6/10/2023

Janusmed kön och genus

Janusmed kön och genus – Buprenorphine Sandoz

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

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Buprenorfin

Buprenorfin

Klass: A

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Produkter

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Buprefarm, Bupremyl, Buprenorfin Actavis, Buprenorfin E......

Buprefarm, Bupremyl, Buprenorfin Actavis, Buprenorfin Evolan, Buprenorphine 2care4, Buprenorphine Bluefish, Buprenorphine Ethypharm, Buprenorphine G.L. Pharma, Buprenorphine Glenmark, Buprenorphine Hydrochloride, Buprenorphine Orifarm, Buprenorphine STADA, Buprenorphine Sandoz, Buprenorphine Teva, Buvidal, Espranor, Norspan, Sixmo, Sublocade, Subutex, Temgesic, Transtec
ATC-koder

N02AE01, N07BC01

N02AE01, N07BC01
Substanser

buprenorfin, buprenorfinhydroklorid

buprenorfin, buprenorfinhydroklorid
Sammanfattning

Buprenorfin används vid smärtbehandling och vid opioidberoende. Det saknas studier som jämför den smärtlindrande effekten mellan kvinnor och män. Både kvinnor och män har nytta av behandling med buprenorfin vid opioidberoende. Lägsta effektiva dos ska användas.

Buprenorfin används vid smärtbehandling och vid opioidberoende. Det saknas studier som jämför den smärtlindrande effekten mellan kvinnor och män. Både kvinnor och män har nytta av behandling med buprenorfin vid opioidberoende. Lägsta effektiva dos ska användas.
Background

The prevalence of several clinical pain conditions is higher in women than in men. Differences in pharmacokinetics, sex hormones, stress response, or socio-cultural aspects may be of importance [1-3]. Therefore, sex and gender differences of pain medications are difficult to interpret [4].

Pharmacokinetics and dosing
Buprenorphine is dosed according to effect and thus dosing should be individualized. Due to extensive first-pass effect sublingual or transdermal administration is common. If the dose is based on age and body weight the pharmacokinetic profile of sublingual and transdermal buprenorphine does not differ between men and women and similar doses should be used [5-7].

Effects
The effect of opioids for pain-relief may differ between men and women. Women may require lower doses of opioids, both in treatment of acute and chronic pain [8]. However, no studies on buprenorphine were included in the meta-analysis. No studies with a sex analysis regarding the effects of buprenorphine have been found.
A randomized controlled study (104 men, 61 women) on the impact of patient’s sex......

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The prevalence of several clinical pain conditions is higher in women than in men. Differences in pharmacokinetics, sex hormones, stress response, or socio-cultural aspects may be of importance [1-3]. Therefore, sex and gender differences of pain medications are difficult to interpret [4]. # Pharmacokinetics and dosing Buprenorphine is dosed according to effect and thus dosing should be individualized. Due to extensive first-pass effect sublingual or transdermal administration is common. If the dose is based on age and body weight the pharmacokinetic profile of sublingual and transdermal buprenorphine does not differ between men and women and similar doses should be used [5-7]. # Effects The effect of opioids for pain-relief may differ between men and women. Women may require lower doses of opioids, both in treatment of acute and chronic pain [8]. However, no studies on buprenorphine were included in the meta-analysis. No studies with a sex analysis regarding the effects of buprenorphine have been found. A randomized controlled study (104 men, 61 women) on the impact of patient’s sex on opioid agonist treatment in opioid use disorder indicates that  both men and women benefit from buprenorphine treatment (dosing 16-32 mg), but females maintained on buprenorphine had significantly fewer opioid-positive urine samples compared to males [9]. Some studies report different rates of treatment retention to buprenorphine in men and women [10]. However, a meta-analysis published in 2022 indicates similar rates of treatment retention (for opioid use disorder) in men and women [11]. # Adverse effects One meta-analysis of clinical trial data found no sex differences in weight change after 12 weeks of buprenorphine treatment [12]. Buprenorphine blocks the human hERG channel which is strongly associated with QT prolongation and risk of Torsades de Pointes ventricular tachycardia. A randomized controlled trial found that no patients taking buprenorphine (36 men, 18 women) experienced a QT prolongation [13]. Known risk factors of drug-induced ventricular arrhythmias are female sex, hypokalemia, bradycardia, and base line QT-prolongation [14]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Försäljning på recept

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Fler kvinnor än män hämtade ut läkemedel innehållande buprenorfin (ATC-kod N02AE01) på recept i Sverige år 2021, totalt 30 332 kvinnor och 12 996 män. Det motsvarar 5,99 respektive 2,55 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 85 år och äldre hos båda könen. I genomsnitt var läkemedel innehållande buprenorfin 2,22 gånger vanligare hos kvinnor [15]. Prevalens för kronisk smärta är högre hos kvinnor [16, 17]. Fler män än kvinnor hämtade ut läkemedel innehållande buprenorfin mot opioidberoende (ATC-kod N07BC01) på recept i Sverige år 2021, totalt 1 314 män och 669 kvinnor [15].
Referenser

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  1. Greenspan JD, Craft RM, LeResche L, Arendt-Nielsen L, Berkley KJ, Fillingim RB et al. Studying sex and gender differences in pain and analgesia: a consensus report. Pain. 2007;132 Suppl 1:S26-45.

  2. Bartley EJ, Fillingim RB. Sex differences in pain: a brief review of clinical and experimental findings. Br J Anaesth. 2013;111(1):52-8.

