Health-related quality of life trajectories among adults with tuberculosis: differences between latent and active infection

BACKGROUND: Tuberculosis (TB) remains a public health threat with significant annual impacts on morbidity and mortality. However, few studies have examined the impact of active and latent TB infection (LTBI) on health-related quality of life (HRQL). METHODS: Patients with recently diagnosed active TB or LTBI patients were administered the Short Form-36 (SF-36) and the Beck depression inventory (DI) at baseline, 3 months, and 6 months. Mixed-effect linear regression was used to compare the trajectory of HRQL over time in the two patient groups after adjusting for potential confounders. Ordinal logistic regression was used to determine the relationship between changes in HRQL of at least the minimal important difference. RESULTS: One hundred four active TB and 102 LTBI patients participated. At baseline, participants with active TB had significantly lower SF-36 mean domain and component scores (4 to 12 points lower, p < 0.03) and higher mean Beck DI scores (4 points higher, p < 0.0001) when compared to LBTI participants. In the responder analysis, those with active TB were associated with reporting improved scores at 6 months of at least the minimal important difference in vitality (odds ratio [OR], 2.7; 95% confidence interval [CI], 1.3 to 5.6), role physical (OR, 3.1; 95% CI, 1.4 to 6.5), mental component score (OR, 3.2; 95% CI, 1.5 to 6.9), social functioning (OR, 11.1; 95% CI, 3.8 to 33), and role emotional (OR, 2.7; 95% CI, 1.2 to 6.0). CONCLUSIONS: Active TB patients had large improvements in most HRQL domains by 6 months. However, when compared to LTBI participants and US norms, HRQL was still low at completion of therapy.     

Pulmonary function vascular index predicts prognosis in idiopathic interstitial pneumonia

Background and objective: Pulmonary hypertension (PH) is associated with increased mortality in fibrotic idiopathic interstitial pneumonia (IIP). We hypothesize that baseline K_CO (diffusing capacity of carbon monoxide/alveolar volume) and 6‐month decline in K_CO reflect PH, thus predicting mortality in IIP. Methods: All IIP referrals (2004–2007) were identified (n = 269). 192 had pulmonary function at 6 months. Fifty‐two (27%) died during follow‐up (median 22.5 months). Outcome was evaluated for early (1 year from 6‐month pulmonary function) and overall mortality. A vascular index best predicting mortality was identified (using baseline and 6‐month decline in K_CO) and evaluated against PH at echocardiography. Results: Baseline and 6‐month decline in K_CO were associated with early and overall mortality. A positive vascular index (baseline K_CO% ≤ 50% and/or ≥15% decline in K_CO at 6 months; n = 40) was strongly predictive of early and overall mortality. Neither a diagnosis of idiopathic pulmonary fibrosis nor PH predicted early death when incorporated into this model. In patients without baseline PH, with follow‐up echocardiography (n = 60), a positive vascular index was associated with PH at follow‐up. Conclusions: A vascular index comprised of baseline and 6‐month decline in K_CO strongly predicted increased mortality and development of PH on echocardiography. In, K_CO may be an important marker for pulmonary vascular disease and its associated mortality.     

Developing a senior healthcare practice using the chronic care model: effect on physical function and health-related quality of life

