PURPOSE: To compare the efficacy and safety of the brand-name and generic 2% dorzolamide/0.5% timololfixed-combination (DTFC) drugs in glaucoma patients. METHODS: This was a prospective single-center study, in which patients using only the brand-name DTFC (Cosopt(®); Merck and Co, Inc.) drug and those using Cosopt with prostaglandin analogs (PGs) were enrolled. In the patients using Cosopt (Group A) and Cosopt with PGs (Group B), Cosopt was switched to its generic counterpart (Batidor(®); Bausch & Lomb, Inc.). The intraocular pressure (IOP) was measured before the switch and 4, 8, and 12 weeks after the switch in both groups. The questionnaire on the discomfort symptoms and on the discomfort score for the use of eye drops was answered by the patients in both groups before the switch and 12 weeks after the switch. RESULTS:A total of 112 patients were enrolled in the study, 62 in Group A and 50 in Group B. The IOPs before the switch and 4, 8, and 12 weeks after the switch showed no statistical difference in both groups (P>0.05). There were higher incidences of bitter taste and blurring with Cosopt, and there was a higher incidence of headache with Batidor in both groups, but no significant differences (P>0.05) were noted. There was, likewise, no significant difference in the discomfort score between 2 drugs in both groups (P>0.05). CONCLUSIONS: After the switch, the IOP-lowering effect of the generic drug Batidor was similar to that of the brand-name drug Cosopt in the monotherapy and combination therapy with PGs. No significant differences were found in terms of the discomfort symptoms and discomfort score between the 2 drugs.
RCT Entities:
PURPOSE: To compare the efficacy and safety of the brand-name and generic 2% dorzolamide/0.5% timolol fixed-combination (DTFC) drugs in glaucomapatients. METHODS: This was a prospective single-center study, in which patients using only the brand-name DTFC (Cosopt(®); Merck and Co, Inc.) drug and those using Cosopt with prostaglandin analogs (PGs) were enrolled. In the patients using Cosopt (Group A) and Cosopt with PGs (Group B), Cosopt was switched to its generic counterpart (Batidor(®); Bausch & Lomb, Inc.). The intraocular pressure (IOP) was measured before the switch and 4, 8, and 12 weeks after the switch in both groups. The questionnaire on the discomfort symptoms and on the discomfort score for the use of eye drops was answered by the patients in both groups before the switch and 12 weeks after the switch. RESULTS: A total of 112 patients were enrolled in the study, 62 in Group A and 50 in Group B. The IOPs before the switch and 4, 8, and 12 weeks after the switch showed no statistical difference in both groups (P>0.05). There were higher incidences of bitter taste and blurring with Cosopt, and there was a higher incidence of headache with Batidor in both groups, but no significant differences (P>0.05) were noted. There was, likewise, no significant difference in the discomfort score between 2 drugs in both groups (P>0.05). CONCLUSIONS: After the switch, the IOP-lowering effect of the generic drug Batidor was similar to that of the brand-name drug Cosopt in the monotherapy and combination therapy with PGs. No significant differences were found in terms of the discomfort symptoms and discomfort score between the 2 drugs.
Authors: Richard A Hansen; Jingjing Qian; Richard Berg; James Linneman; Enrique Seoane-Vazquez; Sarah K Dutcher; Saeid Raofi; C David Page; Peggy Peissig Journal: Pharmacotherapy Date: 2017-03-20 Impact factor: 4.705