Incidence and risk of hypertension in patients newly treated for multiple myeloma: a retrospective cohort study.

BACKGROUND: Hypertension is commonly reported in multiple myeloma (MM) patients and may be associated with older age, disease-related complications and consequences of MM treatments. This study evaluated the incidence rates of and risk factors for hypertension and malignant hypertension in newly-treated MM patients in the United States. METHODS: Newly-treated adult MM patients were identified from Truven MarketScan claims database from 1/1/05 to 3/31/14. Inclusion criteria were new diagnosis of MM with start of MM treatment, ≥12 months continuous enrollment prior to diagnosis, ≥30 days of continuous enrollment following initial diagnosis, and prescription drug coverage. Non-MM patients were matched for age (within +/- 5 years), sex and distribution of index dates to MM patients. Baseline cardiovascular (CV) comorbidities, incidence rate of hypertension and malignant hypertension in the follow-up period, and risk of hypertension and malignant hypertension based on existing baseline CV comorbidities were evaluated. RESULTS: A total of 7895 MM patients (38% with hypertension history) and 23,685 non-MM patients (24% with hypertension history) were included in the study. Twenty-two percent of MM patients versus 3% of non-MM patients had baseline renal failure. A higher percentage of MM versus non-MM patients had baseline hypertension in combination with renal failure, congestive heart failure or both. The incidence rate of hypertension in MM and non-MM patients was 260 and 178 per 1000 person-years, respectively. There was a 30% increase in the risk of hypertension for MM versus non-MM patients: hazard ratio (HR) 1.30 (95% confidence interval [CI] 1.22, 1.37). In MM patients with a history of hypertension, the risk of malignant hypertension was significantly increased with the following comorbid conditions: cardiomyopathy, HR 2.79 (95% CI 1.20, 6.48); renal failure, HR 2.13 (95% CI 1.36, 3.34); and diabetes mellitus, HR 1.59 (95% CI 1.05, 2.39). CONCLUSIONS: This study confirms that the incidence of hypertension and malignant hypertension is significantly higher in newly-treated MM versus non-MM patients. Hypertension is a risk factor for MM patients developing malignant hypertension. Management of CV comorbidities in MM patients is important based on the increased risk of hypertension and malignant hypertension among patients with these comorbidities.

Patient population with multiple myeloma and transitions across different lines of therapy in the USA: an epidemiologic model.

PURPOSE: Multiple myeloma (MM) is a progressive, malignant neoplasia with a worldwide, age-standardized annual incidence of 1.5 per 100 000 individuals and 5-year prevalence around 230 000 patients. Main favorable prognostic factors are younger age, low/standard cytogenetic risk, and undergoing stem cell transplantation. Our aim was to estimate the size of the patient population with MM eligible to receive a new MM therapy at different lines of therapy in the USA. METHODS: We constructed a compartmental, differential equation model representing the flow of MM patients from diagnosis to death, via two possible treatment pathways and distinguished in four groups based on prognostic factors. Parameters were obtained from published references, available statistics, and assumptions. The model was used to estimate number of diagnosed MM patients and number of patient transitions from one line of therapy to the next over 1 year. Model output included 95% credible intervals from probabilistic sensitivity analyses. RESULTS: The base-case estimates were 80 219 patients living with MM, including 70 375 on treatment, 780 symptomatic untreated patients, and 9064 asymptomatic untreated patients. Over a 1-year period, the number of MM patients on treatment line 1 was estimated at 23 629 (credible intervals 22 236-25 029), and the number of transitions from treatment line 1 to treatment line 2 was estimated at 14 423. CONCLUSIONS: The size of the patient population with MM on different lines of therapy and in patient subgroups of interest estimated from this epidemiologic model can be used to assess the number of patients who could benefit from new MM therapies and their corresponding budgetary impact. Copyright © 2016 John Wiley & Sons, Ltd.

Incidence of catheter-related complications in patients with central venous or hemodialysis catheters: a health care claims database analysis.

BACKGROUND: Central venous catheter (CVC) and hemodialysis (HD) catheter usage are associated with complications that occur during catheter insertion, dwell period, and removal. This study aims to identify and describe the incidence rates of catheter-related complications in a large patient population in a United States-based health care claims database after CVC or HD catheter placement. METHODS: Patients in the i3 InVision DataMart® health care claims database with at least 1 CVC or HD catheter insertion claim were categorized into CVC or HD cohorts using diagnostic and procedural codes from the US Renal Data System, American College of Surgeons, and American Medical Association's Physician Performance Measures. Catheter-related complications were identified using published diagnostic and procedural codes. Incidence rates (IRs)/1000 catheter-days were calculated for complications including catheter-related bloodstream infections (CRBSIs), thrombosis, embolism, intracranial hemorrhage (ICH), major bleeding (MB), and mechanical catheter-related complications (MCRCs). RESULTS: Thirty percent of the CVC cohort and 54% of the HD cohort had catheter placements lasting <90 days. Catheter-related complications occurred most often during the first 90 days of catheter placement. IRs were highest for CRBSIs in both cohorts (4.0 [95% CI, 3.7-4.3] and 5.1 [95% CI, 4.7-5.6], respectively). Other IRs in CVC and HD cohorts, respectively, were thrombosis, 1.3 and 0.8; MCRCs, 0.6 and 0.7; embolism, 0.4 and 0.5; MB, 0.1 and 0.3; and ICH, 0.1 in both cohorts. Patients with cancer at baseline had significantly higher IRs for CRBSIs and thrombosis than non-cancer patients. CVC or HD catheter-related complications were most frequently seen in patients 16 years or younger. CONCLUSIONS: The risk of catheter-related complications is highest during the first 90 days of catheter placement in patients with CVCs and HD catheters and in younger patients (≤16 years of age) with HD catheters. Data provided in this study can be applied toward improving patient care.

Development and Validation of an Algorithm to Identify Patients with Multiple Myeloma Using Administrative Claims Data.

PURPOSE: The objective was to expand on prior work by developing and validating a new algorithm to identify multiple myeloma (MM) patients in administrative claims. METHODS: Two files were constructed to select MM cases from MarketScan Oncology Electronic Medical Records (EMR) and controls from the MarketScan Primary Care EMR during January 1, 2000-March 31, 2014. Patients were linked to MarketScan claims databases, and files were merged. Eligible cases were age ≥18, had a diagnosis and visit for MM in the Oncology EMR, and were continuously enrolled in claims for ≥90 days preceding and ≥30 days after diagnosis. Controls were age ≥18, had ≥12 months of overlap in claims enrollment (observation period) in the Primary Care EMR and ≥1 claim with an ICD-9-CM diagnosis code of MM (203.0×) during that time. Controls were excluded if they had chemotherapy; stem cell transplant; or text documentation of MM in the EMR during the observation period. A split sample was used to develop and validate algorithms. A maximum of 180 days prior to and following each MM diagnosis was used to identify events in the diagnostic process. Of 20 algorithms explored, the baseline algorithm of 2 MM diagnoses and the 3 best performing were validated. Values for sensitivity, specificity, and positive predictive value (PPV) were calculated. CONCLUSION: Three claims-based algorithms were validated with ~10% improvement in PPV (87-94%) over prior work (81%) and the baseline algorithm (76%) and can be considered for future research. Consistent with prior work, it was found that MM diagnoses before and after tests were needed.

A retrospective analysis to examine factors associated with mortality in Medicare beneficiaries newly diagnosed with multiple myeloma.

OBJECTIVE: Population-based data on mortality and associated factors in patients with multiple myeloma (MM) are limited. We examined the association between all-cause mortality and demographic and clinical characteristics in newly diagnosed MM patients treated with guideline-recommended chemotherapeutic agents. RESEARCH DESIGN AND METHODS: This retrospective cohort analysis used Medicare 20% data to create a cohort of adult (aged ≥18 years) newly diagnosed MM patients who received chemotherapy 2008-2011 and had no MM diagnosis in the 12 months before the disease index date. Patients were followed from treatment initiation through the earliest of death, loss of insurance coverage, or study end (December 2011). Modified Charlson Comorbidity Index scores and MM-related comorbid conditions (anemia, hypercalcemia, skeletal-related events) were identified in the 6 month pre-index-date period. All-cause mortality and associated factors were examined using multivariable Cox proportional hazard models. RESULTS: We identified 2419 newly diagnosed patients who received MM therapy during follow-up. Mean (SD) and median follow-up were 1.51 (1.0) and 1.37 years. Of the cohort, 55% were female, 78% white, and 92% aged ≥65 years. Pre-index, 54%, 9%, and 5% were diagnosed with anemia, hypercalcemia, and skeletal-related events. Overall, 942 (39%) patients died during follow-up. Factors associated with increased risk of death were older age (≥65 vs. 18-64 years; hazard ratio 1.49, 95% confidence interval 1.13-1.99), higher comorbidity score (≥4 vs. 0; 1.78, 1.43-2.21), anemia (1.23, 1.06-1.42), and hypercalcemia (1.45, 1.19-1.76); female sex (0.86, 0.75-0.98) was associated with decreased risk. CONCLUSIONS: Older age, male sex, high comorbidity burden, anemia, and hypercalcemia were risk factors for death in newly diagnosed Medicare MM patients. Study limitations included non-causal observational design, non-validated MM algorithm, potential treatment misclassification, and non-availability of prognostic factors including disease staging information, biomarkers, and other laboratory variables. Additional analyses are warranted to understand the relationship between treatments and death.