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Annual Meeting Abstracts 2004 FEATURE alent patients (LDL-C goal ≤ 100 mg/dL) and non–CHD 2+ risk factor patients (LDL-C goal ≤130 mg/dL). Methods: Retrospective observational study at randomly selected 25 specialist and 15 general practice (GP) centers in Mexico and Brazil. Physicians at the centers selected at random adult (age ≥ 18) patients that were prescribed lipid lowering drug (LLD) for minimum 12 weeks. Date of first LLD was the index prescription date; patients were followed for minimum 3 months (study period) from index date. Medical records were reviewed by physicians to collect patient-level data. A lipid profile was done in a centralized laboratory at end of the study. Results: Two hundred and forty patients were included for study, 38% from GP practice and 62% from specialist practice: 43% were CHD/CHD–equivalent patients, 35% 2+ risk factor patients and 22% < 2 risk factor patients. Mean (± SD) age was 57 (± 12) years, 53% were female. Median reduction in LDL-C required to attain ATP- III goals was 48% for CHD patients and 25% for 2+ risk factor patients. There was no significant difference in LDL-C reduction required at initiation of LLD in Mexico and Brazil. For CHD group, 27% were prescribed low-dose statins (simvastatin 10 mg or equipotent), 36% medium-dose statins (atorvastatin 10 mg or equipotent) and 19% high-dose statins (atorvastatin 20 mg or equipotent) as initial LLD. Physicians in Brazil prescribed higher equipotent statin doses compared with Mexico (MH chisquare < .05). Overall 44% patients attained ATP- III recommended LDL-C goals. After controlling for age, gender, country, baseline LLD, titration and comorbidities, patients with baseline LDL-C ≥ 190 mg/dL (OR = 0.41; 95% CI, 0.23–0.72), 3+ risk factors (OR = 0.51; 95% CI, 0.27–0.98) and CHD (OR = 0.38; 95% CI, 0.21–0.68) were less likely to achieve LDL-C goal. Conclusions: Majority (56%) of hyperlipidemia patients did not attain recommended ATP-III LDL- C goals. More aggressive lipid management is required in patients with high baseline LDL-C, CHD and multiple CHD risk factors in order to achieve recommended lipid goals in these patients. 196—NOVEL, EPIDURAL, SUSTAINED- RELEASE MORPHINE PROVIDES 48-HOUR POSTOPERATIVE PAIN RELIEF. Viscusi E, Thomas Jefferson University, Martin G, Duke University Medical Center, Hartrick C, William Beaumont Hospital, Singla N, Huntington Memorial Hospital, Manvelian G, SkyePharma, Inc. E-mail: eugene.viscusi@jefferson.edu Objective: Rationale: Epidural morphine provides good postoperative analgesia, but requires use of an indwelling catheter for pain relief beyond 24 hours. Obviating the need for an indwelling catheter with a single dose of sustained-release morphine could eliminate complications associated with indwelling epidural catheters, especially in patients receiving anticoagulants. Objective: To evaluate DepoMorphine, a novel, single-dose, sustainedrelease formulation of epidural morphine, in providing pain relief for 48 hours postoperatively. Methods: Adults (N = 194) undergoing total hip arthroplasty were randomized to receive an epidural injection of placebo (normal saline) or DepoMorphine 15, 20, or 25 mg for postoperative pain management. All patients had access to IV fentanyl via a PCA pump for breakthrough pain relief as needed. Postoperative fentanyl consumption through 48 hours was the primary efficacy end point. Pain intensity and pain relief were also assessed. Results: DepoMorphine reduced mean (± SD) fentanyl use versus placebo (510 ± 708 mcg versus 2,091 ± 1,803 mcg; P < .0001) and delayed median time to first rescue with fentanyl (21.3 hours versus 3.6 hours; P < .0001). DepoMorphine patients had lower mean (± SD) pain intensity scores with activity as measured by the VAS (0–100 mm) at 24 and 48 hours (30 ± 28 versus 52 ± 29 and 29 ± 28 versus 39 ± 27; P < .001 and P = .06). DepoMorphine patients were also more likely to rate pain relief as “good” or “very good” (90% versus 65%; P < .05). More DepoMorphine-treated patients did not require postoperative fentanyl at 12 (57% versus 2%; P < .001) and 48 hours (25% versus 2%; P = .001). The incidence of adverse events was similar across treatment groups except for a higher incidence of vomiting and pruritus (P < .05) with DepoMorphine. Respiratory depression occurred in 5 (4%) of DepoMorphine patients and no placebo patients (NS). Conclusions: Single-dose DepoMorphine provided postoperative pain relief for 48 hours, while avoiding complications associated with indwelling epidural catheters. 