Drug products: Saflutan, Taflotan, Taptiqom, Taptiqom sine
ATC code: S01ED51, S01EE05
Published controlled studies on differences between men and women regarding efficacy and pharmacokinetics of tafluprost eyedrops are lacking.
Pharmacokinetics and dosing
No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of tafluprost eyedrops have been found. According to the manufacturer’s documentation to FDA, the systemic exposure following topical administration of tafluprost is low and the pharmacokinetics has not been studied in men and women separately prior to registration .
No studies with a clinically relevant sex analysis regarding the effects tafluprost eyedrops have been found.
In an observer masked, open-label prospective study Japanese patients with primary open angle glaucoma (19 men, 13 women) were treated with tafluprost during 3 months. The side effect “deepening of the upper eyelid sulcus“ (DUES) was equally common in men and women .
Reproductive health issues
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
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 .
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 .
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 .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) . 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 .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) . A study of endothelial nitric oxide synthase gene variants found an association with open angle glaucoma which might explain this . Studies on the effect of hormonal replacement therapy (HRT) are lacking .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 .
Date of litterature search: 2016-12-02
- 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
- 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
- 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
- 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
- Alsbirk PH. Limbal and axial chamber depth variations A population study in Eskimos. Acta Ophthalmol (Copenh). 1986;64:593-600. PubMed
- Higginbotham EJ. Does sex matter in glaucoma?. Arch Ophthalmol. 2004;122:374-5. PubMed
- 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
- 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
- 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
- Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - TBD (tafluprost) [updated 2011-02-16]. länk
- Maruyama K, Tsuchisaka A, Sakamoto J, Shirato S, Goto H. Incidence of deepening of upper eyelid sulcus after topical use of tafluprost ophthalmic solution in Japanese patients. Clin Ophthalmol. 2013;7:1441-6. PubMed
- Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson