The U.S. Food and Drug Administration is looking into whether Daiichi Sankyo’s blood pressure medicine Benicar increases the risk of heart-related death, although the agency said it still believes the benefits of the drug outweigh its potential risks.

The FDA said it is evaluating data from a pair of clinical trials in which diabetes patients taking the drug, known chemically as olmesartan, had a higher rate of death from heart related causes compared with patients taking a placebo.

In a safety notice posted Friday, the agency cautioned that it has not concluded that Benicar increases the risk of death, and Daiichi has expressed its confidence in the drug.

In addition to reviewing data from the two studies, the FDA said it is considering additional ways to assess the cardiovascular effects of Benicar.

In the long-term trials, patients with type 2 diabetes were given either Benicar or placebo to determine whether Benicar would slow the progression of kidney disease or progression of the diabetes.

In the larger of the two trials, Benicar did appear to slow the onset of kidney disease, Daiichi said.

But an unexpected finding in both trials was a greater number of deaths from heart attack, stroke or sudden death in the Benicar-treated patients compared with those who took a placebo, the FDA said.

“Olmesartan has been around for a long time, and the class of drugs has been around for a very long time. We’ve been very confident, as the FDA has been, in both the efficacy and the safety,” Daiichi’s chief scientific officer, Dr. Glenn Gormley, said in a telephone interview.

There are several classes of drugs that work through different mechanisms to treat high blood pressure. Benicar belongs to a class known as angiotensin receptor blockers, or ARBs, that are also used to prevent kidney failure.

Other ARBs include Merck & Co’s Cozaar and Novartis AG’s Diovan.

“There was a numerical imbalance in some of the cardiovascular side effects,” Gormley said. “We’ve never seen that before in other studies and I don’t think we’ve seen that with other ARBs.”

In the larger of the two studies, which included more than 4,400 patients divided about evenly between those taking Benicar or placebo, there were 15 heart-related deaths in the drug group versus three on placebo.

In the other 557-patient study, there were 10 heart deaths in the Benicar group compared with three on placebo.

“It’s a very small number and the FDA would just like to understand it better, as we would,” said Gormley, adding that the company is working with the agency to help with the analysis.

The FDA is encouraging healthcare professionals and patients to report adverse events or side effects related to the use of Benicar. By Bill Berkrot, msnbc

Everyone has heard a doctor explain how daily exercise and healthy eating make a difference in your overall physical well-being. But it’s hard to listen to your physician prescribe exercise if he or she doesn’t model the advice being dispensed.

Some local doctors don’t just talk about it. They work out daily, maintain busy practices and stay actively involved in family life. They make exercise a daily priority that doesn’t get eclipsed by work, family or other obligations. It’s scheduled; it’s not optional.

“If everyone could eat right and exercise, we wouldn’t have an epidemic of obesity and diabetes,” says Dr. David Balis, 43, of Plano, an internal medicine specialist at UT Southwestern Medical Center and Parkland Health & Hospital System who is also a triathlete. “Physicians definitely need to be role models. If a doctor is overweight and smokes, are the patients going to listen and take it to heart, or laugh in their face?”

His is a local response to a national issue.

In 2003, the president of the American Academy of Family Physicians, Dr. Michael Fleming, issued a personal challenge to the group’s 94,000 members to “walk the talk” by improving their own health. At the time, an e-mail survey of approximately 2,000 members indicated that 60 percent had problems with their own weight, and 69 percent worked out regularly and considered themselves to be healthy role models.

The group has since launchedan initiative to support doctors trying to improve their health and the health of their families, employees and patients.

“The premise behind it is that fitness needs to be the treatment of choice for preventing and treating medical problems,” said Dr. Vance Blackburn of Birmingham, Ala., who is participating in the program. “So much of what we treat is due to poor lifestyle choices, leading to obesity, high blood pressure, diabetes and heart attacks. We need to prevent it.”

Last year, 24 AAFP member practices across the country participated in a pilot program. The program is now being evaluated to see, in part, how patients responded when more emphasis was placed on their physical activity, nutrition and emotional well-being.

“If you’re going to try to make an impact on [patients'] lifestyles, you need to look at your own lifestyle, what you can and can’t do, to try to make the changes you’re recommending to your patients,” said Dr. Wilson Pace, a professor in family medicine with the University of Colorado and a facilitator with the AAFP’s National Research Network, which is evaluating the program.

