The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension

10.1097/IJG.0b013e31818fb434Journal of Glaucoma184293-300JOGL

Validity of code based algorithms to identify primary open angle glaucoma (POAG) in Veterans Affairs (VA) administrative databases

<p><b><i>Purpose</i></b>: The validity of the International Classification of Diseases, 9th revision, Clinical Modification (ICD-9) code for primary open angle glaucoma (POAG) in the Department of Veterans Affairs (VA) electronic medical record has not been examined. We determined the accuracy of the ICD-9 code for POAG and developed diagnostic algorithms for the detection of POAG.</p> <p><b><i>Methods:</i></b> We conducted a retrospective study of abstracted data from the Michael E. DeBakey VA Medical Center’s medical records of 334 unique patients with at least one visit to the Eye Clinic between 1999 and 2013. Algorithms were developed to validly identify POAG using ICD-9 codes and pharmacy data. The positive predictive value (PPV), negative predictive value (NPV), sensitivity, specificity and percent agreement of the various algorithms were calculated.</p> <p><b><i>Results:</i></b> For the ICD-9 code 365.1x, the PPV was 65.9%, NPV was 95.2%, sensitivity was 100%, specificity was 82.6%, and percent agreement was 87.8%. The algorithm with the highest PPV was 76.3%, using pharmacy data in conjunction with two or more ICD-9 codes for POAG, but this algorithm also had the lowest NPV at 88.2%.</p> <p><b><i>Conclusions:</i></b> Various algorithms for identifying POAG in the VA administrative databases have variable validity. Depending on the type of research being done, the ICD-9 code 365.1x can be used for epidemiologic or health services database research.</p

Validity of code based algorithms to identify primary open angle glaucoma (POAG) in Veterans Affairs (VA) administrative databases

<p><b><i>Purpose</i></b>: The validity of the International Classification of Diseases, 9th revision, Clinical Modification (ICD-9) code for primary open angle glaucoma (POAG) in the Department of Veterans Affairs (VA) electronic medical record has not been examined. We determined the accuracy of the ICD-9 code for POAG and developed diagnostic algorithms for the detection of POAG.</p> <p><b><i>Methods:</i></b> We conducted a retrospective study of abstracted data from the Michael E. DeBakey VA Medical Center’s medical records of 334 unique patients with at least one visit to the Eye Clinic between 1999 and 2013. Algorithms were developed to validly identify POAG using ICD-9 codes and pharmacy data. The positive predictive value (PPV), negative predictive value (NPV), sensitivity, specificity and percent agreement of the various algorithms were calculated.</p> <p><b><i>Results:</i></b> For the ICD-9 code 365.1x, the PPV was 65.9%, NPV was 95.2%, sensitivity was 100%, specificity was 82.6%, and percent agreement was 87.8%. The algorithm with the highest PPV was 76.3%, using pharmacy data in conjunction with two or more ICD-9 codes for POAG, but this algorithm also had the lowest NPV at 88.2%.</p> <p><b><i>Conclusions:</i></b> Various algorithms for identifying POAG in the VA administrative databases have variable validity. Depending on the type of research being done, the ICD-9 code 365.1x can be used for epidemiologic or health services database research.</p

The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension

PURPOSE: This study compared the intraocular pressure (IOP)-lowering efficacy of 2 fixed combination products, brinzolamide 1%/timolol 0.5% suspension (Azarga, Brinz/Tim) and dorzolamide 2%/timolol 0.5% solution (Dorz/Tim), in patients with open-angle glaucoma or ocular hypertension who required a change in therapy due to elevated IOP while receiving IOP-lowering medication. METHODS: This was a one-year, multicenter, randomized, double-masked, active-controlled, parallel-group trial of Brinz/Tim and Dorz/Tim. IOP assessments were taken at 8 and 10 AM at week 2 and months 3 and 9, and at 8 AM, 10 AM, and 4 PM at months 6 and 12. Primary efficacy was a noninferiority comparison of mean IOP at the three month 6 time points. RESULTS: Of the 437 patients enrolled, 220 dosed Brinz/Tim whereas 217 dosed Dorz/Tim twice daily. Brinz/Tim produced IOP-lowering efficacy comparable to Dorz/Tim, with the upper 95% confidence limits for the differences between groups within +1.5 mm Hg at all assessment times, including the month 6 primary efficacy time points, establishing noninferiority. Differences in means numerically favored Brinz/Tim at 9 of 12 study visits and times. The IOP reductions ranged from 7.2 to 9.2 mm Hg for Brinz/Tim and from 7.4 to 8.9 mm Hg for Dorz/Tim. Although a similar overall safety profile was observed between the 2 treatment groups, Brinz/Tim showed significantly less ocular irritation (2.7% vs. 10.6%; P=0.0009) than Dorz/Tim. CONCLUSIONS: Brinz/Tim suspension provides statistically significant and clinically relevant IOP-lowering efficacy that is noninferior to Dorz/Tim. Additionally, Brinz/Tim affords an ocular comfort advantage compared with Dorz/Tim. © 2009 Lippincott Williams &amp; Wilkins, Inc