Health-related quality of life of patients with implantable cardioverter defibrillators compared with that of pacemaker recipients.

AIMS: Studies indicate a poorer quality of life (QoL) for implantable cardioverter defibrillator (ICD) patients than for the general population. However, studies comparing the QoL of ICD patients with that of patients with other implantable cardiac devices are scarce. We hypothesized that ICD patients had a poorer QoL than pacemaker patients. METHODS AND RESULTS: All ICD patients living in Iceland at the beginning of 2002 (44 subjects), and a comparison group of 81 randomly selected patients with pacemakers were invited to participate. The Icelandic Quality of Life Questionnaire (IQL), the General Health Questionnaire (GHQ), the Beck Anxiety Inventory (BAI), and the Beck Depression Inventory (BDI) were submitted to measure QoL, psychiatric distress, and symptoms of anxiety and depression. The ICD and pacemaker groups did not differ on IQL, BAI, BDI, or GHQ scores. ICD patients were as a group more fearful of death (P = 0.056) and showed more concerns about returning to work (P = 0.072), although these items fell just short of statistical significance. CONCLUSION: Contrary to our expectations, ICD patients had a comparable QoL with pacemaker recipients and were not more likely to suffer from anxiety, depression, or general psychiatric distress. These findings are encouraging in view of expanding ICD indications.     

Effects of a 5-lipoxygenase-activating protein inhibitor on biomarkers associated with risk of myocardial infarction: a randomized trial

Context  Myocardial infarction (MI) is the leading cause of death in the world. Variants in the 5-lipoxygenase–activating protein (FLAP) gene are associated with risk of MI. Objective  To determine the effect of an inhibitor of FLAP on levels of biomarkers associated with MI risk. Design, Setting, and Patients  A randomized, prospective, placebo-controlled, crossover trial of an inhibitor of FLAP (DG-031) in MI patients who carry at-risk variants in the FLAP gene or in the leukotriene A₄ hydrolase gene. Of 268 patients screened, 191 were carriers of at-risk variants in FLAP (87%) or leukotriene A₄ hydrolase (13%). Individuals were enrolled in April 2004 and were followed up by designated cardiologists from a university hospital in Iceland until September 2004. Interventions  Patients were first randomized to receive 250 mg/d of DG-031, 500 mg/d of DG-031, 750 mg/d of DG-031, or placebo. After a 2-week washout period, patients received DG-031 if they had received placebo first or placebo if they had received DG-031 first. Treatment periods lasted for 4 weeks. Main Outcome Measures  Changes in levels of biomarkers associated with risk of MI. Results  In response to 750 mg/d of DG-031, production of leukotriene B₄ was significantly reduced by 26% (95% confidence interval [CI], 10%-39%; P = .003) and myeloperoxidase was significantly reduced by 12% (95% CI, 2%-21%; P = .02). The higher 2 doses of DG-031 produced a nonsignificant reduction in C-reactive protein (16%; 95% CI, –2% to 31%; P = .07) at 2 weeks. However, there was a more pronounced reduction (25%; 95% CI, 5%-40%; P = .02) in C-reactive protein at the end of the washout period that persisted for another 4 weeks thereafter. The FLAP inhibitor DG-031 was well tolerated and was not associated with any serious adverse events. Conclusion  In patients with specific at-risk variants of 2 genes in the leukotriene pathway, DG-031 led to significant and dose-dependent suppression of biomarkers that are associated with increased risk of MI events.