Association between misoprostol and nonsteroidal anti-inflammatory drug-induced kidney injury: A systematic review and meta-analysis.
misoprostol
nonsteroidal anti-inflammatory drug
randomized controlled trial
systematic review and meta-analysis
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
Sep 2023
Sep 2023
Historique:
revised:
22
05
2023
received:
04
02
2023
accepted:
04
06
2023
pubmed:
13
6
2023
medline:
13
6
2023
entrez:
13
6
2023
Statut:
ppublish
Résumé
Misoprostol is a prostaglandin E1 analogue that is used to prevent nonsteroidal anti-inflammatory drug (NSAID)-induced gastrointestinal disorders. The aim of this systematic review and meta-analysis was to evaluate whether use of misoprostol also decreases the risk of NSAID-induced kidney injury. Randomized controlled trials that compared misoprostol vs. placebo in an adult patient population were selected. The primary outcome was kidney injury and the secondary outcome was severe adverse events. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach. Twelve studies were eligible for inclusion. Although the rates of kidney injury and severe adverse events did not differ significantly between misoprostol and placebo, a posthoc subgroup analysis that excluded studies in which different NSAIDs were used in the misoprostol and placebo groups suggested that misoprostol may reduce the risk of NSAID-induced kidney injury (risk difference -0.09, 95% confidence interval -0.15 to -0.03, P < .01, I There is limited evidence that misoprostol reduces the risk of NSAID-induced kidney injury. Misoprostol possibly contributes to reducing the risk of kidney injury associated with chronic NSAID use. The findings of this meta-analysis suggest further high-quality clinical trials are warranted.
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
2662-2670Subventions
Organisme : None.
Informations de copyright
© 2023 British Pharmacological Society.
Références
Brennan R, Wazaify M, Shawabkeh H, Boardley I, McVeigh J, Van Hout MC. A scoping review of non-medical and extra-medical use of non-steroidal anti-inflammatory drugs (NSAIDs). Drug Saf. 2021;44(9):917-928. doi:10.1007/S40264-021-01085-9
Zhou Y, Boudreau DM, Freedman AN. Trends in the use of aspirin and nonsteroidal anti-inflammatory drugs in the general U.S. population. Pharmacoepidemiol Drug Saf. 2014;23(1):43-50. doi:10.1002/PDS.3463
Zhang X, Donnan PT, Bell S, Guthrie B. Non-steroidal anti-inflammatory drug induced acute kidney injury in the community dwelling general population and people with chronic kidney disease: systematic review and meta-analysis. BMC Nephrol. 2017;18(1):256. doi:10.1186/s12882-017-0673-8
Anwar A, John Anwar I, Delafontaine P. Elevation of cardiovascular risk by non-steroidal anti-inflammatory drugs. Trends Cardiovasc Med. 2015;25(8):726-735. doi:10.1016/J.TCM.2015.03.006
Peng S, Duggan A. Gastrointestinal adverse effects of non-steroidal anti-inflammatory drugs. Expert Opin Drug Saf. 2005;4(2):157-169. doi:10.1517/14740338.4.2.157
Baker M, Perazella MA. NSAIDs in CKD: are they safe? Am J Kidney Dis. 2020;76(4):546-557. doi:10.1053/j.ajkd.2020.03.023
Perazella MA, Rosner MH. Drug-induced acute kidney injury. Clin J am Soc Nephrol. 2022;17(8):1220-1233. doi:10.2215/CJN.11290821
Davies NM, Longstreth J, Jamali F. Misoprostol therapeutics revisited. Pharmacotherapy. 2001;21(1):60-73. doi:10.1592/PHCO.21.1.60.34442
Munger MA, Nelson SD, Teng CC, Cheung AK, Sauer BC. Reduced risk of NSAID-induced adverse events with concomitant use of misoprostol (MICRO study). Pharmacotherapy. 2022;42(7):540-548. doi:10.1002/PHAR.2708
Weir MR, Klassen DK, Hall PS, et al. Minimization of indomethacin-induced reduction in renal function by misoprostol. J Clin Pharmacol. 1991;31(8):729-735. doi:10.1002/J.1552-4604.1991.TB03768.X
Ackerman Z, Cominelli F, Reynolds TB. Effect of misoprostol on ibuprofen-induced renal dysfunction in patients with decompensated cirrhosis: results of a double-blind placebo-controlled parallel group study. Am J Gastroenterol. 2002;97(8):2033-2039. doi:10.1111/J.1572-0241.2002.05847.X
Cooper DL, Murrell DE, Conder CM, et al. Exacerbation of celecoxib-induced renal injury by concomitant administration of misoprostol in rats. PLoS ONE. 2014;9(2):e89087. doi:10.1371/JOURNAL.PONE.0089087
