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FRIDAY, Sept. 8 (HealthDay News) -- A new antidepressant drug designed specifically to treat premature ejaculation proved safe and effective in two large trials, researchers report.

However, it's not likely that dapoxetine, a short-acting selective serotonin reuptake inhibitor (SSRI), will win U.S. approval anytime soon because it can produce side effects, one expert said.

SSRIs, which are used to treat depression and other psychiatric disorders, are now also used "off-label" as a treatment for premature ejaculation. They work because one of their side effects is to delay ejaculation. But, continued SSRI use can have some negative side effects, such as psychiatric problems, skin reactions, weight gain, and loss of libido, experts said.

"This is the first drug specifically developed for premature ejaculation," said lead researcher Dr. Jon L. Pryor, a professor and chairman of urologic surgery at the University of Minnesota. "It worked both in lengthening ejaculation time and in patients' feeling control over ejaculation and both subjects' and partners' feelings of satisfaction with intercourse," he said.

The findings are published in the Sept. 9 issue of The Lancet.

Premature ejaculation is the most common male sexual problem, even more common than erectile dysfunction, affecting 21 percent to 33 percent of American men.

In the study, Pryor and his colleagues looked at the combined results of two trials that tested dapoxetine. The trials included 2,614 men who had moderate to severe premature ejaculation.

The men were randomly assigned to receive a placebo or different doses of dapoxetine. They were told to take the drug one to three hours before having sex. At the start of the study, the men ejaculated, on average, in less than a minute after penetration.

However, after 12 weeks, men taking dapoxetine increased their time to ejaculation to 2.78 minutes for those receiving a 30-milligram dose, and to 3.32 minutes for those receiving a 60-milligram dose, the researchers found. For men taking a placebo, the time to ejaculation averaged 1.75 minutes.

Pryor thinks this study will get people talking more about the problem of premature ejaculation. "I hope this paper brings premature ejaculation out of the closet," he said. "I hope it allows for mature discussion about it, and that people realize that there is hope."

One expert familiar with dapoxetine thinks the drug has promise but will not be available in the United States.

"The problem is that dapoxetine was presented to the U.S. Food and Drug Administration last year, and they rejected it out-of-hand as a treatment for premature ejaculation," said Dr. James Barada, director of the Center for Sexual Health in Albany, N.Y.

The drug can produce side effects such as nausea, headache, upset stomach and weakness. It is being released in Europe, Barada said.

"Premature ejaculation is a real clinical condition that causes distress for the man, his partner and especially the relationship," he added. "Because we have no approved therapy, we are at somewhat of a loss to treat it. For many years, we have been using off-label therapies -- SSRIs -- because of the side effect they have of delaying ejaculation."

Doctors can still use SSRIs, Viagra, and psychotherapy to treat the problem, Barada said. "We need to get better research to understand the mechanisms of premature ejaculation and hopefully design a medicine that has good efficacy and safety that is not an SSRI," he said.

More information

The U.S. National Library of Medicine can tell you more about premature ejaculation.

FRIDAY, Sept. 8 (HealthDay News) -- HIV-suppressing protease inhibitor drugs are extending patients' lives but can also speed hardening of the arteries. Now, U.S. researchers say a special drug combination may decrease that side effect.

Researchers at the University of Kentucky found that giving mice HIV drugs called nucleoside reverse transcriptase inhibitors (NRTI), along with a protease inhibitor, prevented the hardening of the arteries that occurs when a protease inhibitor is used alone.

The mice received a common protease inhibitor called ritonavir and one of two NRTIs -- either d4T or didanosine.

The findings were published in the current issue of the American Journal of Physiology-Cell Physiology.

"The combination prevented the negative cardiovascular effect, hardening of the arteries, of the protease inhibitors without reducing the effectiveness of the protease inhibitors on HIV," study senior author Eric J. Smart said in a prepared statement.

"To our knowledge, these are the first data that indicate that nucleotide reverse transcriptase inhibitors can limit the atherogenic (tendency to form lipid deposits in the arteries) effects of ritonavir," he and his colleagues noted.

More information

The New Mexico AIDS Education and Training Center has more about HIV/AIDS medications  .

WEDNESDAY, Sept. 6 (HealthDay News) -- Children born to moms who drank during their pregnancy are at increased risk of drinking problems by the time they are 21, a new study finds.

"We know about the detrimental effects of alcohol during pregnancy on brain development and some physical malformations, but this is one of the best studies showing that alcohol use itself may be another risk factor," said Dr. James Garbutt, a professor of psychiatry at the University of North Carolina at Chapel Hill. "It's another reason not to drink during pregnancy."

Garbutt was not involved in the study, which was conducted by Australian researchers and was published in the September issue of the Archives of General Psychiatry.

In the study, Rosa Alati, from the University of Queensland, Herston, Australia, and colleagues collected data on alcohol abuse for over 2,100 people followed from birth to age 21.

The participants' mothers were also asked how often and how much they drank at any given time.

At 21 years of age, 25 percent of the children had some kind of alcohol problem, the researchers said. Of these, 13 percent said they developed the problem before they were 18, and 12 percent said they developed the problem between 18 and 21, Alati's team found.

Analysis of the data showed that children of mothers who drank more than three glasses of alcohol on any one occasion during early pregnancy were nearly two-and-a-half times more likely to develop an alcohol disorder before age 18 and more than twice as likely to develop an alcohol problem between ages 18 and 21.

Drinking during other stages of pregnancy, including late pregnancy, also increased the risk, the researchers found.

"Our findings support a biological contribution to the origin of alcohol disorders and suggest that greater attention should be given to the role of the programming effect of in utero alcohol exposure to the development of alcohol disorders in adulthood," Alati's group concluded.

Another expert agreed that the study provides more evidence of the dangers of drinking during pregnancy.

"This paper makes a convincing case that increased maternal alcohol consumption, especially early in pregnancy, is likely a cause of alcohol problems in young adulthood," said Dr. Redford Williams, the director of the Behavioral Medicine Research Center and a professor of psychiatry and behavioral sciences at Duke University.

It is known that increased maternal alcohol use is associated with altered brain development in the fetus, as well as fetal alcohol syndrome in newborns, Williams said.

"The major potential problem in interpreting these findings is the possibility, unexamined in this study, that genetic factors that influence maternal drinking may also be present in the offspring and contribute -- in addition to, or via, an interaction with the increased exposure to alcohol to the offspring's drinking behavior at age 21," Williams said.

However, "whatever the mechanism eventually turns out to be, these findings make a strong case for not drinking during pregnancy," Williams said.

More information

There's more on alcoholism at the U.S. National Institute on Alcohol Abuse and Alcoholism.