Many experimental studies have found that physical exercise can improve cholesterol levels and subsequently decrease the risks of cardiovascular disease; however, few of these studies have included enough participant diversity to provide ethnic breakdowns. Now, a longterm study of over 8,700 middleaged men and women provides race and gender specific data on the cholesterol effects of physical activity, with the interesting result that women, particularly AfricanAmerican women, experience greater benefits as a result of exercise than men.

The analysis of this large Atherosclerosis Risk in Communities (ARIC) Study, which appears in the August issue of Journal of Lipid Research, was carried out by Keri Monda and colleagues at North Carolina and Baylor. They found that over a 12 year period, all individuals who increased their exercise by about 180 metabolic units per week (equivalent to an additional hour of mild or 30 minutes of moderate activity per week) displayed decreased levels of triglycerides and increased levels of the “good” HDL cholesterol. However, statistically significant decreases in the “bad” LDL cholesterol were only observed in women, with particularly strong effects in menopausal women and AfricanAmerican women. And total cholesterol levels were only significantly decreased in AfricanAmerican women.

The authors speculate that these novel differences may arise from hormonal differences between the sexes, especially considering the extra effects seen postmenopause. The racial differences observed may stem from genetic variations that require further exploration.

The authors do also note that their exercise data was assessed by questionnaire and this was nonscientific, though the particular methodology used has been extremely reliable in other studies. They also note that all evaluated participants were healthy, so these results cannot be generalized to individuals with diabetes or those on cholesterollowering medications.

From the article Longitudinal impact of physical activity on lipid profiles in middleaged adults the Atherosclerosis Risk in Communities Study, by Keri L. Monda, Christie M. Ballantyne and Kari North

Source
Nick Zagorski

Most people think arthritis is worse in the cold, winter months but a dirty little secret is that it can be just as painful during the hot, summer months as well.

Paying close attention to your diet and exercising the right way can help minimize the pain. Flexcin International, Inc., a natural supplement company offering the only joint pain remedy products with CM8™, offers five great tips to control arthritis and joint pain during the summer months.

1) Activities like golf and even walking can be a good arthritis remedy because theyre great ways to loosen up the body and keep the joints from becoming sedentary.

2) Drink plenty of water and fluids to stay hydrated. Joint pain and arthritis often worsens as a result of dehydration.

3) People tend to consume more sugars from teas, sodas, sports drinks, cakes and pies in the summer. Too much sugar can actually be bad for arthritis and joints.

4) When traveling, make sure to stretch and get as much exercise and joint pain treatment as possible during stops. For car trips get out and walk around frequently and stretch as much as possible on long airplane rides.

5) With activities like gardening, avoid strenuous movements which can be taxing on joints. “Pain medications mask pain and cause further damage,” said Dr. Jan McBarron, M.D. N.D. and cohost of the nationally syndicated radio show, “Duke and the Doctor.” “Instead I recommend Flexcin, which helps build back the lost cartilage and lubricates your joints similar to how WD40 is used to lubricate the parts of an engine.”

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Servier Laboratories Limited has been granted permission by the Court of Appeal to challenge a High Court decision made at a Judicial Review in February this year, in which Servier was previously successful in its claim that the National Institute for Health and Clinical Excellence (NICE) had unlawfully failed to provide the economic model underlying its Guidance for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. 1,2

The Court of Appeal will hear Serviers appeal against Februarys ruling on one legal point misinterpretation of Serviers clinical data on the reduction of risk of hip fracture by its osteoporosis treatment, Protelos® (strontium ranelate).

Michael Sumpter, CEO of Servier Laboratories Ltd, commented; “We are delighted with todays decision granting Servier the right to appeal on the basis of the irrational consideration by NICE of data submitted by Servier during the appraisal process.”

NICE refused to accept a post hoc analysis of a randomised controlled trial titled “The TReatment Of Peripheral OSteoporosis” (”TROPOS”), which was specifically requested by European Medicines Agencys (the “EMEA”) scientific committee and clearly showed the efficacy of Protelos in teducing the risk of hip fracture. It was accepted as the basis for granting a licence for reduction of risk of hip fracture in post menopausal osteoporotic women by the European Commission on the recommendation of the EMEA.

