A new wrinkle in drug therapy already being used to treat motion sickness, high blood pressure and angina pectoris pain has been tested at UCLA with apparent success in treating the effects of menopause.
The method uses stick-on patches to introduce into the body a drug that was being administered in pills or some other form. Called a "transdermal" application, the patch procedure may help the patient avoid some of the side effects brought on by conventional therapy.
In the case of motion sickness, a drug called scopolaomine is now available in stick-on form to prevent seasickness; the drug clonidine is being used for blood pressure therapy, and a staple of pharmacology, nitroglycerin, is used in its familiar role as the drug of choice for angina.
Now, however, the stick-on patch--whose development was greeted initially in some consumer circles more as a novelty than anything else--is being advocated by UCLA scientists as a way to infuse doses of replacement estrogen into postmenopausal women. A report of the new research findings--focusing on 23 women on whom the estrogen patches were tested--is being published today in the New England Journal of Medicine.
And though the stick-on patch is not yet ready to be sold to the public, independent experts not involved in its development say the research has "the potential of being a real breakthrough." That was the careful assessment of Dr. Jacob Brody, dean of the University of Illinois School of Public Health and a former associate director of the National Institute of Aging.
Alternative to Daily Pills
In the new method, instead of pills taken daily--with the risk of possible uterine cancer, liver damage, high blood pressure and other complications, including nausea and vomiting--women might stick patches of a hormone called estradiol on their bellies twice a week, allowing the drug to be absorbed through the skin directly into their bloodstreams.
So far, the stick-on method seems to have few, if any, of the disadvantages of estrogen replacement pills and the same therapeutic benefits--which come in the form of avoidance of the bone deterioration of osteoporosis, vaginal atrophy and hot flashes.
If the estrogen patch proves in larger tests to work as it has up until now, the new method may avoid most, if not all, of the serious side effects that have kept estrogen replacement therapy highly controversial since it was first used more than 20 years ago.
And for Alza Corp. and Ciba-Geigy Corp., the two drug companies with a cooperative stake in the new product, the so far-favorable test results keep alive the dream of vast commercial success in a market whose size will burgeon between now and the year 2010 as the Baby Boom generation cycles through the population and women probably retain their 7.5-year longevity advantage over men.
In Final Testing Phase
The Alza-Ciba product, which has been given the brand name Estraderm, is in the final phases of pre-market testing, and its makers believe that it could be approved for sale by the U.S. Food and Drug Administration as early as within a year from now.
The UCLA research report follows publication in another journal last August of a preliminary study of Estraderm conducted by the two drug companies themselves.
A side effect-free estrogen replacement therapy could have broad appeal in a market which FDA and U.S. Census Bureau figures indicate may grow exponentially from only about 4 million to 5 million of 40 million postmenopausal women using estrogen now.
Census projections indicate that, by the year 2000, there will be nearly 55 million women over 44--the age range in which menopause becomes commonplace, and, by 2010, there will be more than 65 million in the age bracket.
Until now, the market has been dominated by Premarin, a so-called conjugated estrogen product that has done better than any other pill in treating menopause but about which enough questions about short-term and long-term side effects have been raised to keep it from becoming anything approaching universally used.
The newly published UCLA research was done by a team in Westwood and at Veterans Administration hospitals in Los Angeles and in St. Louis. The project was headed by Dr. Howard Judd of UCLA, one of the nation's half dozen most prominent experts on the phenomenon of menopause.