Aims Haptoglobin (Hp) genotype 2-2 increases cardiovascular diabetes complications. In type 2 diabetes, α-tocopherol was shown to lower cardiovascular risk in Hp 2-2, potentially through HDL function improvements. Similar type 1 diabetes data are lacking. We conducted a randomized, cross-over pilot of α-tocopherol supplementation on HDL function (i.e. cholesterol efflux (CE) and HDL-associated lipid peroxides (LP)) and lipoprotein subfractions in type 1 diabetes. Methods Hp genotype was assessed in members of two Allegheny County, PA type 1 diabetes registries and the CACTI cohort; 30 were randomly selected within Hp genotype, and 28 Hp 1-1, 31 Hp 2-1 and 30 Hp 2-2 were allocated to daily α-tocopherol or placebo for 8 weeks with a 4-week wash-out. Results Baseline CE decreased with the number of Hp 2 alleles (p-trend=0.003). There were no differences in LP or lipoprotein subfractions. In intention-to-treat analysis stratified by Hp, α-tocopherol increased CE in Hp 2-2 (beta=0.79, p=0.03) and LP in Hp 1 allele carriers (betaHp 1-1=0.18, p=0.05 and betaHp 2-1 =0.21, p=0.07); reduced HDL particle size (beta=−0.07, p=0.03) in Hp 1-1 carriers; increased LDL particle concentration in Hp 1-1 and decreased it in Hp 2-2 carriers. However, no significant interactions were observed by Hp. Conclusions In this type 1 diabetes study, HDL function worsened with the number of Hp 2 alleles. α-tocopherol improved HDL function in Hp 2-2 carriers and appeared to adversely affect lipid peroxides and lipoprotein subfractions among Hp 1 allele carriers. As no significant interactions were observed, findings require replication in larger studies.
OBJECTIVETo determine whether type A behavior predicts all-cause mortality and incident coronary artery disease (CAD) in a type 1 diabetic population.RESEARCH DESIGN AND METHODSFollow-up data (22 years) from the Pittsburgh Epidemiology of Diabetes Complications (EDC) study of childhood-onset type 1 diabetes were analyzed for the 506 participants who completed the Bortner Rating Scale (measuring type A behavior) and Beck Depression Inventory (BDI) at baseline (1986–1988). CAD comprised myocardial infarction as determined by hospital records/Q waves on electrocardiogram (ECG), CAD death (determined by a mortality classification committee), angiographic stenosis, ischemic ECG, and angina.RESULTSThere were 128 deaths (25.3%) during follow-up. Univariate analysis showed an inverse relationship between Bortner scores and all-cause mortality (P = 0.01), which remained significant after allowing for age, sex, duration, HbA1c, education, smoking, BMI, and physical activity (P = 0.03). However, the addition of BDI scores attenuated the relationship (P = 0.11) with a significant interaction (P = 0.03) such that any protective effect against mortality was limited among individuals with lower BDI scores (bottom three quintiles) (P = 0.07), whereas no effect was seen in those with higher BDI scores (P = 0.97). Bortner scores showed only a borderline association with incident CAD (P = 0.09).CONCLUSIONSThose with higher type A behavior have lower all-cause mortality in our type 1 diabetic population, an effect that interacts with depressive symptomatology such that it is only operative in those with low BDI scores. Further research should focus on understanding this interaction.