Hooper L, Brown TJ, Elliott RA, Payne K, Roberts C, Symmons D. The effectiveness of five strategies for the prevention of gastrointestinal toxicity induced by non-steroidal anti-inflammatory drugs: systematic review. BMJ. 2004;329(7472):948-952. doi:10.1136/BMJ.38232.680567.EB
Joo MK, Park CH, Kim JS, et al. Clinical guidelines for drug-related peptic ulcer, 2020 revised edition. Gut Liver. 2020;14(6):707-726. doi:10.5009/GNL20246
Rostom A, Wells G, Tugwell P, Welch V, Dube C, McGowan J. Prevention of chronic NSAID induced upper gastrointestinal toxicity. Cochrane Database Syst Rev. 2000;(3):CD002296. doi:10.1002/14651858.CD002296
Al-Aly Z, Maddukuri G, Xie Y. Proton pump inhibitors and the kidney: implications of current evidence for clinical practice and when and how to Deprescribe. Am J Kidney Dis. 2020;75(4):497-507. doi:10.1053/j.ajkd.2019.07.012
Ikuta K, Nakagawa S, Momo K, et al. Association of proton pump inhibitors and concomitant drugs with risk of acute kidney injury: a nested case-control study. BMJ Open. 2021;11(2):e041543. doi:10.1136/BMJOPEN-2020-041543
Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/BMJ.N71
Curtin F, Elbourne D, Altman DG. Meta-analysis combining parallel and cross-over clinical trials. III: the issue of carry-over. Stat Med. 2002;21(15):2161-2173. doi:10.1002/sim.1207
Higgins J, Thomas J, Chandler J, Cumpston M, Li T, Welch V. Cochrane handbook for systematic reviews of interventions version 6.3 The Cochrane collaboration. Published 2022. Accessed July 4, 2022. https://training.cochrane.org/handbook/current
Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336(7650):924-926. doi:10.1136/bmj.39489.470347.AD
GRADEpro GDT: GRADEpro guideline development tool [software]. McMaster University and Evidence Prime, 2022. Accessed April 14, 2023. https://www.gradepro.org/
Inthout J, Ioannidis JP, Borm GF. The Hartung-Knapp-Sidik-Jonkman method for random effects meta-analysis is straightforward and considerably outperforms the standard DerSimonian-Laird method. BMC Med Res Methodol. 2014;14(1):25. doi:10.1186/1471-2288-14-25
Vanderpluym JH, Halker Singh RB, Urtecho M, et al. Acute treatments for episodic migraine in adults: a systematic review and meta-analysis. Jama. 2021;325(23):2357-2369. doi:10.1001/JAMA.2021.7939
Egger M, Smith GD, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315(7109):629-634. doi:10.1136/bmj.315.7109.629
Hinojosa W, Acevedo E, Gutierrez-Ureña S, et al. Tolerability profiles of rofecoxib (Vioxx) and Arthrotec. A comparison of six weeks treatment in patients with osteoarthritis. Scand J Rheumatol. 2001;30(1):19-24. doi:10.1080/030097401750065274
Agrawal NM, van Kerckhove HEJM, Erhardt LJ, Steven GG. Misoprostol coadministered with diclofenac for prevention of gastroduodenal ulcers. AJDD. 1995;40(5):1125-1131. doi:10.1007/BF02064210
Agrawal NM, Caldwell J, Kivitz AJ, et al. Comparison of the upper gastrointestinal safety of Arthrotec® 75 and nabumetone in osteoarthritis patients at high risk for developing nonsteroidal anti-inflammatory drug-induced gastrointestinal ulcers. Clin Ther. 1999;21(4):659-674. doi:10.1016/S0149-2918(00)88318-6
Melo Gomes JA, Roth SH, Zeeh J, Bruyn GAW, Woods EM, Geis GS. Double-blind comparison of efficacy and gastroduodenal safety of diclofenac/misoprostol, piroxicam, and naproxen in the treatment of osteoarthritis. Ann Rheum Dis. 1993;52(12):881-885. doi:10.1136/ARD.52.12.881
Graham DY, White RH, Moreland LW, et al. Duodenal and gastric ulcer prevention with misoprostol in arthritis patients taking NSAIDs. Annals of Clinical Medicine. 1993;119(4):257-262. doi:10.7326/0003-4819-119-4-199308150-00001
Kyaw MH, Otani K, Ching JYL, et al. Misoprostol heals small bowel ulcers in aspirin users with small bowel bleeding. Gastroenterology. 2018;155(4):1090-1097.e1. doi:10.1053/J.GASTRO.2018.06.056
Lanza FL, Fakouhi D, Rubin A, et al. A double-blind placebo-controlled comparison of the efficacy and safety of 50, 100, and 200 micrograms of misoprostol QID in the prevention of ibuprofen-induced gastric and duodenal mucosal lesions and symptoms. Am J Gastroenterol. 1989;84(6):633-636.
