Chronic myeloid leukemia (CML): association of treatment satisfaction, negative medication experience and treatment restrictions with health outcomes, from the patient's perspective.

BACKGROUND: The availability of the tyrosine-kinase inhibitor (TKI), imatinib, and later introduction of second generation TKIs, dasatinib and nilotinib, have not only improved clinical outcomes of patients with chronic myeloid leukemia (CML), but also provide multiple therapeutic options for CML patients. Despite the widespread use of these oral therapies, little is known about the impact of different treatment regimens on patient-reported outcomes (PROs) among CML patients. The objective of this study was to assess the impact of patient-reported treatment restrictions and negative medication experiences (NMEs) on satisfaction and other health outcomes among patients with CML treated with oral TKIs. METHODS: Participants recruited from survey panels and patient networks in the United States (US) and Europe completed an online questionnaire. Respondents included adults (≥ 18 years) with chronic-phase CML currently on TKI treatment. Study variables included treatment difficulty (i.e., difficulty in following treatment regimens), CML dietary/dosing requirements, NMEs, and validated PROs assessing treatment satisfaction, health-related quality of life (HRQoL), activity impairment, and non-adherence. Structural equation models assessed associations among variables, controlling for covariates. RESULTS: 303 patients with CML (US n=152; Europe n=151; mean age 51.5 years; 46.2% male) completed the questionnaire. Approximately 30% of patients reported treatment difficulties; treatment difficulty was higher among nilotinib (63.3%) than among dasatinib (2.6%) or imatinib (19.2%) treated patients (p<0.0001). Non-adherence was generally low; however, patients on nilotinib vs. imatinib reported missing doses more often (p<0.05). Treatment satisfaction was associated with significantly increased HRQoL (p<0.05) and lower activity impairment (p<0.01). NMEs were associated with decreased treatment satisfaction (p<0.01) and HRQoL (p<0.05), and greater activity impairment (p<0.01). Higher overall treatment restrictions were associated with greater treatment difficulty (p<0.001), which correlated with non-adherence (p<0.01). CONCLUSIONS: Treatment satisfaction and NMEs are important factors associated with HRQoL among patients with CML. Increased treatment restrictions and associated difficulty may affect adherence with TKIs. Choosing a CML treatment regimen that is simple and conveniently adaptable in patients' normal routine can be an important determinant of HRQoL and adherence.

Attainment of normal lipid levels among high cardiovascular risk patients: pooled analysis of observational studies from the United Kingdom, Sweden, Spain and Canada.

BACKGROUND: Although low-density lipoprotein cholesterol (LDL-C) is the primary lipid target for cardiovascular disease (CVD) risk reduction, high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG) have also emerged as risk factors. This study evaluated attainment of goal/normal lipid levels in current clinical practice among high-risk patients following lipid-modifying therapy (LMT). METHODS: Data for patients aged ≥35years and on LMT for ≥12months were identified from electronic medical records (United Kingdom and Sweden) and extracted from medical charts (Canada and Spain). High CVD risk was defined according to the Adult Treatment Panel III guidelines. An index period was defined, from January 1995-July 2008, during which patients received an initial LMT prescription. Prevalence of lipid abnormalities was assessed 12months before and after the index date. Multivariate logistic regressions evaluated predictors of attaining goal/normal lipid levels. RESULTS: Among 12,768 high-risk patients, 75% had elevated LDL-C, 37% low HDL-C, and 30% elevated TG before LMT. Despite therapy (97% statins only), 23% had elevated LDL-C, 36% low HDL-C, 16% elevated TG, and 17% had ≥2 abnormal lipid levels. Framingham risk score >20% (Odds Ratio, 95% confidence interval: 0.37,0.31-0.43), diabetes (0.75,0.64-0.88), hypertension (1.26,1.09-1.46), current smoker (0.82,0.70-0.95) and increased body mass index (0.95,0.94-0.96) were associated with the likelihood of attaining ≥2 normal lipid levels (vs. LDL-C goal only). CONCLUSION: Current approaches to lipid management improve LDL-C goal attainment; however, control of multiple lipid risk factors remains poor. Patients may benefit from more comprehensive approaches to lipid management, which treat multiple lipid abnormalities, as suggested in clinical guidelines.

Prospective studies on the relationship between high-density lipoprotein cholesterol and cardiovascular risk: a systematic review.

Epidemiological studies have extensively evaluated the association between high-density lipoprotein cholesterol (HDL-C) and cardiovascular disease (CVD) risk. The objective of this systematic review was to enumerate the number of original prospective studies that showed a significant association between HDL-C and CVD risk and provided evidence of the consistency of this association across other lipid risk factors. A systematic MEDLINE literature search identified 53 prospective cohort and five nested case-control studies that provided multivariate assessments of the association between HDL-C and CVD risk. Among these 58 prospective studies, 31 studies found a significant inverse association between HDL-C and CVD risk for all CVD outcomes and subpopulations studied, whereas 17 studies found a significant association for some CVD outcomes and/or subpopulations assessed. The ratio of studies that found a significant association out of the total studies identified was similar across all CVD outcomes, although there was less evidence for stroke and atherosclerotic outcomes. Only seven studies tested for the consistency of this association across other lipid risk factors, of which six studies suggested that the association was consistent across other lipid levels. In conclusion, the association between HDL-C and CVD risk is significant and strong, although further evidence may be needed to establish whether this association is consistent across other lipid risk factors. Furthermore, uncertainties remain regarding the mechanism in which HDL-C exerts its effects, suggesting a need for further research focused on new methods for reliable measurement.