VEGF Trap-Eye yields positive DME Phase II data

VEGF Trap-Eye demonstrated a statistically significant improvement in visual acuity over 24 weeks compared to macular laser therapy in patients with diabetic macular edema (DME), said co-developers Regeneron Pharmaceuticals (Tarrytown, N.Y.) and Bayer Healthcare (Leuverkusen, Germany) in a joint press release.

In this study, visual acuity improvement was assessed by the mean number of letters gained over the initial 24 weeks of the study, the companies said. The double-masked, prospective, randomized, multi-center Phase II trial evaluated 219 patients with clinically significant DME with central macular involvement. The patients were randomized to five groups.

The control group was given macular laser therapy at week one, and these patients were eligible for repeat laser treatments, but these were available in limited frequency of no more than at 16-week intervals. A total of two groups received monthly doses of 0.5 or 2.0 mg VEGF Trap-Eye throughout the six-month dosing period, and two groups received three initial monthly doses of 2.0 mg of VEGF Trap-Eye (at baseline and weeks four and eight) followed through week 24 by either every eight-week dosing or “as needed” dosing with specific repeat dosing parameters. At week 24, the macular laser therapy group (N=44;1.7 treatments) had gained +2.5 letters; the VEGF Trap-Eye 0.5 mg monthly group (n=44; 5.6 injections) had gained +8.6 letters; the VEGF Trap-Eye 2 mg monthly group (N=44; 5.5 injections) had gained +11.4 letters; the group receiving VEGF Trap-Eye 2 mg every other month, following three monthly injections (N=42; 3.8 injections) gained +8.5 letters, and the group receiving VEGF Trap-Eye as needed following three monthly injections (N=45; 4.4 injections) gained +10.3 letters.

Regeneron said additional results will be available later this year.

Getting Skin in the Game

Orthopedic surgery can be a demanding specialty, and with its rewards comes its challenges and opportunities. No one knows this better than J.F. James Davidson, MD, who specializes in sports medicine, shoulder and knee surgery and who is part of Canyon Orthopaedic Surgeons and also practices at Gateway Surgery Center, both in the metropolitan Phoenix area. He discusses life inside and outside of the OR.

Q: Why was the specialty of orthopedics right for you?

A: I greatly respect physicians in other fields such as family practice, oncology and trauma surgery, to name just a few. Good physicians can solve a complicated medical puzzle and potentially save a sick person’s life. These physicians carry the burden of a weighty responsibility. One reason I chose orthopedics and specifically the area of sports medicine is because our patients usually have treatable problems and the capacity for relatively rapid improvement. They usually do not have life threatening conditions and are highly motivated to improve in order to maximize their quality of life. I remember rotating through cardiology and nephrology in medical school and learning the serious consequences of chronic disease. On the first day of the orthopedic clinic we examined a man with a fractured patella. The patient jovially answered our questions regarding how he managed to be kicked in the knee by a goat. In spite of the discomfort of the fracture the patient laughed at his unusual predicament. I though, now I have found the right specialty.

Q: The practice of medicine is becoming more challenging in terms of medical malpractice, tighter reimbursement, etc., so how do you cope with these modern challenges?

A: I have had some very good teachers and role models. Bill Brainard, MD, one of the founders of our group, Canyon Orthopaedics, taught by example the benefit of finding enjoyment in working with patients and colleagues, and in performing surgery. Our practice has the innate rewards of helping people, solving problems, interacting with others. My partners and I feel fortunate to do what we do. The negatives certainly can be a drain on the system, but we try to focus on the positive reasons that we come to work each day.

Q: Most physicians are never trained in business, and when they become medical entrepreneurs, they can be unprepared for the rigors of business. What has been the most valuable lesson you have learned about being a medical entrepreneur?

A: As I mentioned, I have had some very good teachers. Dave Ott, MD, was the driving force developing our successful orthopedic ASC, Gateway Surgery Center. He proved that bringing traditional competitors together for a common business goal can lead to a win for all. Prior to Gateway’s development, Canyon Orthopedics consulted with a national firm regarding the viability of creating a small ASC as an extension of our six-man group. The consultant determined that the project would be worthwhile, but with lower volume than ideal. Instead we became part of the 30-physician Gateway ASC. This has proven to be far more efficient and successful than the project we could have done on our own. Currently under construction is the Southwest Orthopedic and Spine Hospital, an orthopedic specialty hospital in Phoenix. For this project 37 orthopedists and spine specialists have partnered with Catholic Healthcare West and USPI to build what we are determined to be the highest quality orthopedic facility in the region. Finally, a number of currently independent orthopedic groups in greater Phoenix are now working on the merger of our established practices to form a single large orthopedic group. We are hopeful that this of relationship will benefit from similar synergy as Gateway Surgery Center.

Q: What clinical lessons have you learned from sports medicine that you carry over into your other practice, and vice versa?

A: A high school athlete with the goal of a college scholarship is driven to return to the playing field as quickly as possible. A few extra days off the field may mean missing a game and a chance to help his team win and shine for a college scout. The athlete wants aggressive treatment to get him back in the game as quickly as possible. In worker’s compensation cases, an injured worker may or may not have similar motivation to get back to work quickly. However, fast-tracking treatment leads to more rapid return to the job, and less time on sick leave. Similarly, the injured worker (and his employer) benefit from avoiding unnecessary operations, but meanwhile not delaying the inevitable procedure. If a surgery ultimately will be required then spending time on additional therapy is not advantageous. Making this determination requires experience and judgment. The same is true in the treatment of the athlete. On the other hand, many middle-aged athletes as well as injured workers have degenerative changes seen on an MRI. It is important to make clinical decisions as to what changes seen on scan are degenerative and incidental versus acute and painful. An over-read of an MRI can lead to a potentially avoidable surgery in both the athlete and laborer.

Q: What are the technological/clinical advancements in orthopedic surgery that get you most excited?

A: I’m excited by a number of new devices and procedures. I’m always on the look-out for methods leading to better or more reproducible results; easier or less invasive ways of doing procedures; and faster or less painful recoveries. Throughout the year the Arthroscopy Association of North America (AANA), hosts cadaver training courses to teach new techniques and improved ways of performing standard techniques. I have been an assistant instructor at the AANA shoulder courses for years and always learn from the master faculty leading the discussion and training. Two areas of special interest are the use of preoperative MRI to determine the pattern of rotator cuff tears and method of repair; and the use of an MRI to preoperatively design cutting jigs to add to the precision of total knee replacement.

Q: What do you believe is the future for outpatient orthopedic surgery in terms of keeping up with the ever changing medical and economic environment?

A: Practicing-physician involvement in management and ownership is one key. No one has a greater interest in maintaining a top-flight center than the orthopedist taking care of the patients, doing the surgery, and watching the bottom line. As we discussed earlier, my partners and I are betting on “big is better.” We built Gateway without a corporate partner. Last year for a number of reasons we sold a portion of our center to AmSurg. We are hopeful that this association will lead to economies of scale in purchasing and a stronger position in contracting. Cooperation with our colleagues has led to success in business and has improved our practice of orthopedics as well. We consult one another, adopt best practices, and learn from each other’s successes and failures. Healthcare is changing rapidly and we will all need to stay nimble to adjust to these changes.

J.F. James Davidson, MD, graduated with honors from Yale University and received his MD degree from Columbia University. He then completed his orthopedic residency and sports medicine fellowship in Phoenix. He is board certified by the American Board of Orthopaedic Surgery and is a fellow of the American Academy of Orthopaedic Surgeons. He has also served as an officer in the American Orthopedic Society for Sports Medicine and the Arthroscopy Association of North America. Davidson has published scientific papers and spoken nationally on topics ranging from anterior cruciate ligament reconstruction to arthroscopic rotator cuff repair. He is the lead spring training physician for the Chicago White Sox as well as the team orthopedist for several local schools. His special interests include disorders of the shoulder and knee. Davidson has been with Canyon Orthopaedic Surgeons since 1994.

FDA issues warning letter to researcher about promoting Ipsens Dysport

The U.S. Food and Drug Administration (FDA) has issued a warning to Miami Beach-based researcher Leslie Baumann, M.D., regarding promotional statements she made about Ipsen Biopharm’s (Paris) injectable frown line treatment Dysport (abobotulinumtoxinA), the FDA said in a letter.

Dr. Baumann’s promotional statements about Dysport, which were made to two magazines and NBC’s “Today Show,” were reportedly made in 2006, prior to the drug’s FDA approval. The statements were therefore in violation of the FDA’s regulations on pre-approval promotion, the agency said in its letter.

Dr. Baumann was involved as a researcher in Phase III trials of Dysport, also known as Reloxin, at the time she made the promotional statements, the FDA stated.

Dr. Baumann’s statements about Dysport included claims that its effects “last a month longer than Botox (onabotulinumtoxinA, Allergan, Irvine, Calif.),” the FDA letter cited. The FDA approved Dysport for treating forehead wrinkles and frown lines last spring. Ipsen granted distribution rights for the drug’s cosmetic use to Medicis (Scottsdale, Ariz).

Gov. Paterson proposes bill to require disclosure from PBM

New York Governor David A. Paterson has proposed legislation that would increase transparency and promote competition among pharmacy benefit managers (PBMs) by requiring them to disclose additional drug information to health plans, doctors, and patients.
“PBMs perform a valuable service, but there is little oversight of their practices and little competition,” said New York State Health Commissioner Richard Daines, M.D., in the release. “The three largest PBMs—Medco, Caremark, and Express Scripts—manage pharmacy benefits for 200 million Americans, 95% of those who have prescription drug coverage.”

Under Paterson’s bill, PBMs would be required to disclose the actual use of drugs by the health plan’s participants, any conflict of interest that the PBM might have with the health plan, any increase in the net price to the health plan for a covered drug and the reason for the increase, and all contracts entered into by the PBM with a network pharmacy or pharmaceutical manufacturer. The bill would also notify patients and disclose any relevant clinical and financial information to prescribers before a PBM could switch a patient to a more expensive drug, the governor said in the press release.

Gene expression may be linked to retinoblastoma progression

The inactivation of the 16INK4A gene may play a key role in the progression of retinoblastoma, said researchers at Thomas Jefferson University’s Sbarro Institute for Cancer Research and Molecular Medicine (Philadelphia, Pa.) in a press release.

In a recent study, published in the Journal of Cellular Physiology, researchers focused on the 16INK4A due to its suspected role in retinoblastoma progression and its link to familial cancer predisposition.

In the study, Marco G. Paggi, M.D., Ph.D., and colleagues assessed blood samples taken from 29 patients and their parents. They found low to moderate 16INK4A protein expression in five of 11 (45%) retinoblastoma tumor specimens. They also found reduced p16INK4a RNA expression in blood in 16 of 29 (55%) retinoblastoma patients compared to normal controls. This reduction was associated with the depletion of the p16INK4a gene, the researchers said in the release.

The researchers also found reduced expression in at least one parent among nine of the 16 (56%) patients with reduced p16INK4a RNA expression. This suggests a heritable susceptibility to retinoblastoma, the researchers said.

Lead-based eye makeup may have fought infection in ancient Egypt

Lead-based eye makeup used by ancient Egyptians appears to have had antibacterial mechanisms that may have helped prevent common infections, said researchers from Paris’ École Normale Supérieure in a news report.

In a study originally published in Analytical Chemistry, Christian Amatore, Ph.D., and colleagues used electron microscopy and X-ray diffraction to assess 52 samples from containers of preserved makeup at the Louvre.

The makeup consisted primarily of four lead-based chemicals: galena, cerussite, laurionite, and phosgenite, the researchers said in the news report. Due to deterioration of the makeup samples over the centuries, the researchers were unable to identify what percent of the makeup was lead. The researchers contend that during periods in which the Nile River flooded, the population was particularly vulnerable to infections caused by particles that entered the eye, causing inflammation.

