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How Viagra Helped Give an Infant a New Lease on Life

The active ingredient in Viagra is being studied in babies with extreme fetal growth restriction.

The active ingredient in Viagra is being studied in babies with extreme fetal growth restriction.

Viagra’s active ingredient is a substance called sildenafil.

Though it is most famous as a treatment for erectile dysfunction, the drug appears to have a number of medical uses having nothing to do with erection problems, in men, women, children, newborns, and potentially even in utero.

Sildenafil belongs to a class of drugs called PDE-5 inhibitors. By inhibiting a substance called PDE-5, which is found in numerous bodily tissues, sildenafil allows the smooth muscles lining the walls of blood vessels to relax, helping the blood vessels to expand so that blood can flow more readily. In the penis, this makes it easier for men to achieve erections in the presence of sexual stimulation. Elsewhere in the body it can address other types of blood flow issues, some of them life-threatening.

Survival of Premature Baby in UK Credited to Sildenafil

The survival of a premature girl in Manchester has been credited to a clinical trial in which her mother received sildenafil once it was determined that the baby was not growing properly in the womb. The baby was born 11 weeks premature, at only 1.3 lbs., but her parents don’t believe she would have survived without the sildenafil trial.

The trial was designed to give pregnant women whose babies were not growing properly in utero sildenafil three times a day, in hopes of increasing blood flow through the umbilical cord and giving the babies more time to grow in the womb. In the case of Baby Casey, after a 24-week ultrasound, a problem with her mother’s placenta was identified, and tests discovered that blood flow through the umbilical cord was inconsistent, stunting growth and drastically lowering the baby’s chances of survival.

Casey’s mom received sildenafil as part of what is called the STRIDER clinical trial, which hopes to show that when pregnant mothers with babies who have stunted growth in the womb take sildenafil, blood flow to the baby improves, allowing it to remain in the womb longer and improving chances of survival.

The STRIDER Trials

STRIDER stands for sildenafil therapy in dismal prognosis early-onset intrauterine growth restriction, and the purpose of these clinical trials is to learn if survival chances of babies with extremely poor prognoses can be helped when the mother takes sildenafil. Early-onset extreme fetal growth restriction results in a high risk of premature birth and very poor prognosis.

The purposes of the STRIDER trials are two-fold. First, they are designed to assess whether sildenafil benefits babies with extreme fetal growth restriction, and second, they are designed to provide data on whether effects are modified in clinically meaningful ways due to factors related to the mothers or to the trial protocol.

The trials began in 2013 and will end in 2017. The full data analysis of individual trials is expected to be completed in 2019. In the meantime, however, many of the babies whose mothers were given sildenafil due to extreme fetal growth restriction are being born, and individual cases, like the one in the UK are showing promise.

Sildenafil and Pulmonary Hypertension in Newborns

Extreme fetal growth restriction isn’t the only way that sildenafil is used in babies. It can also be used to treat pulmonary hypertension in newborns. Persistent pulmonary hypertension in neonates, or PPHN, has a high mortality rate and is usually treated with assisted ventilation and inhaled nitric oxide. But the expense of nitric oxide prevents it from being used in resource-poor facilities.

However, due to high concentrations of PDE complexes in these babies’ pulmonary vasculature, studies have been conducted on the use of PDE-5 inhibitors like sildenafil as an alternative to inhaled nitric oxide.

Only a few small studies of sildenafil in newborns with PPHN have been conducted, and they have primarily been conducted in places with limited resources. Sildenafil appears to improve physiological parameters in these babies, but large, randomized trials for its safety and effectiveness have not yet been conducted. Scientists hope that studies in both resource-limited and resource-rich settings can answer more questions, particularly about sildenafil as a stand-alone versus an add-on therapy.

Other Potential Prenatal Uses for Sildenafil

A study published in 2012 in the journal Clinical and Experimental Hypertension tested sildenafil in human umbilical arteries from healthy pregnant women and from pregnant women with preeclampsia, which is a pregnancy complication resulting in high maternal blood pressure and damage to other maternal organ systems, often the kidneys.

This very small trial involving 18 healthy pregnant women and 18 pregnant women with preeclampsia found that maximal relaxation response of the umbilical artery was achieved by sildenafil compared to other drugs. Though this was a small trial and researchers have not fully determined the exact mechanism of action of sildenafil in this situation, the results were encouraging.

Why Fetal Therapy Trials Are Particularly Challenging

Emotions run high in cases of endangered and premature infants, so trials proceed slowly and carefully.

Emotions run high in cases of endangered and premature infants, so trials proceed slowly and carefully.

As you might imagine, fetal therapy trials of any kind are challenging. Identification of mothers and fetuses that are appropriate for the trials has to take place quickly, and gaining parental consent can be complicated by the fact that parents are under tremendous emotional stress once they know their baby’s health or life is at risk. Randomized clinical trials can occasionally be used, but it can take many years (as in the STRIDER trials) to amass enough data from which to draw conclusions. Fortunately, many early trials involving sildenafil and newborns or fetuses have showed promising results, making parental decisions about clinical trials a bit easier in the face of potentially devastating fetal conditions like extreme restricted growth.

Some of the Non-Erectile Dysfunction Uses of Viagra

Babies are far from the only patients who may potentially benefit significantly from sildenafil therapy. The drug is routinely used in primary pulmonary hypertension in adults, and is being studied for a range of conditions, including menstrual cramps, high altitude sickness, stroke, and benign childhood lymphatic tumors. After starting life in the laboratory as a potential treatment for a heart condition called angina, sildenafil went on to become famous for its revolutionary ability to treat erectile dysfunction. Now science may be coming full circle as many new and non-erection-related problems are able to take advantage of the unique properties of sildenafil and drugs like it.

Conclusion

Viagra and other drugs in the PDE-5 class have been used for over a decade to successfully treat erectile dysfunction. eDrugstore.com has worked with US-licensed pharmacists for over 15 years, serving over half a million customers with name brand lifestyle prescriptions like Viagra, Cialis, and Levitra. We are proud of our outstanding customer service, fast shipping, and commitment to online ordering security.

Don Amerman has spent more than three decades in the business of writing and editing. During the last 15 years, his focus has been on freelance writing. For almost all of his writing, He has done all of his own research, both online and off, including telephone and face-to-face interviews where possible. Don Amerman on Google+