had less mood-related impact than the atenolol strategy. 195—LIPID MANAGEMENT AND FAC- TORS AFFECTING GOAL ATTAINMENT IN LATIN AMERICA. Alemao E, Merck and Co., Meaney E, Cardiovascular Unit Head, ISSSTE Regional Hospital 1º de octubre, Armaganijan D, Chief of Caronariopaty Medical Session, Dante Pazzanese Institute of Cardiology, Ramos A, Innoval, S.A. de C.V, Yin D, Merck and Co. E-mail: evo_alemao@merck.com Objective: Despite proven value of cholesterol reduction in coronary heart disease (CHD) prevention, many studies in Europe and the United States suggest that majority of patients receiving treatment do not achieve the efficacy needed for CHD prevention. The objective of this study was to evaluate treatment of hyperlipidemia patients in Mexico and Brazil and determine factors associated with attaining goals as defined in the Third Report of the Adult Treatment Panel of the National Cholesterol Education Program (ATP-III) in CHD/CHD-equiv- 274 Journal of the American Pharmacists Association www.japha.org March/April 2004 Vol. 44, No. 2 Downloaded From: http://japha.org/ on 01/25/2014
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