An ambulatory senior health clinic was developed using the chronic care model (CCM), with emphasis on an interdisciplinary team approach. To determine the effect of this care model approach in a nonprofit healthcare system, an observational, longitudinal panel study of community-dwelling Medicare beneficiaries was performed to examine the effect on physical function and health-related quality of life (HRQL). Participants in the study were recruited from a community sample of 6,864 eligible Medicare beneficiaries. Informed consent and baseline data were obtained from 1,709 individuals (recruitment response rate=25%) and complete data across 30 months from 1,307 (completion response rate=76%). Participants receiving care in the CCM-based senior healthcare practice (n=318) were compared with patients of primary care physicians supported by care managers (n=598) and a group without care managers (n=391). Self-reported data were collected over the telephone to measure physical function and HRQL at baseline and 6, 18, and 30 months. A multiple group mixture growth model was used to analyze physical function and HRQL across the 30 months. Physical function and HRQL mean scores decreased across time in all participants and were moderately correlated at each wave (correlation coefficient=0.74–0.79). Two latent growth classes were identified. In class 1, physical function decreased, and HRQL remained stable across time. In class 2, physical function and HRQL decreased in parallel. Ninety-seven percent of intervention group patients were in class 1, and 99% of patients in comparison groups 1 and 2 were in class 2. Despite physical function decline, patients in a senior health clinic care model maintained HRQL over time, whereas patients receiving traditional care had physical function and HRQL decline. An interdisciplinary team CCM approach appears to have a positive effect on HRQL in this population.     

Age, functional capacity, and health-related quality of life in patients with heart failure

BACKGROUND: Although heart failure disproportionately affects older persons and is associated with significant physical disability, existing data on physical limitations and health-related quality of life (HRQL) derive largely from studies of younger subjects. We compared the relationship between functional limitation and HRQL between older and younger patients with heart failure. METHODS AND RESULTS: We evaluated 546 outpatients with heart failure enrolled in a multicenter prospective cohort study. At baseline and 6 +/- 2 weeks later, functional status was assessed by New York Heart Association (NYHA) classification and 6-minute walk testing. HRQL was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ). Comparing older (age >65 years, n = 218) and younger patients (n = 328), we assessed baseline HRQL across strata of functional status. In the 484 patients who completed follow-up (194 older and 290 younger patients), we also assessed the changes in HRQL associated with changes in functional status over time. At baseline, older patients had better HRQL than younger patients (mean KCCQ score 60 +/- 25 versus 54 +/- 28, P = .005) in spite of worse NYHA class (mean 2.54 versus 2.35, P < .001) and lower 6-minute walk distances (824 +/- 378 versus 1064 +/- 371 feet, P < .001). After multivariable adjustment including baseline NYHA class, older age was independently correlated with better HRQL (beta = +7.9 points, P < .001). At follow-up, older patients with a deterioration in NYHA class experienced marked declines in HRQL compared with younger patients (mean HRQL change of -14.4 points versus +0.3 points, respectively, P < .001). Analyses using 6-minute walk distance as the functional measure yielded similar results. CONCLUSIONS: Although older patients with heart failure have relatively good HRQL in spite of significant functional limitations, they are at risk for worsening HRQL with further decline in functional status. These results underscore the importance of treatments aimed at maintaining functional status in older persons with heart failure, including those with significant baseline functional limitations.     

肺动脉高压对扩张型心肌病预后的影响

目的探讨肺动脉高压对扩张型心肌病患者的预后影响。方法连续入选2016年1月-2018年12月在本院住院的扩张型心肌病患者。肺动脉高压定义为最大三尖瓣反流速度>3.0 m/s。随访患者主要终点包括全因死亡、植入型心脏复律除颤器治疗和因心力衰竭住院。结果共入选139例扩张型心肌病患者,基线平均左室射血分数为31%±5%,其中43.88%的患者合并肺动脉高压。中位随访15个月(1~33个月)期间,33. 09%的患者发生主要心血管不良事件。合并肺动脉高压患者发生主要心血管不良事件风险显著增高(HR 2.202,95%CI 1.151~4.213,P<0. 01)。结论在扩张型心肌病患者中,合并肺动脉高压的预后差。     

Correlates of health-related quality of life among lower-income, urban adults with congestive heart failure

BACKGROUND: Improving health-related quality of life (HRQL) is a primary goal in the treatment of patients with congestive heart failure (CHF), yet few studies have explored correlates of HRQL among CHF patients. OBJECTIVES: We report on the association of demographic and pathophysiologic measures, social-cognitive measures, and environmental variables with HRQL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), Chronic Heart Failure (CHQ), and a single question of perceived overall health (PH). METHODS: Cross-sectional data were obtained from the baseline interview and electronic medical records of 212 patients 50 years of age and older who were enrolled during the first 7 months of a medication adherence study. RESULTS: Mean age was 63; 32% were male; 53% were black; the mean Charlson comorbidity score was 3.7; and the mean New York Heart Association class was 2.1. Correlations between KCCQ and CHQ subscale scores and PH ranged from 0.16 to 0.37. Multivariate regression analyses showed that the pathophysiologic measures ejection fraction and comorbidity were not associated with any of the HRQL measures. Overall PH was associated with greater age and more positive health beliefs. Persons of greater age, males, and black respondents had higher CHF-specific HRQL scores, as did persons reporting more positive health beliefs, greater income, social support, and communication with their physician. Variance explained ranged from 14 to 33%. CONCLUSION: These cross-sectional data highlight the potential significance of social and behavioral factors in CHF-specific HRQL.     

Change in health-related quality of life in patients with coronary artery disease predicts 4-year mortality

Aims

Self-reported health-related quality of life (HRQL) and changes in HRQL have been shown to predict mortality and/or adverse events in patients with coronary artery disease. MacNew Heart Disease HRQL questionnaire scores were examined as predictors of 4-year all-cause mortality.

Methods

Following referral for angioplasty in 385 patients with coronary artery disease, data were analyzed for differences in all-cause mortality by MacNew Global and subscale baseline and 1- and 3-month change scores (deteriorated ≥ 0.50; unchanged (− 0.49 to + 0.49); and improved ≥ 0.50 points).

Results

Mean baseline, 1-month, and 3-month MacNew Global and subscale scores were similar in survivors and non-survivors. Mean 1- and 3-month Global and emotional subscale and mean 1-month social subscale change scores decreased more in non-survivors than survivors. Compared with patients whose Global MacNew HRQL scores improved at one month, 4-year all-cause mortality hazard ratio (HR) was higher in patients whose HRQL deteriorated (HR, 1.70, 95% CI, 1.09, 2.65; p = 0.021). Compared with patients whose Global MacNew HRQL improved at three months, 4-year all-cause mortality was higher in both patients whose HRQL had deteriorated (HR, 2.07, 95% CI, 1.29, 3.32; p = 0.003) and patients with unchanged HRQL (HR, 2.62, 95% CI, 1.11, 6.17; p = 0.028).

Conclusions

A deterioration of ≥ 0.50 points in MacNew HRQL Global scores at both one and three months is predictive of 4-year all-cause mortality. Serial HRQL information may be useful to identify patients at higher risk for adverse cardiac events and mortality and may have implications for determining follow-up frequency and treatment in individual patients.     

Health-related quality of life after coronary artery bypass grafting surgery and the role of gender

ObjectiveHeart disease is the leading cause of death for women. Previous studies suggest that women undergoing coronary artery bypass (CABG) surgery present with a higher severity of disease and that this may be an indicator of delays in treatment preceding diagnosis thus presenting challenges for recovery. The aim of this study was to examine gender differences in CABG morbidity and reported health-related quality of life (HRQL) at baseline and six months post-surgery. It was hypothesized that female gender would be an independent predictor for lower HRQL at six months following CABG surgery.MethodsFour hundred and ninety-six (n = 496) adult patients who underwent a first-time, isolated CABG procedure with baseline and 6-month follow-up were included. Stepwise multivariate regressions were conducted to evaluate the factors predictive of 6-month HRQL scores.ResultsFemales had more preoperative co-morbidities and scored significantly lower on HRQL compared to males at both baseline (p values < 0.01) and six months (p values < 0.01) on all ten domains. Gender was a significant predictor of 6-month HRQL in regression models for 8 out of 10 HRQL domains including Physical Component Summary score (B = ? 2.54, p = 0.02).ConclusionsFemale patients were at higher risk as reflected by their perioperative risk factors and baseline HRQL. These findings may reflect a delayed referral for surgery. Results indicated that female gender predicts lower HRQL 6-months post-CABG surgery, which can have an impact on recovery and outcomes. Efforts should be made to identify and treat female patients earlier to improve post-surgical outcomes.     

