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Pilocarpine - topical

Classification: B

Drug products: Fotil, Fotil forte, Isopto®-Pilokarpin, Pilocarpina Farmigea, Pilocarpine, Pilokarpin APL, Pilokarpin Trimb

ATC code: S01EB01, S01ED51

Summary

Published controlled studies on differences between men and women regarding efficacy, safety and pharmacokinetics of pilocarpine eye-drops are lacking.
 
The present evidence concerning differences between men and women is very limited and do not motivate differentiation in dosing or treatment.

Additional information

Pharmacokinetics and dosing

No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of pilocarpine eye-drops have been found. According to the manufacturer’s documentation to FDA, the systemic exposure following topical administration of pilocarpine is low and the pharmacokinetics has not been thoroughly studied in men and women separately prior to registration [10].

Effects

No studies with a clinically relevant sex analysis regarding the effects pilocarpine eyedrops have been found.

Adverse effects

No studies with a clinically relevant sex analysis regarding the adverse effects of pilocarpine eyedrops have been found.

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Other information

A retrospective nonrandomized comparative study of patients (15 men, 19 women) visiting an eye clinic due to unilateral idiopathic tonic pupil showed that women had a more dilated pupil (anisocoria) at arrival and a greater ratio of pupil decrease after pilocarpine instillation than men. The authors interpreted the result as the degree of pupillo-accommodative dysfunction could be greater in female patients. In a subgroup of patients who had a symptom onset > 2 months before arrival, women had a larger pupil size at first examination and a longer near-point of accommodation after instillation of pilocarpine than men [11].

A retrospective study of glaucoma patients (56 men, 64 women) pretreated with brimonidine 0.2% and pilocarpine 1% one hour before selective laser trabeculoplasty (SLT) showed in univariate analysis that SLT was less efficacious in women (relative risk 0.75). In multivariate analysis the sex difference in treatment outcome could not be confirmed [12].

A study of out-patients using topical glaucoma drugs > 3 months (113 male eyes, 103 female eyes) showed that men and women developed conjunctival metaplasia to the same extent while the control group without medication did not. The authors suggest that the presence of the preservative benzalkonium chloride in the medications caused this side effect [13]. In a population-based survey study including a medical examination in 4744 Australians, 2.3% were previously diagnosed with ocular hypertension or open angle glaucoma (52 male, 56 female). The proportion reporting a history of glaucoma surgery or treatment with glaucoma medication was similar in men and women [1].

In a study from the US nearly half of the individuals who had filled one glaucoma prescription discontinued the treatment within six months. Among glaucoma patients aged 40-49 years, living in the Southeast region of the US and being a woman were factors associated with discontinuation [2].

General differences between men and women with glaucomaIn a randomized clinical trial of normal-tension glaucoma patients, an untreated subset of patients (61 men, 99 women) was analyzed regarding risk factors for (a high) progression rate of visual field loss. The time to measurable decrease in visual field was shorter in women than in men (1849 vs. 2356 days and the speed of deterioration was higher in women than in men (0.47 vs. 0.23 decibels per year). Migraine and optic disk hemorrhage were other risk factors for an increased progression rate (OR 2.58 and 2.72, respectively). According to the authors, it could be wise to treat women with migraine or optic disk hemorrhage aggressively as they are at a higher risk of faster progression than others [3].An eye examination of a West Greenland Eskimos population > 40 years old (162 men, 182 women) aimed at detecting primary angle-closure glaucoma (PACG) showed a higher prevalence in women than in men (age-group 60-69: 5% in men, 15% in women and age-group 70+: 3% in men, 27% in women) [4]. Measurements of the right eyes (155 men, 156 women) showed that the limbal chamber depth (LCD), as well as the axial chamber depth (ACD) was lower in women than in men [5].In a population based study in the Netherlands it was noted that women who were postmenopausal before the age of 45 had a higher risk of open-angle glaucoma (odds ratio 2.6) compared to those who were older at menopause (odds ratio for open angle glaucoma of 1.1) [6]. A study of endothelial nitric oxide synthase gene variants found an association with open angle glaucoma which might explain this [7]. Studies on the effect of hormonal replacement therapy (HRT) are lacking [8].In a retrospective study, glaucoma patients (64 men, 59 women) underwent selective laser trabeculoplasty (SLT). The intra ocular pressure (IOP) lowering efficacy of SLT was equal in men and women and regardless of type, or absence of glaucoma medication at 6 months post-laser [9].

Updated: 2019-02-26

Date of litterature search: 2015-12-02

References

  1. Weih LM, Van Newkirk M, McCarty CA, Taylor HR. Patterns of glaucoma medication use in urban and rural Victoria. Aust N Z J Ophthalmol. 1998;26 Suppl 1:S12-5. PubMed
  2. Nordstrom BL, Friedman DS, Mozaffari E, Quigley HA, Walker AM. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005;140:598-606. PubMed
  3. Drance S, Anderson DR, Schulzer M, Collaborative Normal-Tension Glaucoma Study Group. Risk factors for progression of visual field abnormalities in normal-tension glaucoma. Am J Ophthalmol. 2001;131:699-708. PubMed
  4. Alsbirk PH. Early detection of primary angle-closure glaucoma Limbal and axial chamber depth screening in a high risk population (Greenland Eskimos). Acta Ophthalmol (Copenh). 1988;66:556-64. PubMed
  5. Alsbirk PH. Limbal and axial chamber depth variations A population study in Eskimos. Acta Ophthalmol (Copenh). 1986;64:593-600. PubMed
  6. Higginbotham EJ. Does sex matter in glaucoma?. Arch Ophthalmol. 2004;122:374-5. PubMed
  7. Kang JH, Wiggs JL, Rosner BA, Hankinson SE, Abdrabou W, Fan BJ et al. Endothelial nitric oxide synthase gene variants and primary open-angle glaucoma: interactions with sex and postmenopausal hormone use. Invest Ophthalmol Vis Sci. 2010;51:971-9. PubMed
  8. Vajaranant TS, Nayak S, Wilensky JT, Joslin CE. Gender and glaucoma: what we know and what we need to know. Curr Opin Ophthalmol. 2010;21:91-9. PubMed
  9. Singh D, Coote MA, O'Hare F, Walland MJ, Ghosh S, Xie J et al. Topical prostaglandin analogues do not affect selective laser trabeculoplasty outcomes. Eye (Lond). 2009;23:2194-9. PubMed
  10. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - ISOPTO CARPINE (pilocarpine hydrochloride) [updated 2010-05-21]. länk
  11. Koh KM, Kim US. Characteristics of pupillo-accommodative functions according to time of onset, gender and age in tonic pupil. Int J Ophthalmol. 2013;6:659-61. PubMed
  12. Martow E, Hutnik CM, Mao A. SLT and adjunctive medical therapy: a prediction rule analysis. J Glaucoma. 2011;20:266-70. PubMed
  13. Turaçli E, Budak K, Kaur A, Mizrak B, Ekinci C. The effects of long-term topical glaucoma medication on conjunctival impression cytology. Int Ophthalmol. 1997;21:27-33. PubMed
  14. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-06-30.] Socialstyrelsens statistikdatabas

Authors: Maria Enghag, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson