New Zealand researchers review the study on Viagra after the death of a baby

The deaths of infants involved abroad in a clinical trial exploring a potential treatment using Viagra have aroused the interest of researchers who conducted a study aligned here in New Zealand.

The international research consortium STRIDER involved four trials – one of them was conducted here and in Australia to investigate a possible use of the drug in the treatment of fetal growth restriction.

Sildenafil, marketed as Viagra, is used to treat erectile dysfunction in men. if it could work the same way in pregnant women by increasing the blood supply to the placenta.

But last week, one of the trials, which was underway in the Netherlands, was interrupted prematurely for security reasons.

The results of a planned interim analysis showed that more babies in the sildenafil group were suffering from a serious lung disease, called persistent pulmonary hypertension, which may have around 26.6% of the babies in the group Sildenafil suffered from severe lung disease, compared to 5.2% in the placebo group, while 26.8% died before being released. compared to 14.3 percent in the placebo group.

The Dutch trial began in 2015 and was to continue until 2020, with the participation of 350 patients.

The tests on humans were approved after successful experiments on

The New Zealand and Australian study focused on 122 pregnant women from New Zealand and Australia, half of whom were taking Viagra regularly, the other half took a placebo.

Her chief investigator, Katie Groom of the Auckland-based University Liggins Institute, said that the local study had found no evidence of a positive effect of sildenafil – but no evidence of harm.

This was consistent with the results of STRIDER UK, published in 2017. [1] 9659002] "This discovery was very unexpected and, until now, it is unclear whether this increase in hypertension pulmonary was caused by treatment with sildenafil, "said Groom

" We fully support the decision of the Dutch researchers to stop the study.And let the time to fully investigate the results.Our consortium will continue to work together to achieve this. "

In the Australasian trial, only two cases of pulmonary arterial hypertension were reported – in one case, the mother had received sildenafil and the other placebo.

similar number of neonatal deaths in both groups. These results were similar in the UK trial.

Groom and his colleagues examined all cases in both British and Australasian trials, but did not expect this to change.

British and Australasian trials include Childhood Outcome studies, examining all children born to mothers who participated in the study at the age of two to three years, and these were ongoing.