Greater benefits with Seretide
Patients suffering from chronic obstructive pulmonary disease (COPD) treated with salmeterol/fluticasone (Seretide) gained a significant improvement in health status and greater survival benefit than those treated with tiotropium bromide (Spiriva), according to results of a new study that also showed both medicines had similar impact on exacerbation rates.
"The results seen in INSPIRE showing improvements in quality of life and survival are important for patients with COPD. There is no cure for COPD so we must manage the disease as effectively as possible to provide patients with the best outcomes," said Prof. Wisia Wedzicha of London's Royal Free Hospital.
INSPIRE (Investigating new standards for prophylaxis in reduction of exacerbations) is the first study to look at differences in exacerbation rates and related outcomes associated with two commonly used medicines in the treatment of COPD.
The results, published in The American Journal of Respiratory and Critical Care Medicine in December, showed that while exacerbation rates reported between the two groups was not significantly different (1.28 for Seretide v. 1.32 for tiotropium, p = 0.656), the treatment for the acute exacerbation chosen by investigators while blinded was different. Exacerbation requiring antibiotics occurred more frequently in patients treated with Seretide while exacerbation requiring systemic steroids occurred more frequently in patients taking tiotropium, suggesting that the nature of the exacerbation was dissimilar and that COPD treatments affect individuals in different ways.
Seretide also reduced the risk of COPD patients dying from any cause by 52 percent compared with patients on tiotropium bromide, a statistically significant finding (p = 0.012). This reduction in the risk of dying was seen by week 13 of treatment and continued to grow throughout the study. In addition, patients on Seretide had significant improvements in quality of life from early on in the study compared with patients on tiotropium (2.07 units improvement at two years, p = 0.038), as measured by the St. George's Respiratory Questionnaire.
In terms of safety and tolerability there was an increase in reported pneumonias in the Seretide group (eight percent) compared with the tiotropium group (four percent). Candidiasis was also reported twice more often in the Seretide group (six v. three percent).
Wedzicha said the study raises important questions on the nature of COPD. "Patients appeared to experience differences in the nature of their exacerbations.… Seretide patients received more antibiotics during their exacerbations and tiotropium patients more oral corticosteroid treatments and this resulted in different outcomes for patients. This study therefore could have important implications for the choice of medication used to manage patients with COPD," he concluded.
Crestor v. Lipitor in SATURN
LONDON
AstraZeneca announced the launch of a new clinical trial designed to measure the impact of rosuvastatin (Crestor) 40 mg and atorvastatin (Lipitor) 80 mg on the progression of atherosclerosis in high-risk patients. Dubbed as SATURN (Study of coronary atheroma by intravascular ultrasound: effect of rosuvastatin versus atorvastatin), the study will compare the effects of these two statins on the ability to decrease progression or induce regression of atherosclerosis, the main cause of cardiovascular disease, following two years of treatment in patients with coronary-artery disease.
"The impact on atherosclerosis has been studied previously in separate clinical trials involving rosuvastatin and atorvastatin," said Elisabeth Bjork, global medical science director for Crestor. "This study, for the first time, will provide physicians with important information to better understand how these two statins compare when treating dyslipidaemic patients with advanced atherosclerosis."
SATURN is a 104-week, parallel-group, multicenter, double-blind, phase IIIb intravascular ultrasound (IVUS) imaging study of approximately 1,300 patients at 170 centers worldwide expected to complete in 2011. It is part of AstraZeneca's extensive GALAXY clinical trials program designed to address important unanswered questions in statin research and to investigate the impact of rosuvastatin on control of lipids, atherosclerosis, and cardiovascular morbidity and mortality. More than 63,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY program.
"Two major studies in the GALAXY program have already demonstrated the significant impact of rosuvastatin 40 mg on atherosclerosis across the disease spectrum. The ASTEROID study was the first to show regression of coronary atherosclerosis in patients with established disease, while the METEOR study showed that rosuvastatin can also slow or delay the progression of carotid atherosclerosis in patients with early signs of the disease. The results of SATURN will provide additional information on how best to treat patients with the very serious condition of advanced atherosclerosis, said Elisabeth Bjork. "We believe the data from this study will underscore the benefits of intensively managing cholesterol levels with rosuvastatin … to reduce the burden of atherosclerosis."
Crestor has received regulatory approvals in at least 90 countries and been prescribed to more than 11 million patients worldwide.
Extended Arimidex beneficial
MACCLESFIELD, United Kingdom
New data published in the Journal of the National Cancer Institute in December demonstrate the significant benefits of extended adjuvant treatment with anastrozole (Arimidex) for postmenopausal women who have completed five years of treatment with tamoxifen for hormone receptor-positive early breast cancer.
Currently the standard duration of endocrine treatment for these patients is five years. This latest report demonstrates the safety and efficacy of Arimidex in the extended adjuvant setting, and adds to the ongoing debate on what the optimal duration of adjuvant endocrine therapy should be. The new data support extension of the current five-year treatment cycle with Arimidex to give women additional protection against the risk of recurrence.
The Austrian Breast and Colorectal Cancer Study Group (ABCSG) 6a study involving 856 patients was designed to investigate the effect of extending adjuvant therapy with Arimidex for postmenopausal women with hormone-receptor-positive early breast cancer after five years of tamoxifen. The study showed that women who received Arimidex (n = 387) rather than no further treatment (n = 469) experienced:
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a 38-percent reduction in the risk of recurrence (p = 0.031),
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a 47-percent reduction in the risk of distance metastasis (p = 0.034), and
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no unexpected adverse events.