The dosage of lead in the makeup was a key factor in its potential benefits, Dr. Amatore said in the news report.

Retail clinics on hit-or-miss trajectory

RETAIL HEALTH clinics have embarked on a period of retrenchment, according to a recent analysis by the Deloitte Center for Health Solutions.

There are currently more than 1,100 retail health clinics in the United States offering non-urgent healthcare services in pharmacies and grocery stores.

Between July 2008 and July 2009, the number of operators increased nearly 40%, including the entry of acute care organizations via contractual arrangements with drug store and grocery chains. In addition to the six largest players in the market, more than 50 organizations now operate nearly 140 clinics, claiming 11% of the market.

But just as new players jump in, many established operators are refining.

Clinic openings slowed from an astounding 350% growth rate in 2007 to 30% in 2008. During the first five months of 2009, the market contracted 5%, although the report forecasts modest growth for the year. Nearly 150 clinics closed in 2008. Although more than half of those were associated with smaller retail stores and startups, established operators likewise contracted.

RediClinic, which operated more than 50 sites in 2007, operated just 21 by mid-2009. CVS Caremark’s MinuteClinics, which dominate the market with 451 sites, shed dozens of locations in stores not owned by the company and closed 104 underperforming clinics in the first two quarters of 2009, according to the report.

But don’t read that trend as a retreat or as a direct effect of a recession, says Paul Keckley, executive director of the Deloitte Center for Health Solutions. Keckley says disruptive innovations in healthcare delivery rarely progress on a smooth trajectory.

For the most part, the report notes, retail clinics are modestly profitable and enjoy adequate patient volume. There’s also increasing evidence that insurers are covering their services.

FORMULA FOR GROWTH

The pullback, Keckley says, “has been a decision by the hosts to really focus on refining the model to make it scalable.”

For businesses accustomed to operating in the retail arena, that means refining business models to manage extended hours, liability and additional personnel costs. The hosts likewise need to determine exactly what range of services they’ll provide in a scaled model. Most clinics offer a limited range, such as diagnosing upper respiratory infections and prescribing the appropriate antibiotic. Potential new services could include injection and infusion services, chronic disease management, smoking cessation and direct-to-employer insurance programs.

Keckley expects retail clinics to emerge from this “breather” period with more refined business models tailored to the type of host site—be it a pharmacy, supermarket, big box retailer or employer setting—where the clinic operates. He anticipates a second wave of cautious growth through 2011 followed by more accelerated growth through 2014 with the market topping out at about 4,000 clinics in 2015. Most of the growth, he says, will occur in suburban markets where clinic users would most likely have commercial insurance.

John Bigalke, national managing partner for Deloitte’s health sciences practice, says the clinics could play an important role in providing healthcare for Medicaid recipients as well. As states grapple with providing primary care for the growing Medicaid population, retail health clinics may offer one way they can “continue to uphold their end of the social contract,” he says.

HHS pandemic plan unlikely to receive adequate funding

Prompted by 2006 legislation, the Department of Health and Human Services (HHS) released its first National Health Security Strategy last month, hard on the heels of the H1N1 pandemic.

The plan is focused on protecting people’s health during a large-scale emergency, according to a statement from HHS, and includes 10 objectives and an implementation guide to assist public and private healthcare organizations prepare for and manage health threats.

The policy is unlikely to receive adequate funding in the near future, according to Joseph White, professor of public policy, epidemiology and biostatistics, and director of the Center for Policy Studies at Case Western Reserve University in Cleveland.

“The details in the interim strategy seem reasonably well-considered, [but] the overall rhetoric is boilerplate,” says White. “There won’t be much result because the budget situation is awful, and there is unlikely to be real money.”

BIRD FLU PROMPTS NEW PLAN

The security strategy was mandated in the Pandemic and All Hazards Preparedness Act, passed shortly after the avian flu scare in 2005 and the SARS epidemic in 2003. The legislation directed the HHS secretary to develop the plan with an accompanying implementation process by 2009 and to revise the documents every four years. HHS stated, however, that it will update the implementation plan every two years to reflect advances in public health and medicine.

“As we’ve learned in the response to the 2009 H1N1 pandemic, responsibility for improving our nation’s ability to address existing and emerging health threats must be broadly shared by everyone—governments, communities, families, and individuals,” HHS Secretary Kathleen Sebelius said in a statement. “The National Health Security Strategy is a call to action for each of us so that every community becomes fully prepared and ready to recover quickly after an emergency.”

White believes this policy is, in part, the Obama administration’s attempt to better define duties between the HHS and the Federal Emergency Management Agency (FEMA), which joined the Department of Homeland Security after 9/11. Before the terrorist attacks, FEMA took an “all hazards” approach to disaster management, which included health epidemics, White says.

“A lot of serious public administration people whom I know said at the time that putting FEMA in DHS was a terrible idea,” he says. “So ‘all hazards’ was eliminated, and FEMA basically stopped paying attention to little things like hurricanes and epidemics.”

The goals of HHS’s strategy, such as building community resilience and strengthening and sustaining emergency response systems make sense, he says, but are unlikely to be high priorities.

“I’d be shocked if there is real money behind it,” he says.

Tuberculosis treatment requires medication and monitoring

Tuberculosis (TB) continues to be a problem in the United States, particularly among at-risk populations. The groups at highest risk for TB include people living with someone who has active disease, and those with a lowered immune response, such as HIV patients.

“Every medical center in our region has tuberculosis on its risk assessment list, that is, its list of potential issues to monitor on a continuing basis,” says Stephen Parodi, MD, chief of infectious disease for Kaiser Permanente, Northern California. “We make it a priority to ensure that patients at risk for infection with TB are screened for latent infections.”

The region includes 20 medical centers serving 3.1 million members. Dr. Parodi says the plan encourages screening for those who have been incarcerated or have a history of IV drug use and has educated primary care physicians and pediatricians to screen for TB.

“We saw a significant surge in TB cases when the HIV epidemic first hit; since then we’ve seen a leveling off,” he says. “In terms of epidemiology, it’s interesting to note that many cases we’re now seeing are in foreign-born individuals. We live in a global world, and we need to be aware that constant vigilance and aggressive, early recognition of latent and active disease will prevent further spread.”

Most people infected with tuberculosis don’t have any symptoms. When a patient is positive for latent TB, the clinician looks at the risk factors and determines (based on criteria from the Centers for Disease Control) whether the person is a candidate for preventive medicine.

“Preventive medicine is a lot easier than treating the active form of the disease,” Dr. Parodi says. “With latent disease we can treat with one drug, as opposed to active disease, where we typically have to use a minimum of four drugs initially.”

Patients who develop active TB experience symptoms such as weight loss, fever, night sweats, cough, chest pain and bloody sputum.

“Until susceptibility results are available, empiric initial treatment for active TB should include four drugs: isoniazid, rifampin, pyrazinamide and ethambutol,” says Mark Abramowicz, MD, editor-in-chief of The Medical Letter on Drugs and Therapeutics, a non-profit newsletter that critically appraises drugs. “When susceptibility to isoniazid, rifampin and pyrazinamide has been documented, ethambutol can be omitted.”

DIRECT PATIENT OBSERVATION NEEDED

One of the greatest problems in TB treatment today is the emergence of drug-resistant strains of the bacteria.

“Poor adherence to TB therapy is the most common cause of treatment failure, and can lead to drug resistance,” says Dr. Abramowicz. “Medical Letter consultants recommend that most patients, including those with disease due to drug-susceptible strains, take drugs for active TB under direct observation.”

At Kaiser, patients with active TB are monitored closely, typically with a monthly office visit. Kaiser physicians sign the orders for directly observed therapy, which is provided by the county public health department.

“We provide medications, lab testing to monitor potential side effects, symptom assessments, and imaging, x-rays or CT scans as needed,” Dr. Parodi says. “Protocols differ from jurisdiction to jurisdiction in terms of exactly who gets directly observed therapy, but in our experience, most counties are aggressive. If there is an identified case of active, potentially contagious TB, that person is receiving directly observed therapy.”

Extensively drug-resistant TB is a form of the disease caused by strains that are resistant to all the most effective anti-TB drugs. The World Health Organization reports that 41 countries have cases of extensively drug-resistant TB, including the United States.

“Confirmed multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis should be treated with directly observed therapy in collaboration with a clinician familiar with management of these conditions,” says Dr. Abramowicz. “Regimens for these conditions must include at least four drugs to which the organism is susceptible; the duration of therapy usually should be 18 to 24 months.”

In recent years, researchers have made considerable progress toward developing new medications that could treat tuberculosis more effectively. Eleven new medications from seven different drug classes are currently in clinical trials for tuberculosis.

“The medications that are farthest along are antibiotics called fluoroquinolones, which have the potential to shorten the duration of therapy,” says Eric Nuermberger, MD, associate professor of medicine and international health at Johns Hopkins School of Medicine, who is on the faculty of Hopkins’ Center for Tuberculosis Research. “Current medications require six to nine months; we hope fluoroquinolones will reduce that to four months. Four phase II studies of fluoroquinolones are currently underway, and we should have an answer in about two years.”

Fluoroquinolone drugs are already on the market in the United States for acute conditions such as community-acquired respiratory tract infections and urinary tract infections.

Of the medications that are being developed solely for tuberculosis, the one that’s furthest along is TMC207, developed by Tibotec.

According to a recent study in The New England Journal of Medicine, when researchers added TMC207 to a standard regimen for multidrug-resistant tuberculosis, a significantly higher proportion of patients had negative sputum cultures at two months.

Elaine Zablocki has been reporting on healthcare for more than 20 years. She is based in Oregon.

This article is based on information supplied by The Medical Letter (www.medicalletter.org), a non-profit organization that publishes newsletters offering critical appraisals of new drugs and comparative reviews of older drugs. The Medical Letter is independent of the pharmaceutical industry and supported entirely by subscription sales. Institutional site license inquiries can be sent to info@medicalletter.org [info@medicalletter.org]

Mortality, costs higher for women with cardiovascular disease

HEART DISEASE SHOULD top the list of women’s health concerns. Women disproportionately fear dying from breast cancer compared to heart disease, dutifully scheduling annual mammography, oblivious to their cardiovascular risks. There is little demand by women and the medical community for an urgent agenda or a “march for the cure” for heart disease in women.

Cardiovascular disease (CVD) is the single most common cause of death in women and men. Despite widespread assumptions to the contrary, women have accounted for more than one-half of the almost 1 million deaths due to heart disease and stroke in the United States annually since 1984. Women, compared to men, especially those under the age of 50 years, experience higher rates of recurrent myocardial infarction, heart failure and mortality after a first myocardial infarction, and are more likely to be misdiagnosed or diagnosed late in the course of their illness.

Annual hospitalizations and mortality for heart failure and total CVD expenditures are greater for women than men. While mortality from cardiovascular diseases has significantly declined over the past three decades, women have not experienced the same reductions in death and disability as have men. This significant gender-related mortality gap persists due to a combination of low awareness, misconceptions by physicians and women, gender-based physiologic differences, and disparities in care.

While these data might initially appear discouraging, improving these measures represents a significant opportunity to improve women’s CVD outcomes as well reduce overall healthcare expenditures by providing optimal screening and preventive services, appropriate and accurate diagnostic tests and timely cardiac care.

LESS THERAPY FOR WOMEN

The underlying causes for these disparities are multifactorial and the solutions complex. Gender-based disparities in preventive, diagnostic and therapeutic interventions are present on multiple levels. Women receive fewer cardiac diagnostic evaluations and less intensive therapy, from preventive interventions, to revascularization procedures to aspirin prescriptions. Even after a diagnosis of heart disease, gender-based differences in provision of care are present.

