Swiss review hormone therapies following US trial

American researchers announced they were stopping a clinical trial into one particular HRT drug Keystone

Switzerland is to review the use of hormone therapy following US reports that a certain type of drug may increase the risk of breast cancer and heart disease.

This content was published on July 15, 2002 - 11:00

Swissmedic - the Swiss Agency for Therapeutic Products - said it was responding to a clinical trial conducted in the United States into hormone replacement therapy (HRT), which revealed that long-term use of one type of drug could have more long-term negative effects on a woman's health than beneficial ones.

HRT is prescribed to millions of women struggling with health problems during and after menopause.

Results of clinical trial

The US clinical trial was abandoned this week after five years when researchers discovered that long-term use of the American oral HRT drug, Prempro, significantly increased a healthy woman's risk of breast cancer and heart disease.

Swiss authorities have been quick to point out that the specific US drug examined in the trial is not available or marketed in Europe - but they admit there is a need for more general research into the effects of HRT.

"We need to evaluate the situation with specialists and look at the data," said Jean-Christian Krayenbühl of Swissmedic's prescription medicine division.

"Then we will decide about what further measures we might eventually have to take," he added.

Krayenbühl told swissinfo the challenge for scientists and medical practitioners alike would be to reconsider the "benefit-risk profile" of HRT drugs.

"Only then can we assess if there should be further measures...and we have advised that the treatment should not be stopped by patients now," he commented.

Calls for more research

Swissmedic has announced that research into other forms of HRT will not be conducted before a full analysis of the results of the US trial.

"As a first step we will look at this study and we are expecting...a final report," said Krayenbühl.

"Of course, one question ought to be whether the conclusions of this study apply to other hormonal preparations or to preparations which are, for instance, not administered orally but transdermally via patches," he added.

The Swiss pharmaceutical giant, Novartis, is one company which produces hormone replacement therapies, but it says that the vast majority of its HRT drugs are supplied as patches, while only seven per cent are sold as oral preparations.

"The [US] study concludes that transdermal [preparations] may provide a different risk-benefit profile," said Mark Hill, a spokesman for Novartis.

"So it is possible that prescribers may move away from oral therapy and go for transdermal patches," he told swissinfo.

But the company admits that the preliminary results of the US clinical trial may make more women think twice about beginning a course of hormone replacement therapy.

"It is quite possible that there may be a downturn in the use of oral HRT," said Hill.

swissinfo

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