Clinical trials (28) |
ADR: Diarrhea, vomiting and circulatory problems |
Patients with reflux esophagitis (193) |
Bate et al., 19955050. Bate CM, Booth SN, Crowe JP, et al. Omeprazole 10 mg or 20 mg once daily in the prevention of recurrence of reflux esophagitis. Solo Investigator Group. Gut. 1995;36(4):492-8. PMID: 7737552; doi: 10.1136/gut.36.4.492. https://doi.org/10.1136/gut.36.4.492...
|
ADR: Dyspepsia, flatulence, abdominal pain and diarrhea |
Patients with active duodenal ulcer (180) |
Marzio et al., 19955151. Marzio L, Biasco G, Cifani F, et al. Short- and long-term omeprazole for the treatment and prevention of duodenal ulcer, and effect on Helicobacter pylori. Am J Gastroenterol. 1995;90(12):2172-6. PMID: 8540510.
|
ADR: Abdominal pain, diarrhea, nausea, headache and respiratory tract infection |
Patients with gastric ulcer (520) |
Valenzuela et al., 19965252. Valenzuela JE, Kogut DG, McCullough AJ, et al. Comparison of once-daily doses of omeprazole (40 and 20 mg) and placebo in the treatment of benign gastric ulcer: a multicenter, randomized, double-blind study. Am J Gastroenterol. 1996;91(12):2516-22. PMID: 8946978.
|
ADR: Diarrhea, headache, melena, chills and mononucleosis infection plus allergic reaction |
Patients with duodenal ulcer (381) |
Labenz et al., 19975353. Labenz J, Beker JA, Dekker CP, et al. Doubling the omeprazole dose (40 mg b.d. vs. 20 mg b.d.) in dual therapy with amoxycillin increases the cure rate of Helicobacter pylori infection in duodenal ulcer patients. Aliment Pharmacol Ther. 1997;11(3):515-22. PMID: 9218075.
|
ADR: Stroke, cancer, pulmonary embolism and gastrointestinal bleeding/perforation |
Patients with peptic ulcer with bleeding (274) |
Muckadell et al., 19973939. Schaffalitzky de Muckadell OB, Havelund T, Harling H, et al. Effect of omeprazole on the outcome of endoscopically treated bleeding peptic ulcers. Randomized double-blind placebo-controlled multicentre study. Scand J Gastroenterol. 1997;32(4):320-7. PMID: 9140153.
|
ADR: Cardiovascular events such as myocardial infarction, heart failure, stroke, pulmonary embolism, gastrointestinal bleeding and cancer |
Patients with peptic ulcer in the stomach or duodenum (333) |
Hasselgren et al., 19975454. Hasselgren G, Lind T, Lundell L, et al. Continuous intravenous infusion of omeprazole in elderly patients with peptic ulcer bleeding. Results of a placebo-controlled multicenter study. Scand J Gastroenterol. 1997;32(4):328-33. PMID: 9140154.
|
ADR: Diarrhea, stomatitis, metallic taste in the mouth and abdominal pain |
Patients with active gastric or duodenal ulcer (78) |
Annibale et al., 19975555. Annibale B, D'Ambra G, Luzzi I, et al. Does pretreatment with omeprazole decrease the chance of eradication of Helicobacter pylori in peptic ulcer patients? Am J Gastroenterol. 1997;92(5):790-4. PMID: 9149186.
|
ADR: Epigastric pain, facial erythema and loss of libido |
Patients with erosive or ulcerative esophagitis, grade 2 or 3 (231) |
Annibale et al., 19985656. Annibale B, Franceschi M, Fusillo M, et al. Omeprazole in patients with mild or moderate reflux esophagitis induces lower relapse rates than ranitidine during maintenance treatment. Hepatogastroenterology. 1998;45(21):742-51. PMID: 9684126.
|
ADR: Dizziness, fatigue and aphthous stomatitis |
Outpatients with symptoms of reflux esophagitis (70) |
Ladas et al., 20005757. Ladas SD, Tassios PS, Raptis SA. Selection of patients for successful maintenance treatment of esophagitis with low-dose omeprazole: use of 24-hour gastric pH monitoring. Am J Gastroenterol. 2000;95(2):374-80. PMID: 10685738; doi: 10.1111/j.1572-0241.2000.t01-1-01756.x. https://doi.org/10.1111/j.1572-0241.2000...
