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Ramipril

Klassificering: A

Preparat: Pramace, Pramace®, Ramipress, Ramipril Actavis, Ramipril Arrow, Ramipril Aurobindo, Ramipril HEXAL, Ramipril Krka, Ramipril Orifarm, Ramipril Ranbaxy, Ramipril ratiopharm, Ramipril Sandoz, Ramipril STADA, Ramipril STADA®, Ramipril Teva, Ramipril Winthrop, Ramipril/Hydrochlorothiazide Krka, Ramipril/Hydroklortiazid 2care4, Ramipril/Hydroklortiazid Actavis, Ramipril/Hydroklortiazid Alternova, Ramipril/Hydroklortiazid Ebb, Ramipril/Hydroklortiazid HEXAL, Ramipril/Hydroklortiazid Orifarm, Riprosil, Triatec, Triatec comp, Triatec®, Triatec® comp, Triatec® comp mite, Triatec® H.O.P., Triatec® Start

ATC kod: C09AA05, C09BA05

Substanser: ramipril

Sammanfattning

Ramipril minskar risken för död och allvarlig hjärtsvikt. Nyttan av behandling är lika för båda könen.
Män som behandlas med ramipril vid kronisk nefropati verkar löpa en ökad risk för sjukdomsprogression på grund av lägre behandlingseffekt av ramipril, jämfört med kvinnor.
Hosta är en vanlig icke-dosberoende biverkan av ACE-hämmare och förekommer oftare hos kvinnor. Angiotensinreceptorblockerare kan då vara ett alternativ.
 
Det finns inga kliniskt relevanta könsskillnader i effekt eller farmakokinetik av ramipril beskrivna, men hosta som biverkan av ACE-hämmare är vanligare hos kvinnor.

Additional information

Pharmacokinetics and dosing

In a pharmacokinetic study (18 men, 18 women), patients received a single 5 mg oral dose of ramipril. Cmax and half-lives of the active metabolite ramiprilat were identical in both sexes, but women showed a higher AUC/kg than men. Since both men and women received a fixed dose, the differences were explained by a higher dose/kg in women, as a consequence of their lower body weight [12].

Effects

In the large randomized double-blind AIRE trial (1461 men, 525 women), 2.5 mg ramipril daily was compared with placebo, 2-9 days after acute myocardial infarction. Ramipril reduced the risks of death from any cause by 27%. The benefits of ramipril therapy were similar in both sexes [13,14].Another randomized clinical trial (269 men, 83 women) investigated the impact of sex on the outcome of non-diabetic chronic proteinuric nephropathy and effect of ramipril treatment. Ramipril decreased proteinuria less effectively in men than in women (-7.8 ± 4.2% vs. -21.9 ± 5.7%). Compared to conventional treatment (placebo plus antihypertensive therapy), ramipril decreased the difference in GFR (-52% vs. -19%) and progression to end-stage renal disease (-74% vs. -40%) more effectively in women than in men. Among patients with chronic proteinuric nephropathies, men are at increased risk of progression due to their lower response to ACE inhibitor treatment. ACE inhibition is uniformly renoprotective in women regardless of the ACE polymorphism, and in men with the DD genotype [15].

Adverse effects

A pharmacoepidemiological study (5259 men, 5111 women) of ramipril found an incidence of ramipril-induced cough of 7.1%. Female sex was significantly and independently associated with the onset of ramipril-related cough (odds ratio 1.35) [16].Several studies have reported a female predominance in the prevalence of ACE inhibitor induced cough [1-9]. The pathogenesis of the cough reaction is unknown. Different threshold for coughing in men and women have been proposed [10], as well as ethnic differences in cough tendency [11]. One study suggests that sex hormones do not have any influence on cough, since most of the women in the study were postmenopausal [1].

Drug interactions

Swedish users, please consult Janusmed Interactions (Janusmed interaktioner).

Birth defects

Ramipril should not be used in pregnant women. Swedish users, please consult Janusmed Birth Defects (Janusmed fosterpåverkan).

Försäljning på recept

Fler män än kvinnor hämtade ut tabletter innehållande ramipril (ATC-kod C09AA05) på recept i Sverige år 2015, totalt 75 153 män och 40 522 kvinnor. Det motsvarar 15 respektive 8 personer per tusen invånare. Andelen som hämtat ut läkemedel ökade med stigande ålder hos båda könen. I genomsnitt var tabletter innehållande ramipril 2,5 gånger vanligare hos män [17].

