Get More Mileage from Erectile Dysfunction Drugs: Tadalafil for Raynaud’s?

When it gets chilly, but not freezing, my right index finger starts to turn white and numb. I’m told this is Raynaud’s syndrome, and the numbness goes away without much disruption to my life.

 But Raynaud’s phenomenon is a whole different problem: structural damage to the blood vessels that can be serious enough to cause ulcers and gangrene. Raynaud’s phenomenon is common in people with scleroderma, and it can be tough to treat, Dr. Vikas Agarwal, of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, said at the annual scientific meeting of the American College of Rheumatology
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courtesy of flickr user littlelupie (creative commons)

Dr. Agarwal and some fellow rheumatology researchers theorized that a vasodilator that improves blood flow in one extremity might do the same for other extremities. They randomized 53 patients (50 of whom were women) to a placebo or tadalafil (Cialis), a vasodilator better know for its use in treating erectile dysfunction. All participants reported at least four episodes of Raynaud’s per week despite taking other vasodilators.

 So, did it work? In this study, 20 mg of tadalafil every other day for 8 weeks significantly improved the frequency, duration, and severity of the Raynaud’s episodes.

But wait, there’s more. At the start of the study, 18 patients in the tadalafil group and 13 in the placebo group had ulcers on their fingers. At the end of the study, these ulcers had healed in 14 of the 18 patients in the tadalafil group, vs. 5 of the 13 patients in the placebo group.

This is a small study, and none of the researchers disclosed any financial conflicts. Will we see more research if some erectile dysfunction drug makers decide to expand their horizons to a different population? 

–Heidi Splete (on twitter @hsplete)

Why The Limp Sales?

After years of go-go growth, it appears that the market for erectile dysfunction drugs in the U.S. and overseas is flat.

Courtesy Flickr user fhwrdh

That’s according to Eli Lilly, which told investors this morning that the global market for ED drugs grew just 1% over the first 9 months of this year. Will this market shrinkage cause primary care doctors to find themselves in the crosshairs of promotion?

Lilly crowed that its Cialis (tadalafil), dubbed “le weekend” by randy Frenchmen because of its reputed 36-hour effect, had 4% sales growth overall (17% in the U.S.).  Some $1.1 billion worth was sold from January to October — nothing to sneeze at, but not a blockbuster like Zyprexa, which had $3.5 billion in sales over the same period.

Cialis has edged ahead of Pfizer’s Viagra (sildenafil) among prescribing urologists in the U.S., the company said. But it has a tougher sell with primary care physicians, who write for Viagra for about 55% of prescriptions.

Bayer’s Levitra (vardenafil) is a distant third.

But overall, in the U.S. and Europe, even Lilly’s own charts show a straight, flat line of sales growth for these drugs.

Meanwhile, in the U.S. at least, ED drugs continue to be promoted like flat screen TVs on Black Friday.  According to a recent report from the Congressional Budget Office, ED drugs were the most heavily promoted class to consumers in 2008.  The three ED manufacturers spent $350 million on television, print, and Internet efforts. Another $175 million was spent promoting the drugs to physicians.

Only those ubiquitous Sally Field ads for Boniva and promos for other osteoporosis ads came close, clocking in at about $250 million in direct-to-consumer spending and $250 million on physician promotions.

So what’s with the slowdown in the ED market? Are there no more men (and their partners) out there who could benefit from these drugs?

Lilly may have an answer for that. According to its presentation, the company is making inroads in China.

How do you say “le weekend” in Mandarin?

— Alicia Ault (on Twitter @aliciaault)