Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Naproxen

Klassificering: A

Preparat: Alpoxen, Bonyl, Eox, Ipaflex, Miranax, Naprocur, Naprosyn, Naprosyn® Entero, Naproxen 2care4, Naproxen ABECE, Naproxen Apofri, Naproxen Bluefish, Naproxen Ebb, Naproxen Mylan, Naproxen Orifarm, Pronaxen, Pronaxen®, Vimovo

ATC kod: M01AE02, M01AE52

Substanser: naproxen, naproxennatrium

Sammanfattning

Det saknas publicerade kontrollerade studier om skillnader mellan könen avseende effekt av naproxen. Studier har visat att kvinnor har högre fri koncentration av naproxen men den kliniska effekten av detta är oklar.
En stor retrospektiv studie fann högre risk för magblödning för NSAID-behandlade patienter och riskökningen var större för män.
Risken för NSAID-inducerad leverskada var högre hos kvinnor i en liten fall-kontrollstudie, medan en stor kohortstudie inte visade någon könsskillnad.
 
Kunskapsunderlaget avseende skillnader mellan kvinnor och män är begränsat och motiverar inte olika dosering eller behandling.

Additional information

Pharmacokinetics and dosing

Plasma samples from patients (62 men, 173 women) with osteoarthritis treated with 750 mg naproxen, showed that women had 65% higher free concentration and 41% higher unbound fraction than men. However, no association between free concentration and effect or adverse events was found within the naproxen concentration ranges in this study [6]. Another larger study found similar results (192 men, 433 women) [7]. No sex differentiation in dosing has been recommended by the manufacturer [8].

Effects

No studies with a clinically relevant sex analysis regarding the effects of naproxen have been found.

Adverse effects

A nested control study estimated the risk of upper gastrointestinal complications associated with selective cox 2-inhibitors and non-selective NSAIDs compared with non-use of NSAIDs. In all > 600 000 individuals contributed to >1 million person-years of observation and 726 upper gastrointestinal complications were identified. Male sex and high age carried a higher risk of complication and suggested a synergistic effect between these factors and NSAIDs on the risk of upper gastrointestinal complications. The risk for upper gastrointestinal complications differed between the various NSAIDs. Adjusted for male sex and age, the OR for diclofenac was 2.2 compared to 4.0 for naproxen, and 1.6 for ibuprofen [1].A retrospective cohort study (625 307 patients with 2 130 820 prescriptions, one third of these were to men) found that incidence rates of NSAID-induced acute liver injury were similar for men and women and for the young and the elderly [2]. However, a case-control study (136 men, 130 women) found an association between NSAID exposure and liver injury in women but not in men (OR 6.49 vs. 1.06). This may be due to differences in pharmacokinetics or circulating level hormones and/or greater use of multiple medications in women [3] or to a generally higher risk of drug-induced liver injury in women [4].A meta-analysis evaluated NSAID use and the risk of Parkinson’s disease. Pooled risk ratio of Parkinson’s disease were similar in men and women using NSAID (men 0.79 (95%CI 0.69, 0.92); women 0.72 (95%CI 0.45, 1.15)) [5].

Reproductive health issues

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

Försäljning på recept

Fler kvinnor än män hämtade ut läkemedel innehållande naproxen (ATC-kod M01AE02) på recept i Sverige år 2015, totalt 245 160 kvinnor och 176 830 män. Det motsvarar 50 respektive 36 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 50-64 år hos båda könen. I genomsnitt var läkemedel innehållande naproxen 1,5 gånger vanligare hos kvinnor [9].

Fler kvinnor än män hämtade ut tabletter innehållande kombination av naproxen och esomeprazol (ATC-kod M01AE52) på recept i Sverige år 2015, totalt 1 775 kvinnor och 1 151 män. Det motsvarar 0,4 respektive 0,2 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 45-64 år hos båda könen. I genomsnitt var tabletter innehållande kombination av naproxen och esomeprazol 1,6 gånger vanligare hos kvinnor [9].

Receptförskrivet naproxen står för 90% av försäljningsvolymen [10].

Uppdaterat: 2019-02-26

Litteratursökningsdatum: 2014-10-14

Referenser

  1. Castellsague J, Holick CN, Hoffman CC, Gimeno V, Stang MR, Perez-Gutthann S. Risk of upper gastrointestinal complications associated with cyclooxygenase-2 selective and nonselective nonsteroidal antiinflammatory drugs. Pharmacotherapy. 2009;29:1397-407. PubMed
  2. García Rodríguez LA, Williams R, Derby LE, Dean AD, Jick H. Acute liver injury associated with nonsteroidal anti-inflammatory drugs and the role of risk factors. Arch Intern Med. 1994;154:311-6. PubMed
  3. Lacroix I, Soussan C, Portolan G, Montastruc JL. Drug-induced adverse reactions via breastfeeding: a study in the French Pharmacovigilance Database. Fundam Clin Pharmacol. 2013;27 (Suppl. 1):42-3. Abstract 26-01.
  4. Leise MD, Poterucha JJ, Talwalkar JA. Drug-induced liver injury. Mayo Clin Proc. 2014;89:95-106. PubMed
  5. Samii A, Etminan M, Wiens MO, Jafari S. NSAID use and the risk of Parkinson's disease: systematic review and meta-analysis of observational studies. Drugs Aging. 2009;26:769-79. PubMed
  6. Hundal O, Rugstad HE, Husby G. Naproxen free plasma concentrations and unbound fractions in patients with osteoarthritis: relation to age, sex, efficacy, and adverse events. Ther Drug Monit. 1991;13:478-84. PubMed
  7. Rugstad HE, Hundal O, Holme I, Herland OB, Husby G, Giercksky KE. Piroxicam and naproxen plasma concentrations in patients with osteoarthritis: relation to age, sex, efficacy and adverse events. Clin Rheumatol. 1986;5:389-98. PubMed
  8. Pronaxen (naproxen). Summary of Product Characteristics. Medical Products Agency - Sweden; 2012.
  9. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk
  10. Conicse. Stockholm: eHälsomyndigheten. 2015 [cited 2016-03-23.] länk

Författare: Linnéa Karlsson Lind, Desirée Loikas

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson