Belviq Is First New Prescription Weight Loss Drug in 13 Years

Reviewed by Louise Chang, MD

June 27, 2012 -- For the first time in more than a decade, the FDA has approved a new drug to help people lose weight.

Today, Arena Pharmaceuticals' Belviq (lorcaserin hydrochloride) became the firstprescription weight loss drug approved by federal regulators in 13 years.

The FDA approved Belviq as an addition to a reduced-calorie diet and exercise, for use in chronic weight control.

The approval is specifically for use in adults with a BMI above 30 (considered obese), and for adults with a BMI of 27 (considered overweight) or above if they also have at least one weight-related medical condition, such as high blood pressure,type 2 diabetes, or high cholesterol.

Belviq should not be used during pregnancy.

Today's move comes almost two years after the FDA refused to approve the drug, citing concerns about its safety and effectiveness.

But last May, an FDA advisory committee overwhelmingly endorsed making the drug available to people who are obese and those with health issues related to being overweight.

The drug's manufacturer will be required to conduct six post-marketing studies, including a long-term trial to look for heart attack and stroke risks, the FDA announced today.

Weight Loss Drug Targets Hunger Center

Belviq works by targeting a key area of the brain that regulates appetite, known as the serotonin 2C receptor.

This is the same appetite-controlling hormone targeted by fenfluramine, the "fen" component of the notorious 1990s diet drug combo fen-phen. Fen-phen was linked to potentially life-threatening heart valve problems in as many as one in three users.

But Belviq is much more selective than fenfluramine and much safer, its manufacturer says, because it specifically targets serotonin receptors associated with hunger.

In a study published two years ago in the New England Journal of Medicine, about half of obese people who took the drug for a year lost at least 5% of their body weight, compared to 20% of dieters who took a placebo pill, while about 1 in 5 Belviq users lost 10% or more of their body weight, compared to 1 in 14 placebo users.

People who continued on the drug for two years were able to maintain their weight loss better than those who switched to placebo after one year.

Study participants were monitored closely for heart valve irregularities, and no difference was seen in the two groups.

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Poor sleep may lead to heart disease and obesity

Washington, Jan 20 : People who suffer from sleep disturbance three nights per week or more are at a major risk for obesity, diabetes and coronary artery disease, say researchers.

A new research from the Perelman School of Medicine at the University of Pennsylvania, analyzing the data of over 130,000 people, also indicates that general sleep disturbance (difficulty falling asleep, staying asleep, and/or sleeping too much) may play a role in the development of cardiovascular and metabolic disorders.

The researchers examined associations between sleep disturbances and other health conditions, focusing on perceived sleep quality, rather than just sleep duration.

Patients with sleep disturbances at least three nights per week on average were 35 percent more likely to be obese, 54 percent more likely to have diabetes, 98 percent more likely to have coronary artery disease, 80 percent more likely to have had a heart attack, and 102 percent more likely to have had a stroke.

"Previous studies have demonstrated that those who get less sleep are more likely to also be obese, have diabetes or cardiovascular disease, and are more likely to die sooner, but this new analysis has revealed that other sleep problems, such as difficulty falling asleep, staying asleep, or even too much sleep, are also associated with cardiovascular and metabolic health issues," Michael A Grandner, PhD, research associate at the Center for Sleep and Circadian Neurobiology at Penn and lead author of the study, was quoted as saying.

Grandner and colleagues analyzed data of 138,201 people from the 2009 Behavioral Risk Factor Surveillance System (BRFSS). The BRFSS is an annual, state-based, random digit-dialed telephone interview survey of adults aged 18 years and older from all over the US. Read more...

More US women having twins; rate at 1 in 30 babies

By MIKE STOBBE, AP Medical Writer – Wed Jan 4, 5:13 pm ET

ATLANTA – The number of twins born in the U.S. soared over the last three decades, mostly the result of test-tube babies and women waiting to have children until their 30s, when the chances of twins increase.

In 2009, 1 in every 30 babies born in the U.S. was a twin, an astounding increase over the 1 in 53 rate in 1980, according to a government report issued Wednesday.

"When people say it seems like you see more twins nowadays, they're right," said Joyce Martin, an epidemiologist who co-authored the Centers for Disease Control and Prevention report.

Some increase was expected as more women are delaying starting a family until they are over 30. For some unknown reason, mothers in their 30s are more likely to have twins than younger or older women. As much as a third of the increase can be attributed to that, Martin said.

The rest of the rise is due to fertility drugs and treatments.

"You have a double whammy going on. There are more older moms and more widespread use of fertility-enhancing therapies," Martin said.

Starting in the early 1980s, couples who had trouble conceiving began to benefit from medical advances like fertility drugs and in vitro fertilization and other procedures. These treatments became fairly widespread in the 1990s but are expensive, and availability and insurance coverage varies.

The twin birth rate rose by more than 2 percent a year, on average, from 1980 through 2004. It leveled off to less than 1 percent annually although the rise from 2008 to 2009 was nearly 2 percent.

In 2009, twin rates increased in all 50 states, though the jumps were highest in lower New England, New Jersey and Hawaii. In Connecticut, twins now account for nearly 5 percent of births. Read more...