Pharmacist guidance may be cost-effective management strategy for treating heart disease patients
A recently published study claims that chemotherapy in addition to surgery, or surgery and radiation, improves survival outcomes among older women suffering from breast cancer.
Considering that the average patient age at the time of breast cancer diagnosis is 63 years, there is a need to prove that safe, effective therapeutic treatments exist for elderly women suffering from this disease. However, owing to the fact that older women with breast cancer are under-represented in clinic trials, data on the effects of chemotherapy used in addition to therapies such as surgery are scarce.
A recently published study recruited 600 women through the Cancer and Leukemia Group B of the National Cancer Institute’s Clinical Trials Cooperative Group Program.
The study compared treatment outcomes after a combination of standard-treatment chemotherapy drugs (either cyclophosphamide, methotrexate and fluouracil, or doxorubicin plus cyclophosphamide) or a single oral drug (capecitabine) in patients aged 65 years and older presenting with early-stage breast cancer. The combination therapy provided significantly better outcomes than the single drug, mirroring previous results in similar studies in women aged up to 70 years.
Patients receiving the single-drug oral treatment were twice as likely to experience a relapse, with the rate of relapse-free survival at 68% in the single-therapy group versus 85% in the standard-chemotherapy group 3 years post-therapy. Patients did, however, prefer oral over intravenous chemotherapy, suggesting that an oral agent suitable for multidrug treatment would be desirable to treat elderly breast cancer patients.
“This study is important because it is among the first several trials specifically targeted to older women with early-stage breast cancer and shows that chemotherapy can make a difference,” commented Hyman Muss, Professor of Medicine at the University of North Carolina at Chapel Hill (NC, USA) and lead author of this study.
Source: Muss HB, Berry DA, Cirrincione CT et al. Adjuvant chemotherapy in older women with early-stage breast cancer. N. Engl. J. Med. 360, 2055–2065 (2009).
Study aims to pinpoint economic cost of dengue in endemic countries
A collaborative study published in the American Journal of Tropical Medicine and Hygiene set out to estimate the true economic burden of dengue fever over a multicountry study. Annual direct and indirect costs accrued as a consequence of dengue in eight countries in South America and Asia collectively reached an approximate calculation of US$1.8 billion.
The study followed 1695 dengue patients from Brazil, El Salvador, Guatemala, Panama, Venezuela, Cambodia, Malaysia and Thailand. To calculate direct and indirect costs, factors taken into account included whether the patient was hospitalized or treated at home (hospitalized cases averaged approximately three-times the cost of ambulatory cases), school absenteeism, lost productivity and the unpaid time of caregivers resulting from the disease. “This study shows that a case of dengue affects not only the patient, but also other household members who must take time off from work or school to provide care,” explains coauthor Donald Shepard from the Heller School for Social Policy and Management at Brandeis University (MA, USA).
Two-fifths of the world’s population (∼2.5 billion people) live in parts of the world affected by dengue, and an additional 120 million people travel to dengue-affected areas annually. The WHO claims that rising numbers of people are becoming affected owing to human population growth and the increased spread of vector mosquitoes. Between 50 and 100 million people are thought to become infected annually.
Jose Suaya, a visiting scholar at Brandeis’s Heller School and lead author of the study, warns that “…dengue poses a very heavy economic burden to the health system and society, and it underscores the need for full development of preventive measures, such as a dengue vaccine and vector control.”
Source: Suaya JA, Shepard DS, Siqueira JB et al. Cost of dengue cases in eight countries in the Americas and Asia: a prospective study. Am. J. Trop. Med. Hyg. 80, 846–855 (2009).
‘Pill burden’ may reduce quality of life in kidney dialysis patients
Rajnish Mehrotra et al. at Los Angeles Biomedical Research Institute (CA, USA) investigated how the ‘pill burden’ affected the health-related quality of life of kidney disease patients undergoing dialysis and found that patient satisfaction with everyday life decreases with increasing numbers of medications.
