Explaining benefits enhances acceptance of therapy

Key Points

At the annual meeting of the Association for Research in Vision and Ophthalmology, Steven M. Silverstein, MD, and colleagues reported their findings from a multicenter, open-label, investigator-masked study in which 106 patients starting treatment with bimatoprost 0.03% ophthalmic solution (Lumigan, Allergan) for ocular hypertension or glaucoma were randomly assigned either to an intervention group or to a no-intervention group. Patients in the intervention group received a fact sheet explaining the importance of lowering IOP and the efficacy of bimatoprost. The information was reviewed in the office, then patients took the fact sheet home. Patients in the no-intervention group were told only to instill their medication daily.

Patients returned for evaluation after 1 day and again at 1, 4, and 6 weeks after starting treatment. Investigator gradings of hyperemia showed that its average severity was similar among patients in both groups throughout the study, and patient survey responses indicated that most were not bothered by the redness. Patients in the intervention group, however, were more aware of the importance of IOP lowering and were more willing to tolerate the hyperemia.

"Hyperemia associated with prostaglandin analogue therapy is of cosmetic significance only and does not represent an inflammatory or allergic reaction," said Dr. Silverstein, a private practitioner in Kansas City, MO, and a clinical professor of ophthalmology, University of Missouri–Kansas City School of Medicine. "The findings of our study reconfirm previous reports that those reactions are generally transient and not disturbing to patients," he continued. "Nevertheless, patients were even less likely to be bothered by the hyperemia if they were fully informed at the outset of therapy about the importance of IOP lowering and the efficacy of their medication. Based on our study, and considering the potent IOP-lowering effects of prostaglandin analogues, we believe the potential for treatment-induced hyperemia should not be a consideration when selecting ocular hypotensive therapies."

The basis for performing this study lies in the recognition that no other class of medications used in ophthalmology is more "high maintenance" than the prostaglandin analogues, he said.

"Ophthalmologists and other office staff have always spent time discussing side effects with patients. However, the prostaglandin analogues stand out in terms of the amount of time devoted to explaining the potential for side effects, addressing patient concerns about side effects, and dealing with patient noncompliance or requests for a change in therapy because of side effects. Therefore, we were interested in studying whether playing a more proactive role in educating patients would have a positive impact," Dr. Silverstein explained.

"Our premise was that if patients understood the importance of their medication, they would be more tolerant of a benign and transient side effect when they weighed it against the ease, convenience, and efficacy of treatment with a prostaglandin analogue," he added.

Demographics similar

In the study, the two groups were similar in their demographic characteristics. Almost two-thirds of the patients enrolled in the study were female, about 60% were Caucasian, and the mean age was 65 years.

The investigator hyperemia gradings showed that the peak severity occurred at the day 1 visit when the mean score in both groups was 1.2 (1 = mild). By day 7, mean scores in both groups were approximately trace (mean 0.79) and by month 1, the mean severity scores were even lower.

Consistent with those results, self-reports showed that patients were only slightly bothered by the hyperemia on day 1, and their bother scores decreased progressively during the course of the study. At all visits, mean bother scores were lower in the intervention group, but the between-group differences were not statistically significant.