Daily Archives: May 5, 2010

Should Cholesterol Drugs Be Used By Those Without High Cholesterol?

Some experts say statins help healthier people, but others worry about risks. So, when the U.S. Food and Drug Administration (FDA) approved the use of the cholesterol-lowering statin drug Crestor for some people with normal cholesterol levels, cardiologist Dr. Steven E. Nissen cheered the decision. But, not everyone did. Here are the details in a report from HealthDay News:

“You have to go with the scientific evidence,” said Nissen, who is chairman of cardiovascular medicine at the Cleveland Clinic. “A clinical trial was done and there was a substantial reduction in morbidity and mortality in people treated with this drug.”

But Dr. Mark A. Hlatky, a professor of health research and policy and medicine at Stanford University, has expressed doubts about the FDA move. He worries that more people will rely on a pill rather than diet and exercise to cut their heart risk, and also points to studies linking statins such as Crestor to muscle troubles and even diabetes.

“I haven’t seen anything that changes my mind about that,” Hlatky said.

So, will millions of healthy Americans soon join the millions of less-than-healthy people who already take these blockbuster drugs?

The FDA’s February approval of expanded use of rosuvastatin (Crestor) was based on results of the JUPITER study, which involved more than 18,000 people and was financed by the drug’s maker, AstraZeneca.

People in the trial who took the drug for an average of 1.9 years had a 44 percent lower risk of heart attack, stroke and other cardiovascular problems compared to those who took a placebo — results so outstanding that the trial was cut short.

Based on JUPITER, an FDA advisory committee voted 12 to 4 in December to approve widened use of the drug.

The people in the trial included men over 50 and women over 60 with normal or near-normal cholesterol levels.

However, these individuals did have high levels of C-reactive protein, a marker of inflammation that has also been linked to cardiovascular problems. They also had at least one other heart risk factor, such as obesity or high blood pressure.

For that specific group, Crestor makes sense, Nissen said. “Over a five-year period of time, you prevent one death or minor stroke for every 25 people treated,” he noted.

Whether or not others with normal cholesterol should take Crestor or another statin remains unclear. “Not everyone with normal cholesterol should be treated,” Nissen said. “You should give it to people with a high enough risk.”

And he added that the results applied only to Crestor. Other popular statins include Lipitor, Pravachol and Zocor, as well as some generic versions.

Those statins might not produce the same benefits, Nissen said. “Statins differ from each other in terms of potency,” Nissen said.

Crestor, which is available only in a more expensive brand-name form, is toward the top of the list in terms of potency, he noted, while generic drugs such as simvastatin (Zocor) and pravastatin (Pravachol) have much less powerful effects.

“For patients who need a lot of cholesterol reduction, I use the most powerful drug,” Nissen said. “If I can get a patient there with a generic drug, of course I use a generic drug.”

But Hlatky has his doubts about the advisability of widening statins’ reach. He said he’s reluctant to have people at cardiovascular risk pop a pill rather than change the lifestyle factors that put them in trouble in the first place.

“My view has always been that you start with the basics and do the simple things first before you go to drugs,” Hlatky said. “Lots of people are not doing the sensible things. They’re not eating the right diet, they’re not exercising, they’re still smoking. Most of the people in the JUPITER trial were smack in the middle of that group.”

So Hlatky says he might still prescribe a statin for someone in that group, “but I would have an informed conversation about the long-term risks and benefits and what you need to do to reduce the risks.”

“It is so much easier to prescribe a drug than to change behavior, and that is my worry,” Hlatky said. “We’re heading down that road. Cardiovascular risk prevention is moving in the wrong direction.”

He’s also worried about exposing more people to the rare but still possible side effects that come with statins. The drugs can cause myalgia — severe muscle pain — and a recent study published in the British journal The Lancet found a 9 percent increase in diabetes incidence among people taking statins.

But Nissen believes the benefits of expanded use of Crestor outweigh possible risks. The study that found an increased incidence of diabetes did not find that it was accompanied by any increase in cardiovascular problems and deaths, he noted.

“The is one example where the FDA got it exactly right,” Nissen said.

And, from my perspective, I agree.

Online Brazilian Diet Pills Can Be Addictive

Researcher have found a dangerous mix of amphetamines, tranquilizers and antidepressants found in some pills. Although marketed on the Internet as “natural,” the popular weight loss supplements known as Brazilian diet pills contain potentially addictive ingredients. Here are the details in a report from HealthFinder:

The U.S. Food and Drug Administration warned consumers in 2006 of dangers associated with the diet pills, but they remain popular and easy to order online, the researchers say.

“What we have seen and what the FDA has found is that, unfortunately, there are dozens of products that are sold as dietary supplements that are contaminated with pharmaceutical compounds,” said lead researcher Dr. Pieter Cohen, an instructor in medicine at Harvard Medical School.

People already prone to addiction can become dependent on these nonprescription drugs, and stricter oversight by the FDA is needed, Cohen said.

“When you are purchasing these products, you have no idea what you are getting,” he noted. “There is a very lax regulatory framework that surrounds dietary supplements. Basically, all dietary supplements are assumed to be harmless until the FDA demonstrates that they are dangerous.”

In the article, published in the American Journal on Addictions, Cohen and a colleague, Benjamin Smith, tell the story of a 29-year-old who needed psychiatric care to kick her addiction to Brazilian diet pills.

The problem wasn’t with the herbal content; rather, it was a mixture of amphetamines, tranquilizers and antidepressants, the researchers say.

Although sometimes unemployed and homeless, the woman increased her dose over four years, eventually taking four pills a day at a daily cost of $160, Cohen noted.

“Even though she couldn’t afford the pills, she borrowed money so she wouldn’t have to stop,” Cohen said.

When she tried to wean herself off them, she experienced symptoms of withdrawal, including tremor, headache, cravings and anxiety. Only under a psychiatrist’s care was she able to kick her addiction.

Her case is proof that undeclared ingredients in some dietary supplements can cause serious psychiatric problems, Cohen said.

Earlier research found some of these diet pills cause chest pain, racing heart and insomnia, but the resulting psychiatric problems are not well-understood, Cohen said.

The pill makers probably add the pharmaceutical agents because they are the ingredients that promote weight loss, not the herbal concoction, he said.

“If you are taking a dietary supplement and it’s actually working, then I’d be concerned that something else is in that pill,” Cohen said. “Everyone who is consuming dietary supplements, which is half of U.S. adults, are in some ways guinea pigs,” he said.

Given that about 20 million Americans use nonprescription diet pills a year but don’t tell their doctors, the authors said physicians should screen for their use.

Dr. Ihsan Salloum, professor of psychiatry and chief of the division of alcohol and drug abuse at the University of Miami Miller School of Medicine, agreed that the mix of drugs in the diet pills can cause devastating symptoms of addiction.

“When people are withdrawing from a stimulant, they could also have suicidal thoughts and ideation,” he said.

“The frightening thing is they are sold over-the-counter, so people think they’re safe and natural,” Salloum said.

Expectant Mom’s Exercise Keeps Newborn’s Birth Weight Down

A pregnant mother’s exercise may lower her baby’s risk of obesity later in life. The new research shows that regular moderate-intensity exercise during pregnancy reduces an infant’s birth weight, which may lower the child’s risk of obesity later in life. In a new study, 84 first-time pregnant women were randomly assigned to exercise or control groups, with those in the exercise group participating in a weekly maximum of five 40-minute sessions on a stationary cycle. They did this program until at least 36 weeks into their pregnancy. Here are the details from HealthDay News:

Babies born to mothers in the exercise group were an average of 143 grams lighter than infants born to mothers in the control group, and also had a lower body-mass index (a measurement that takes into account height and weight), the researchers found.

The exercise training had no effect on the mothers’ body weight or body-mass index during late pregnancy, and had no effect on insulin resistance from the start of the study to late gestation, according to the report published online in the Journal of Clinical Endocrinology & Metabolism.

“Our findings show that regular aerobic exercise alters the maternal environment in some way that has an impact on nutrient stimulation of fetal growth, resulting in a reduction in offspring birth weight,” study co-author Dr. Paul Hofman, of the University of Auckland in New Zealand, said in an Endocrine Society news release.

“Given that large birth size is associated with an increased risk of obesity, a modest reduction in birth weight may have long-term health benefits for offspring by lowering this risk in later life.”

Hofman added that the “physiological response to pregnancy appears to supersede the chronic improvements in insulin sensitivity previously described in response to exercise training in non-pregnant individuals. This may be an important finding for athletes who want to continue regular training during their pregnancy as it suggests that training will not have a major adverse impact on insulin resistance.”

For more information, the Nemours Foundation has more about exercising during pregnancy.