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Bendroflumetiazid

Klassificering: A

Preparat: Bendroflumetiazid Alternova, Bendroflumetiazid Evolan, Salures®

ATC kod: C03AA01

Substanser: bendroflumetiazid

Sammanfattning

En stor randomiserad, kontrollerad klinisk blodtrycksstudie med bendroflumetiazid visade en mortalitetssänkning hos män men inte hos kvinnor.

Risken för gikt och impotens har i en stor randomiserad studie visats vara vanligare för män behandlade med bendroflumetazid. I denna studie avbröt fler män än kvinnor behandling i studien, främst på grund av dessa biverkningar.

Additional information

Pharmacokinetics and dosing

No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of bendroflumethiazide have been found.

Effects

The large Medical Research Council (MRC) trial of treatment of mild hypertension (7513 men, 6945 women) compared treatment with bendroflumethiazide and propranolol. Results showed a benefit associated with bendroflumethiazide treatment in men, but the opposite effect in women. All-cause mortality rates were: 7.5% deaths in bendroflumethiazide-treated men compared with 8.2% in placebo-treated men; 4.5% deaths in bendroflumethiazide-treated women compared with 3.5% on placebo [1].

Adverse effects

Adverse reactions to bendroflumethiazide were evaluated in a sub-analysis of theMRC treatment trial. Patients received 5 mg bendroflumethiazide twice daily. Men had significantly higher incidences of gout and of impotence, compared with controls. After 5 years, 17.1% of the men had been withdrawn from treatment with bendroflumethiazide compared with 12.8% of the women (p<0.05). The difference is mainly due to the higher incidences of impotence and gout in men [2].

Studies have reported a fall in serum potassium concentration in patients taking bendroflumethiazide, but there are conflicting results whether there are sex differences [2-4]. In the MRC trial, mean serum potassium concentration fell to a similar level in men and women after 3 years of treatment with bendroflumethiazide [2]. Also, one retrospective study (158 men, 231 women) found that the serum potassium concentration in patients treated with bendroflumethiazide was not related to sex [3]. However, in another retrospective study (91 men, 102 women), women had lower serum potassium concentration than men after taking bendroflumethiazide 5 mg daily. Serum potassium remained significantly related to patient’s sex independent of body weight. The etiology of this sex difference is not known, but it may reflect a general tendency for women to develop hypokalemia which is not specifically related to diuretics. Severe hypokalemia was uncommon and showed no difference between the sexes [4].

Reproductive health issues

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

Other information

In a clinical trial (62 men, 23 women), bendroflumethiazide was administrated to patients with recurrent calcium oxalate urinary stone disease. Twenty-two men and four women (31%) stopped treatment within the first two years because of side effects. Symptoms divided by sex were not shown [5].

Försäljning på recept

Fler kvinnor än män hämtade ut tabletter innehållande bendroflumetiazid (ATC-kod C03AA01) på recept i Sverige år 2018, totalt 57 303 kvinnor och 36 908 män. Det motsvarar 11 respektive 7 personer per tusen invånare. Andelen som hämtat ut läkemedel ökade med stigande ålder hos båda könen. I genomsnitt var tabletter innehållande bendroflumetiazid 1,4 gånger vanligare hos kvinnor [6].

Uppdaterat: 2019-05-27

Litteratursökningsdatum: 2019-05-02

Referenser

  1. MRC trial of treatment of mild hypertension: principal results Medical Research Council Working Party. Br Med J (Clin Res Ed). 1985;291:97-104.
  2. Adverse reactions to bendrofluazide and propranolol for the treatment of mild hypertension Report of Medical Research Council Working Party on Mild to Moderate Hypertension. Lancet. 1991;2:539-543.
  3. Ramsay LE, Boyle P, Ramsay MH. Factors influencing serum potassium in treated hypertension. Q J Med. 1977;46:401-10. PubMed
  4. Toner JM, Ramsay LE. Thiazide-induced hypokalaemia; prevalence higher in women. Br J Clin Pharmacol. 1984;18:449-52. PubMed
  5. Ahlstrand C, Tiselius HG, Larsson L, Hellgren E. Clinical experience with long-term bendroflumethiazide treatment in calcium oxalate stone formers. Br J Urol. 1984;56:255-62. PubMed
  6. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2018 [cited 2019-03-08.] länk

Författare: Linnéa Karlsson Lind

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson