Managing Glaucoma in those with Co-morbidity: Not as Easy as it Seems

Roughead, Elizabeth E.; Kalisch, Lisa M.; Pratt, Nicole; Killer, Graeme; Barnard, Amanda; Gilbert, Andrew L.

doi:10.3109/09286586.2011.638743

Cited by 32 publications

(23 citation statements)

References 17 publications

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“…A study of nearly 26,000 veterans with glaucoma revealed how frequently patients with glaucoma have such contraindications. In that study, 23% of patients had reactive airways disease (an umbrella term encompassing diagnoses of bronchitis, emphysema, asthma, and chronic obstructive pulmonary disease) and 12% had congestive heart failure 9. This represents a substantial portion of an elderly population (median age 80 years) in which timolol is contraindicated.…”

Section: Discussionmentioning

confidence: 99%

Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension

Whitson

Realini

Nguyen

et al. 2013

OPTH

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BackgroundThe objective of this study was to examine the safety and intraocular pressure (IOP)-lowering efficacy of a fixed combination of brinzolamide 1% + brimonidine 0.2% (BBFC) after six months of treatment in patients with open-angle glaucoma or ocular hypertension.MethodsThis was a randomized, multicenter, double-masked, three-month, three-arm contribution-of-elements study with a three-month safety extension. Patients were randomly assigned 1:1:1 to treatment with BBFC, brinzolamide 1%, or brimonidine 0.2% after a washout period. Patients dosed their study medications three times daily at 8 am, 3 pm, and 10 pm for six months. Patients returned for visits at two weeks, six weeks, three months, and six months. IOP measurements were used to assess efficacy. Safety assessments were adverse events, corrected distance visual acuity, slit-lamp biomicroscopy, pachymetry, perimetry, fundus parameters, and cardiac parameters.ResultsA total of 690 patients were randomized. Six-month mean IOP values were similar to those at three months, when the mean IOP in patients treated with BBFC was significantly lower than that of either monotherapy group. A total of 175 patients experienced at least one treatment-related adverse event (BBFC, 33.0%; brinzolamide, 18.8%; brimonidine, 24.7%), eight of which were severe, and five resulted in discontinuation. Seventy-seven patients discontinued participation due to treatment-related adverse events (BBFC, 17.2%; brinzolamide, 2.1%; brimonidine, 14.5%). There were 21 serious adverse events (n = 7 in each group), none of which was related to treatment. Resting mean pulse and blood pressure with BBFC were similar to those with brimonidine, demonstrating modest, clinically insignificant decreases. No new or increased risks were identified with use of BBFC relative to either monotherapy.ConclusionThis study showed that, after six months of treatment, the safety profile of BBFC was similar to that of its individual components and its IOP-lowering activity was similar to its efficacy at three months, when it was superior to both brinzolamide 1% alone and brimonidine 0.2% alone.

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Section: Discussionmentioning

confidence: 99%

Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension

Whitson

Realini

Nguyen

et al. 2013

OPTH

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“…As the sole payer of these health services, the DVA maintains custodianship over a wide variety of routine data collections including dispensing and medical service claims and hospitalisations. Not surprisingly, the vast majority of studies using individual‐level data with linkages to other health datasets are based on this subset of elderly Australians . However, the DVA client population is small (approximately 220 000 veterans and their dependents with health care entitlements across Australia in 2014) and therefore of insufficient size to power a broad range of comparative effectiveness and safety evaluations…”

Section: Discussionmentioning

confidence: 99%

Studies using Australia's Pharmaceutical Benefits Scheme data for pharmacoepidemiological research: a systematic review of the published literature (1987-2013)

Pearson

Pesa

Langton

et al. 2015

Pharmacoepidemiol Drug Saf

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Pharmaceutical Benefits Scheme claims represent a significant resource to examine Australia's billion-dollar annual investment in prescribed medicines. The body of research is growing and has increased in complexity over time. Australia has great potential to undertake world-class, whole-of-population pharmacoepidemiological studies. Recent investment in data linkage infrastructure will significantly enhance these opportunities.

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“…4 A study of nearly 26 000 veterans with glaucoma revealed that 23% also had reactive airways disease (an umbrella term encompassing bronchitis, emphysema, asthma, and COPD diagnoses) and 12% had congestive heart failure. 14 This represents a substantial portion of an elderly population (median age of 80 years) 14 in whom beta blocker use may be inappropriate. Furthermore, in that study, 88% of patients with reactive airways disease were dispensed glaucoma medications (primarily beta blockers) that had the potential to aggravate bronchoconstriction.…”

Section: Discussionmentioning

confidence: 99%

Fixed-combination brinzolamide 1%/brimonidine 0.2% vs monotherapy with brinzolamide or brimonidine in patients with open-angle glaucoma or ocular hypertension: results of a pooled analysis of two phase 3 studies

Realini

Nguyen

Katz

et al. 2013

Eye

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PurposeTo describe pooled efficacy and safety data from two phase 3 studies comparing brinzolamide 1%/brimonidine 0.2% fixed combination (BBFC) with its component medications, brinzolamide and brimonidine, in patients with open-angle glaucoma or ocular hypertension.MethodsData were pooled from two nearly identical clinical trials comparing BBFC with its component medications, each given three times daily. The 3-month efficacy outcome was mean intraocular pressure (IOP) at 0800, 1000, 1500, and 1700 hours. Safety outcomes included adverse events (AEs), best-corrected visual acuity, examination of ocular structures, pachymetry, perimetry, and vital signs.ResultsA total of 1350 patients were enrolled and included in this analysis (BBFC, n=437; brinzolamide, n=458; brimonidine, n=455). Baseline mean IOP levels were similar among the three treatment groups. At 3 months, mean IOP of the BBFC group was significantly lower than that of either monotherapy group (P<0.0001) at all the four time points. A total of 272 patients (20.1%) experienced at least one treatment-related AE (BBFC, 24.6% brinzolamide, 18.7% brimonidine, 17.4%), the majority of which were ocular AEs. One serious AE, moderate intensity chest pain, was considered related to brinzolamide treatment and resulted in study discontinuation.ConclusionsThis analysis strengthens the conclusions drawn from the two individual phase 3 studies showing that, in patients with open-angle glaucoma or ocular hypertension, BBFC had significantly superior IOP-lowering activity compared with either brinzolamide or brimonidine alone and a safety profile consistent with that of its individual components.

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Managing Glaucoma in those with Co-morbidity: Not as Easy as it Seems

Cited by 32 publications

References 17 publications

Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension

Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension

Studies using Australia's Pharmaceutical Benefits Scheme data for pharmacoepidemiological research: a systematic review of the published literature (1987-2013)

Fixed-combination brinzolamide 1%/brimonidine 0.2% vs monotherapy with brinzolamide or brimonidine in patients with open-angle glaucoma or ocular hypertension: results of a pooled analysis of two phase 3 studies

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