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Editors Selection IGR 10-4
Medical Treatment: Real-life effectiveness and clinical trial efficacy of anti-glaucoma drugs
Comment by Robert Feldman on:
56218 Effectiveness of intraocular pressure-lowering medication determined by washout, Jampel HD; Chon BH; Stamper R et al., JAMA ophthalmology, 2014; 132: 390-395
See also comment(s) by Ramanjit Sihota •Lowering IOP remains the predominant strategy for treating glaucoma, and medications are an invaluable tool. They are cost-effective, non-invasive, and effective, which results in medications generally being the first-line of treatment. Randomized clinical trials (RCTs) are considered the definitive source of information about a medication's efficacy. However, as Jampel et al. point out, while RCTs are invaluable to modern medical research and provide crucial information about a drug's efficacy and safety, certain aspects of an RCT may not be comparable to real world patients. RCTs have a specific population dictated by inclusion and exclusion criteria and dedicated coordinators reminding patients to take their medications, minimizing confounding variables. In the real world, the setting is not as stringent, and patients are often noncompliant, administer drops incorrectly, and have other comorbid conditions.
The goal of Jampel et al.'s study was to investigate medication use in a real world setting and compare the IOP-lowering effectiveness in the real world to IOP-lowering efficacy in an RCT setting. They investigated the 'efficacy-effectiveness gap' by analyzing the difference in IOP in 619 primary open-angle glaucoma (POAG) patients before (ON IOP) and after (OFF IOP) the medication washout phase for a large RCT. They found that when one, two, or three medications were removed, there was a statistically significant increase in IOP, with the biggest change in IOP occurring after removal of one medication.
When these data were compared to previous RCTs, the effectiveness of removing one medication matched the efficacy of the clinical trials, contrary to the authors' hypothesis. This effectiveness-efficacy relationship also held for 2 and 3 medications. While this study has the inherent limitations of a retrospective study, the data show that RCTs aren't that far off from approximating real world patients.
The 'effectiveness-efficacy gap' isn't a very large gap, and RCTs are confirmed as an excellent way to evaluate glaucoma medications.
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