Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Sakubitril + valsartan

Klassificering: A

Preparat: Entresto®

ATC kod: C09DX04

Sammanfattning

Substansen sakubitril ges i fast kombination med angiotensin-II-antagonisten valsartan. Studier genomförda av tillverkaren rapporterar inga könsskillnader i effekt eller säkerhet av valsartan/sakubitril. Det saknas andra publicerade kontrollerade studier om könsskillnader i effekt och säkerhet.
 
Vår bedömning är att nuvarande kunskapsunderlag inte motiverar skillnad i dosering eller behandling mellan kvinnor och män.

Additional information

Pharmacokinetics and dosing

According to the original manufacturer, pharmacokinetics of valsartan/sacubitril is similar in men and women [1]. A study in healthy adults receiving 400 mg oral single dose valsartan/sacubitril (19 men, 17 women) showed no sex or age differences in pharmacokinetics [2, 3]. Dose adjustment based on age or sex is not considered necessary [2, 4].

Effects

According to a study sponsored by the manufacturer, sub-group analyses on primary efficacy endpoint of cardiovascular death or hospitalization for worsening heart failure was shown to be consistent across all subpopulations, including sex, for valsartan/sacubitril compared to enalapril [4, 5]. No placebo-controlled efficacy studies with a clinically relevant sex analysis have been found.

Adverse effects

In a pivotal phase III study conducted by the manufacturer, valsartan/sacubitril was safe and well tolerated in men and women and in patients >65 years. Safety of valsartan/sacubitril in patients below 18 years has not been evaluated [4].­­

Reproductive health issues

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

Försäljning på recept

Fler män än kvinnor hämtade ut läkemedel innehållande kombination av valsartan och sakubitril (ATC-kod C09DX04) på recept i Sverige år 2016, totalt 399 män och 85 kvinnor [6].

Uppdaterat: 2019-02-26

Litteratursökningsdatum: 2017-05-16

Referenser

  1. Entresto (valsartan/sakubitril). Summary of Product Characteristics. European Medicines Agency (EMA); 2017.
  2. Gan L, Langenickel T, Petruck J, Kode K, Rajman I, Chandra P et al. Effects of age and sex on the pharmacokinetics of LCZ696, an angiotensin receptor neprilysin inhibitor. J Clin Pharmacol. 2016;56:78-86. PubMed
  3. Ayalasomayajula S, Langenickel T, Pal P, Boggarapu S, Sunkara G. Clinical Pharmacokinetics of Sacubitril/Valsartan (LCZ696): A Novel Angiotensin Receptor-Neprilysin Inhibitor. Clin Pharmacokinet. 2017;-:[Epub ahead of print]. PubMed
  4. Food and Drug Aministration (FDA). Clinical Pharmacology and Biopharmaceutics Review - ENTRESTO (sacubitril/valsartan). Food and Drug Administration [www]. [updated 2015-01-27, cited 2017-05-16]. länk
  5. McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371:993-1004. PubMed
  6. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2017-05-20.] länk

Författare: Linnéa Karlsson Lind

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson