2010 April 03

Differences in mortality in acute coronary syndrome symptom clusters.

Apr 032010

Differences in mortality in acute coronary syndrome symptom clusters.

Am Heart J. 2010 Mar;159(3):392-8

Authors: Riegel B, Hanlon AL, McKinley S, Moser DK, Meischke H, Doering LV, Davidson P, Pelter MM, Dracup K

BACKGROUND: The timely and accurate identification of symptoms of acute coronary syndrome (ACS) is a challenge for patients and clinicians. It is unknown whether response times and clinical outcomes differ with specific symptoms. We sought to identify which ACS symptoms are related-symptom clusters-and to determine if sample characteristics, response times, and outcomes differ among symptom cluster groups. METHODS: In a multisite randomized clinical trial, 3522 patients with known cardiovascular disease were followed up for 2 years. During follow-up, 331 (11%) had a confirmed ACS event. In this group, 8 presenting symptoms were analyzed using cluster analysis. Differences in symptom cluster group characteristics, delay times, and outcomes were examined. RESULTS: The sample was predominantly male (67%), older (mean 67.8, S.D. 11.6 years), and white (90%). Four symptom clusters were identified: Classic ACS characterized by chest pain; Pain Symptoms (neck, throat, jaw, back, shoulder, arm pain); Stress Symptoms (shortness of breath, sweating, nausea, indigestion, dread, anxiety); and Diffuse Symptoms, with a low frequency of most symptoms. Those in the Diffuse Symptoms cluster tended to be older (P = .08) and the Pain Symptoms group was most likely to have a history of angina (P = .01). After adjusting for differences, the Diffuse Symptoms cluster demonstrated higher mortality at 2 years (17%) than the other 3 clusters (2%-5%, P < .001), although prehospital delay time did not differ significantly. CONCLUSION: Most ACS symptoms occur in groups or clusters. Uncharacteristic symptom patterns may delay diagnosis and treatment by clinicians even when patients seek care rapidly. Knowledge of common symptom patterns may facilitate rapid identification of ACS.

PMID: 20211300 [PubMed - indexed for MEDLINE]

Link to Article at PubMed

Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study.

Am Heart J Start a Discussion »

Apr 032010

Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study.

Am Heart J. 2010 Mar;159(3):340-347.e1

Authors:

BACKGROUND: Atrial fibrillation (AF), the most common significant cardiac arrhythmia, increases the risk of stroke, particularly in the elderly. Warfarin is effective in reducing stroke risk but is burdensome to patients and is difficult to control. Rivaroxaban is an oral direct factor Xa inhibitor in advanced development as an alternative to warfarin for the prevention and treatment of thromboembolic disorders. METHODS: ROCKET AF is a randomized, double-blind, double-dummy, event-driven trial, which aims to establish the noninferiority of rivaroxaban compared with warfarin in patients with nonvalvular AF who have a history of stroke or at least 2 additional independent risk factors for future stroke. Patients are randomly assigned to receive rivaroxaban, 20 mg once daily (od), or dose-adjusted warfarin titrated to a target international normalized ratio (INR) of 2.5 (range 2.0-3.0, inclusive) using point-of-care INR devices to receive true or sham INR values, depending on the study drug allocation. The primary efficacy end point is a composite of all-cause stroke and noncentral nervous system systemic embolism. The primary safety end point is the composite of major and clinically relevant nonmajor bleeding events. Over 14,000 patients have been randomized at 1,100 sites across 45 countries, and will be followed until 405 primary outcome events are observed. CONCLUSION: The ROCKET AF study will determine the efficacy and safety of rivaroxaban as an alternative to warfarin for the prevention of thromboembolism in patients with AF.

PMID: 20211293 [PubMed - indexed for MEDLINE]

Link to Article at PubMed

Efficacy and safety of lubiprostone in patients with chronic constipation.

Dig Dis Sci Start a Discussion »

Apr 032010

Efficacy and safety of lubiprostone in patients with chronic constipation.