“There’s a push to recognize that we’re not going to solve our crisis with another drug or another surgery. We need to start rethinking: how you eat, how you exercise. This isn’t an afterthought. It needs to be a central component to help people stay healthy.”

Leading by example

Dr. Michele Kettles, 45, medical director of the Cooper Clinic in Dallas, shows what kind of influence a healthy doctor can have.

Her patient Pat Allen, 73, credits Kettles with inspiring and guiding her through a lifestyle change. Kettles explained to Allen that her rising blood-sugar numbers could lead to a pre-diabetic condition. Allen, who comes to Dallas from Bryan to see Kettles, said she had never exercised and had grown up eating unhealthy fried foods.

“I could see Dr. Kettles’ vitality and the energy she had,” Allen said. “I knew it was because she ate right, and she exercised. I could tell she really believed in what she was talking about. It made a difference that she did it herself.”

Allen said she lost more than 40 pounds, and her blood work returned to normal ranges over the course of a year.

“I reached the point where I felt so much better,” she said. “I wanted to keep doing it. I didn’t say it was easy.”

Finding time

Physicians also have to work hard to fit exercise into their schedules.

Kettles, who specializes in preventive medicine, knows that a low fitness level is an indicator of poor health. She says it helps that she can show her patients it’s possible to schedule fitness into your life. She tells patients it matters how you set up your life, and that you have to schedule healthy behaviors and make them convenient.

Her workday ends at 5:30 p.m., when her husband brings their two children to her office. She and her family walk around the Cooper Institute campus most days. They sometimes swim or use the gym during family time.

“I have a stressful job,” said Kettles, who also runs at least three miles three times a week. “I need to burn the stress at the end of the day. I’m a much better wife and mother if I’m destressed than if I worked another 30 minutes.”

Kettles said she’s shocked at how often people comment about her family exercising together. “They think it’s an anomaly. People should do this.”

Both Balis and Dr. Bradley Weprin, 43, a Dallas pediatric neurosurgeon, get their workouts in before daybreak. Weprin, a marathon runner, trains at 5 a.m.

“I have to get my workouts in extremely early, or I wouldn’t get it done,” he said. “It helps my mind open. I’m probably a much better person, in a much better mood, when I’m active.”

He has his share of aches but says the benefits far outweigh the pains.

Balis cycles, swims, runs or lifts weights at the gym. He then showers and heads straight to work, eating a couple pieces of fruit and an energy bar en route.

Balis said he encourages his patients to do something and to gradually push themselves to do more. When they say they don’t have time, he counsels them to prioritize and to manage their time, even if it means cutting back on watching television or playing on the computer. He says there has to be some point in the day you can work out.

“You have to figure out when that time is for you and block it out,” he said. “You have to do it every day.” By Debbis Fetterman, The Dallas Morning News

The Department of Obstetrics, Gynaecology and Child Health, University of the West Indies, Mona, will host the ninth Annual Perinatal Audit and Symposium ‘Pregnancy in the woman of advanced maternal age’ on February 12 and 13 at the Main Medical Lecture Theatre, University Hospital of the West Indies.

Associate Professor, Department of Obstetrics and Gynaecology, University of Toronto, and Director, Prenatal Screening Service, Mount Sinai Hospital, Dr N. Okun, will deliver the keynote address during the opening ceremony titled ‘Prenatal Screening for Chromosomal Abnormalities’. The first day of the conference will involve a perinatal audit as well as workshops on neonatal mortality and ethics.

Day two will address preconceptional assessment, pregnancy planning and health promotion for women of advanced maternal age. Topics to be covered include obesity in pregnancy; assessment, counselling and support of women after perinatal loss, twin pregnancy, post-discharge follow-up of the premature infant and infant of the diabetic mother. Other topics to be discussed are an approach to the infant with congenital abnormalities and approach to the infant with Trisomy 21, a chromosomal abnormality more commonly known as Down’s Syndrome.

The Department of Obstetrics, Gynaecology and Child Health has been conducting annual perinatal audits since 2001. The primary objective is to educate health-care professionals about management of problems in areas of expertise. It should be of particular interest to doctors (consultants, residents and interns), nurses, midwives, allied health-care professionals and medical and nursing students. The Gleaner