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Br J Ophthalmol. 1995 November; 79(11): 996–1002.
PMCID: PMC505314

Absence of effect of simvastatin on the progression of lens opacities in a randomised placebo controlled study. Oxford Cholesterol Study Group.


AIMS--A detailed assessment of ophthalmic effects of an HMG CoA reductase inhibitor, simvastatin, was performed. METHODS--Six hundred and twenty one individuals considered to be at increased risk of coronary heart disease were randomised, following an 8 week placebo 'run in' period, to receive 40 mg daily simvastatin, 20 mg daily simvastatin, or matching placebo. Patients with a baseline corrected visual acuity better than 6/24 and without a history of cataract were eligible for detailed ophthalmic assessment at 6 months (539 patients assessed) and at 18 months (474 patients assessed). RESULTS--No significant differences between the treatment groups were detected at the 6 month or 18 month visit in the refractive condition of the eye or in the mean intraocular pressure. Nor were there clear differences in the Oxford grading system scores for various measures of the major types of cataract (cortical spokes, posterior subcapsular cataract, nuclear brunescence, white scatter) or for other morphological features visible within the lens (fibre folds or focal dots). Scheimpflug slit image photographs and retroillumination analysis of the percentage of cataract within a defined region of the lens were also performed at each visit, with no clear differences observed between the treatment groups. CONCLUSION--This single centre double blind study found no good evidence of any adverse effects of 18 months of simvastatin treatment on lens opacity formation, using a variety of validated techniques to assess cataract development. Routine clinic follow up of visual symptoms and admission to hospital for ophthalmic procedures over 5 years of treatment was also reassuring, with no excess adverse outcomes observed with simvastatin.

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Selected References

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  • Brown MS, Goldstein JL. Lowering plasma cholesterol by raising LDL receptors. N Engl J Med. 1981 Aug 27;305(9):515–517. [PubMed]
  • Tobert JA. New developments in lipid-lowering therapy: the role of inhibitors of hydroxymethylglutaryl-coenzyme A reductase. Circulation. 1987 Sep;76(3):534–538. [PubMed]
  • George AL, Jr, Folk BP, 3rd, Crecelius PL, Campbell WB. Pre-arrest morbidity and other correlates of survival after in-hospital cardiopulmonary arrest. Am J Med. 1989 Jul;87(1):28–34. [PubMed]
  • Gerson RJ, MacDonald JS, Alberts AW, Chen J, Yudkovitz JB, Greenspan MD, Rubin LF, Bokelman DL. On the etiology of subcapsular lenticular opacities produced in dogs receiving HMG-CoA reductase inhibitors. Exp Eye Res. 1990 Jan;50(1):65–78. [PubMed]
  • Cenedella RJ. Source of cholesterol for the ocular lens, studied with U18666A: a cataract-producing inhibitor of lipid metabolism. Exp Eye Res. 1983 Jul;37(1):33–43. [PubMed]
  • Behrens-Baumann W, Morawietz A, Thiery J, Creutzfeldt C, Seidel D. Ocular side effects of the lipid-lowering drug simvastatin? A one year follow-up. Lens Eye Toxic Res. 1989;6(1-2):331–337. [PubMed]
  • Schmidt J, Schmitt C, Hockwin O. No lens changes caused by simvastatin results from a prospective drug safety study. Lens Eye Toxic Res. 1990;7(3-4):643–650. [PubMed]
  • Lundh BL, Nilsson SE. Lens changes in matched normals and hyperlipidemic patients treated with simvastatin for 2 years. Acta Ophthalmol (Copenh) 1990 Dec;68(6):658–660. [PubMed]
  • Havel RJ, Hunninghake DB, Illingworth DR, Lees RS, Stein EA, Tobert JA, Bacon SR, Bolognese JA, Frost PH, Lamkin GE, et al. Lovastatin (mevinolin) in the treatment of heterozygous familial hypercholesterolemia. A multicenter study. Ann Intern Med. 1987 Nov;107(5):609–615. [PubMed]
  • Boccuzzi SJ, Bocanegra TS, Walker JF, Shapiro DR, Keegan ME. Long-term safety and efficacy profile of simvastatin. Am J Cardiol. 1991 Nov 1;68(11):1127–1131. [PubMed]
  • Laties A, Keates E, Lippa E, Shear C, Snavely D, Tupy-Visich M, Chremos AN. Field test reliability of a new lens opacity rating system utilizing slit-lamp examination. Lens Eye Toxic Res. 1989;6(3):443–464. [PubMed]
  • Laties AM, Shear CL, Lippa EA, Gould AL, Taylor HR, Hurley DP, Stephenson WP, Keates EU, Tupy-Visich MA, Chremos AN. Expanded clinical evaluation of lovastatin (EXCEL) study results. II. Assessment of the human lens after 48 weeks of treatment with lovastatin. Am J Cardiol. 1991 Mar 1;67(6):447–453. [PubMed]
  • Keech A, Collins R, MacMahon S, Armitage J, Lawson A, Wallendszus K, Fatemian M, Kearney E, Lyon V, Mindell J, et al. Three-year follow-up of the Oxford Cholesterol Study: assessment of the efficacy and safety of simvastatin in preparation for a large mortality study. Eur Heart J. 1994 Feb;15(2):255–269. [PubMed]
  • Ferris FL, 3rd, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. Am J Ophthalmol. 1982 Jul;94(1):91–96. [PubMed]
  • Sparrow JM, Bron AJ, Brown NA, Ayliffe W, Hill AR. The Oxford Clinical Cataract Classification and Grading System. Int Ophthalmol. 1986 Dec;9(4):207–225. [PubMed]
  • Sparrow JM, Brown NA, Shun-Shin GA, Bron AJ. The Oxford modular cataract image analysis system. Eye (Lond) 1990;4(Pt 4):638–648. [PubMed]
  • Harris ML, Smith GT, Brown NA. Inter and intra observer reproducibility of the new Oxford CCD Scheimpflug camera. Eye (Lond) 1991;5(Pt 4):487–490. [PubMed]
  • Harris ML, Hanna KJ, Shun-Shin GA, Holden R, Brown NA. Analysis of retro-illumination photographs for use in longitudinal studies of cataract. Eye (Lond) 1993;7(Pt 4):572–577. [PubMed]
  • Sparrow JM, Ayliffe W, Bron AJ, Brown NP, Hill AR. Inter-observer and intra-observer variability of the Oxford clinical cataract classification and grading system. Int Ophthalmol. 1988 Jan;11(3):151–157. [PubMed]

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