IntroductionAcute myeloid leukemia (AML) imposes significant burden on patients, their families, and the healthcare system. Published literature has reported many AML signs and symptoms, as well as their impact on patients. However, there are no publications on the experience of living with AML from the patient's perspective. In this study, we performed qualitative interviews with patients with AML to understand their experience.MethodsParticipants were recruited from the US and Japan. All patients were screened to assess eligibility, and were divided into four subgroups (i.e., newly-diagnosed, high-intensity chemotherapy; newly-diagnosed, low-intensity chemotherapy; relapse/refractory; and post-transplant). Patients were interviewed over the phone by a trained researcher and asked about their day-to-day experience with AML. Signs/symptoms and impacts were coded, analyzed using Atlas.ti software, and reported as frequencies, with the medians of patient-reported disturbance levels (0–10) computed for each symptom and impact.ResultsThe most commonly reported sign/symptom in the US was fatigue (95.7%), followed by bruising and weakness (both 78.3%), and in Japan, nausea (94.4%), followed by fatigue and headache (both 88.9%). The most commonly reported impact in the US was a decreased ability to maintain social/familial roles (91.3%), followed by anxiety and a decreased ability to function (both 87.0%), and most commonly reported in Japan was anxiety, a decreased ability to function, and remission uncertainty (94.4%).ConclusionAlthough the frequency of signs/symptoms and their level of disturbance varied between the US and Japan, there was remarkable consistency in the types of signs/symptoms and impacts reported across all patients. The consistency in the experience of the disease across patients suggests that measurement of AML experience can be achieved by using the same tool for most, if not all, of these patients.FundingAstellas Pharma Inc., Northbrook, IL, USA.Electronic supplementary materialThe online version of this article (doi:10.1007/s40487-016-0029-8) contains supplementary material, which is available to authorized users.
A 1 -A 3 1 8 progression on health-related quality of life (HRQOL). We report findings from a prospective medical record registry that examined HRQOL as measured by patient reported outcomes (PROs) in patients (pts) newly diagnosed with advanced NSCLC through one year of follow-up. Methods: Pts starting first-line treatment of stage IIIB/IV nonsquamous NSCLC were prospectively enrolled and consented at 34 US-based community oncology settings. PROs were collected once per cycle during treatment, and at each visit if patients discontinued treatment. PROs included the EORTC QLQ-C30 and QLQ-LC13, the MDASI-LC, and the Rotterdam Activity Level Scale (RALS). Results: Of 155 eligible pts enrolled, 145 provided follow-up data, including 1,100 PRO surveys. Pts received standard, widely used chemotherapy regimens, and were 58.5% male, 86.4% Caucasian, with mean age 64.8 (±10.9) years. 13.6% had impaired performance status (ECOG 2+ or equivalent). PFS events occurred in 141 of 147 pts (95.9%) based on scan records and physician progress notes, with overall median PFS of 5.59 (4.83-6.25) months. Fifty-nine pts provided PRO data after disease progression. Linear mixed models showed that disease progression was associated with significant or near significant adverse impact on HRQOL in 18 of 32 PRO endpoints. Among the 12 significant effects, the average adverse effect of disease progression was 5.7% of the instrument range, where 5% -10% change is the minimum important difference (Ringash, et al., 2007). The strongest effects were QLQ-LC13, Sore mouth (8.0%) and Dyspnea (7.3%), and QLQ-C30 constipation (7.6%). Effects on the QLQ-C30 Global Health Status and Physical Functioning measures were 4.7% and 5.3%, respectively (all p < 0.05). ConClusions: PROs showed significant and clinically meaningful worsening of symptoms at disease progression, as indicated by widely used HRQOL measures. objeCtives:To test the effectiveness of interventions to mitigate taste dysfunction (IMTD) on improving nutrition and health related quality of life (HRQoL) in a group of head and neck cancer treatment survivors (HNCTS). Methods: In order to test the theory that IMTD will improve nutrition and HRQoL in HNCTS, a prospective randomized trial was conducted. The sample for this pilot study was drawn from a pool of HNCTS seen in a surgery follow up clinic at a Midwestern academic medical center. The sample of adult head and neck cancer treatment survivors (n = 23) who had completed all treatment at least 3 months prior to participation where recruited over a six month period and followed for up to three post treatment data collection time points. Results: Significant improvements in taste scores were observed in the treatment group (p= 0.01). No significant differences in the dependent variables were observed between the treatment and control group. Dry mouth and oral/throat pain were negatively associated with taste scores. ConClusions: Tailored intervention may help improve in taste perception in head and neck cancer survivors. Greater attention to ...
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