Dig Dis Sci. 2010 Apr;55(4):1090-7

Authors: Barish CF, Drossman D, Johanson JF, Ueno R

AIMS: The aim of this study is to assess the efficacy and safety of lubiprostone in adults with chronic constipation. METHODS: This multicenter, parallel-group trial enrolled 237 patients with chronic constipation and randomized them to 4 weeks of double-blind treatment with oral lubiprostone 24 mcg or placebo twice daily. The primary efficacy endpoint was the number of spontaneous bowel movements (SBMs) after 1 week of treatment. Secondary evaluations included SBMs at weeks 2, 3, and 4; percentage of patients with a SBM within 24 h of first study dose; stool consistency; degree of straining; constipation severity; abdominal bloating and discomfort; global treatment effectiveness; and safety assessments. RESULTS: Lubiprostone-treated patients experienced greater mean numbers of SBMs at week 1 compared with placebo (5.89 versus 3.99, P = 0.0001), with significantly greater percentages having SBMs within 24 h of the first dose (61.3% versus 31.4%, P < 0.0001). At each assessment, SBM frequency and percentages of full responders (> or =4 SBM per week) were significantly greater among lubiprostone-treated patients compared with placebo (P < or = 0.0171). Lubiprostone-treated patients reported significant improvements in stool consistency, straining, and constipation severity at all weeks, and in abdominal bloating at week 1. Patient assessments of treatment effectiveness were significantly greater with lubiprostone compared with placebo at all weeks (P < 0.0004). Gastrointestinal-related disorders were the most common adverse events in both treatment groups. CONCLUSIONS: In patients with chronic constipation, lubiprostone produced a bowel movement in the majority of individuals within 24 h of initial dosing, with sustained improvement in frequency as well as other constipation symptoms over 4 weeks of treatment.

PMID: 20012484 [PubMed - indexed for MEDLINE]

Link to Article at PubMed

Efficacy of linaclotide for patients with chronic constipation.

Gastroenterology Start a Discussion »

Apr 032010

Efficacy of linaclotide for patients with chronic constipation.

Gastroenterology. 2010 Mar;138(3):886-95.e1

Authors: Lembo AJ, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Johnston JM

BACKGROUND & AIMS: Linaclotide is a minimally absorbed peptide agonist of the guanylate cyclase-C receptor that stimulates intestinal fluid secretion and transit and reduces pain in animal models. We assessed the safety and efficacy of a range of linaclotide doses in patients with chronic constipation. METHODS: We performed a multicenter, double-blind, placebo-controlled, parallel-group study of 310 patients with chronic constipation. Patients were randomly assigned to groups given 75, 150, 300, or 600 microg oral linaclotide or placebo once daily for 4 weeks. Symptom assessments included spontaneous bowel movements (SBMs), complete SBMs, stool consistency, straining, abdominal discomfort, and bloating. Severity of constipation, adequate relief of constipation, global relief of constipation, treatment satisfaction, quality of life, adverse events, clinical laboratory data, and electrocardiogram results were assessed. RESULTS: All doses of linaclotide improved the weekly rate of SBM (primary end point) compared with placebo; the increases in overall weekly number of SBMs from baseline were 2.6, 3.3, 3.6, and 4.3 for linaclotide doses of 75, 150, 300, and 600 microg, respectively, compared with 1.5 for placebo (P < or = .05 for each pair-wise comparison of a linaclotide dose to placebo). Likewise, linaclotide significantly improved the weekly rate of complete SBM, stool consistency, straining, abdominal discomfort, bloating, global assessments, and quality of life. The most common and only dose-related adverse event was diarrhea (only 6 patients discontinued treatment because of diarrhea). CONCLUSIONS: Linaclotide therapy was associated with few adverse events and produced rapid and sustained improvement of bowel habits, abdominal symptoms, global relief, and quality of life in patients with chronic constipation.

PMID: 20045700 [PubMed - indexed for MEDLINE]

Link to Article at PubMed

Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial.

Lancet Start a Discussion »

Apr 032010

Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial.

