Prascend® PPID (Equine Cushings Disease) Treatment Approved by FDA for US Horses

Maybe I'm biased, but I thought that the CSI (Cushings Scene Investigation) ad run by Boehringer-Ingelheim Vetmedica in British horse magazines was the most clever horse ad so far this year. It heralded the introduction of Prascend to treat Cushings-suffering horses; Prascend will soon be available in the USA.

The following press release is not an ad, it is published here as a "heads up". Anyone involved in the world of Hoofcare + Lameness is going to hear about this. Farriers and veterinarians will be asked questions by horseowners about this medication, and you need to know about how pergolide has evolved into Prascend®.

Prascend has been available in the United Kingdom for a few months, and Boehringer-Ingelheim Vetmedica has launched an awareness campaign there to urge horse owners to have their horses tested for PPID. I don't know yet what B-I has planned in the USA, but I feel confident in saying that "this is news".

In 2007, this blog reported that a potential crisis loomed for horseowners who were treating the symptoms of their horses' PPID condition with Permax (pergolide). (See links at end of this blog post.) The medication was taken from the market temporarily because of problems with human prescriptions. Before long, it became available again in the compounded form, which many horse owners ordered directly and in different forms.

Compounding pharmacies have been at the center of a controversy in the veterinary industry. At this time, it is too early to give a reliable answer whether compounded (and less expensive) pergolide will remain an option for horseowners as pill-only Prascend enters the marketplace. Ideally, horseowners will have safe and multiple alternatives to keep their horses comfortable.

Much more information will be available at or following the AAEP Convention in San Antonio later this month. 

Everyone can recognize the advanced PPID (Cushing disease) horse. But laminitis and stretched white lines in younger horses may not seem to be related to PPID until much later, when a definitive diagnosis is made. Only careful testing will discern if horses without obvious signs suffer from PPID. (photo provided by Dr. Christian A. Bingold)

Boehringer Ingelheim’s Prascend^® Approved for PPID in Horses

Product is the first and only FDA-approved treatment for the management of PPID.

ST. JOSEPH, Mo. (November 2, 2011) – Boehringer Ingelheim Vetmedica, Inc. (BIVI), has received approval from the Food and Drug Administration (FDA) to market Prascend® (pergolide mesylate), for treatment of clinical signs associated with pituitary pars intermedia dysfunction (PPID), also known as equine Cushing’s disease.

PRASCEND is the first and only FDA-approved product for the management of PPID in horses. (1) Administered in tablet form, treatment with PRASCEND can improve the quality of life for PPID-affected horses by managing clinical signs and decreasing the risk of complications of the disease, including those that have the potential to be life-threatening.

It is estimated that one in seven horses over the age of 15 has PPID (2) and horses as young as seven years of age have been diagnosed with the disease (3). In addition, up to 70 percent of clinical laminitis cases also may be affected with underlying PPID4. The most common clinical signs of advanced-stage PPID that occur in horses are hirsutism (hypertrichosis) or an abnormal amount of hair growth, abnormal sweating, weight loss, muscle wasting, abnormal fat distribution, lethargy, laminitis, polyuria/polydipsia and chronic/recurrent infections.

“Unfortunately, PPID is not a curable disease,” says Dr. John Tuttle, BIVI equine technical services veterinarian. “However, PRASCEND does offer a safe and efficacious treatment option to veterinarians and horse owners that can help reduce the clinical signs of the disease and effectively improve the quality of life of infected horses.”

While PPID is typically considered a late-stage-of-life disease in the horse, Tuttle adds that with horse owner vigilance and regular veterinary care, the disease may be detected earlier.

“Because the early symptoms of PPID may be difficult to recognize, some horses with PPID may go undiagnosed until the disease becomes more advanced,” says Tuttle. “Through regular veterinary wellness exams, oftentimes the disease can be caught earlier. By beginning treatment in the earlier stages of the disease, we are able to reduce the risk of some of the potential complications associated with PPID, such as laminitis, recurring infections, dental disease and other potential issues of uncontrolled PPID.”

Farriers often notice the early signs of PPID in horses' feet while trimming. As Cushings diseases advances, farriers are challenged to keep PPID sufferers comfortable and manage any flare-ups of chronic lamiitis. (Massachusetts farrier Allie Hayes trimming a Cushings-affected pony, photo © Hoofcare Publishing)

Not only can PRASCEND aid in the management of clinical signs of disease, the FDA approval also assures the product has been thoroughly evaluated for safety and efficacy. In addition, PRASCEND has met the standards set forth by the FDA in regard to production to preserve its identity, strength, quality, purity and consistency from batch to batch, and the product has demonstrated stability and effectiveness over time through a variety of environmental conditions.

“We are excited to offer a treatment option for horses suffering from PPID,” says Tuttle. “We encourage horse owners to continue to work with their veterinarians to find the best treatment for their horse and are confident that PRASCEND can help make a difference in the lives of horses suffering from this disease.”

PPID horses may be quite thin under all that hair. Cushings sufferers are also believed to be more highly perceptible to worms than non-sufferers. Many people clip their long-haired horses to be more aware of body condition. (photo © Hoofcare Publishing)

PRASCEND is for use in horses only. PRASCEND has not been evaluated in breeding, pregnant or lactating horses. Refer to the package insert for complete product information or contact Boehringer Ingelheim Vetmedica at 800-325-9167.

(Hoof Blog note: A web address should be available soon.)

Reference:

1.  PRASCEND^® (pergolide mesylate) [Freedom of Information Summary]. St. Joseph, MO: Boehringer Ingelheim Vetmedica, Inc.; 2011.
2. McGowan TW, Hodgson DR, McGowan CM. The prevalence of equine Cushing’s syndrome in aged horses. In: Proceedings from the 25th American College of Veterinary Internal Medicine Forum; June 6–9, 2007; Seattle, WA. Abstract 603.
3. Schott HC. Pars pituitary intermedia dysfunction: challenges of diagnosis and treatment. In: Proceedings from the 52nd American Association of Equine Practitioners Annual Convention; December 2–6, 2006; San Antonio, TX.
4. Donaldson MT. Evaluation of suspected pituitary pars intermedia dysfunction in horses with laminitis. J Am Vet Med Assoc. 2004;224(7):1123–1127.

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Equine Pituitary Dysfunction Test Choices Analyzed by New Bolton Center's Jill Beech VMD

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© Fran Jurga and Hoofcare Publishing; Fran Jurga's Hoof Blog is a between-issues news service for subscribers to Hoofcare and Lameness Journal. Please, no use without permission. You only need to ask. This blog may be read online at the blog page, checked via RSS feed, or received via a digest-type email (requires signup in box at top right of blog page). To subscribe to Hoofcare and Lameness (the journal), please visit the main site, www.hoofcare.com, where many educational products and media related to equine lameness and hoof science can be found. Questions or problems with this blog? Send email to blog@hoofcare.com.  

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Equine Pituitary Dysfunction Test Choices Analyzed by New Bolton Center's Jill Beech VMD

In our new age of horses as companion animals, a significant proportion of our equine population would be considered into or at least approaching the geriatric phase of life. Equine pituitary disease and disorders are a concern in the horse-owning public and what we call simply "Cushings Disease" is being studied by researchers as a complex condition or even set of conditions and/or disease.

For horse owners, the problem is always to obtain a definitive diagnosis and to understand a prognosis, if it is possible to have one. Laminitis, in subtle or complex forms, often is a side effect of pituitary disease and any progress in understanding, diagnosing and treating the disease more effectively is welcome. Here's an update from one researcher at the University of Pennsylvania.

Jill Beech VMD presented data resulting from recent research at the Dorothy Havemeyer Geriatric Workshop in Cambridge, Massachusetts, October 24-27. Dr. Beech (show left, University of Pennsylvania photo) is the Georgia E. and Philip B. Hofmann Professor of Medicine and Reproduction at University of Pennsylvania School of Veterinary Medicine’s New Bolton Center in Kennett Square, PA. Her clinical and research expertise is focused on equine pituitary disease and disorders. The Dorothy Russell Havemeyer Foundation, Inc. is a private foundation that conducts scientific research to improve the general health and welfare of horses.

Dr. Beech’s research compared two different diagnostic tests, using two different hormones, to measure equine pituitary dysfunction. “First,” says Dr. Beech, “I compared measuring alpha-melanocyte stimulating hormone [MSH] with measuring adrenocorticotropic hormone [ACTH] to determine if one hormone was superior to the other in making a diagnosis. MSH is more specific for the part of the pituitary that is abnormal in horses with Cushing’s disease.”

Although both hormones are secreted from that area, ACTH is also secreted from another area in the pituitary, so it was hypothesized that MSH would be more specific and a better hormone for evaluation. Results, however, did not indicate that MSH was a more sensitive or specific indicator for pituitary dysfunction. Those data, along with the fact that ACTH, but not MSH, can be measured in diagnostic laboratories available to veterinarians has important practical application.

“This means,” says Dr. Beech, “that veterinarians can continue to measure ACTH in a reliable laboratory. At New Bolton Center, we use the laboratory at Ryan Veterinary Hospital of the University of Pennsylvania or the New York State diagnostic laboratory at Cornell.”

Data collected also indicates that when horses have high levels of these hormones, single samples can be misleading due to variability of endogenous concentrations; veterinarians should therefore obtain several basal samples for ACTH measurement.

“If basal levels of ACTH are high, it can be an indication that the horse has Pituitary Pars Intermedia Dysfunction [PPID] or Cushing’s Disease. However, some affected horses have normal basal levels, and in those cases,” says Dr. Beech, “ACTH response to a thyroid releasing hormone [TRH] test should be performed. Affected horses have an abnormal and prolonged increase in their ACTH levels compared to normal horses.”

She and her co-investigators also compared the TRH stimulation test to the domperidone stimulation test, a diagnostic test that initially appeared promising for diagnosing pituitary disease in horses. In this population of horses, the domperidone stimulation test did not appear as good as the TRH stimulation test in differentiating horses with PPID from normal horses.

--end press release--

© Fran Jurga and Hoofcare Publishing; Fran Jurga's Hoof Blog is a between-issues news service for subscribers to Hoofcare and Lameness Journal. Please, no use without permission. You only need to ask. This blog may be read online at the blog page, checked via RSS feed, or received via a digest-type email (requires signup in box at top right of blog page). To subscribe to Hoofcare and Lameness (the journal), please visit the main site, www.hoofcare.com, where many educational products and media related to equine lameness and hoof science can be found. Questions or problems with this blog? Send email to blog@hoofcare.com.

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