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Thrombosis Research 02/2013; · 2.44 Impact Factor
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ABSTRACT: The epidemiology of tamoxifen and venous thromboembolism (VTE) is not well understood, and most data on tamoxifen toxicity are from adjuvant clinical trials. This study examined the relationship between the duration of tamoxifen use in female patients with breast cancer and the risk of VTE in a large population-based setting.
Retrospective electronic data extraction on tamoxifen utilization was undertaken among a cohort of 3572 women with breast cancer seen at Marshfield Clinic between January 1, 1994 and June 31, 2009. Observational follow-up extended until February, 2010.
On initial exposure to tamoxifen, women had a clustering of VTE events. Cox proportional hazards regression, adjusting for multiple clinically-important covariates including age, body mass index, cancer stage, and concurrent diabetes, demonstrated that as use of tamoxifen continued in those without earlier VTE events, risk of subsequent VTE gradually increased, albeit at a lower rate (hazard ratio per year of tamoxifen duration=1.225, P <0.0001).
In our study population, initiating tamoxifen coincided with an initial clustering of VTE events, with risks due specifically to tamoxifen, increasing during continued exposure. Evidence suggested that the VTE clustering occurred in high risk individuals at initiation of tamoxifen therapy. Careful selection of patients for whom tamoxifen therapy is appropriate based on susceptibility to VTE is thus required prior to initiation of therapy.
Thrombosis Research 12/2011; 130(1):27-31. · 2.44 Impact Factor
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ABSTRACT: Background/Aims Tamoxifen is a widely prescribed endocrine therapy for prevention and treatment of breast cancer in pre- and post-menopausal women and is commonly recommended for five years duration. While most people tolerate tamoxifen reasonably well, thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction or cerebrovascular accident can be serious complications. Study aims include evaluation of epidemiology of tamoxifen-related thromboembolic event in a large community setting, determination of rate and temporal distribution of thromboembolic events, description of patient clinical characteristics, analysis of time from tamoxifen initiation to first thromboembolic event, description of incidence of events among subgroups of patients related to antiplatelet, anticoagulant and statin medication use. Methods Retrospective electronic extraction of tamoxifen-use patient data from Marshfield Clinic/ St. Joseph's Cancer Registry and the Marshfield Clinic Electronic Medical Record (EMR) from 1/1/1992 - 6/31/2009, with manual data validation. Medication use was identified by MedsManager and by Freepharma™. Thromboemoblic events and comorbidity diagnoses were identified by ICD9 codes, and cancer diagnosis by ICD9 code or inclusion in the Registry. Analysis included descriptive statistics, Kaplan-Meier estimates of event-free survival over time and estimates of event rates and hazard ratios. Risk factors were assessed in univariate and multivariate analyses. Results Primary analysis was limited to 3283 women with breast cancer. Mean age at first tamoxifen use was 62.1 years (range 22 - 97). Tamoxifen adherence rates (censored for death or 18 months after last visit) showed 88.6% of women on tamoxifen at year one, 78.1% at year 2, 67.4% at year 3 and 56.9% at year 4. Thromboembolic events (venous and arterial) occurred in 5% of women under age 45, 7% of women age 45-54, 14% in women age 55-64, 19% in women age 65-74 and 27% in women older than 75 years. Thromboembolism continued to occur over time, unlike other studies that reported clustering of thromboembolism in the first year. Conclusions Tamoxifen use should be recommended with caution, and patients monitored closely over the entire period of tamoxifen use for development or prevention of thromboembolic events. Further investigation into tamoxifen discontinuation rates is warranted.
Clinical Medicine & Research 11/2011; 9(3-4):150.
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ABSTRACT: A biomaterial composed of carboxymethylcellulose, poly(ethylene oxide), and calcium can be prepared in a variety of ways to reduce fibrin deposition and adhesion formation. This biomaterial platform can be formulated into a flowable gel with tissue adherence appropriate for use in minimally invasive surgery. The device remains at the site of placement even in gravitationally dependent areas. A peridural formulation was shown in preclinical studies to be safe and effective in reducing adhesions to dura following spinal surgery. A peritoneal formulation used on pelvic organs following peritoneal cavity surgery was also shown to be safe and effective. A clinical feasibility study showed that patients with severe back pain and lower extremity weakness treated with the peridural formulation, applied over their nerve roots following laminectomy or laminotomy, experienced significantly reduced symptoms when compared with surgery-only controls. The peritoneal formulation was shown in two multicenter feasibility studies of women undergoing pelvic surgery to significantly reduce adhesion formation when compared with surgery-only controls. Confirmation of the feasibility studies awaits results from pivotal clinical trials. These formulations were safe, effective, and easy to use. This biomaterial provided a benefit to patients undergoing surgery where postsurgical adhesion formation is a concern.
Journal of Biomedical Materials Research Part B Applied Biomaterials 05/2007; 81(1):239-50. · 2.15 Impact Factor
