Jill S. Burkiewicz

Denosumab in Osteoporosis and Oncology

Objective: To review the pharmacology, pharmacokinetics, pharmacodynamics, safety, efficacy, and use of denosumab in osteoporosis, breast cancer, prostate cancer, and multiple myeloma. Data Sources: Studies and abstracts were identified through MEDLINE and International Pharmaceutical Abstracts (1966–July 2009). Key search terms include denosumab, AMG-162, and receptor activator of nuclear factor-κB ligand system. Information available in abstract form was retrieved from major oncology and bone metabolism meetings. Additional data were obtained from the manufacturer. Study Selection and Data Extraction: All available studies in humans were included except for studies in rheumatoid arthritis and giant cell tumor of the bone. Data Synthesis: In patients with osteoporosis, denosumab significantly reduces bone resorption and fractures. Studies of denosumab in the prevention and treatment of osteoporosis have demonstrated significantly increased bone mineral density and reduced bone turnover markers. Studies of denosumab versus placebo in the treatment of osteoporosis have demonstrated reductions in vertebral, hip, and nonvertebral fractures. In oncology, positive results from clinical trials in patients receiving endocrine therapy for breast and prostate cancer demonstrated decreases in bone loss and skeletal-related events. Denosumab seems to be at least as effective in reducing bone turnover markers as intravenous bisphosphonates in the oncology setting. The most common adverse effects in patients with osteoporosis were arthralgia, nasopharyngitis, back pain, and headache. The most common adverse effects in patients with cancer were infection, pain in the extremities, arthralgia, bone pain, fatigue, and pain. Serious adverse effects include infections requiring hospitalization. Conclusions: Denosumab has documented efficacy and safety in patients with osteoporosis, breast cancer, and prostate cancer. Additional clinical trial data are needed to more completely establish the effectiveness of denosumab in the treatment of osteoporosis and neoplastic disease as well as its cost-effectiveness and long-term safety.

Effect of access to anticoagulation management services on warfarin use in patients with atrial fibrillation

Study Objective. To determine the effect of access to ambulatory anticoagulation management services (AMS) on the rate of warfarin use in patients with atrial fibrillation.

International Normalized Ratio values in group versus individual appointments in a pharmacist-managed anticoagulation clinic

PURPOSE The clinical effectiveness of a group-visit model versus individual point-of-care visits is compared by International Normalized Ratio (INR) monitoring in a pharmacist-managed anticoagulation clinic. METHODS This study was a prospective, randomized, repeated-measures, two-group, intention-to-treat comparison and survey at a pharmacist-managed anticoagulation clinic in a managed-care ambulatory care setting. Patients were eligible for this study if they were taking warfarin therapy for at least 30 days, had a goal INR range, and provided consent. At a routine point-of-care visit, eligible patients were randomly invited to participate in group visits. The number of visits and INR values were documented prospectively for both groups during the 16-week study period. RESULTS Of the 45 patients who consented and enrolled in group visits, 28 patients participated for the 16-week study period. The control group included 108 patients seen by a pharmacist for individual anticoagulation appointments. No significant difference in the percentage of INR values within the therapeutic range was detected between patients in the group-visit model versus patients receiving individual visits (59% versus 56.6%, respectively; p = 0.536). Seventy-three percent of INR values for patients who attended group visits were within +/- 0.2 of the desired INR range compared with 71.9% of those in the control group ( p = 0.994). In addition, 79% of group-visit patients were within the therapeutic range at their last clinic visit compared with 67% of patients who attended individual appointments (p = 0.225). Group visits were preferred by 51% (n = 38) of patients who completed the satisfaction survey. Of the 92 patients who declined group-visit participation, 36% indicated that the time of day that group visits were offered was inconvenient. There were no thromboembolic or hemorrhagic events documented in either group during the study period. CONCLUSION Group visits in a pharmacist-managed anticoagulation clinic may provide a safe and effective alternative to individual appointments.

Online tool for pharmacy students seeking residency positions

Our institution sought to increase pharmacy students’ awareness of pharmacy practice residencies. To assist in this effort, residency seminar sessions were initiated on campus in 2000 and were well received.[1][1] However, pharmacy students seeking residency positions are often away from campus

Survey of bisphosphonate regimen preferences in an urban community health center.

OBJECTIVE to determine patient preference for bisphosphonate therapy based on dosage form and dosing schedule. DESIGN prospective telephone survey. SETTING urban community health center. PATIENTS, PARTICIPANTS all patients who were seen in the osteoporosis clinic during the 22-month time period were contacted. Patients were excluded if they could not complete the survey in English, had difficulty hearing, had cognitive impairment, or were unable to be reached by telephone. INTERVENTIONS patients were asked which route and frequency of bisphosphonate therapy was preferred, convenient, and easiest to remember. MAIN OUTCOME MEASURE(S) patient-reported preference for route and frequency of bisphosphonate administration. RESULTS ninety patients were included in the final analysis. Preference for bisphosphonate therapy illustrated that equal numbers of respondents preferred either once-monthly or once-yearly regimens (24.4% for each, n = 22). One-third of respondents (n = 30) indicated that a once-yearly infusion was the most convenient method of administration. The survey revealed no strong association of which regimen was easiest to remember. CONCLUSION the majority of patients preferred once-monthly or less frequent dosing schedules. Clinicians may consider discussing patient preferences during initiation and throughout therapy.

Update in Handheld Electronic Resources for Evidence-Based Practice in the Community Setting

OBJECTIVE To provide an update on the handheld electronic resources for evidence-based practice (EBP) in the community setting. DATA SOURCES Electronic resources for EBP in the community setting were identified by compiling the commonly used, well-established resources and by searching MEDLINE and other Internet sites. Search terms included evidence-based medicine, evidence-based practice, resources, and abstraction. Only sources available for personal digital assistants were included. DATA EXTRACTION Three databases were identified that provided abstraction and evaluation of the medical literature for the handheld platform. Content, features, ease of use, system requirements, and costs of each resource were evaluated. DATA SYNTHESIS FIRSTConsult, InfoRetriever, and UpToDate were evaluated, and the utility of each in the community pharmacy setting was evaluated by tracking a clinically relevant example through each system. FIRSTConsult provides evidence-based information organized by diagnosis but is not searchable on the handheld platform. InfoRetriever focuses on searchable evidence-based summaries, while UpToDate includes comprehensive topic reviews. The latter 2 platforms have large system memory requirements. All 3 sources provide evidence-based abstraction of the medical literature for the PDA platform, convenient for use at the point of care in community pharmacy. CONCLUSIONS While users may select a particular resource based on unique features, each provides evidence-based abstraction of the medical literature that is a practical approach to EBP in the community pharmacy setting.

BISPHOSPHONATES IN RENAL INSUFFICIENCY: COMPARISON OF ESTIMATED GLOMERULAR FILTRATION RATE METHODS

bladder catheterization is not possible, to resolve urine retention, emergent real-time ultrasound-guided suprapubic cystostomy might be performed, which will cause the aneurysm to rupture and may cause massive internal bleeding. Isolated IAAs are rare and account for approximately 2% to 7% of all abdominal aneurysms. Atherosclerotic vascular disease is the most common cause of aneurysm; other causes, such as pregnancy or infection, are infrequent. Most IAAs occur in elderly men; the mean age at diagnosis is 74, and the male:female ratio is 5:1. Another study reported similar results in the past 12 years and showed the mean age to be 72, with 96% of IAAs occurring in men. Because of their pelvic location, symptoms of solitary IAAs are variable and nonspecific and include lower abdominal, flank, and groin pain. They are usually found incidentally using CT or ultrasonography; IAAs are silent or asymptomatic in 45% to 73% of patients and are diagnosed using imaging studies or when they rupture or enlarge enough to compress adjacent organs, such as the bladder, ureter, colon, and rectum. In the current case, the IAA was large enough to compress the bladder, resulting in LUTSs. The average size of isolated IAAs at diagnosis is 5.5 cm, with a rupture rate of 33%. The operative mortality rate is as high as 40% if IAAs rupture. Therapeutic management depends on size. IAAs smaller than 3 cm in diameter can be closely observed using ultrasound or CT; IAAs larger than 3 cm in diameter are managed using open surgical or endovascular repair. The previous study reported that endovascular repair of isolated IAA is a safe and effective alternative in appropriately selected patients and is associated with a significantly shorter hospital stay, less need for transfusion, and less mortality than with open repair.

