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Ibuprofen

Klassificering: A

Preparat: Alindrin®, Ardinex®, Brufen Retard, Brufen®, Burana, Burana Comp, Burana®, Ibumax, Ibumetin, Ibumetin®, Ibuprofen ABECE, Ibuprofen Actavis, Ibuprofen Apofri, Ibuprofen B. Braun, Ibuprofen Orifarm, Ibuprofen Orion, Ibuprofen ratiopharm, Ibuzin, Ifenin, Ipren, Ipren®, Iprensa, Neoprofen, Nurofen Apelsin, Nurofen Junior, Pedea®

ATC kod: C01EB, C01EB16, M01AE01, M02AA13, N02AJ08

Substanser: ibuprofen, ibuprofen dc 85, ibuprofenarginin, ibuprofen-D,L-lysin, ibuprofennatriumdihydrat

Sammanfattning

Ibuprofen ger smärtlindring hos både kvinnor och män. Studier har dock visat motsägande resultat om ibuprofens effekt hos kvinnor och män. En omfattande metaanalys på tandsmärta visar att ibuprofen har likartad effekt hos män och kvinnor. Det finns dock ett par mindre studier där män/pojkar påvisats bättre effekt.
En stor epidemiologisk smärtstudie med flera olika analgetika har visat att kvinnor får mer biverkningar.
Risken för NSAID-inducerad leverskada var högre hos kvinnor i en liten fall-kontrollstudie, medan en stor kohortstudie inte visade någon könsskillnad.
En stor retrospektiv studie fann högre risk för magblödning för NSAID-behandlade patienter och riskökningen var större för män.

Additional information

Pharmacokinetics and dosing

The effect of patient's sex on the pharmacokinetics after a single dose 600 mg ibuprofen was evaluated in healthy volunteers (18 men, 19 women). Patient's sex did not influence peak plasma concentration or the extent of binding to plasma protein. However, half-life was shorter and oral clearance was higher in young men compared to elderly men and women of all studied ages [6]. No influence of oral contraceptives on ibuprofen pharmacokinetics has been shown [7]. No sex differentiation in dosing has been recommended by the pharmaceutical company [8].

Effects

A meta-analysis evaluated the effect of patient’s sex on ibuprofen 400 mg in men and non-pregnant women with moderate to severe dental pain (119 men, 195 women, 15-35 years of age). No sex differences in analgesic response to ibuprofen were found [9]. A small study investigated the analgesic efficacy of ibuprofen 600 mg on postoperative endodontic pain (8 men, 7 women). There were no differences in pain reduction between men or women in the ibuprofen and placebo group [10]. However, in a small randomized, double-blind, placebo-controlled trial examining the ability of ibuprofen to reduced experimental (voltage induced C-fiber nociceptive activation) pain in healthy young pain-free subjects (10 men, 10 women, 18-30 years of age), analgesic effect of ibuprofen 800 mg was found only in men [11].

A more recent study (10 men, 10 women) analysed sex differences in ibuprofen and placebo analgesia expectancy. In men, both placebo and ibuprofen analgesia were dependent upon expectancy; when they were told they were receiving ibuprofen, they had an analgesic response, even if receiving placebo. In women, ibuprofen was ineffective in producing analgesia regardless of their expectations [12].

Pain relief in children with migraine was examined in a randomized, double-blind, placebo-controlled study (49 boys, 35 girls, age 6-12 years). They were given ibuprofen 7.5 mg/kg or placebo. Boys taking ibuprofen responded effectively while girls did not. No analysis of pharmacokinetics variables was performed [13].

Adverse effects

The PAIN study (3611 men, 5009 women) was a large randomized double-blind trial of the tolerability of paracetamol, aspirin and ibuprofen. Analysis of potential risk factors for adverse events among patients in the PAIN study shows that female sex is one risk factor [14].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].A cross-sectional study (19 756 men, 18 640 women) investigated the relationship between use of aspirin or ibuprofen and risk of colorectal polyp prevalence. A trend for dose-dependent risk reductions were seen in men using aspirin or ibuprofen > 2 times/day. A trend for protective effects in women were only found among those with BMI <25 and a regular use of aspirin or ibuprofen [15].

Reproductive health issues

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

Försäljning på recept

Läkemedel innehållande ibuprofen (ATC-koder M01AE01, M02AA13, C01EB16) köps huvudsakligen receptfritt och därför saknas könsspecifika användningsdata [16].

Uppdaterat: 2019-05-27

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. Johnson CC, Hayes RB, Schoen RE, Gunter MJ, Huang WY, PLCO Trial Team. Non-steroidal anti-inflammatory drug use and colorectal polyps in the Prostate, Lung, Colorectal, And Ovarian Cancer Screening Trial. Am J Gastroenterol. 2010;105:2646-55. PubMed
  7. Greenblatt DJ, Abernethy DR, Matlis R, Harmatz JS, Shader RI. Absorption and disposition of ibuprofen in the elderly. Arthritis Rheum. 1984;27:1066-9. PubMed
  8. Knights KM, McLean CF, Tonkin AL, Miners JO. Lack of effect of gender and oral contraceptive steroids on the pharmacokinetics of (R)-ibuprofen in humans. Br J Clin Pharmacol. 1995;40:153-6. PubMed
  9. Brufen (ibuprofen). Summary of Products Characteristics. Medical Products Agency - Sweden; 2016.
  10. Averbuch M, Katzper M. A search for sex differences in response to analgesia. Arch Intern Med. 2000;160:3424-8. PubMed
  11. Ryan JL, Jureidini B, Hodges JS, Baisden M, Swift JQ, Bowles WR. Gender differences in analgesia for endodontic pain. J Endod. 2008;34:552-6. PubMed
  12. Walker JS, Carmody JJ. Experimental pain in healthy human subjects: gender differences in nociception and in response to ibuprofen. Anesth Analg. 1998;86:1257-62. PubMed
  13. Butcher BE, Carmody JJ. Sex differences in analgesic response to ibuprofen are influenced by expectancy: a randomized, crossover, balanced placebo-designed study. Eur J Pain. 2012;16:1005-13. PubMed
  14. Lewis DW, Kellstein D, Dahl G, Burke B, Frank LM, Toor S et al. Children's ibuprofen suspension for the acute treatment of pediatric migraine. Headache. 2002;42:780-6. PubMed
  15. Moore N, Charlesworth A, Van Ganse E, LeParc JM, Jones JK, Wall R et al. Risk factors for adverse events in analgesic drug users: results from the PAIN study. Pharmacoepidemiol Drug Saf. 2003;12:601-10. PubMed
  16. Concise (INSIKT). Kalmar: eHälsomyndigheten. 2018 [cited 2019-03-14.] länk

Författare: Linnéa Karlsson Lind

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson