Catherine Davis

Hypertension Knowledge, Awareness, and Attitudes in a Hypertensive Population

OBJECTIVE: Improved recognition of the importance of systolic blood pressure (SBP) has been identified as one of the major public health and medical challenges in the prevention and treatment of hypertension (HTN). SBP is a strong independent risk factor for cardiovascular disease but no information is available on whether patients understand the importance of their SBP level. The purpose of this study was to assess HTN knowledge, awareness, and attitudes, especially related to SBP in a hypertensive population.DESIGN/SETTING/PATIENTS: We identified patients with HTN (N=2,264) in the primary care setting of a large midwestern health system using automated claims data (International Classification of Diseases, Ninth Revision [ICD-9] codes 401.0–401.9). We randomly selected 1,250 patients and, after excluding ineligible patients, report the results on 826 completed patient telephone interviews (72% response rate [826/1,151]).MAIN RESULTS: Ninety percent of hypertensive patients knew that lowering blood pressure (BP) would improve health and 91% reported that a health care provider had told them that they have HTN or high BP. However, 41% of patients did not know their BP level. Eighty-two percent of all patients correctly identified the meaning of HTN as “high blood pressure.” Thirty-four percent of patients correctly identified SBP as the “top” number of their reading; 32% correctly identified diastolic blood pressure (DBP) as the “bottom” number; and, overall, only 30% of patients were able to correctly identify both systolic and diastolic BP measures. Twenty-seven percent of patients with elevated SBP and DBP (as indicated by their medical records) perceived that their BP was high. Twenty-four percent of patients did not know the optimal level for either SBP or DBP. When asked whether the DBP or SBP level was more important in the control and prevention of disease, 41% reported DBP, 13% reported SBP, 30% reported that both were important, and 17% did not know.CONCLUSIONS: These results suggest that, although general knowledge and awareness of HTN is adequate, patients do not have a comprehensive understanding of this condition. For instance, patients do not recognize the importance of elevated SBP levels or the current status of their BP control. An opportunity exists to focus patient education programs and interventions on the cardiovascular risk associated with uncontrolled HTN, particularly elevated SBP levels.

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

BackgroundThe 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.MethodsParticipants 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.Results303 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).ConclusionsTreatment 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.

The relative efficacy of imatinib, dasatinib and nilotinib for newly diagnosed chronic myeloid leukemia: a systematic review and network meta-analysis

ObjectivesDasatinib 100 mg daily and nilotinib 600/800 mg daily have been compared to imatinib as first line treatments for CML in two recent randomised studies. However, no head to head evidence exists of the relative efficacy of dasatinib and nilotinib.MethodsWe conducted a systematic literature review and used the data extracted to perform an indirect comparison meta-analysis of the three interventions.ResultsData from eight clinical studies (3,520 individuals) were included, all of which were of good quality (low risk of bias). At six months, the odds of complete cytogenetic response (CCyR) for dasatinib and nilotinib were approximately three times those for imatinib (range 2.77 to 3.06, all values not significant). At twelve months datatinib and nilotinib were significantly better than imatinib for both CCyR and major molecular response (MMR) (CCyR odds range 2.06 to 2.41, MMR odds range 2.09 to 2.87). At eighteen months dasatinib and nilotinib were again significantly better in terms of CCyR than imatinib (response odds 1.55 to 2.01). When dasatinib and nilotinib were compared to each other, for both clinical endpoints at all time points the response odds were not significantly different.ConclusionsOn the basis of a systematic review of the current literature base, dasatinib 100 mg, nilotinib 600 mg and nilotinib 800 mg should be viewed as equivalent in terms of complete cytogenetic and major molecular response.

Relationship between Treatment Effects on Progression-Free Survival and Overall Survival in Multiple Myeloma: A Systematic Review and Meta-Analysis of Published Clinical Trial Data

Background: Demonstrating improved overall survival (OS) with new multiple myeloma (MM) treatments is becoming difficult because of extended survival, so progression-free survival (PFS) is commonly used as a surrogate endpoint for OS. We evaluated PFS as a potential surrogate for OS by examining whether observed treatment effects on PFS are positively associated with treatment effects on OS in MM. Methods: A systematic literature review identified 21 randomized control trials reporting hazard ratios (HRs) for treatment effects on PFS and OS. Pearsons r estimated the relationship between HRs (HRPFS and HROS), and between log-transformed HRs (log(HRPFS) and log(HROS)). R2 values were estimated from linear regression models of the HR and the log(HR) relationships. Sensitivity and subgroup analyses examined the robustness of the HR findings. Results: Positive correlations were found between HRPFS and HROS (r = 0.82; p < 0.0001) and between log(HRPFS) and log(HROS) (r = 0.80; p < 0.0001). Linear regression models produced R2 values of 0.67 and 0.63 when regressing HROS on HRPFS, and log(HROS) on log(HRPFS), respectively. Sensitivity analyses supported the HR findings. Conclusion: This analysis provides evidence for a positive association between treatment effects on PFS and OS. Studies involving patient level data are necessary to confirm whether PFS is a valid surrogate for OS in MM.

The role of observational studies in optimizing the clinical management of chronic myeloid leukemia

Survival has increased dramatically for patients with chronic phase chronic myeloid leukemia (CP-CML) using BCR-ABL targeted tyrosine kinase inhibitors, such that life expectancy is expected to approximate that of patients without CP-CML. Randomized controlled trials (RCTs) and observational studies provide valuable insights into the management of chronic diseases such as CP-CML. RCTs are undoubtedly the backbone of clinical research, and the ‘gold standard’ for evaluating the efficacy and safety of new therapies. However, many questions surrounding the optimal management of patients with CML remain unanswered, and it is widely accepted that these questions will be best answered by evaluating the use of available therapies in clinical practice. Observational studies can extend the knowledge base beyond the clinical trial setting and thus capture a more accurate picture of everyday clinical practice, particularly patients’ experiences of long-term CML treatment. There is therefore growing interest in and appreciation of the value of observational research. This review article will examine the relative merits of RCTs and observational studies in the setting of CML, highlighting those factors – such as the advancing age of the CML patient population and growing importance of patient-reported outcomes – that mean that observational studies should play an important role in shaping clinical practice. This article also provides an overview of what observational studies have told us thus far about the optimal management of patients with CML, outlines some of the key remaining unanswered clinical questions in CML, and summarizes ongoing observational studies designed to provide answers to these key questions.

Treatment Sequencing Patterns And Costs of Care in Patients with Relapsed/Refractory Multiple Myeloma

N N Multiple myeloma (MM) is a cancer of plasma cells of the bone marrow, and the 5-year survival rate among patients with MM is 45%. N N Treatment practices are changing rapidly, with novel agents and stem cell transplantation now recommended for MM treatment. N N An analysis of data from 1999–2007 found that use of traditional chemotherapies has decreased substantially in the US, while use of novel agents (thalidomide, bortezomib, and lenalidomide) has increased. N N Despite the availability of novel therapies and a general improvement in survival, the unmet need continues to be high, with patients requiring multiple lines of treatment. N N As patients go through multiple relapses, the complexity of treatment regimens increases, likely increasing the burden on healthcare resources. N N The current analysis evaluates treatment regimens, sequences, and associated healthcare costs across lines of therapy of patients who have initiated a 2nd-line (2L) therapy.

Impact of elotuzumab treatment on pain and health-related quality of life in patients with relapsed or refractory multiple myeloma: results from the ELOQUENT-2 study

Treatment of relapsed/refractory multiple myeloma (RRMM) aims to prolong survival while maintaining health-related quality of life (HRQoL) by managing disease-related symptoms and complications—one of the most frequent and debilitating being bone pain. In the ELOQUENT-2 study (NCT01239797), which evaluated the addition of elotuzumab to lenalidomide plus dexamethasone versus lenalidomide plus dexamethasone, pain and HRQoL were assessed in patients with relapsed/refractory disease using the Brief Pain Inventory–Short Form (BPI-SF) and the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Core 30 module (QLQ-C30) and myeloma-specific module (QLQ-MY20). Mean baseline pain scores were low and remained so throughout treatment with both regimens; mean HRQoL scores did not change substantially from baseline. A significantly higher proportion of patients with objective response than without had clinically meaningful improvements in worst pain over two consecutive treatment cycles (29 versus 12%; p < 0.001). Patients with very good partial response (VGPR) or better reported reduced scores for pain severity and worst pain; those with progressive disease reported increased scores for these domains and pain interference. These findings show that previously reported improvements in progression-free survival and response rate with elotuzumab are achieved without detriment to HRQoL, which is maintained over time.