Fler män än kvinnor hämtade ut tabletter innehållande kombination av ramipril och hydroklortiazid (ATC-kod C09BA05) på recept i Sverige år 2015, totalt 2 139 män och 1 560 kvinnor. Det motsvarar 0,4 respektive 0,3 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 70-84 år hos båda könen. I genomsnitt var tabletter innehållande kombination av ramipril och hydroklortiazid 1,6 gånger vanligare hos män [17].

Uppdaterat: 2017-03-31

Litteratursökningsdatum: 2013-12-13

Referenser

  1. Coulter DM, Edwards IR. Cough associated with captopril and enalapril. Br Med J (Clin Res Ed). 1987;294:1521-3. PubMed
  2. Strocchi E, Valtancoli G, Ambrosioni E. The incidence of cough during treatment with angiotensin converting enzyme inhibitors. J Hypertens Suppl. 1989;7:S308-9. PubMed
  3. Kostis JB, Shelton B, Gosselin G, Goulet C, Hood WB, Kohn RM et al. Adverse effects of enalapril in the Studies of Left Ventricular Dysfunction (SOLVD) SOLVD Investigators. Am Heart J. 1996;131:350-5. PubMed
  4. Sharma S, Gupta U, Bapna JS, Sahai A. Tolerability of enalapril in mild to moderate hypertension. J Assoc Physicians India. 1995;43:475-6. PubMed
  5. Yeşil S, Yeşil M, Bayata S, Postaci N. ACE inhibitors and cough. Angiology. 1994;45:805-8. PubMed
  6. Yeo WW, Ramsay LE. Persistent dry cough with enalapril: incidence depends on method used. J Hum Hypertens. 1990;4:517-20. PubMed
  7. Just PM. The positive association of cough with angiotensin-converting enzyme inhibitors. Pharmacotherapy. 1989;9:82-7. PubMed
  8. Gibson GR. Enalapril-induced cough. Arch Intern Med. 1989;149:2701-3. PubMed
  9. Os I, Bratland B, Dahlöf B, Gisholt K, Syvertsen JO, Tretli S. Female sex as an important determinant of lisinopril-induced cough. Lancet. 1992;339:372. PubMed
  10. Dykewicz MS. Cough and angioedema from angiotensin-converting enzyme inhibitors: new insights into mechanisms and management. Curr Opin Allergy Clin Immunol. 2004;4:267-70. PubMed
  11. Morimoto T, Gandhi TK, Fiskio JM, Seger AC, So JW, Cook EF et al. An evaluation of risk factors for adverse drug events associated with angiotensin-converting enzyme inhibitors. J Eval Clin Pract. 2004;10:499-509. PubMed
  12. Vree TB, Dammers E, Ulc I, Horkovics-Kovats S, Ryska M, Merkx et al. Lack of male-female differences in disposition and esterase hydrolysis of ramipril to ramiprilat in healthy volunteers after a single oral dose. ScientificWorldJournal. 2003;3:1332-43. länk
  13. Altace (ramipril). DailyMed [www]. US National Library of Medicine. [updated 2013-11-01, cited 2013-12-13]. länk
  14. [No authors listed]. Effect of ramipril on mortality and morbidity of survivors of acute myocardial infarction with clinical evidence of heart failure The Acute Infarction Ramipril Efficacy (AIRE) Study Investigators. Lancet. 1993;342(8875):821-8. länk
  15. Ruggenenti P, Perna A, Zoccali C, Gherardi G, Benini R, Testa A et al. Chronic proteinuric nephropathies II Outcomes and response to treatment in a prospective cohort of 352 patients: differences between women and men in relation to the ACE gene polymorphism Gruppo Italiano di Studi Epidemologici in Nefrologia (Gisen). J Am Soc Nephrol. 2000;11:88-96. PubMed
  16. Wyskida K, Jura-Szołtys E, Smertka M, Owczarek A, Chudek J. Factors that favor the occurrence of cough in patients treated with ramipril--a pharmacoepidemiological study. Med Sci Monit. 2012;18:PI21-8. PubMed
  17. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Författare: Linnéa Karlsson Lind, Desirée Loikas

Faktagranskat av: Mia von Euler, Ellen Vinge

Godkänt av: Karin Schenck-Gustafsson