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Erectile Dysfunction- Three New Drugs

If you have erectile dysfunction, you don’t have to shop for the increasingly rare rhinoceros horn or the often deadly Spanish fly, which is made from the remains of the blister beetle. There are hundreds of other reputed aphrodisiacs, but none have been found to work.

What about Viagra, Levitra, and Cialis?
You don’t even have to inject a drug into your penis, which was the best thing that Western medicine had to offer just eight years ago. Before that, the best you could do was either use a pump to draw blood into your penis or a penile implant, which meant the surgical placement of plastic rods in your penis.


Ouch!

Now, we have a choice of three quite effective and well tested oral drugs for erectile dysfunction (often described by the acronym ED). They are not aphrodisiacs, because they will not increase sexual drive. They work by blocking an enzyme called phosphodiesterase-5, or PDE-5. This helps the smooth muscles in the penis to relax, which effectively increases blood flow, allowing an erection. But for them to be effective, sexual stimulation is also required.

ED is the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance. Obviously an intensely private matter, it is not something that we have begun to talk about in public until quite recently. Consequently it is a common health condition among men that is largely untreated. And it has only since Viagra (sildenafil citrate) came on the market in April 1998 that we have begun to realize how many men suffer from ED.

The best estimates are that some degree of ED affects more than one half of all men over the age of 40—perhaps 152 million men worldwide and 30 million men in the United States alone. Despite this high prevalence, nine out of 10 men in the U.S. have not yet sought treatment from a physician.

ED is three times more prevalent among men who have diabetes than in the general population. More than half of men with diabetes notice the onset of ED within 10 years of their diagnosis. It occurs in nine percent of men with diabetes between age 20 and 29 years and rises to 95 percent by age 70.

Surprisingly, ED is more common among men with type 2 diabetes than among those with type 1, according to Martyn A. Vickers, MD, Chief of Surgery, Togus (Maine) VA Medical Center, and Associate Professor of Urology, University of Massachusetts Medical Center. He writes in “Phosphodiesterase type 5 inhibitors for the treatment of erectile dysfunction in patients with diabetes mellitus,” International Journal of Impotence Research (2002) 14, 466-471; abstract online at PubMed. Some 46 percent of men with type 2 diabetes have ED. This compares with 32 percent of those with type 1 diabetes.

So add ED to your list of common complications of diabetes. ED is often a manifestation of neuropathy. Like peripheral neuropathy, to which ED is often related, there is no “one size fits all” treatment. But unlike peripheral neuropathy, we now have in our arsenal three drugs that are effective for most men.

These three drugs are closely related:

  • Viagra Most well known and available in the U.S. for the past five years is Viagra (sildenafil citrate), which Pfizer Inc. produces. The product’s official website is http://www.viagra.com. The biggest difference among these drugs is how long they last. “Take Viagra about one hour before you plan to have sex,” the Viagra website http://www.viagra.com/consumer/general/importantInfo.asp says. “Beginning in about 30 minutes and for up to 4 hours, Viagra can help you get an erection if you are sexually excited.”
  • Levitra, pronounced Luh-VEE-trah, (vardenafil HCl), obtained FDA approval in August 2003 and became available in the U.S. later that month. Bayer AG and GlaxoSmithKline plc co-developed and co-promote it. The product’s official website is http://www.levitra.com. “Maximum observed plasma concentrations after a single 20 mg dose in healthy volunteers are usually reached between 30 minutes and 2 hours (median 60 minutes after oral dosing),” according to the product’s official website at http://www.univgraph.com/bayer/inserts/levitra.pdf.
  • Cialis, pronounced see-AL-iss, (tadalafil), obtained FDA approval in November 2003 and became available in December. In February 2003 it was launched in Europe. Eli Lilly and Company, partnering with the drug’s original developer, ICOS, market it in a joint development venture. The product’s website is http://www.cialis.com/index.jsp. In Europe this drug already has a catchy nickname. It’s known there as “le weekend” pill. The product’s label says that Cialis can improve erectile function for up to 36 hours.

This is the only drug where I was able to find a curve of its effectiveness. Source of graphic: http://www.univgraph.com/bayer/inserts/levitra.pdf

Aside from how long these three drugs work, they are chemically similar and have similar side effects. Apparently, the biggest difference is that men using Viagra are more likely to experience temporary abnormalities of color vision. Additionally, taking Viagra with food decreases its effectiveness by 29 percent, while food has little if any effect on Levitra or Cialis.

They are even priced close to each other. Price is an important consideration, especially if your health insurance plan doesn’t include these drugs in its formulary.

The best legitimate prices I have been able to find come from Drugstore.com. This online pharmacy lists 10 Viagra tablets of 100 mg each at $87.99. Strangely, the 25 mg and 50 mg tablets list for the same price.

Likewise, Drugstore.com lists 10 Levitra tablets of 20 mg each at $87.99. The 2.5 mg, 5 mg, and 10 mg tablets list for the same price. The Drugstore.com price for 10 Cialis tablets of 5 mg, 10 mg, or 20 mg each is nearly the same—$89.99.

Spam offering Viagra, Levitra, and/or Cialis is rampant. But another strange pricing situation is that the prices at which spammers offer these drugs are far higher.

None of these drugs is inexpensive. Generic versions of prescription drugs are generally much less expensive, so you might be tempted to buy a generic version of Viagra, Levitra, or Cialis.

That could be a serious mistake. All generic versions of these drugs are manufactured abroad—often in third-world countries—and none of them have FDA approval.

A fourth new drug for ED, Uprima (apomorphine HCl), works on the brain and nervous system to trigger an erection. An FDA advisory committee is concerned about its safety, and it is not for sale in the United States. It is, however, marketed in Europe and Latin America. Uprima was developed and marketed by TAP Pharmaceutical Products Inc., a joint venture between Abbott Laboratories and Takeda Chemical Industries Ltd.

The company’s website is http://www.tap.com.

Which one of these drugs is right for you? That’s a question that you are going to have to answer yourself.

Dr. Vickers, whose study I link above, attempted to compare Viagra, Levitra, and Cialis on the basis of their Phase 3 trials of efficacy and safety for the general population and specifically for men with diabetes. However, criteria for inclusion, exclusion, classification of ED, dosing methodology, and duration of the studies varied too much to make valid comparisons possible.

Eventually, some researcher might publish head-to-head comparative trials of these drugs. Meanwhile, any of them look like they are better than the alternative.

Update
Tim Cady reminds me that the pump—which is painless—works in many cases where these new drugs are ineffective.
Most insurance plans and medicare provide coverage.

 
Hypoglycemic Supplies

David Mendosa is a freelance journalist and consultant on diabetes. Since 1995, his Web site, www.mendosa.com, has become one of the largest about diabetes. He publishes '"Diabetes Update'" online each month and is a coauthor of the book "What Makes My Blood Sugar Go Up and Down."

Like comedian Rodney Dangerfield, glucose tablets and gels "don't get no respect." That's not good grammar, but nothing else better captures the low regard that many of us have for this wonderful product.

...glucose...is the sugar that our bodies use the fastest.

Maybe it's the cost. None of the five manufacturers make expensive tablets or gels, and one brand of glucose tablets lists for less than a dime per tab. We might respect them more if they cost as much as, for example, test strips.

Maybe it's the taste. Glucose tabs may look like candy, but they certainly don't taste as good. Actually, that's intentional. They don't taste bad, but they are medicine. You don't want to continually eat them, and not have them when you need them.

Maybe it's their over-the-counter status. You can buy them in most drug stores and on the Internet without a prescription. All glucose tabs and gels are essentially pure glucose. This is the sugar that our bodies use the fastest. When our blood glucose levels drop below 60 or 70 mg/dl, we are at risk of hypoglycemia and need to take quick action.

The easiest strategy to remember is "the rule of 15." Paddock Laboratories of Minneapolis, the only company that makes both glucose tablets and gels, recommends that we take 15 grams of glucose when we go low, wait 15 minutes, and then take 15 more grams of glucose—if necessary. The available tabs are four or five grams each, and the gels are 15 or 24 grams. If we take too much, we can yo-yo to quite high blood glucose levels.

The article, "Products for Treating Low Blood Sugar," part of the American Diabetes Association's Resource Guide 2003 and a supplement to Diabetes Forecast, concurs with the rule of 15 and provides much more information.

The other companies making glucose tabs are Becton Dickinson of Franklin Lakes, New Jersey, Wal-Mart Stores of Bentonville, Arkansas, and Can-Am Care of Chazy, New York. Can-Am Care, formerly a subsidiary of Inverness Medical, doesn't have a Web site, but sells glucose tabs both as drugstore brands and under its own name in other drugstores. ICN Pharmaceuticals http://www.nitebite.com/IGnutrition.html in Costa Mesa, California, makes glucose gel.

Glucose tabs and gels aren't just for people with type 1 diabetes. Anyone who uses insulin—about 40 percent of people with type 2 diabetes—are also at risk of "an insulin reaction," where we take too much insulin for the amount of food we consume.

The sulfonylurea drugs can also cause hypoglycemia. Except for the alpha-glucosidase inhibitors Precose and Glyset, other drugs for people with type 2 diabetes rarely, if ever, cause hypoglycemic reactions. Because Precose and Glyset slow the digestion of complex sugars, people who take either of these drugs should always treat lows with glucose, which is a simple sugar.

Actually, complex sugars don't work fast enough for anyone who has gone low. The recommendation that always irritates me the most is to drink orange juice, which is mostly two complex sugars, sucrose and fructose.

For years the standard list has included a half glass of orange juice, sugar cubes, three or four Life Savers, a half cup of Coke or Pepsi, and two tablespoons or raisins. But none of these can compare with glucose tabs or gels in convenience, knowing how much to take, and especially speed.

Whatever you do, don't wait until it's too late to take one of these great products. When someone loses consciousness, never give that person anything to eat or drink. Instead, give him or her a glucagon injection or immediately get that person to the nearest emergency room.

All of us susceptible to hypoglycemia really need to keep one of these products next to our beds, in our cars, and purses or briefcases. Treat your body and your glucose tabs or gels with respect and, as the Boy Scouts say, be prepared.

-------------------------------------------------------------------------------- The American Diabetes Association originally published this article on its Web site as one of my “About the Internet” columns.

 
The medicare Mystery

David Mendosa is a freelance journalist and consultant on diabetes. Since 1995, his Web site, www.mendosa.com, has become one of the largest about diabetes. He publishes '"Diabetes Update'" online each month and is a coauthor of the book "What Makes My Blood Sugar Go Up and Down."

Working with medicare is one of the biggest challenges for people seeking coverage of diabetes supplies and services. '"People have a hard time with medicare,'" says Tim Cady of Advanced Diabetes Supply (www.northcoastmed.com.), a division of North Coast Medical Supply in San Diego.

Tim should know, because his national mail order diabetes company specializes in helping people who have medicare insurance get their testing and insulin pump supplies. medicare is the nation's largest health insurance program, covering about 40 million people.

You are probably eligible for medicare if you are disabled, have reached your 65th birthday or have permanent kidney failure treated with dialysis or a transplant. If medicare is an enigma that you haven't unraveled, this column can help.

Q: Where can I find the government's own regulations to argue my case?

A: The Internet has two excellent resources:

The Official U.S. Government Site for People With medicare at medicare.gov. Search for "Medicare Coverage of diabetes supplies and Services." Medicare's detailed regulations are available on the Web sites of each of Medicare's four Durable Medical Equipment Regional Carriers (DMERCs). Each of these DMERCs have the same regulations, and the easiest to find and use is that of Palmetto Government Benefits Administrators at http://palmettogba.com. Search for '"Chapter 38'mdash;Home Blood Glucose Monitors.'" It is the first link returned.

Once the deductible has been met, medicare Part B will generally pay 80 percent of the cost of blood glucose testing supplies. Your supplemental insurance, if any, will usually pay most of the balance. medicare is difficult to navigate now, but for most of us, it was impossible six years ago. In July 1998, medicare expanded coverage of blood glucose meters and test strips for all people with diabetes. Earlier, it covered blood glucose monitors and test strips only for people with insulin-dependent diabetes. medicare will cover everything you need for testing, whether you use insulin or not.

This includes:


  • The Meter itself
  • Test Strips
  • Lancets

But medicare sets some low test-supply limits. If you use insulin, the standard limit is 100 test strips and lancets every month. If you don't use insulin, the standard limit is 100 test strips and lancets every three months. The government seems to think that we test for the fun of it. Three tests a day when you use insulin and just once a day if you don't is far fewer tests than many of us need.

Well-written prescriptions, however, can get you what you need. They should not say, '"test once or twice a day,'" because medicare would understand that to mean once a day. When you need to test more often than Medicare's limits, the prescription also has to give specific reasons. These can include fluctuating blood glucose, uncontrolled blood glucose, hypoglycemia, hyperglycemia or an adjustment in your medication.

64 DIABETES HEALTH / DECEMBER 2004 / www.diabeteshealth.com

 
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