DISCREPANCIES IN T-SCORE READINGS BETWEEN PATIENTS WITH ASYMMETRICAL GAIT

To the Editor: We have recently established an Osteoporosis Clinic at our federally qualified health center and have now obtained bone mineral density (BMD) measurements using dual-energy x-ray absorptiometry (DXA) in 114 postmenopausal women and others at risk. For these patients, we have measurements of the lumbar spine and, where obtainable, both femurs. From these initial readings, we have noted that many of our patients have a discrepancy between left and right total hip BMD that is greater than precision error of the system can explain. Of the 76 patients who had both hips measured, 18 had T-score discrepancies of at least 0.5, a difference large enough in some cases to determine whether we would initiate pharmacological therapy. Given that weight-bearing exercise is known to influence bone density, we wondered whether one explanation for the large discrepancies might be gait asymmetry. In all five patients with a T-score discrepancy of 0.7 or greater, we have confirmed that the patient has an easily identifiable gait asymmetry (Table 1). Discrepancies between the right and left total hip T-scores in the same patient have been noted in some studies. Recommendations for how to use this information differ. Some feel that the percentage of patients with changes in diagnostic categories is so small that routine monitoring of bilateral femur BMD does not yield clinically significant benefit. Nevertheless, there has been the suggestion that from a public health perspective bilateral measurements may be warranted, because the absolute number of patients affected is large. Current recommendations from the International Society for Clinical Densitometry are that treatment decisions be based on the BMD measurement from one hip or, if both hips are measured, that the mean of the two measurements be used. One factor worth considering at this point is that the additional time needed to obtain a second femur reading is minimal, in contrast to the amount of time that was needed with first-generation scanners. Given that there is a potential physiological explanation for a difference in T-scores in the hips of a single individual, we suggest that, where possible, both hips be measured and that treatment decisions be based on the lower of the T-scores rather than on the mean T-score. If bilateral measurements are not feasible in all patients, we recommend that, at least in patients with obvious gait asymmetry, both hips be measured.

Retrospective Evaluation of Prescription Frequency in Heart Failure

Background: Current clinical guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA) recommend that all patients with heart failure, in the absence of absolute contraindications, be treated with both a β-blocker and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB). Despite guideline recommendations and strong evidence of mortality benefit, studies of practice patterns show suboptimal use of such drugs. Objective: To determine the frequency of ACE inhibitor or ARB and β-blocker combination therapy in patients diagnosed with heart failure. Methods: Medical records of patients diagnosed with heart failure through ICD-9 codes at an urban community health center were reviewed over a one year period to determine the frequency of use of β-blockers, ACE inhibitors, and ARBs. Data were classified according to patient characteristics and comorbid conditions. Results: Combination therapy with both a β-blocker and ACE inhibitor or ARB was used in 61.1% (107/175) of patients. Overall, 65.7% (115/175) of patients had no relative contraindications to therapy and were more likely to be prescribed combination therapy than those with contraindications (72.2% vs 40.0%; p < 0.001). Patients with relative contraindications to β-blocker therapy (chronic obstructive pulmonary disease, asthma) were less likely to be on combination therapy than patients without such contraindications (51.0% vs 81.0%; p < 0.001). Conclusions: Although a majority of patients were taking both a β-blocker and either an ACE inhibitor or ARB, a large number of patients were not prescribed appropriate ACC/AHA–recommended therapy. Interventions within health systems should be explored as a means to bridge this gap to improve patient outcomes and ensure quality of care.