  3. Sorge RE, Totsch SK. Sex Differences in Pain. J Neurosci Res. 2017;95(6):1271-1281.

  4. Dance A. Why the sexes don't feel pain the same way. Nature. 2019;567(7749):448-450.

  5. Moody DE, Fang WB, Morrison J, McCance-Katz E. Gender differences in pharmacokinetics of maintenance dosed buprenorphine. Drug Alcohol Depend. 2011;118:479-83.

  6. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - SUBUTEX (buprenorphine) [updated 2002-10-08].

  7. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - BUTRANS (buprenorphine) [updated 2010-06-30].

  8. Pisanu C, Franconi F, Gessa GL, Mameli S, Pisanu GM, Campesi I et al. Sex differences in the response to opioids for pain relief: A systematic review and meta-analysis. Pharmacol Res. 2019;148:104447.

  9. Jones HE, Fitzgerald H, Johnson RE. Males and females differ in response to opioid agonist medications. Am J Addict. 2005;14:223-33.

  10. Ling S, Mangaoil R, Cleverley K, Sproule B, Puts M. A systematic review of sex differences in treatment outcomes among people with opioid use disorder receiving buprenorphine maintenance versus other treatment conditions. Drug Alcohol Depend. 2019;197:168-182.

  11. Hochheimer M, Unick GJ. Systematic review and meta-analysis of retention in treatment using medications for opioid use disorder by medication, race/ethnicity, and gender in the United States. Addict Behav. 2022;124:107113.

  12. Manza P, Kroll D, McPherson KL, Johnson A, Dennis E, Hu L et al. Sex differences in weight gain during medication-based treatment for opioid use disorder: A meta-analysis and retrospective analysis of clinical trial data. Drug Alcohol Depend. 2022;238:109575.

  13. Wedam EF, Bigelow GE, Johnson RE, Nuzzo PA, Haigney MC. QT-interval effects of methadone, levomethadyl, and buprenorphine in a randomized trial. Arch Intern Med. 2007;167:2469-75.

  14. Roden DM. Drug-induced prolongation of the QT interval. N Engl J Med. 2004;350:1013-22.

  15. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2021 [cited 2022-03-15.]

  16. Wändell P, Carlsson AC, Wettermark B, Lord G, Cars T, Ljunggren G. Most common diseases diagnosed in primary care in Stockholm, Sweden, in 2011. Fam Pract. 2013;30:506-13.

  17. Shega JW, Tiedt AD, Grant K, Dale W. Pain measurement in the National Social Life, Health, and Aging Project: presence, intensity, and location. J Gerontol B Psychol Sci Soc Sci. 2014;69 Suppl 2:S191-7.

  1. Greenspan JD, Craft RM, LeResche L, Arendt-Nielsen L, Berkley KJ, Fillingim RB et al. Studying sex and gender differences in pain and analgesia: a consensus report. Pain. 2007;132 Suppl 1:S26-45.
  2. Bartley EJ, Fillingim RB. Sex differences in pain: a brief review of clinical and experimental findings. Br J Anaesth. 2013;111(1):52-8.
  3. Sorge RE, Totsch SK. Sex Differences in Pain. J Neurosci Res. 2017;95(6):1271-1281.
  4. Dance A. Why the sexes don't feel pain the same way. Nature. 2019;567(7749):448-450.
  5. Moody DE, Fang WB, Morrison J, McCance-Katz E. Gender differences in pharmacokinetics of maintenance dosed buprenorphine. Drug Alcohol Depend. 2011;118:479-83.
  6. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - SUBUTEX (buprenorphine) [updated 2002-10-08].
  7. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - BUTRANS (buprenorphine) [updated 2010-06-30].
  8. Pisanu C, Franconi F, Gessa GL, Mameli S, Pisanu GM, Campesi I et al. Sex differences in the response to opioids for pain relief: A systematic review and meta-analysis. Pharmacol Res. 2019;148:104447.
  9. Jones HE, Fitzgerald H, Johnson RE. Males and females differ in response to opioid agonist medications. Am J Addict. 2005;14:223-33.
  10. Ling S, Mangaoil R, Cleverley K, Sproule B, Puts M. A systematic review of sex differences in treatment outcomes among people with opioid use disorder receiving buprenorphine maintenance versus other treatment conditions. Drug Alcohol Depend. 2019;197:168-182.
  11. Hochheimer M, Unick GJ. Systematic review and meta-analysis of retention in treatment using medications for opioid use disorder by medication, race/ethnicity, and gender in the United States. Addict Behav. 2022;124:107113.
  12. Manza P, Kroll D, McPherson KL, Johnson A, Dennis E, Hu L et al. Sex differences in weight gain during medication-based treatment for opioid use disorder: A meta-analysis and retrospective analysis of clinical trial data. Drug Alcohol Depend. 2022;238:109575.
  13. Wedam EF, Bigelow GE, Johnson RE, Nuzzo PA, Haigney MC. QT-interval effects of methadone, levomethadyl, and buprenorphine in a randomized trial. Arch Intern Med. 2007;167:2469-75.
  14. Roden DM. Drug-induced prolongation of the QT interval. N Engl J Med. 2004;350:1013-22.
  15. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2021 [cited 2022-03-15.]
  16. Wändell P, Carlsson AC, Wettermark B, Lord G, Cars T, Ljunggren G. Most common diseases diagnosed in primary care in Stockholm, Sweden, in 2011. Fam Pract. 2013;30:506-13.
  17. Shega JW, Tiedt AD, Grant K, Dale W. Pain measurement in the National Social Life, Health, and Aging Project: presence, intensity, and location. J Gerontol B Psychol Sci Soc Sci. 2014;69 Suppl 2:S191-7.
Uppdaterat

Litteratursökningsdatum 2/12/2015

Litteratursökningsdatum 2/12/2015