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New Livostin study shows as-needed dosage effective
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BETHESDA, Md. — The results of a new study conducted to determine the optimum dosing plan for a leading anti-allergy drug suggest "as-needed" dosing may be effective in relieving ocular discomfort for patients suffering symptoms of allergic conjunctivitis. The Food and Drug Administration (FDA) approved Livostin in 1994 based on studies of four times daily use for a maximum of 2 weeks.
The new study, conducted by Gordon D. Raphael, MD, an allergist here, closely monitored daily pollen counts while test patients with seasonal grass allergy used the drug Livostin (levocabastine HCl ophthalmic suspension), manufactured by Ciba Vision Ophthalmics, of Duluth, Ga., only as needed to relieve ocular symptoms of allergic conjunctivitis. The study was funded by Ciba Vision Ophthalmics.
"The point of the study was to show that treating symptoms of allergic conjunctivitis on an as-needed basis is the most cost-effective way to treat allergies," said Steve Gallopo, marketing manager for Ciba’s OTC Allergy Products Lines.
"Pollen counts vary daily, and the amount of medication required to treat allergies on a daily basis [should] coincide with the pollen count," he said. "With products such as Alomide (lodoxamide tromethamine, Alcon), Crolom (cromolyn sodium, Bausch & Lomb) and Patanol (olopatadine HCl, Alcon), patients are required to dose them on a strict twice-daily or four-times-a-day regimen regardless of the pollen count or if the patient exhibits the signs and symptoms of allergies."
The less medication the better
Mr. Gallopo also emphasized that the as- needed dosing is not outside the product’s labeling.
"The maximum dosage of Livostin is four times a day," he said. "So, basically, our claim is that the less medication needed to treat the disease or condition and reduce the signs and symptoms, the better off you are.
"The study proved the amount of the drug needed to control allergies is less than twice daily and, in fact, that the primary way to treat allergies with Livostin is through as-needed use," Mr. Gallopo continued. "The proof of that within the study is that itchy eyes is not an occurrence that happens every hour on the hour or every 6 to 8 hours or even every 12 hours; it’s not a routine occurrence. Therefore, the dosing of your medication should not be routine, either. It should directly coincide with your signs and symptoms."
Dr. Raphael monitored 20 test patients over a period of 2 weeks during peak grass and pollen season last spring. The study patients were first skin tested to prove they were allergic. He asked each participant to keep a strict diary of how many doses of Livostin he or she required daily to control or completely quell the event of ocular allergy symptoms. Dr. Raphael instructed the test patients to use Livostin to control their symptoms, but — most importantly — to use as little as possible to achieve that goal.
"The packaging suggested that it is given several times a day — up to four times a day — and my clinical impression was that you don’t need that much," he said.
The results, Dr. Raphael explained, were striking.
Patients satisfied
"All 20 patients enrolled in the study found that the eye drops were well tolerated and controlled their ocular allergy symptoms," Dr. Raphael said. "Some said there was a small amount of temporary burning, but others reported that they found the drops soothing immediately. On the whole, all 20 said they experienced significant relief from their symptoms within 1 to 2 minutes.
"I was pretty impressed," Dr. Raphael said. "It may be that the eye drop solution itself is quite soothing. However, I felt that these eye drops, in particular, produced a surprisingly rapid improvement in the patient’s symptoms."
In a summary of the study, Dr. Raphael noted that "the 20 subjects used an average of just under two doses of Livostin per day. Most subjects agreed that the drops were helpful in controlling their eye symptoms and that they would like to continue using the drops after the study." Interestingly enough, when Livostin was introduced in 1995, Dr. Raphael regarded the drug cautiously.
"When I first started using it, I was a little skeptical because it did not contain a decongestant as did some of the other competing products." However, Dr. Raphael continued, "it is really a very good antihistamine, and I am very impressed at how well this single agent drug takes care of all of the patient’s symptoms."
In his concluding remarks, Dr. Raphael added that "topical therapy with a drug like Livostin, on an as-need basis only, appears to be an excellent and cost-effective way to treat the symptoms of seasonal allergic conjunctivitis."
For Your Information:
- Steve Gallopo is marketing manager for Ciba Vision’s OTC Allergy Products Lines. He can be reached at Ciba Vision Ophthalmics, 11460 Johns Creek Parkway, Duluth, Ga 30155; (770) 418-4175; fax: (770) 418-3139.
- Gordon D. Raphael, MD, is an allergist in private practice in Bethesda, Md., who conducts ongoing research into allergy-related illnesses and allergy medications. He can be reached at 4915 Auburn Ave., Suite 202, Bethesda, MD 20814; (301) 907-3442; fax: (301) 907-7796. Dr. Raphael has no direct financial interest in the products mentioned in this article, nor is he a paid consultant for any company mentioned.
- Livostin is available from Ciba Vision Ophthalmics, 11460 Johns Creek Parkway, Duluth, GA 30155; (770) 418-4175.