Servier challenged NICE at Judicial Review because it believes the osteoporosis guidance unfairly and unnecessarily restricts access to Protelos for many patients who could benefit from it. Servier remains satisfied with the ruling by Mr Justice Holman on 19 February 2009 that NICE acted with procedural unfairness and, therefore, unlawfully by not releasing the economic model on which it based its decisions in the osteoporosis guidance. As a result of the February ruling, NICE has shared a copy of the economic model with the stakeholders who submitted evidence for the current NICE guidance. In addition, the current guidance is now being reevaluated.

Professor Tim Spector, Consultant Rheumatologist at St Thomas Hospital said; “Many of my patients are unable to tolerate the treatment recommended by NICE under the current guidance, but I have to wait for their disease to deteriorate before I can give them an alternative treatment. This leaves them unprotected from the risk of fracture for many years. While the previous court ruling means that the original NICE guidance is already under review, todays decision means there is a greater chance of the appropriate data being considered. This will hopefully result in new guidance that is simpler and more flexible, giving clinicians a real choice in prescribing for women with osteoporosis, who all have individual needs.”

Osteoporosis is a severe disease that affects one in two women over the age of 50 and one in five men. Up to 20% of women who suffer a hip fracture die within the first year of a fracture.3 Half of those suffering an osteoporotic hip fracture can no longer live independently as a result of the injury. Following a hip fracture, 64% need a walking aid and half can no longer move about outside on their own.4The appeal will be heard by the Court of Appeal in due course. The date will be confirmed by the Court.

About the Judicial Review

In January 2009, Servier challenged NICE on three grounds

1. Lack of transparency around the economic model used to evaluate cost effectiveness
2. Misinterpretation of Serviers clinical data around hip fracture data
3. Unlawful discrimination on the basis of disability

On 19 February 2009, the High Court found in Serviers favour on ground one Lack of transparency around the economic model used. The Judge ruled that the procedure by which the NICE guidance on treatments for primary and secondary prevention of osteoporosis was produced (Final Appraisal Determination dated 30 June 2008) was unlawful and the guidance must therefore be reevaluated. The Judge ruled that the current guidance will not be quashed pending reevaluation.

In light of Februarys decision NICE has been ordered to grant access to the economic model to stakeholders who will be given the opportunity to comment on the assumptions NICE made when developing the guidance. NICE will then be required under their legal duty of transparency to reevaluate the guidance in light of the comments it receives.

The High Court did not find in Serviers favour on grounds two and three.

About the NICE guidance

The Final Appraisal Determinations (FADs) on the treatment of osteoporosis were published on 26 June 2007. An appeal hearing involving the National Osteoporosis Society, the Alliance for Better Bone Health and Servier Laboratories took place in October 2007. A decision upholding the appeal was published in December 2007 and the revised FADs were published by NICE in July 2008. Serviers second appeal took place in September 2008. Subsequently, technology appraisal guidance for both the primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women was published in October 2008. The Judicial Review took place 2022 January 2009. The decision by Mr Justice Holman was announced on 19 February 2009.

About Servier Laboratories Limited

Servier Laboratories Limited is the UK subsidiary of The Servier Research Group, a researchbased pharmaceutical company specialising in innovative pharmaceuticals. Servier UK offers a range of products in a number of medical areas cardiovascular disease, especially hypertension and cardiac disease, diabetes, osteoporosis and diseases of the central nervous system. Servier develops truly innovative drugs and invests in therapeutic areas where there is an unmet patient need.

About osteoporosis

The World Health Organisation defines osteoporosis as a progressive skeletal disease characterised by low bone mass and microarchitectural deterioration of bone tissue with a consequential increase in bone fragility and susceptibility to fracture. There is increased risk of fracture particularly of spine, hip, pelvis and forearm. It is predominantly a disease of postmenopausal women and risk of fracture increases with age. Fractures caused by osteoporosis affect one in two women and one in five men over the age of 50.

About Protelos

Protelos is a true innovation which was developed to improve quality of life for osteoporosis patients.5,6,7 Protelos is unlike other treatments and works by building bone to promote bone strength and reducing hip and spinal fractures.8,9,10 Unlike more traditional osteoporosis treatments the most common side effects of Protelos are mild and transient.11

References

1. Case number CO/2469/2008 between The Queen on the application of Servier Laboratories Ltd and the National Institute for Health and Clinical Excellence

2. National Institute for Health and Clinical Excellence (NICE). Alendronate, etidronate, risedronate and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women and Alendronate, etidronate, risedronate, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. Available from snice.org.uk (last accessed February 09)

3. Cooper C, et al. Am J Epidemiol 1993;13710011005

4. Osnes EK, Lofthus CM, Meyer HE, et al. Osteoporos Int 2004;15567 574

5. Jiang Y, Zhao JJ, Genant HK. Osteoporos Int 2006;17(suppl2)late breaking news

6. Arlot ME, et al. J Bone Miner Res 2008;23(2)215222

7. Ammann P, et al. J Bone Miner Res 2004;19(12)20122020

8. Protelos SPC

9. Meunier PJ, et al. N Engl J Med 2004;350459468

10. Reginster JY, et al. Arthritis Rheum 2008;58(6)6871695

11. Reginster JY, et al. J Clin Endocrinol Metab 2005;90(5)28162822

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Researchers have found a way to directly convert spermatogonial stem cells, the precursors of sperm cells, into tissues of the prostate, skin and uterus. Their approach, described this month in the journal Stem Cells, may prove to be an effective alternative to the medical use of embryonic stem cells.

The hunt for alternatives to embryonic stem cells has led to some promising yet problematic approaches, some of which involve spermatagonial stem cells (SSCs). Researchers recently observed, for example, that SSCs grown in the laboratory will eventually give rise to a few cells that look and act like embryonic stem cells. This process can take months, however, and only a small percentage of the SSCs are converted into “embryonic stemlike” cells.

Other researchers have used viruses to insert genes into SSCs that will spur them to turn into ESlike cells. But this approach is problematic and the use of viruses to ferry in the needed genes has caused concern.

The new method, recently developed at the University of Illinois, takes advantage of the unusual interaction of two tissue types the epithelium and the mesenchyme. The epithelium lines the cavities and surfaces of glands and many organs and secretes enzymes and other factors that are essential to the function of these tissues. The mesenchyme is the connective tissue in embryos. (In adults, the connective tissue is called stroma.)

In the 1950s, scientists discovered that the epithelium takes its developmental instructions from the mesenchyme. For example, when researchers put bladder epithelial cells on the mesenchyme of a prostate gland, the bladder cells were changed into prostatic epithelium. The prostatic mesenchyme had altered the fate of the bladder epithelium.

“The mesenchyme its the director; its controlling the show,” said University of Illinois veterinary biosciences professor Paul Cooke, who led the new study with postdoctoral researcher Liz Simon.

Cooke began the effort with what even he considered an unlikely proposition.

“Could we take spermatagonial stem cells and cause them to directly change into other cell types by putting them with various mesenchymes and growing them in the body?” he said. “I thought it was possible, but I didnt think it would work.”

The experiment did work, however. When Simon placed SSCs from inbred mice on prostate mesenchyme and grafted the combination into living mice, the SSCs became prostatic epithelium. When combined with skin mesenchyme and grown in vivo, the SSCs became skin epithelum. The researchers were even able to convert SSCs into uterine epithelium by using uterine mesenchyme.

The newly formed tissues had all the physical characteristics of prostate, skin or uterus, and produced the telltale markers of those tissue types, Cooke said. They also stopped looking and behaving like SSCs.

To assure that their tests were not contaminated with epithelial cells from the source of the mesenchyme cells, the researchers repeated the experiments using a mouse whose cells contained a gene that fluoresces green under ultraviolet light. The SSCs were obtained from a greenfluorescing mouse, but the mesenchyme came from a nonfluorescing mouse. This enabled the researchers to trace the fate of the SSCs. If the newly formed prostatic epithelium glowed green even though the mesenchyme did not, for example, the researchers knew that the SSCs had been converted into prostatic epithelium.

Cooke hopes that a more streamlined approach can be developed that makes use of a mans own SSCs and stroma (the adult equivalent of the mesenchyme) to produce new skin cells or other tissues when needed for example, to replace skin damaged in a burn. And his team is investigating the use of ovarian stem cells instead of SSCs to see if the same results can be obtained with ovarian tissue.

This work was supported by the Billie A. Field Endowment, the U. of I., and the National Institutes of Health.

“Direct Transdifferentiation of Stem/Progenitor Spermatogonia Into Reproductive and Nonreproductive Tissues of All Germ Layers” appears in Volume 27, Number 7, of the journal Stem Cells. The authors Liz Simon, Gail C. Ekman, Natalia Kostereva, Zhen Zhang, Rex A. Hess, MarieClaude Hofmann, Paul S. Cooke.

Source
Diana Yates

The rates of serious complications among individuals with type 1 diabetes appear lower than reported historically, especially when patients are treated intensively, according to a report in the July 27 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

“The clinical course of type 1 diabetes mellitus, including its treatment, metabolic outcomes and longterm clinical complications, has changed dramatically in the past 20 years,” the authors write as background information in the article. Treatment innovations, including insulin pumps and analogues, along with the improved treatment of cooccurring illnesses such as high blood pressure and abnormal cholesterol have contributed to changes in the management of type 1 diabetes. In addition, clinical trials such as the Diabetes Control and Complications Trial (DCCT)a study conducted between 1983 and 1993 comparing the thencurrent standard of care with more intensive therapyand its longterm observational followup, the Epidemiology of Diabetes Interventions and Complications (EDIC) study, have shown the benefits of more careful control of blood glucose levels.

The DCCT/EDIC Research Group analyzed the incidence of longterm complications among participants in those studies, including both patients who were originally assigned to intensive therapy and those who received standard therapy until the DCCT clinical trial ended in 1993 and all patients were offered intensive therapy. In addition, they assessed complication rates among participants in the Pittsburgh Epidemiology of Diabetes Complications study, an observational study in which researchers have collected data on patients who were diagnosed with type 1 diabetes between 1950 and 1980.

“After 30 years of diabetes, the cumulative incidences of proliferative retinopathy [an eye disease associated with diabetes], nephropathy [kidney disease] and cardiovascular disease were 50 percent, 25 percent and 14 percent, respectively, in the DCCT conventional treatment group, and 47 percent, 17 percent and 14 percent, respectively, in the Pittsburgh Epidemiology of Diabetes Complications cohort,” the authors write. “The DCCT intensive therapy group had substantially lower cumulative incidences (21 percent, 9 percent and 9 percent) and fewer than 1 percent became blind, required kidney replacement or had an amputation because of diabetes during that time.”

Differing methods of ascertaining and defining complications make exact historical comparisons difficult. However, the rates of retinopathy (30 percent) and nephropathy (12 percent) in DCCT/EDIC participants after 25 years compare favorably to rates in studies of individuals who developed diabetes 10 to 20 years prior (40 percent to 53 percent for retinopathy and approximately 35 percent for nephropathy). Rates of functional impairment, such as vision loss and the need for kidney transplant, are also difficult to compare but were low in the overall DCCT/EDIC cohort, with only three of 1,441 patients becoming legally blind and 18 requiring kidney replacement therapy after an average of 25 years.

“While the results of the DCCT/EDIC conventional therapy and of the Pittsburgh Epidemiology of Diabetes Complications study supply clinicians with a realistic description of clinical outcomes that they can discuss with their patients who have had their type 1 diabetes mellitus in the past 25 years, the intensive treatment group results provide a view of what patients with type 1 diabetes mellitus can expect in the future. Intensive therapy, now the standard of care, should result in more than 50 percent reduction in the rates of complications over time, with implementation early in the course of diabetes providing the most powerful salutary effect.”

Arch Intern Med. 2009;169[14]13071316.

Research to be presented at the Annual Meeting of the Society for the Study of Ingestive Behavior (SSIB), July 28 August 1, 2009, the foremost society for research into all aspects of eating and drinking behavior, finds that women who possess genetic modifications associated with low activity of the reward neurotransmitter dopamine in the brain when they imagine eating appetizing foods are more prone to weight gain. Functional Magnetic Resonance Imaging (fMRI) scans of brain activity revealed that women who had lower activity in food reward regions of the brain and who had genetic modifications associated with lower dopamine activity showed the greatest weight gain after one year. Eric Stice from the Oregon Research Institute says, “These findings provide some of the first prospective evidence that people who experience blunted reward from food may compensate by overeating, increasing risk for unhealthy weight gain.” Overconsumption of appetizing foods may occur in an attempt to increase brain reward in less responsive systems. The results of this study highlight the need for further research into the role that neural reward systems play in the development of obesity. “It may be useful for individuals who show low foodrelated reward to increase their physical activity, which not only promotes activity the same reward circuitry but also reduces unhealthy weight gain from overeating” says Stice.

Lead author Eric Stice, Oregon Research Institute, Eugene, OR, USA

Coauthors S. Spoor and C. Bohon, Oregon Research Institute and University of Oregon, C.N. Marti, University of Texas at Austin, USA.

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Jamie Price

Abortion opponent Rep. Tim Ryan (DOhio) and abortionrights supporter Rep. Rosa DeLauro (DConn.) held a press conference on Thursday to announce a bill that aims to reduce the need for abortion by preventing unintended pregnancies, among other proposals, the New York Times “The Caucus” reports. The bill crafted in part by the centrist group Third Way would increase access to contraceptive services, sex education, health care coverage for pregnant women and children, and adoption. It also would expand access to comprehensive sex education and adoption programs.

The bill has the support of abortionrights groups like the Planned Parenthood Federation of America and NARAL ProChoice America, both of which had representatives at the press conference. The bill also has the support of antiabortionrights religious leaders like Joel Hunter of Northland, Fla., and Derrick Harkins of Washington, D.C.

The bill, which has been introduced in each of the past three congressional sessions, could “broker a detente” and help “turn down the volume on the culture war,” DeLauro said at the press conference. Ryan called the bill an “idea whose time has come,” noting that it has gained support from advocates on both sides of the abortionrights debate.

During the press conference, Hunter said advocates of the bill, regardless of their side in the abortionrights debate, are “taking heat” from other members of their side. He added that the bill is important because it “links together traditional adversaries in a way that advances each of our goals without compromising any of our values” (Becker, “The Caucus,” New York Times, 7/23). Harkins said that he is “more optimistic now than I ever have been,” adding that women “need real support that divisive debates cannot provide” (Stephenson, CQ HealthBeat, 7/23).

Despite support from some antiabortionrights advocates, the bill has not been welcomed by all groups opposed to abortion rights, including conservative groups Family Research Council, National Right to Life and Democrats for Life of America. Kristen Day, executive director of Democrats for Life, said her group does not support the bill because preventing unintended pregnancies already is a goal of other programs. She noted that her group instead supports the Pregnant Women Support Act (HB 2035, SB 270), which focuses on services for women who carry their pregnancies to term but does not include prevention (CQ HealthBeat, 7/23). In a statement, Family Research Council President Tony Perkins said the bill is “fraught with funding for abortion providers and provisions that further encourage promiscuous sex and discourage parental involvement.”

Although the White House has not voiced a position on the bill, there are “reasons to believe” that the Obama administration will support some of the legislations proposals, “The Caucus” reports (”The Caucus,” New York Times, 7/23). DeLauro said that she and Ryan plan to seek Republican cosponsors for the bill, although they do not yet have any. She added that she thinks President Obama will support the bill because it includes language similar to his rhetoric on reducing the need for abortion. In addition, Obamas chief of staff, Rahm Emanuel, was a cosponsor of the bill when he served in the House (CQ HealthBeat, 7/23). Ryan said that the bill, which does not yet have an estimated cost, is “now open for support from all quarters.”

According to “The Caucus,” the bill is being introduced at a time when abortion is a growing topic in health care reform legislation. Policymakers on both sides of the abortionrights debate are expressing concern about how private insurance coverage of abortion is treated in health care reform. Ryan and DeLauro both support a policy that would neither require nor forbid insurance companies from covering the procedure (”The Caucus,” New York Times, 7/23). During the press conference, DeLauro said that the new bill would not force insurance providers to cover abortion services. She said, “What we dont want to do is go backward. We should neither prohibit nor require insurance companies to offer these kinds of services” (CQ HealthBeat, 7/23).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

Volunteers are needed for the final phase of a Diabetes UKfunded study investigating whether flavonoids compounds found in chocolate can protect older women with diabetes from heart disease.

The first group of volunteers, recruited last April, have already been eating specially formulated chocolate twice a day for a year. Now researchers at the University of East Anglia need 40 more women to take part in the study.

Eating chocolate every day

Participants will be required to eat a small amount of chocolate everyday for one year and have their risk of heart disease tested on five occasions to see whether changes occur. This will involve giving blood and urine samples, having an ultrasound scan of their arteries and filling in questionnaires about their lifestyle. These tests will take place in Norwich, at either UEA or NNUH, and travel expenses will be reimbursed up to a distance of 60 miles roundtrip.

Heart disease risk higher in women

The risk of death from coronary heart disease associated with Type 2 diabetes is about 50 per cent greater in women than it is in men. Research suggests that although statin therapy can reduce the risk of heart disease, foods like cocoa and soy which contain flavonoids, can offer further protection from the disease.

It is hoped the trial will pave the way for a larger clinical study to examine the subject in more detail.

Diabetes UK warns that people must not consume vast quantities of chocolate. “We certainly dont advise people to start eating a lot of chocolate as its very high in sugar and fat”, said Dr Iain Frame, Director of Research at Diabetes UK. “We would always recommend that people with diabetes eat a diet low in fat, salt and sugar with plenty of fruit and vegetables.

A study led by Johns Hopkins and Utah State University researchers suggests that a particularly close relationship with caregivers may give people with Alzheimers disease a marked edge over those without one in retaining mind and brain function over time. The beneficial effect of emotional intimacy that the researchers saw among participants was on par with some drugs used to treat the disease.

A report on the study, believed to be the first to show that the patientcaregiver relationship may directly influence progression of Alzheimers disease, is published in the September 2009 The Journals of Gerontology Series B Psychological Sciences and Social Sciences and currently available online.

“Weve shown that the benefits of having a close caregiver, especially a spouse, may mean the difference between someone with AD staying at home or going to a nursing facility,” says Constantine Lyketsos, M.D., M.H.S., the Elizabeth Plank Althouse Professor in Alzheimers Disease Research and director of the Johns Hopkins Memory and Alzheimers Treatment Center.

Lyketsos cautions that it remains unclear how or why this benefit was evident in the study, since the results may be due to milder forms of Alzheimers disease among those who reported close relationships. “A close relationship might prompt caregivers to deliver more attentive treatment, but it might be the other way around, with a milder illness helping caregivers stay close,” Lyketsos says. “Our next study is designed to detangle whats going on.”

Researchers have long been interested in the relationships between caregivers and Alzheimers disease patients, with many studies focusing on the wellbeing of caregivers. However, little was known about the converse relationshiphow caregivers affect the wellbeing of people with Alzheimers disease.

To find out, Lyketsos and colleagues at Johns Hopkins, Utah State, University of Washington, Duke University and Boston University examined 167 pairs of caregivers and Alzheimers patients. The pairs were recruited from the Cache County (Utah) Dementia Progression Study, which has tracked hundreds of people with Alzheimers and other types of dementia since 1994. All of the study participants live in Cache County, whose residents topped the longevity scale in the 1990 United States census.

Starting in 2002, the researchers met with patientcaregiver pairs in their homes every six months for periods up to four years. At each meeting, the patients underwent a battery of tests to assess physical, cognitive, functional and behavioral health. The researchers also interviewed the caregivers spouses, adult children or adult childreninlaw about the caregiving environment and gave them a survey to assess how close their relationships were with the patients. The survey asked caregivers to rate their level of agreement or disagreement with six statements, such as “My relationship with the care recipient is close”; “The care recipient makes me feel like a special person”; and “The care recipient and I can always discuss things together.”

At the outset of the study, all patients scored similarly on cognitive and functional tests. However, as time progressed, the researchers found marked differences between patients whose caregivers had scored their relationships as close or more distant on the surveys. Patients with whose caregivers felt particularly close to them retained more of their cognitive function over the course of the study, losing less than half as many points on average by the end of the study on a common cognitive test called the MiniMental State Exam (MMSE), compared to patients with more distant caregivers. Patients with close caregivers also scored better on a functional test called the Clinical Dementia Rating, remaining significantly closer to baseline over time compared to those with more distant caregivers.

The “closeness effect” was heightened for pairs in which the caregiver was a spouse, as opposed to an adult child or inlaw. Patients with close spouses declined the slowest overall, with scores on the MMSE showing changes over time similar to patients participating in recent clinical trials for FDAapproved Alzheimers drugs called acetylcholinesterase inhibitors.

“Weve shown that the benefits of having a close caregiver, especially a spouse, may be substantial. The difference in cognitive and functional decline over time between close and notasclose pairs can mean the difference between staying at home or going to a nursing facility,” says Lyketsos.

AcelRx Pharmaceuticals, Inc. announced positive results from its first Phase 2 clinical study evaluating the functionality of the handheld device component of its ARX01 Sufentanil NanoTab(TM) PCA System for management of acute postoperative pain in patients requiring opioid analgesia during hospitalization. Patients reliably selfadministered sufentanil NanoTabs repeatedly over the 12hour study without any ARX01 System failures or dosing errors of any kind.

This multicenter, openlabel study included 30 patients (median age 68; range 5174) undergoing elective unilateral knee replacement surgery. Patients selfadministered 15 mcg doses of ARX01 Sufentanil NanoTabs sublingually as needed using the ARX01 handheld, with a minimal redosing interval of 20 minutes. The primary endpoint was device functionality assessed as the proportion of patients who successfully completed the study without any type of System failure. There were no System failures or dosing errors of any kind throughout the study, which included over 375 dispensed NanoTabs. Additionally, preliminary analysis of efficacy results indicated a dropout rate due to inadequate analgesia of less than 10%, consistent with the superior efficacy reported for the 15 mcg dose in two earlier Phase 2 placebocontrolled studies. ARX01 was welltolerated, and there were no serious adverse events related to study drug.

AcelRx Chief Engineering Officer, Anil Dasu, commented, “These results confirm the simple usability and consistent functionality of the handheld component of the ARX01 Sufentanil NanoTab PCA System in the hands of postsurgical patients. Not only have the patients been pleased with the ease of use of the ARX01 System, but the medical staff has also been highly satisfied with Systems ease and speed of setup and reliability.”

In addition to this device functionality study, AcelRx has conducted two placebocontrolled Phase 2 studies of ARX01 Sufentanil NanoTabs in patients undergoing elective unilateral knee replacement surgery and in patients undergoing major abdominal surgery. Both of those studies demonstrated highly significant efficacy results for the 15 mcg dose relative to placebo in reducing pain intensity over the 12hour study periods.

About Acute PostOperative Pain

Annually, approximately 8 million patients in the U.S. receive intravenous (IV) patientcontrolled analgesia (PCA), typically utilizing morphine, for inpatient postoperative pain, with a similar number in the E.U. Despite its widespread use, the IV PCA architecture has several limitations. The IV line tethering the patient to the PCA pump discourages mobility, which is a critical factor in preventing postoperative complications and advancing recovery. Furthermore, the invasive nature of the IV delivery mode poses infection risk as well as predisposition to analgesic gaps due to infiltrated and dislodged IV catheters. Additionally, the complexity and programmability of IV PCA pumps introduce opportunities for medication errors, which in some instances may be fatal.

About ARX01 Sufentanil NanoTab PCA System

ARX01 is a novel drug/device combination product candidate designed for use in hospital settings to provide noninvasive patientcontrolled analgesia and maximize patient satisfaction with postoperative pain management. The ARX01 Sufentanil NanoTab PCA System avoids many of the limitations of IV PCA approaches by providing a noninvasive, preprogrammed, handheld PCA solution. The handheld component of ARX01 allows for convenient patient selfadministration of sufentanil NanoTabs sublingually for oral transmucosal absorption. Sufentanil is a high therapeutic index opioid approved for IV and epidural administration. Although the analgesic efficacy of sufentanil has been well established, its use has been limited due to its short IV plasma halftime. In the NanoTab oral transmucosal dosage form, sufentanil demonstrates a therapeutically appropriate pharmacokinetic profile for postoperative PCA usage and has the potential for improved patient tolerability over IV PCA morphine.

About AcelRx Pharmaceuticals, Inc.

AcelRx Pharmaceuticals is a privately held pharmaceutical company dedicated to the development and commercialization of new therapies for the treatment of pain and other conditions where there is an unmet need for improved safety and efficacy. The company applies its proprietary NanoTab dosage form and delivery technologies to enhance the safety, therapeutic benefit and commercial attractiveness of currently approved compounds.