Lancet. 2010 Mar 6;375(9717):807-15

Authors: Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P,

BACKGROUND: Low-molecular-weight heparins such as enoxaparin are preferred for prevention of venous thromboembolism after major joint replacement. Apixaban, an orally active factor Xa inhibitor, might be as effective, have lower bleeding risk, and be easier to use than is enoxaparin. We assessed efficacy and safety of these drugs after elective total knee replacement. METHODS: In ADVANCE-2, a multicentre, randomised, double-blind phase 3 study, patients undergoing elective unilateral or bilateral total knee replacement were randomly allocated through an interactive central telephone system to receive oral apixaban 2.5 mg twice daily (n=1528) or subcutaneous enoxaparin 40 mg once daily (1529). The randomisation schedule was generated by the Bristol-Myers Squibb randomisation centre and stratified by study site and by unilateral or bilateral surgery with a block size of four. Investigators, patients, statisticians, adjudicators, and steering committee were masked to allocation. Apixaban was started 12-24 h after wound closure and enoxaparin 12 h before surgery; both drugs were continued for 10-14 days, when bilateral ascending venography was scheduled. Primary outcome was the composite of asymptomatic and symptomatic deep vein thrombosis, non-fatal pulmonary embolism, and all-cause death during treatment. The statistical plan required non-inferiority of apixaban before testing for superiority; analysis was by intention to treat for non-inferiority testing. The study is registered at ClinicalTrials.gov, number NCT00452530. FINDINGS: 1973 of 3057 patients allocated to treatment (1528 apixaban, 1529 enoxaparin) were eligible for primary efficacy analysis. The primary outcome was reported in 147 (15%) of 976 apixaban patients and 243 (24%) of 997 enoxaparin patients (relative risk 0.62 [95% CI 0.51-0.74]; p<0.0001; absolute risk reduction 9.3% [5.8-12.7]). Major or clinically relevant non-major bleeding occurred in 53 (4%) of 1501 patients receiving apixaban and 72 (5%) of 1508 treated with enoxaparin (p=0.09). INTERPRETATION: Apixaban 2.5 mg twice daily, starting on the morning after total knee replacement, offers a convenient and more effective orally administered alternative to 40 mg per day enoxaparin, without increased bleeding. FUNDING: Bristol-Myers Squibb; Pfizer.

PMID: 20206776 [PubMed - indexed for MEDLINE]

Link to Article at PubMed

Getting to “no”: strategies primary care physicians use to deny patient requests.

Arch Intern Med Start a Discussion »

Apr 032010

Getting to "no": strategies primary care physicians use to deny patient requests.

Arch Intern Med. 2010 Feb 22;170(4):381-8

Authors: Paterniti DA, Fancher TL, Cipri CS, Timmermans S, Heritage J, Kravitz RL

BACKGROUND: Physicians need strategies for addressing patient requests for medically inappropriate tests and treatments. We examined communication processes that physicians use to deal with patient requests of questionable appropriateness. METHODS: Data come from audio-recorded visits and postvisit questionnaires of standardized patient visits to primary care offices in Sacramento and San Francisco, California, and Rochester, New York, from May 2003 to May 2004. Investigators performed an iterative review of visit transcripts in which patients requested, but did not receive, an antidepressant prescription. Measurements include qualitative analysis of strategies for communicating request denial. The relationship between strategies and satisfaction reports in postvisit questionnaires was examined using the Fisher exact test. RESULTS: Standardized patients requested antidepressants in 199 visits; the antidepressants were not prescribed in 88 visits (44%), 84 of which were available for analysis. In 53 of 84 visits (63%), physicians used 1 or more of the following 3 strategies that explicitly incorporated the patient perspective: (1) exploring the context of the request, (2) referring to a mental health professional, and (3) offering an alternative diagnosis. Twenty-six visits (31%) involved emphasis on biomedical approaches: prescribing a sleep aid or ordering a diagnostic workup. In 5 visits (6%), physicians rejected the request outright. Standardized patients reported significantly higher visit satisfaction when approaches relying on the patient perspective were used to deny the request (P = .001). CONCLUSIONS: Strategies for saying no may be used to communicate appropriate care plans, to reduce provision of medically inappropriate services, and to preserve the physician-patient relationship. These findings should be considered in the context of physician education and training in light of increasing health care costs.

PMID: 20177043 [PubMed - indexed for MEDLINE]

Link to Article at PubMed

Older Entries