Kidney disease patients undergoing dialysis are required to take a large daily dosage of medication. While these medications are administered for optimal control of the disease, a balance is needed to avoid a negative impact on health-related quality of life or perceived physical and mental health, and to prevent subsequent side effects from overzealous prescribing.
The study included 233 chronic dialysis patients from three clinics. On average, patients took 19 pills daily, with the top 25% taking more than 25 pills daily. Patients with a higher pill burden were found to not only have a lower perceived physical health state but also be less likely to take their medications as directed.
Phosphate binders, administered to control phosphorus levels in the bloodstream, accounted for approximately half of the patients’ daily pill dose. In total, 62% of the patients failed to self-administer these medications correctly, and the rate of errors increased with the number of phosphate binders prescribed. This suggests that any attempts to reform current treatment burdens should address the issue of phosphorus binders, as increasing the dosage may negatively impact on quality of life without positively benefiting patients’ health.
Source: Chiu Y, Teitelbaum I, Misra M, de Leon EM, Adzize T, Mehrotra R. Pill burden, adherence, hyperphosphatemia, and quality of life in maintenance dialysis patients. Clin. J. Am. Soc. Nephrol. DOI: 10.2215/CJN.00290109 (2009) (Epub ahead of print).
Promising outcomes from Phase III CLARITY study for the treatment of multiple sclerosis announced
Merck KGaA recently announced the results of their pivotal 2-year, placebo-controlled Cladribine Tablets Treating Multiple Sclerosis Orally (CLARITY) Phase III trial – which used cladribine tablets to treat patients with relapsing-remitting multiple sclerosis – for the first time at the 61st Annual Meeting of the American Academy of Neurology (AAN) in Seattle (WA, USA). The short-course treatment with this promising new drug led to a significant reduction in disability progression, brain lesions and clinical relapses, in addition to increasing the proportion of patients who remained relapse-free compared with placebo.
“All primary and secondary end points of the CLARITY study were statistically significant and demonstrate that annual short-course treatment with cladribine tablets in this study was effective across multiple important clinical and MRI efficacy measures,” announced Gavin Giovannoni, principal investigator of the study, from the Institute of Cellular and Molecular Science, Barts and The London School of Medicine and Dentistry, UK.
During the 2-year study period, patients treated with low-dose and high-dose regimens of cladribine tablets experienced 58 and 55% relative reductions in annual relapse rates compared with placebo, respectively (p < 0.001 for both dose regimens). In total, 80% of the patients treated with the low-dose regimen of the drug and 79% of the patients treated with the high-dose regimen experienced no clinical relapse, compared with 61% of the patients in the placebo group (p < 0.001 for both dose regimens). Disability progression measured increases in the Expanded Disability Status Scale, which were sustained for at least 3 months. Patients in the active drug group experienced a 30% reduction in the risk of disability progression relative to patients in the control group (low-dose regimen: hazard ratio = 0.67; p = 0.018; and high-dose regimen: hazard ratio = 0.69; p = 0.026).
Adverse events and incidence of infection were comparable in the control and study groups. Common side effects included headaches, nasopharyngitis, upper respiratory tract infections and nausea. Lymphopenia, an expected side effect resulting from cladribine consumption, occurred more frequently in the active drug group (low-dose regimen: 22%; high-dose regimen: 31%; placebo: 2%). Of the patients treated with cladribine tablets, 2.3% reported herpes zoster infections, although these were localized to the skin and were responsive to preventative treatment.
“We are very pleased with the successful outcome of the CLARITY study,” comments Elmar Schnee of the Merck Executive Board with responsibility for the pharmaceuticals business sector. “This is an exciting development in multiple sclerosis clinical research and represents an important step towards delivering an oral therapy to people living with this condition.”
Merck plans to submit cladribine tablets for registration to the EMEA and the US FDA through its Merck Serono division, which specializes in multiple sclerosis therapy, soon.
Source: Merck Serono www.merckserono.com
Outcomes study supports the feasibility of home-based phototherapy treatments for psoriasis
Researchers in The Netherlands claim that home-based UVB psoriasis phototherapy treatments are not only as safe and effective as the conventional hospital-based equivalent but also improve the quality of life and reduces disease burden in the eyes of psoriasis patients.
UVB treatment for psoriasis is generally considered safe and effective; however, availability and practicality issues resulting from the lengthy, time-consuming treatment courses (three-times weekly hospital visits for 8–10 weeks) precludes many sufferers from receiving it.
The investigators recruited 196 psoriasis patients for a randomized, multicenter trial. The patients were split into two study groups: one receiving home-based UVB phototherapy treatment and the other receiving standard hospital treatment. Recognized scoring scales were used to measure disease severity after treatment, and side effects and total cumulative dose of UVB were also recorded. Post-study questionnaires were administered to patients to ascertain the burden of treatment, quality of life and patient satisfaction.
The results demonstrate home phototherapy and outpatient phototherapy to be equally safe and effective, both clinically and in terms of quality of life. Patients who self-treated at home reported a significantly lower treatment burden and greater patient satisfaction. The majority of patients said they would prefer home UVB therapy over hospital-based therapy in the future.
In an accompanying editorial, Alex Anstey (Royal Gwent Hospital, Gwent, UK) suggested that current UK guidelines should be updated to reflect these findings. “…an economic assessment of different UVB service models is needed,” he explained. “Meanwhile, healthcare commissioners should work with local dermatologists to improve access to UVB phototherapy services”.
Sources: Koek MBG, Buskens E, van Weelden H et al. Home versus outpatient ultraviolet B phototherapy for mild to severe psoriasis: pragmatic multicentre randomised controlled non-inferiority trial (PLUTO study). BMJ 338, b1542 (2009); Anstey A. Home UVB phototherapy for psoriasis. BMJ 338, b607 (2009).
Pharmacist guidance may be cost-effective management strategy for treating heart disease patients
Involving pharmacists in the treatment of patients with heart disease prevents unnecessary hospitalizations, emergency room visits and associated healthcare costs, according to a new study from the University of North Carolina (NC, USA).
In the single-center study, 800 heart disease patients with an average age of 59 years were classified as either complicated or uncomplicated cases, and were studied for approximately 1 year. Patients in the former study contingent had been previously diagnosed with heart failure, coronary heart disease, stroke, heart attack or kidney problems. Patients in the latter study had high blood pressure but no other evidence of a heart or kidney condition. All patients were taking at least one medication for their condition, with complicated patients taking an average of ten medicines.
All study participants were placed into one of two groups: the intervention group, in which patients were assigned a pharmacist who took a medical history, tracked medication refills, monitored their bodyweight and laboratory tests, advised on medication use, and communicated regularly with the patients and their doctors and nurses; or the control group, who received no extra attention from a pharmacist.
During the study period, 90% of all adverse events reported occurred in the complicated patients. However, researchers found that the pharmacist’s guidance and advice offered to the intervention group patients reduced adverse drug events and medication errors by 34%.
Patients in the intervention group were more than a third less likely to experience medication problems under a pharmacist’s care than patients in the control group who received no special attention from a pharmacist. The economic benefit from this drop in adverse reactions and prescription errors saved approximately US$2,600 per patient.
“By working closely with doctors and nurses, pharmacists can help people avoid problems with their medications for chronic conditions such as high blood pressure and heart failure with favorable effects on health and health-care costs,” comments Michael D Murray, a distinguished Professor at the university’s School of Pharmacy and lead author of the journal paper.
Source: Murray MD, Ritchey ME, Wu J, Tu W. Effect of a pharmacist on adverse drug events and medication errors in outpatients with cardiovascular disease. Arch. Intern. Med. 169(8), 757–763 (2009).