197—ONSET OF IMPROVEMENT IN EMOTIONAL AND PAINFUL PHYSICAL SYMPTOMS OF DEPRESSION WITH DULOXETINE TREATMENT. Gonzales J, Wohlreich M, Eli Lilly and Company, Brannan S, Cyberonics, Mallinckrodt C, Detke M, Lu Y, Watkin J, Tollefson G, Eli Lilly and Company. E- mail: mvmd@lilly.com Objective: Duloxetine, a potent reuptake inhibitor of serotonin (5-HT) and norepinephrine (NE), is expected to show robust and rapid efficacy in treating emotional symptoms of depression. 5-HT and NE also play an important role in modulation of pain via a descending inhibitory pain pathway in the spinal cord. Therefore we hypothesized that duloxetine would also demonstrate efficacy in painful physical symptoms, which are commonly associated with depression. We examined the temporal pattern of efficacy of duloxetine 60 mg QD in both the emotional and painful physical symptoms associated with major depression. Methods: Data were pooled from two, 9-week randomized, double-blind, clinical trials of duloxetine 60 mg QD (N = 244) and placebo (N = 251). Emotional symptom outcomes included the 17-item Hamilton Rating Scale for Depression (HAMD17) total score and its subfactors and items, as well as the Clinical Global Impression of Severity (CGI-S), and Patient Global Impression of Improvement (PGI-I) scales. Painful physical symptom outcomes included Visual Analog Scales (VAS) for pain. Results: For all emotional symptom outcomes, meaningful and significant advantages of duloxetine over placebo were observed at week 1 or 2, and continued to increase throughout the trial. In physical symptom outcomes, meaningful and significant advantages were again observed at week 1 or 2; however, maximal improvement was observed by week 3. For example, at weeks 1 and 9 the advantage of duloxetine over placebo in mean changes on HAMD17 item 1 were 0.19 and 0.57, respectively. For back pain, the advantage of duloxetine over placebo at weeks 1 and 9 in mean percent improvement was 23.1% and 25.1%, respectively. Conclusions: In these studies, duloxetine (60 mg QD) demonstrated rapid onset of robust and sustained antidepressant efficacy across a wide range of emotional and physical symptom outcomes. Original Citation: Society of Biological Psychiatry Annual Meeting, May 2003. 198—OPEN-LABEL TREATMENT WITH DULOXETINE 60 MG ONCE-DAILY IN THE ACUTE TREATMENT OF MAJOR DEPRES- SIVE DISORDER. Gonzales J, Detke M, Wang F, Wiltse C, Prakash A, Wohlreich M, Eli Lilly and Company. E-mail: mdetke@lilly.com Objective: Open-label studies may better mimic normal clinical practice and may offer a better approximation of clinical practice results with duloxetine 60 mg QD than those seen in placebocontrolled studies. Together with data from placebocontrolled studies, the information from this study may help clinicians to determine the place for duloxetine among current pharmacotherapy choices for the treatment of major depressive disorder (MDD). Methods: Results were obtained from an openlabel, 12-week, multinational clinical trial in MDD outpatients (age ≥ 18) receiving duloxetine at 60 mg (administered once daily.) Results: A total of 533 patients enrolled in this study. Mean changes in the HAMD17 total score, HAMD subfactors, CGI-Severity, and Visual Analog Scales for pain all showed highly significant (P < .001) improvements at all assessment times. Response and remission rates at end point were 67.9% and 52.8%, respectively. Adverse events led to discontinuation in 11.3% of patients. The most frequently reported treatment-emergent adverse events were nausea (35.8%), headache (20.3%), dry mouth (18.0%), somnolence (13.5%), insomnia (10.5%), and dizziness (10.1%). Mean changes for pulse, systolic and diastolic blood pressure, and body weight were 1.72 bpm, 1.35 mm Hg, 0.71 mm Hg, and –.08 kg, respectively. Conclusions: Results from this study were generally consistent with previously reported doubleblind placebo-controlled studies that had established the safety and efficacy of duloxetine in the treatment of major depression. The results reported herein 2004 Abstracts of Contributed Papers Vol. 44, No. 2 March/April 2004 www.japha.org Journal of the American Pharmacists Association 275 Downloaded From: http://japha.org/ on 01/25/2014
