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Efficacy of antiglaucoma fixed combination therapy versus unfixed components in reducing intraocular pressure: a systematic review
  1. Jacqueline Cox, BA(hons) M (jacqueline.cox{at}uhcw.nhs.uk),
  2. Susan P Mollan, MBCHB MRCO (soozmollan{at}doctors.org.uk),
  3. John Bankart, BA(hons), (mjb65{at}leicester.ac.uk),
  4. Rosemary Robinson, FRCOphth F (rosemary.robinson{at}uhcw.nhs.uk)
  1. University Hospitals Coventry and Warwick NHS Trust, United Kingdom
  2. University Hospitals Coventry and Warwick NHS Trust, United Kingdom
  3. Trent Research and Development Support Unit and Department of Health Sciences, United Kingdom
  4. University Hospitals Coventry and Warwick NHS Trust, United Kingdom

    Abstract

    Aim To evaluate the efficacy of the fixed combination ocular hypotensive therapies compared to their non-fixed components used concomitantly for lowering intraocular pressure (IOP) in glaucoma and ocular hypertension.

    Methods A systematic review of the literature, up to May 2007, without limits on year or language of publication was performed. Seven randomised controlled trials (n=2,083 eyes) were identified. Assessment of methodological quality was made using standardised criteria. Results were pooled quantitatively using meta-analysis methods and statistical analysis was performed using STATA® software. The difference in mean intraocular pressure (mmHg) from baseline between the fixed combination and non-fixed component therapies was compared. Non-inferiority in terms of efficacy was set at an upper confidence limit of ≤1.5mmHg for all time points (hour 0, hour 2 and hour 8) and evaluated at 12 weeks. Safety was evaluated from data on adverse events as reported in the included studies.

    Results Of the 679 abstracts identified, 7 randomised controlled trials met the selection criteria. The quality scores of included studies were high, (mean of 29.4, maximum score 30). The mean differences (95% CI) and p-values at 12 weeks were as follows: 0.200mmHg, (CI -0.106 to 0.507), p=0.20 for Hr0, 0.393mmHg (CI 0.038 to 0.747), p=0.03 for Hr2 and 0.501mmHg (CI 0.156 to 0.846), p = 0.004 for Hr8. Although both Hr2 and Hr8 showed statistical significance favouring the non-fixed combinations, the non-inferiority measure ≤1.5mmHg upper confidence limit was not exceeded.

    Conclusions Fixed combination therapies are equally safe and effective at lowering IOP as their non-fixed components administered concomitantly.

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