New research suggests that patients newly diagnosed with obstructive sleep apnea (OSA) who use a short-course of the sleep aid, eszopiclone, when beginning continuous positive airway pressure (CPAP) therapy, are more adherent with therapy in six months.

The findings were presented at the American Thoracic Society’s International Conference in San Diego on May 17.

OSA is a common disorder that leads to multiple adverse effects on health and quality of life. CPAP is recommended as the first-line therapy for most patients with OSA, and has been shown to improve sleep quality, reduce daytime sleepiness and enhance quality of life. Despite its many benefits, however, compliance to CPAP is notoriously poor.

“We know that non-benzodiazepine sedative hypnotics promote sleep onset and continuity. Additionally, they can be safely used in patients with OSA, especially those already using CPAP,” said Anita Shah, D.O., author of the study. “To date, the only consistently reliable predictor of long-term use has been compliance with CPAP at treatment initiation. Studies suggest that long-term adherence patterns may be established very early in the course of therapy.”

To test whether eszopiclone would improve early CPAP adherence, the researchers conducted a prospective, double-blind, randomized, placebo-controlled trial involving patients newly diagnosed with OSA who were beginning CPAP therapy. A total of 154 patients were recruited into the study and were randomized to receive either eszopiclone or placebo for their first 14 days of CPAP therapy. CPAP adherence was measured weekly for 24 weeks. The study period began the first day of CPAP therapy.

At the conclusion of the study, researchers found significant differences between the eszopiclone group and the placebo group. On average, patients who received eszopiclone used their CPAP devices more nights per week, and for an hour longer per night. Although the sedative hypnotics were used for only two weeks, the increased adherence with CPAP was sustained for the entire six-month study period.

“Because we know that CPAP therapy improves sleep quality, reduces daytime sleepiness, enhances quality of life and may mitigate the excessive risk for cardiovascular events associated with this disorder, this small intervention could represent a profound clinical benefit to these patients,” said Christopher Lettieri, M.D., principal investigator. “Given the poor adherence to CPAP therapy in many patients, any simple intervention that can reliably improve adherence should be strongly considered.”

This study is part of the CPAP Promotion and Prognosis - The Army Sleep Apnea Program (CPAP ASAP Trial) being conducted at Walter Reed Army Medical Center. The CPAP ASAP Trial will examine multiple outcomes related to therapeutic adherence, health care utilization, co-morbid conditions and quality of life among patients with newly diagnosed OSA.

Source:
Keely Savoie

American Thoracic Society

Pathfinders, a program designed to care for the whole person — body, mind and spirit — has been found to help women with terminal cancer cope and has improved their quality of life, according to a study led by researchers in the Duke Comprehensive Cancer Center.

“The program helped improve distress and despair during the initial three months and up to six months after diagnosis among women with metastatic breast cancer and a six month life expectancy,” said Amy Abernethy, M.D., an oncologist at Duke University Medical Center and lead investigator on the study. “Even though the women were getting sicker and experiencing more symptoms related to their cancer, they reported that they felt less distress and despair as a result of being able to better cope with the cancer.”

Pathfinders focuses on the seven pillars of personal recovery: hope, balance, inner strengths, self care, support, spirit and life review. The program provides patient navigation, counseling, coping skills training, mind and body techniques and lifestyle advice.

“The goal of the program is to teach patients coping skills for dealing with their cancer,” said Tina Staley, director of Pathfinders. “To reach this goal, we have created a common language between patients, nurses, physicians and Pathfinders for communicating coping skills.”

For this pilot study, the researchers enrolled 50 adult breast cancer patients with a prognosis of less than six months survival. The women met with a Pathfinder, a trained social worker, at least monthly, plus telephone conversations and e-mail exchanges. The social workers helped the women identify inner strength, taught them coping skills and encouraged them to engage in complementary and alternative medical services.

The researchers present their findings on a poster at the 2009 American Society of Clinical Oncology meeting in Orlando, on Sunday, May 31.

“There is a growing body of data that shows cancer patients have unmet psychosocial needs, and with programs like Pathfinders we are able to care for the whole person,” Abernethy said. “As a result, we found that this group of women reported a higher quality of life three months after being diagnosed than was expected.”

Additional authors on the study include Tina Staley, James Herndon II, April Coan, Jane Wheeler, Krista Rowe, Barbara Horne and H. Kim Lyerly of Duke.

Source:
Erin Pratt

Duke University Medical Center

Today, 15 new research projects aimed at bringing innovative medicines more quickly to the market have been selected to receive 246 million euros from the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The projects will foster understanding of health issues such as asthma and psychiatric disorders while increasing drug safety. They will also help improve the training of researchers and clinicians involved in medicines development. The projects were chosen following the first call for proposals launched within the Innovative Medicines Initiative (IMI), a public-private partnership - so called Joint Technology Initiative- between the European Commission and the pharmaceutical industry. With this selection, IMI has reached a key milestone. This initiative marks the first time that pharmaceutical competitors are pooling their resources, together with research organisations, patient groups and other stakeholders in large consortia, in order to develop generic, pre-competitive knowledge. The Commission’s contribution of €110 million is backed up with €136 million provided in-kind from the pharmaceutical industry. The successful projects will now enter into the final negotiation phase.

“I’m happy to see that this unique public-private partnership that was launched as a new instrument for research two years ago is bearing fruit. In times of crisis, such a model of cooperation is proving particularly well suited to answering both EU public health and economic needs,” said Janez Poto?nik, the EU Commissioner for Science and Research.

Arthur Higgins, CEO of Bayer Healthcare and president of the EFPIA, stated, “I am delighted to see that this pioneering model of collaboration between industry and the Commission has been taken up so positively all across Europe. The IMI will set new standards in data sharing and knowledge exchange.”

Better medicines reaching patients faster

The projects selected will address the main causes of delay, or “bottlenecks”, in the pharmaceutical research and development (R&D) process. The overall objective is to encourage the more rapid discovery and development of better medicines for patients while improving the competitiveness of the European pharmaceutical industry. The projects will help to increase predicted safety and efficacy of medicines, enhance data exchange between researchers and improve education and training in the sector.

The selection process: a substantial interest from stakeholders

Around 150 applications were received. The best consortia, consisting of research organisations, Small and Medium Enterprises (SMEs), academia, patient organisations, and regulatory bodies, were selected in the first peer review to form joint project teams with the corresponding EFPIA consortia. On the basis of stringent scientific criteria and their potential impact on the identified “bottlenecks”, 15 projects from these teams have been selected.

European funding to boost the R&D capabilities of the public sector and SMEs

Pharmaceutical companies within EFPIA will fully fund their own participation by providing R&D resources including staff, laboratory facilities, materials and clinical research. European Community’s funds will be allocated exclusively to other participants (public sector, SMEs, patient groups, academics).

Further steps

Contract negotiations for the 15 projects should be finished by November 2009. A second Call for Proposals is to be launched in autumn 2009. It is planned to seek proposals for projects in oncology, diagnosis of infectious diseases, chronic inflammatory diseases and knowledge management.

Background

Launched in 2007, the Innovative Medicines Initiative was one of the first Joint Technology Initiatives (JTI) to be created. The total IMI budget for the period 2008-2013 is €2 billion (1 billion from the European Community and 1 billion from the industry).

Created in 2007, the Innovative Medicines Initiative Joint Undertaking (IMI JU), representing both the European Community and the industry, implements IMI and is responsible for the launch of Calls for Proposals and the award of grants.

To find out more about IMI: http://imi.europa.eu and http://www.imi-europe.org
To find out more about Joint Technology Initiatives: http://cordis.europa.eu/fp7/jtis/
See the list of the 15 research projects as well as the name of 5 joint technology initiatives in the annex attached.

Annex: Full list of selected projects with their expected outcome

1. Non-genotoxic carcinogenesis

Expected outcome: proven reliable role of early biomarkers in the prediction of cancer development.

2. Expert systems for in silico toxicity prediction

Expected outcome: in silico prediction and expert systems for secondary pharmacology prediction and for pure chemistry-related toxicity.

3. Qualification of translational safety biomarkers

Expected outcome: new specific and sensitive safety biomarkers and their respective assays for human sample for improved predictivity between non-clinical and early clinical studies.

4. Strengthening the monitoring of the benefit/risk of medicines

Expected outcome: new methodologies in pharmacovigilance and pharmacoepidemiology

5. Islet cell research

Expected outcome: better understanding of ?-cell proliferation, differentiation and apoptosis permitting the identification of approaches to preserve ß cell function aiding the development of preventive and curative treatments for diabetes types 1 and 2.

6. Surrogate markers for vascular endpoints

Expected outcome: biomarkers/surrogate endpoints for micro- and macrovascular hard endpoints in diabetes clinical research and new in vitro or in silico tools to test novel therapies.

7. Pain research

Expected outcome: improved understanding of the pathways and mechanisms mediating different kinds of pain, and markers for patient stratification and quantitative pain assessment for efficient testing of new analgesics.

8. New tools for the development of novel therapies in psychiatric disorders

Expected outcome: blood/CSF markers, imaging and/or electrophysiological measures suitable for clinical assessments to be used for preclinical models with sensitive pharmacodynamic markers that are closely linked with psychiatric disorders

9. Neurodegenerative disorders

Expected outcome: translatable animal and human volunteer models for better prediction of clinical efficacy of new therapies in patients with Alzheimer’s disease, Parkinson’s disease and multiple sclerosis.

10. Understanding severe asthma

Expected outcome: a large longitudinal patient cohort enabling validation of novel biomarkers and development of diagnostic criteria for mechanistic and therapeutic trials.

11. COPD patient recorded outcomes

Expected outcome: a framework for better understanding of patients’ experience of chronic obstructive pulmonary disease (COPD) leading to better strategies for measuring clinical trials outcomes

12. European Medicines Research Training Network

Expected outcome: a European biopharmaceutical research training platform providing a sustainable academia-industry cross-disciplinary approach to efficient organisation of training courses on emerging science and technologies across Europe.

13. Safety sciences for medicines training programme

Expected outcome: training programme integrating all safety-relevant disciplines linking animal and human/patient safety data thereby facilitating a more holistic evaluation of new medicines

14. Pharmaceutical medicine training programme

Expected outcome: establish a network of academic centres that delivers postgraduate training programmes in pharmaceutical medicine including quality management of the processes and outcomes.

15. Pharmacovigilance training programme

Expected outcome: customised training programmes for professionals in pharmacovigilance from industry and regulatory agencies to support proactive pharmacovigilance and risk management of medicines.

On Joint Technology Initiatives

JTI’s are a major new element of the EU’s 7th Research Framework Programme. They provide a way of creating new partnerships between publicly and privately-funded organisations involved in research, focussing on areas where research and technological development can contribute to European competitiveness and quality of life.

5 JTI’s have been developed so far: Innovative Medicines Initiative (IMI), Embedded Computing Systems (ARTEMIS), Aeronautics and Air Transport (Clean Sky), Nanoelectronics Technologies 2020 (ENIAC), Hydrogen and Fuel Cells Initiative (FCH).

Source
EFPIA