Women hospitalized with myocardial infarction are more likely than men to be managed by generalists, rather than referred for cardiology consultation, and are less likely to be transferred from community hospitals to centers for advanced care—practices associated with poorer short-term outcomes.

Additionally, societal and individual misconceptions about cardiovascular risk and what a heart patient “looks like,” along with inadequate gender-specific research data on cardiovascular disease and risk factors, contribute to lower awareness and poorer outcomes. While women’s symptoms can sometimes be challenging to address, both women and their physicians can be too quick to attribute potential manifestations of cardiac disease to menopause or aging. It is important to counteract the widely held belief that women do not develop heart disease except at advanced ages by raising physicians’ “index of suspicion” for cardiovascular disease in women.

There is also a growing body of literature documenting important biologic gender differences in CVD that may impact clinical care delivery. There are obvious differences due to the effects of gonadal hormones. However, differences in symptoms, accuracy of diagnostic tests, response to therapy, prevalence and relative risk of cardiovascular risk factors, as well as social and behavioral issues have all been identified. It is not always apparent whether or not these differences warrant a variation in established practice.

Many early cardiovascular clinical trials routinely exclude women or make no effort to enroll women in sufficient numbers to draw gender-based conclusions. With few exceptions, women currently make up only 20% to 30% of participants in cardiovascular clinical trials. Even when women are included as research subjects, it is often difficult to determine their outcomes from published reports. Only a quarter of recent cardiovascular trial results published in major U.S. internal medicine and cardiology journals reported gender-specific outcomes.

The lack of relevant research in women has resulted in a substantial and persistent gender-based knowledge gap about everything from the symptoms of heart attack in women, to the risks and benefits of commonly used cardiovascular diagnostic tests and therapies. Better evidence from properly designed research studies can better serve women with CVD.

An important example is the National Heart, Lung and Blood Institute (NHLBI)-funded multi-center Women’s Ischemic Syndrome Evaluation (WISE) study of approximately 900 women who underwent coronary angiography for chest pain symptoms and a multitude of other investigations designed to better characterize ischemic heart disease in women. We have already learned a great deal from numerous WISE publications that have underscored the value of gender-specific research and fundamentally changed the understanding of chest pain, CVD risk factors, vascular function, hormone interactions and atherosclerosis in women.

Cardiovascular clinical trial design must include women in adequate numbers to provide gender-specific data, and that data must be analyzed and reported by gender.

Systemic contributions to differences in cardiovascular care for women also include physician practice and referral patterns. In the United States, many women receive all or most of their medical care from specialists in obstetrics and gynecology during their reproductive years and continue those relationships well past menopause, or until a significant non-gynecologic illness occurs. Traditionally, there has been a greater focus on reproductive and breast health than on other health risks, and less awareness and self efficacy among these specialists about early cardiovascular risk identification and treatment.

RISK FACTORS ON THE RISE

The rise in risk factor prevalence in younger women, especially smoking, obesity and diabetes, has led to a growing number of individuals at high risk who do not look like typical heart patients. Reducing women’s future burden of CVD will depend heavily on improved preventive measures which currently fall short of recommendations. Simply taking what has been proven effective, and widely and appropriately applying it to women, can markedly improve care and outcomes.

Critical to this effort is continued education about women’s cardiovascular risks, symptoms and the use of appropriate diagnostic tests and therapies.

The most recent guideline, published in 2007 by the American Heart Assn. and endorsed by multiple professional and patient organizations, has simplified the risk assessment and decision-making process for easier implementation in daily practice.

The guidelines encourage clinicians and patients to focus on reducing long-term, rather than 10-year CVD risk. With few exceptions, those therapies that have been shown efficacious in men also prevent CVD in women and should be recommended to women at risk.

Sharonne Hayes, MD, FACC, is the director of the Mayo Clinic Women’s Heart Clinic and associate professor of medicine for the Mayo Clinic College of Medicine.

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