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Eprosartan

Classification: A

Drug products: Teveten, Teveten®, Teveten® Comp, Tevetenz

ATC code: C09CA02, C09DA02

Substances: eprosartan, eprosartan mesylate

Summary

The antihypertensive effect of eprosartan is similar between men and women in several subgroup analyses in clinical studies. There are no reported sex differences regarding adverse effects of eprosartan treatment.

Additional information

Clinical and epidemiologic evidence suggests that women with renal disease have a slower progression to end stage compared with men, but the underlying mechanisms remain unknown [1]. A possible contributing phenomenon is a physiologic sex-based difference in the function of the renin-angiotensin system (RAS) [1].

Pharmacokinetics and dosing

No differences in eprosartan pharmacokinetics were found between men and women (pooled population pharmacokinetic analysis from two phase III-trials with 299 men, 172 women) and no sex differentiation in dosing is recommended by the manufacturer [2, 3].

A study (18 men, 18 women), with results stratified by sex, indicates (non-significant results) that eprosartan 600 mg/hydrochlorothiazide 25 mg combination tablet was bioequivalent to coadministration of one 600 mg eprosartan tablet and one 25 mg hydrochlorothiazide tablet in women, but not in men [4]. The combination tablet appears to have a lower bioavailability, in men, than the coadministration of one eprosartan tablet and one hydrochlorothiazide tablet [4].

Effects

The antihypertensive effect of eprosartan (change in systolic and diastolic blood pressure, pulse pressure, mean blood pressure), compared to placebo, have been shown to be similar between men and women in subgroup analyses in several clinical studies (in total 825 men, 839 women) [5-7]. The same results have also been reported in other clinical studies, but where the data is not shown [8-11]. The manufacturer also reports that the antihypertensive effect of eprosartan is similar in men and women (data not shown) [3].

A statistically significant difference in the reduction in sitting diastolic blood pressure is reported for women but not for men in a subgroup analysis after 9 weeks of treatment of eprosartan compared to placebo (136 men, 107 women) [11]. Changes from baseline in mmHg for placebo vs eprosartan twice daily and eprosartan once daily, respectively were: -3.6 vs -7.8 and -6.9 respectively (men) and -5.5 vs -11.7 and -10.0 respectively (women) [11].

In a meta-analysis, the cardiovascular risk for men and women was evaluated with different blood pressure-lowering treatments (including angiotensin receptor blockers; ARB) with post-hoc analysis data from different studies (103268 men, 87349 women in total; 3442 men, 4360 women with ARB). For ARB (losartan, candesartan and eprosartan) compared to placebo or other blood pressure-lowering treatments, no statistically significant difference in the risk of major cardiovascular events, stroke, coronary heart disease, heart failure, cardiovascular death and total mortality was found, neither for men nor women [12].

Adverse effects

The manufacturer reports that adverse effects of eprosartan treatment are similar between men and women [3]. In one study, men and women reported at least one adverse effect with a similar frequency (61.9% of 1412 men, 66.6% of 922 women) [13]. In another study, the authors conclude that the patient's sex did not have any impact on the results (including the incidence of adverse effects), but data was not shown (127 men, 156 women) [8].

Reproductive health issues

Angiotensin II-antagonists (like eprosartan) should not be used during pregnancy, especially not during the second or third trimester. Treatment during this period has been associated with complications during pregnancy and the neonatal period [14]. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Updated: 2021-06-07

Date of litterature search: 2021-02-10

References

  1. Miller JA, Cherney DZ, Duncan JA, Lai V, Burns KD, Kennedy CR et al. Gender differences in the renal response to renin-angiotensin system blockade. J Am Soc Nephrol. 2006;17(9):2554-60. PubMed
  2. Teveten (eprosartan). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2020-09-16, cited 2021-02-10]
  3. Food and Drug Administration (FDA). Prescribing information - Teveten HCT (eprosartan mesylate/hydrochlorothiazide). Drugs@FDA [www]. [updated 2014-07-22, cited 2021-02-10]. länk
  4. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - TEVETEN HCT (eprosartan mesylate/hydrochlorothiazide). Drugs@FDA [www]. [updated 2001-05-24, cited 2021-02-10]. länk
  5. de la Sierra A, Munoz A, Arcos E, Lopez JS, Relats J, Investigators of the Etapa-II Study. Effect of eprosartan on pulse pressure and blood pressure components in patients with isolated systolic hypertension. Blood Press Suppl. 2004;2:5-10. PubMed
  6. Hedner T. Management of hypertension: the advent of a new angiotensin II receptor antagonist. J Hypertens Suppl. 1999;17(2):S21-5. PubMed
  7. Gradman AH, Gray J, Maggiacomo F, Punzi H, White WB. Assessment of once-daily eprosartan, an angiotensin II antagonist, in patients with systemic hypertension Eprosartan Study Group. Clin Ther. 1999;21(3):442-53. länk
  8. Punzi, HA and Punzi, CF. Once-daily eprosartan mesylate in the treatment of elderly patients with isolated systolic hypertension: data from a 13-week double-blind, placebo-controlled, parallel, multicenter study. J Hum Hypertens. 2004;18(9):655-61. länk
  9. Sachse A, Verboom CN, Jäger B. Efficacy of eprosartan in combination with HCTZ in patients with essential hypertension. J Hum Hypertens. 2002;16(3):169-76. länk
  10. Food and Drug Administration (FDA). Medical review(s), part 2 - TEVETAN (eprosartan). Drugs@FDA [www]. [updated 2001-06-25, cited 2021-02-10]. länk
  11. Food and Drug Administration (FDA). Medical review(s), part 5 - TEVETAN (eprosartan). Drugs@FDA [www]. [updated 1997-09-09, cited 2021-02-10]. länk
  12. Turnbull F, Woodward M, Neal B, Barzi F, Ninomiya T, Chalmers J et al. Do men and women respond differently to blood pressure-lowering treatment? Results of prospectively designed overviews of randomized trials. Eur Heart J. 2008;29(21):2669-80. PubMed
  13. Food and Drug Administration (FDA). Medical review(s), part 6 - TEVETAN (eprosartan). Drugs@FDA [www]. [updated 1997-09-09, cited 2021-02-10]. länk
  14. Yerman T, Gan WQ, Sin DD. The influence of gender on the effects of aspirin in preventing myocardial infarction. BMC Med. 2007;5:29. PubMed
  15. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.] länk

Authors: Therese Wennersten, Linnéa Karlsson Lind

Reviewed by: Diana Rydberg

Approved by: Karin Schenck-Gustafsson