Type-D personality but not implantable cardioverter-defibrillator indication is associated with impaired health-related quality of life 3 months post-implantation.

AIMS: Little is known about the impact of ICD indication (primary vs. secondary) on health-related quality of life (HRQL). Indication may also interact with psychological factors, such as personality. Using a prospective design, we examined whether ICD indication and type-D personality (i.e. experiencing increased negative emotions paired with emotional non-expression) serve as modulators of HRQL at baseline and 3 months post-implantation. METHODS AND RESULTS: Consecutively implanted ICD patients (n = 154) completed the Type-D Scale (DS14) at baseline and the Short-Form Health Survey 36 (SF-36) at baseline and 3 months. Of all patients, 82 (53%) received an ICD due to prophylactic reasons; the prevalence of type-D was 23%. Indication had no influence on HRQL (P = 0.75). Further stratification by personality showed a main effect for type-D personality (P < 0.001), with type-D patients generally experiencing poorer HRQL; there was no main effect for indication (P = 0.45) nor was the interaction effect indication by type-D significant (P = 0.22). There was a significant improvement in HRQL over time (P = 0.001). Type-D remained an independent predictor of impaired HRQL, adjusting for clinical factors and shocks during follow-up (P < 0.001). However, in adjusted analysis there was no longer a significant change in HRQL over time (P = 0.099). CONCLUSION: Type-D personality but not ICD indication was associated with impaired HRQL at the time of implantation and at 3 months. In the quest for enhancing risk stratification in clinical practice, personality factors, such as type-D, should not be ignored, as both type-D and poor HRQL have been associated with increased risk of mortality in cardiac patients.     

Baseline nutritional status is predictive of response to treatment and survival in patients treated by definitive chemoradiotherapy for a locally advanced esophageal cancer

OBJECTIVES: To assess the impact of baseline nutritional status on treatment response and survival in nonmetastatic patients with a locally advanced esophageal cancer (LAEC) treated with definitive chemoradiotherapy (CRT). METHODS: One hundred five patients with LAEC treated by definitive CRT were retrospectively included. The CRT regimen was based on an external radiotherapy (RT) delivered concomitantly to a cisplatin-based chemotherapy (CT). Patients were considered to have a complete response (CR) to CRT when no residual tumor was detected on CT scan and esophagoscopy performed 2 months after the end of CRT. Multivariate analysis of predictive factors of response to CRT and survival were performed using a logistic regression and a Cox model, respectively. RESULTS: Mean value of baseline nutritional parameters was significantly different between nonresponder (N = 42) and responder (N = 63) patients to CRT (weight loss 10%vs 5.8%, P= 0.0047; serum albumin level 35 g/L vs 38.7 g/L, P= 0.0004; BMI 22.8 kg/m2vs 25.2 kg/m2, P= 0.01). In multivariate analysis, serum albumin level > 35 g/L was the only independent predictive factor of CR to CRT (P= 0.009). Independent prognostic factors of survival were BMI > 18 kg/m2 (P= 0.003), dysphagia Atkinson score <2 (P= 0.008), dose of RT > 50 Grays (Gy) (P < 0.0001) and CR to CRT (P < 0.0001). CONCLUSIONS: Survival was influenced by baseline nutritional status as well as dysphagia, dose of RT, and CR to CRT. Despite the retrospective design of the study, our results may provide the concept basis for performing a prospective nutritional intervention study in patients treated by definitive CRT for an esophageal cancer.     

Response‐adjusted ISS (RaISS) is a simple and reliable prognostic scoring system for predicting progression‐free survival in transplanted patients with multiple myeloma

Complete response (CR) is associated with better outcome in patients with multiple myeloma (MM) treated with autologous transplant even though the progression‐free survival (PFS) can be very variable among patients with good response. No simple and reliable prognostic scoring system, able to predict the duration of response, are so far available. Aim of this study was to identify any correlation between baseline clinical findings, response after transplant and the length of PFS, and thus develop a prognostic model. The new prognostic model was developed in a learning cohort of 549 patients with MM transplanted in five Italian hospitals. The prognostic value of this new score was confirmed in a validation cohort of 276 distinct patients with MM transplanted in two different Italian hospital. Univariate and multivariate analyses were performed using Cox models. The most important independent baseline predictor of transplant outcome, together with response after transplant, was International Staging System (ISS). We thus incorporated response to transplant and baseline ISS in a new scoring system, named response‐adjusted international scoring system (RaISS), that was able to classify patients in three risk groups (low, intermediate, high) with different probabilities of progression after transplant (median PFS 35.9–15.4 months). The prognostic value of this new score was confirmed in the validation cohort. In conclusion, RaISS is a new simple and easily available scoring system that, accurately defining the risk of progression, can allow to identify patients who could deserve further treatment after transplant (consolidation, maintenance). Am. J. Hematol. 2011. © 2011 Wiley Periodicals, Inc.     

Effects of aging and long-term caloric restriction on hepatic microsomal monooxygenases in female fischer 344 rats: Alterations in basal cytochrome P-450 catalytic activities

The effects of aging and caloric restriction on uninduced levels of hepatic microsomal cytochrome P-450s and specific P-450-related catalytic activities were evaluated in female Fischer 344 rats. Microsomes were isolated from livers of ad libitum (AL) fed rats 1, 3, 6, 16 and 26 months of age, and from calorie-restricted (CR) rats 6, 16 and 26 months of age. The recovery of microsomal protein was higher in CR than AL rats at 6, 16 and 26 months of age. Between ages 3 and 26 months there was a gradual decline in recovered microsomal P-450, but the differences between successive age categories were not significant. A different trend was observed for total cytochrome P-450 per liver. AL rats showed a 2-fold decline in P-450/liver between 6 and 26 months of age, while P-450/liver of corresponding CR rats increased 1.7-fold. Neither cytochrome b₅ nor NADPH cytochrome C reductase varied consistently as a function of increased age, with all age groups showing greater reductase activity for CR rats than for AL rats. Phenobarbital (PB) and methylcholenthrene (MC) inducible cytochrome P-450 catalytic activities (pentoxy [PROD] and ethoxy [EROD] resorufin O-deethylases) exhibited similar age-related alterations that were distinctly different from the two other enzymes examined. Both PROD and EROD showed dramatic declines in activity between 1 and 3 months of age, with a slight increase in activity at 6 months and maintenance of the activity levels through 26 months. Benzphetamine N-demethylase (BND) and aniline p-hydroxylase (APH) activities were also altered as a function of increased age, with CR rats exhibiting increased isozyme activity above that seen for aging AL rats. Calorie restriction appears to have a modulating effect, compensating for an age-related decline of hepatic microsomal monooxygenase activity in female Fischer 344 rats.     

First report of outcomes in patients with stage IIIb AL amyloidosis treated with Dara–VCD front-line therapy

Although Dara–VCD (daratumumab–bortezomib–cyclophosphamide–dexamethasone) has revolutionized the treatment of newly diagnosed Amyloid Light chain (AL) amyloidosis, patients with stage IIIb disease were excluded in the pivotal trial. We performed a multicentre retrospective cohort study to investigate the outcomes of 19 consecutive patients treated with Dara–VCD front-line therapy who had stage IIIb AL at diagnosis. More than two thirds presented with New York Heart Association Class III/IV symptoms, and had a median of two organs involved (range, 2–4). The haematologic overall response rate was 100%, with 17/19 patients (89.5%) achieving a very good partial response (VGPR) or better. Haematologic responses were achieved rapidly, as evidenced by 63% of evaluable patients with involved serum free light chains (iFLC) < 2 mg/dl and the difference between involved and uninvolved serum free light chains (dFLC) <1 mg/dl at three months. Among 18 evaluable patients, 10 (56%) achieved a cardiac organ response and six (33%) cardiac VGPR or better. The median time to first cardiac response was 1.9 months (range, 0.4–7.3). At a median follow-up of 12 months for surviving patients, estimated one-year overall survival was 67.5% [95% confidence interval (CI), 43.8–84.7]. The incidence of grade 3 or higher infections was 21%, with no infection-related mortality thus far. In summary, Dara–VCD has a promising efficacy and safety profile in stage IIIb AL, and should be studied in prospective trials.     

Endoscopic,deep mural implantation of Enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial

OBJECTIVES: This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD. METHODS: Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score < or = 11 on PPI and > or = 20 off PPI, and 24-hour PH probe with > or = 5% total time at PH < or = 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period. RESULTS: At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p < 0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p < 0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation. CONCLUSIONS: The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.     

Paradoxical Herniation After Unilateral Decompressive Craniectomy Predicts Better Patient Survival: A Retrospective Analysis of 429 Cases

Paradoxical herniation (PH) is a life-threatening emergency after decompressive craniectomy. In the current study, we examined patient survival in patients who developed PH after decompressive craniectomy versus those who did not. Risk factors for, and management of, PH were also analyzed.This retrospective analysis included 429 consecutive patients receiving decompressive craniectomy during a period from January 2007 to December 2012. Mortality rate and Glasgow Outcome Scale (GOS) were compared between those who developed PH (n = 13) versus those who did not (n = 416). A stepwise multivariate logistic regression analysis was carried out to examine the risk factors for PH.The overall mortality in the entire sample was 22.8%, with a median follow-up of 6 months. Oddly enough, all 13 patients who developed PH survived beyond 6 months. Glasgow Coma Scale did not differ between the 2 groups upon admission, but GOS was significantly higher in subjects who developed PH. Both the disease type and coma degree were comparable between the 13 PH patients and the remaining 416 patients. In all PH episodes, patients responded to emergency treatments that included intravenous hydration, cerebral spinal fluid drainage discontinuation, and Trendelenburg position. A regression analysis indicated the following independent risk factors for PH: external ventriculostomy, lumbar puncture, and continuous external lumbar drainage.The rate of PH is approximately 3% after decompressive craniectomy. The most intriguing findings of the current study were the 0% mortality in those who developed PH versus 23.6% mortality in those who did not develop PH and significant difference of GOS score at 6-month follow-up between the 2 groups, suggesting that PH after decompressive craniectomy should be managed aggressively. The risk factors for PH include external ventriculostomy, ventriculoperitoneal shunt, lumbar puncture, and continuous external lumbar drainage.     

Reduction in oral corticosteroid use with mometasone furoate dry powder inhaler improves health-related quality of life in patients with severe persistent asthma.

Severe persistent asthma can have a substantial impact on a patient's health-related quality of life (HRQL), both as a result of symptoms and from side effects of treatment. The HRQL impact of two doses (400 and 800 microg twice daily) of mometasone furoate dry powder inhaler (MF DPI) was compared with placebo in patients with severe persistent asthma previously maintained on oral steroids as a component of a previously published randomized, 12-week, double-blind, placebo-controlled, multicenter trial. A 9-month open-label extension (OLE), with all patients treated with MF DPI, followed. Patients 12 years of age or older completed a generic HRQL measure, the Medical Outcomes Trust Short Form-36 (SF-36), and an asthma-specific measure, the Marks Asthma Quality of Life Questionnaire (AQLQ-M), at baseline, at endpoint (last evaluable visit) of the double-blind phase (EODBP), and after the first 3 months of the OLE. Of 132 patients enrolled in the study, 128 provided HRQL data at baseline and at EODBP. Mean SF-36 scores at baseline showed significant HRQL impairment compared with U.S. general population norms. With treatment, the reduction in oral corticosteroid (OCS) requirements of the MF-DPI-treated groups was accompanied by significant (p < 0.05) improvement over placebo in the physical domain of HRQL (SF-36 physical component summary score and the physical function subscale) at EODBP. MF-DPI-treated patients also showed significant improvements at EODBP in each of the four subscales of the AQLQ-M (p<0.05). From EODBP to the OLE 3-month endpoint, patients treated with MF DPI twice daily maintained, or improved, SF-36 scores in most domains. Symptomatic improvement and reduction in OCS use with MF DPI were accompanied by significant improvement in HRQL in patients with severe persistent asthma. These improvements were maintained during the 3-month period of the OLE in which HRQL was evaluated.     