Nesher G, Sonnenblick M, Dwolatzky T. Protective effect of misoprostol on indomethacin induced renal dysfunction in elderly patients. J Rheumatol. 1995;22(4):713-716.
Piette F, Teillet L, Naudin R, Boichut D, Capron MH. Efficacy of misoprostol in the prophylaxis of gastroduodenal lesions induced by short-term nonsteroidal antiinflammatory drug therapy in elderly patients. A multicenter double-blind, placebo-controlled trial. Rev Rhum Engl Ed. 1997;64(4):259-266.
Roth S, Agrawal N, Mahowald M, et al. Misoprostol heals gastroduodenal injury in patients with rheumatoid arthritis receiving aspirin. Arch Intern Med. 1989;149(4):775-779. doi:10.1001/archinte.1989.00390040017004
Roth SH, Tindall EA, Jain AK, et al. A controlled study comparing the effects of nabumetone, ibuprofen, and ibuprofen plus misoprostol on the upper gastrointestinal tract mucosa. Arch Intern Med. 1993;153(22):2565-2571. doi:10.1001/archinte.1993.00410220073008
Taha AS, McCloskey C, McSkimming P, McConnachie A. Misoprostol for small bowel ulcers in patients with obscure bleeding taking aspirin and non-steroidal anti-inflammatory drugs (MASTERS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2018;3(7):469-476. doi:10.1016/S2468-1253(18)30119-5
Munger MA, Gardner SF, Ateshkadi A, et al. Misoprostol effects on diclofenac-induced cardiorenal changes in salt-sensitive patients with hypertension: the MEDIC study. Pharmacotherapy. 2008;28(7):834-842. doi:10.1592/PHCO.28.7.834
Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-c184. doi:10.1159/000339789
Azırak S. Prevention of nephrotoxicity induced by amikacin: the role of misoprostol, a prostaglandin E1 analogue. Prostaglandins Other Lipid Mediat. 2023;164:106682. doi:10.1016/J.PROSTAGLANDINS.2022.106682
Kelly JD, Young MRA, Johnston SR, Keane PF. Clinical response to an oral prostaglandin analogue in patients with interstitial cystitis. Eur Urol. 1998;34(1):53-56. doi:10.1159/000019679
Gagnier P. Review of the safety of diclofenac/misoprostol. Drugs. 1993;45 Suppl 1:31-35. doi:10.2165/00003495-199300451-00008
Chassany O, Michaux A, Bergmann JF. Drug-induced diarrhoea. Drug Saf. 2000;22(1):53-72. doi:10.2165/00002018-200022010-00005
Zhang J, Zhou K, Shan D, Luo X. Medical methods for first trimester abortion. Cochrane Database Syst Rev. 2022;2022(5):CD002855. doi:10.1002/14651858.CD002855.PUB5
Foote EF, Lee DR, Karim A, Keane WF, Halstenson CE. Disposition of misoprostol and its active metabolite in patients with normal and impaired renal function. J Clin Pharmacol. 1995;35(4):384-389. doi:10.1002/J.1552-4604.1995.TB04078.X
Gladziwa U, Klotz U. Pharmacokinetic optimisation of the treatment of peptic ulcer in patients with renal failure. Clin Pharmacokinet. 1994;27(5):393-408. doi:10.2165/00003088-199427050-00006
Foote EF, Garnett WR, Lee DR, et al. Disposition of misoprostol and its active metabolite in impaired hepatic function. Am J Ther. 1994;1(2):162-168. doi:10.1097/00045391-199408000-00010
Nicholson PA, Karim A, MS. Pharmacokinetics of misoprostol in the elderly, in patients with renal failure and when coadministered with NSAID or antipyrine, propranolol or diazepam. J Rheumatol Suppl. 1990;20:33-37.