FEATURE Annual Meeting Abstracts 2004 provide a useful estimation of the outcomes that will be seen in normal clinical practice. Original Citation: U. S. Psychiatric & Mental Health Congress, November 2003. 199—PREVALENCE OF COMORBIDI- TIES IN DVT AND PE PATIENTS. Yin H, University of Illinois at Chicago, Vogenberg R, Aon Consulting. E-mail: hyin3@uic.edu Objective: Deep vein thrombosis (DVT) and pulmonary embolism (PE) patients tend to have multiple comorbidities that need to be considered when evaluating pharmacotherapy outcomes. DVT patients may have different comorbidities from PE patients, and until now this comparison had not been examined in the literature. This study aims to identify the prevalence of comorbidities in DVT and PE patients and to compare comorbidity prevalence of the DVT group to that of the PE group. Methods: The study is based on an administrative database from eight U.S. hospitals. There are 2,506 DVT patients and 1,973 PE patients’ records in the pooled database. Patients with both DVT and PE were considered only as PE patient in the analysis. Comorbidities were categorized and summarized according to ICD-9-CM codes. A comorbidity was included in the analysis only when prevalence in DVT or PE group was greater than 1%. A chisquare test was performed to analyze whether the comorbidity burdens were similar or different between the two groups. Results: There are 29 comorbidities with prevalence greater than 1% in either DVT or PE group. DVT patients are found to be more likely to have peripheral vascular disease, anemia, cerebrovascular disease, and renal disease. PE patients are more likely to have cardiac arrhythmias, congestive heart failure, mild to moderate diabetes, chronic pulmonary disease, and cases of drug abuse. Further, a PE patient tends to have more comorbidities overall compared with a DVT patient. Conclusions: Prevalence of comorbidities differs between DVT and PE patients. Additional study is needed to address the reasons why PE patients are more likely to have certain comorbidities. DVT patients who have these comorbidities should be identified in effort to prevent PE development through pharmacotherapy prophylaxis. 200—PROLONGED EPIDURAL ANALGE- SIA WITH SINGLE-DOSE, ENCAPSULATED MORPHINE VERSUS STANDARD EPIDU- RAL MORPHINE FOR POSTOPERATIVE PAIN AFTER HIP SURGERY. Viscusi E, Thomas Jefferson University, Kopacz D, Virginia Mason Medical Center, Hartrick C, William Beaumont Hospital, Martin G, Duke University Medical Center, Manvelian G, SkyePharma, Inc. E- mail: eugene.viscusi@jefferson.edu Objective: To evaluate the analgesic efficacy and safety of a single, preoperative, epidural injection of sustained-release morphine (DepoMorphine) compared with standard preservative-free morphine sulfate (MS) in patients undergoing total hip arthroplasty with intrathecal anesthesia. Methods: A prospective, open-label, serial cohort, dose-ranging trial at six U.S. sites enrolled 39 patients scheduled for total hip arthroplasty with intrathecal anesthesia. Patients were assigned to receive DepoMorphine 10 (N = 4), 15 (N = 1), 20 (N = 12), 25 (N = 1), or 30 mg (N = 8) or a control of MS 5 mg (N = 13) as a single injection via epidural catheter 30 minutes preoperatively. Regional anesthesia was then administered with an intrathecal injection of bupivacaine (12.5–17.5 mg). Patients had postoperative access to intravenous patient-controlled analgesia using fentanyl for treatment of breakthrough pain. Efficacy parameters were total fentanyl consumption, time to first fentanyl use, pain intensity rated by 100 mm visual analog (VAS), and 4-term categorical (CAT) scales. Safety was evaluated through clinical assessments and laboratory testing. Results: Mean total fentanyl use for DepoMorphine 10, 20, and 30 mg groups were 598 ± 230 mcg, 261 ± 95 mcg, and 143 ± 101 mcg, respectively, and 1,095 ± 280 mcg for MS (P = .01). Median times to first fentanyl dose were 18, 36, and 35 hours for DepoMorphine 10, 20, and 30 mg, respectively, and 6 hours for MS (P < .001). VAS and CAT scores were comparable among all groups. Pain medication was rated “excellent” by 46% of DepoMorphine-treated patients and 15% of MStreated patients. The most common postoperative adverse effects for both groups were pruritus, fever, and nausea; respiratory effects were mild to moderate in severity and similar for both groups. Conclusions: DepoMorphine provided prolonged dose-dependent postoperative analgesia versus MS 5 mg in patients undergoing total hip arthroplasty with intrathecal anesthesia. This new treatment modality offers clinicians a new option that may simplify postoperative pain management. 