Commented Prof. Michael Gnant, president of the ABCSG: "While the best available treatment should be offered at the earliest opportunity in order to reduce the risk of recurrence and minimise life-threatening side effects, these data confirm that women can be given Arimidex later in the treatment cycle to extend their chance of living cancer-free for longer."
Medical University of Vienna's Prof. Raimund Jakesz welcomed the new data, "because they show that Arimidex can further reduce the risk of recurrence in women with hormone receptor-positive early breast cancer who have completed their five-year adjuvant treatment."
Treatment strategies for early breast cancer have changed significantly in recent years. The introduction of aromatase inhibitors (AIs) such as Arimidex, which have proved to be not only more effective but better tolerated than tamoxifen, has led to international guidelines now recommending that all postmenopausal women with hormone receptor-positive early breast cancer should receive an AI at some point during their treatment to reduce the risk of disease recurrence.
Although, as this latest study shows, patients benefit from extending adjuvant therapy with Arimidex on completion of tamoxifen, other trials indicate earlier use may be more effective in helping women remain disease-free.
AstraZeneca Press Office
Ambien CR improves sleep
Results from a new study showed that zolpidem tartrate (Ambien CR) extended-release tablets provided improvement in sleep onset, sleep maintenance, and total sleep time for patients with comorbid chronic insomnia and generalized anxiety disorder (GAD) compared with placebo. Ambien CR also improved sleep-related next-day functioning measures.
"The anxiety experienced by patients with GAD can often lead to sleep problems such as difficulty falling asleep or staying asleep," said Thomas Roth, director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, Michigan, in the United States. "Data from this study show that Ambien CR can be considered a treatment option for the insomnia in GAD to help them get the full night's sleep they need to maintain their next-day functioning."
The multicenter, double-blind, parallel-group, randomized, placebo-controlled trial involved 381 adults ages 21 to 64 with comorbid chronic insomnia and GAD. It evaluated the overall improvement of insomnia, as measured by total sleep time in patients treated with Ambien CR and the antidepressant escitalopram (Lexapro) compared to treatment with placebo and escitalopram.
Researchers assessed treatment efficacy during clinic visits at weeks one, two, four, six, and eight and through daily patient-reported morning sleep questionnaires (MSQ), which measured the primary efficacy outcome of total sleep time in addition to measurements of sleep onset latency, wake time after sleep onset, number of awakenings, quality of sleep, and sleep-related next-day functioning.
Total sleep time was increased in the Ambien CR group throughout the study. At week eight, patients reporting sleeping an average of 106 minutes more than baseline compared to placebo-treated patients who reported sleeping an average 68 minutes more (p < 0.0001). On average, Ambien CR-treated patients reported falling asleep sooner and exhibited improved sleep maintenance based upon fewer night-time awakenings and decreased wake time after sleep onset compared to placebo-treated patients (p < 0.0001). At week eight, the number of night-time awakenings decreased in the Ambien CR/escitalopram group (-1.33 ± 1.26) compared to the placebo/escitalopram group (-0.76 ± 1.02), and time to sleep onset was reduced 55.1 (±67.3) minutes with Ambien CR compared with a reduction of 26.8 (±58.7) minutes with placebo (p < 0.0001). In addition, patients reported improvements in secondary measures relating to daytime functioning, including morning energy, morning concentration and sleep impact on daily activities.
Ambien CR, made by Sanofi-Aventis, is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and sleep maintenance.
Enhanced potential for Sutent
Pfizer's Sutent (sunitinib malate) continues to show enhanced potential as a stand-alone treatment or in combination with standard therapy for advanced breast cancer, based on ongoing studies.
Dr. Luca Gianni, lead investigator of the Sutent studies and head of oncology at the Istituto Nazionale Tumori in Milan, Italy, said: "Previous studies have shown sunitinib malate to be well tolerated in combination with standard chemotherapy regimens, including paclitaxel and capecitabine, in patients with advanced breast cancer. This compound is continuing to be evaluated both as a single agent and in combination with other agents to treat metastatic breast cancer."
A phase-I study proved that sunitinib malate can be given among patients with severe neutropenia with no need for dose interruption. In this study, 11 patients discontinued treatment for reasons including lack of efficacy (five), adverse events (two), and non-treatment-related discontinuations (four). Of 18 evaluable patients, 72.2 percent experienced partial responses. Nine of these patients experienced decreases in tumor size after two cycles of therapy.
Phase-III studies, meanwhile, are now underway. These studies aim to evaluate the role of Sutent in the treatment of various solid tumors like advanced breast cancer, advanced non-small-cell lung cancer, and advanced colorectal cancer. An ongoing substudy compares Sutent plus docetaxel with docetaxel monotherapy in the first-line treatment of advanced breast cancer.
Preliminary findings from these studies reveal good activity for the Sutent-docetaxel combo. There were also no significant interactions with other medications.
The Philippines has among the highest incidence rate of breast cancer in Asia and is today considered to have the ninth highest incidence rate in the world today. In 2005 alone, the Philippine Cancer Society (PCS) reported more than 14,000 new breast-cancer cases and about 7,000 expected deaths.
Based on studies by the World Health Organization (WHO), a woman has a 13.4-percent chance of developing breast cancer throughout her lifetime. The chance that breast cancer will be the cause for a woman's death is about one in 33, or three percent.
This trend is expected to continue, although there is significant increase in survival rates in recent years because of early detection and new treatments.
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