A risk stratification for systemic immunoglobulin light-chain amyloidosis with renal involvement

Renal involvement is found in about 70% of patients with systemic immunoglobulin light-chain (AL) amyloidosis. However, there is no risk stratification system specialized for renal AL concerning patients’ survival. Galectin-3 (Gal-3) has been reported to portend poor prognosis in other renal diseases. We measured Gal-3 and several traditional risk biomarkers of AL in baseline samples from 253 consecutive patients diagnosed with renal AL. At baseline, Gal-3 [Hazard ratio (HR): 1·46; P = 0·033], high-sensitivity cardiac troponin T (hs-cTnT) (HR: 2·65; P < 0·001) and difference between involved and uninvolved free light chains (dFLC) (HR: 1·81; P = 0·001) were independent predictors of all-cause mortality. The cut-off points for Gal-3, hs-cTnT, and dFLC were 20·24 ng/ml, 0·026 ng/ml, and 75·89 mg/l, respectively. Patients were stratified into four stages by assigning a score of 1 for each of the three biomarkers above the cut-off point. The proportions of patients with disease stages 1, 2, 3 and 4 were 17·0%, 37·2%, 29·2% and 16·6%, and the median overall survival times from diagnosis were 100, 60, 29 and 15 months, respectively (P < 0·01). Higher level of Gal-3 is associated with increased risk for mortality, and the risk stratification based on Gal-3 is a reliable model for predicting mortality in AL amyloidosis with renal involvement.     

Elevated fibrinogen and homocysteine levels enhance the risk of mortality in patients from a high-risk preventive cardiology clinic

Fibrinogen (Fib) plays an important role in platelet aggregation and thrombus formation, and homocysteine (tHcy) causes endothelial dysfunction and injury. Therefore, an interaction toward an enhanced risk of thrombotic events and consequent mortality might be expected in patients with both factors elevated. To determine whether patients exposed jointly to high Fib and high tHcy were at increased risk of mortality, we compared them with those with only one or neither risk factors elevated. Prevalence of coronary artery disease (cross-section) and short-term mortality (30+/-14 months) were assessed in 2084 patients with available baseline tHcy and Fib. Upper quartiles were used to define high tHcy (>14.2 micromol/L) and high Fib (>382 mg/dL). Cox models adjusting for Framingham risk score, creatinine, and coronary artery disease status were used to estimate the risk of high tHcy and high Fib and their combinations. Mean age of the patients was 56+/-12 years (35% women) with 71 (3.4%) recorded deaths. Risk-adjusted longitudinal models showed a hazard ratio of 2.14 (P=0.03) for isolated high tHcy, 2.28 (P=0.02) for isolated high Fib, and 3.29 (P<0.001) for both high tHcy and high Fib in comparison with neither risk factor high. Independence of each parameter and lack of synergism was found on longitudinal as well as cross-sectional analyses. Conjoint elevation of Fib and tHcy increased the risk of death by approximately 3-fold in three years. Although no significant interaction between Fib and tHcy was demonstrated, both provided independent information after adjustment for traditional risk factors.