201—SUSTAINED-RELEASE EPIDURAL MORPHINE REDUCES POSTOPERATIVE PCA FENTANYL USE FOR 48 HOURS AFTER LOW ABDOMINAL SURGERY. Gambling D, Sharp Mary Birch Hospital for Women, Hughes T, Woodland Memorial Hospital, Martin G, Duke University Medical Center, Manvelian G, SkyePharma, Inc. E-mail: dgamb@san.rr.com Objective: Rationale: Complications can arise from epidural catheterization, especially when anticoagulants are administered. A new, sustainedrelease morphine (DepoMorphine [DM]) may obviate the need for an indwelling epidural catheter and provide prolonged analgesia. Objective: To compare analgesic efficacy and safety of four dosage strengths of DM with a single dose of DM 5 mg (dose-control) and with standard epidural morphine sulfate (MS) 5 mg after elective low abdominal surgery. Methods: 519 adults were randomly assigned to receive preoperative epidural injection of MS 5 mg or DM 5, 10, 15, 20, or 25 mg. Patients had patientcontrolled analgesia (PCA) using intravenous fentanyl for postoperative pain control. Fentanyl consumption through 48 hours was the primary efficacy endpoint. Pain intensity (VAS: 0–100 mm) and overall pain control (very good, good, fair, or poor) were also assessed. Adverse events were recorded. Results: Mean (± SD) total fentanyl use through 48 hours decreased from 995.1 ± 987.0 mcg to 682.5 ± 620.0 mcg, respectively, with DM 10 and 25 mg compared with 1,213.3 ± 1079 mcg and 1217.1 ± 894.0 mcg, respectively, with DM 5 mg and MS 5 mg (P< .05). In the DM 10, 15, 20, and 25 mg groups, 15% of patients required no supplemental fentanyl through 48 hours compared with 6% and 2%, respectively, in DM 5 mg and MS 5 mg groups (P < .01). VAS scores were better with DM for 48 hours postdose. On Day 2, pain control was rated significantly better in the 15 and 25 mg DM groups versus the MS group (P < .05). Urinary retention and pruritus occurred more frequently in DM patients (9% versus 3% and 54% versus 39%, respectively; P < .05); other adverse events were similar across groups. Conclusions: A single epidural injection of DM provides prolonged postoperative analgesia, improved pain control, and decreased need for postoperative PCA fentanyl, thereby simplifying postoperative pain treatment. 202—WEIGHT CHANGES DURING LONG-TERM TREATMENT WITH DULOX- ETINE AND PAROXETINE. Gonzales J, Mallinckrodt C, Detke M, Eli Lilly and Company, Raskin J, Eli Lilly Canada, Tran P, Watkin J, Wohlreich M, Eli Lilly and Company. E-mail: cmallinc@lilly.com Objective: Weight gain during long-term antidepressant treatment is a common concern and may interfere with compliance with pharmacotherapy. Methods: Data were pooled from two doubleblind studies. Patients received placebo (N = 192), duloxetine 80 mg/day (40 mg BID; N = 188), duloxetine 120 mg/day (60 mg BID; N = 196), or paroxetine 20 mg QD (N = 183) for 8 weeks. Acute treatment responders (≥ 30% reduction from baseline HAMD17 total score) continued double-blind therapy for an additional 26 weeks. Data from a 52- week open-label study of duloxetine 80–120 mg/day (40–60 mg BID; N = 1,279) were analyzed separately. Results: Following acute treatment, mean changes in weight for patients receiving duloxetine 80 mg/day (–0.2 kg), duloxetine 120 mg/day (–0.2 kg), or paroxetine 20 mg QD (–0.1 kg) did not differ significantly from placebo (0.1 kg). After 34 weeks, mean weight changes for duloxetine (80 mg/day: 0.8 kg; 120 mg/day: 1.0 kg) did not differ significantly from placebo (0.1 kg), while patients receiving paroxetine 20 mg QD had a mean weight change significantly greater than the placebo group (1.2 kg; P = .020). Incidences of weight gain ≥ 7% during the 34-week study were: placebo (3.0%), duloxetine 80 mg/day (3.2%), duloxetine 120 mg/day (8.8%), and paroxetine 20 mg QD (11.5%). In the open-label study, mean changes in weight at weeks 8, 32 and 52 were –.2 kg, 1.5 kg, and 2.1 kg, respectively. Conclusions: In these studies, changes in body 276 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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