|
TI: Omeprazole failed to control the gastric acidity of some patients |
Patients with gastroesophageal reflux disease (88) |
Leite et al., 19985858. Leite LP, Johnston BT, Just RJ, Castell DO. Persistent acid secretion during omeprazole therapy: a study of gastric acid profiles in patients demonstrating failure of omeprazole therapy. Am J Gastroenterol.. 1998;91(8):1527-31. PMID: 8759655.
|
ADR: Diarrhea, taste disorder, increased levels of liver enzymes and cholecystitis |
Patients diagnosed with at least one duodenal ulcer and with a test for H. pylori (539) |
Lind et al., 19996161. Lind T, Mégraud F, Unge P, et al. The MACH2 study: role of omeprazole in eradication Helicobacter pylori with 1-week triple therapies. Gastroenterology. 1999;116(2):248-53. PMID: 9922303.
|
ADR: Death due to cardiovascular problems |
Patients with persistent reflux esophagitis and who did not respond to treatment with H2 receptor antagonists (230) |
Klinkenberg-Knol et al., 20006060. Klinkenberg-Knol EC, Nelis F, Dent J, et al. Long-term omeprazole treatment in resistant gastroesophageal reflux disease: efficacy, safety, and influence on gastric mucosa. Gastroenterology. 2000;118(4):661-9. PMID: 10734017.
|
ADR: Diarrhea, nausea, headache, cold, vomiting and fever |
Patients with gastroesophageal reflux without erosive esophagitis (359) |
Richter et al., 20005959. Richter JE, Peura D, Benjamin SB, Joelsson B, Whipple J. Efficacy of omeprazole for the treatment of symptomatic acid reflux disease without esophagitis. Arch Intern Med. 2000;160(12):1810-6. PMID: 10871975.
|
Clinical trials (28) |
TI/ADR: Worsening of symptoms; taste disorder and scarlet fever |
Patients with chronic functional dyspepsia with or without gastritis due to H. pylori (974) |
Blum et al., 20006262. Blum AL, Arnold R, Stolte M, et al. Short course acid suppressive treatment for patients with functional dyspepsia: results depend on Helicobacter pylori status. The Frosch Study Group. Gut. 2000;47(4):473-80. PMID: 10986206.
|
ADR: Diarrhea, pericarditis and chest pain |
Patients with erosive gastroesophageal reflux cured within 90 days (243) |
Thjodleifsson et al., 20006363. Thjodleifsson B, Beker JA, Dekkers C, et al. Rabeprazole versus Omeprazole in preventing relapse of erosive or ulcerative gastroesophageal reflux disease: a double-blind, multicenter, European trial. The European Rabeprazole Study Group. Dig Dis Sci. 2000;45(5):845-53. PMID: 10795744.
|
ADR: Diarrhea, abdominal pain and headache |
Patients with dyspeptic symptoms (73) |
Gottrand et al., 20013333. Gottrand F, Kalach N, Spyckerelle C, et al. Omeprazole combined with amoxicillin and clarithromycin in the eradication of Helicobacter pylori in children with gastritis: A prospective randomized double-blind trial. J Pediatr. 2001;139(5):664-8. PMID: 11713443; doi: 10.1067/mpd.2001.118197. https://doi.org/10.1067/mpd.2001.118197...
|
TI: Some patients did not respond to treatment with omeprazole |
Patients with dyspepsia (514) |
Rabeneck et al., 20026464. Rabeneck L, Souchek J, Wristers K, et al. A double blind, randomized, placebo-controlled trial of proton pump inhibitor therapy in patients with uninvestigated dyspepsia. Am J Gastroenterol. 2002;97(12):3045-51. PMID: 12492188; doi: 10.1111/j.1572-0241.2002.07123.x. https://doi.org/10.1111/j.1572-0241.2002...
|
ADR: Increased fibroblast growth factor 2 |
Patients with gastric neoplasm (16) |
Esaki et al., 20026565. Esaki M, Aoyagi K, Matsumoto T, et al. Effects of omeprazole and famotidine on fibroblast growth factor-2 during artificial gastric ulcer healing in humans. Eur J Gastroenterol Hepatol. 2002;14(4):365-9. PMID: 11943947.
|
ADR: Myocardial infarction, ventral hernia, deep vein thrombosis, miscarriage, headache, respiratory infection, diarrhea and abdominal pain |
Patients who suffered with burning in the stomach for at least three months (390) |
Armstrong et al., 20056666. Armstrong D, Veldhuyzen van Zanten SJ, Barkun AN, et al. Heartburn-dominant, uninvestigated dyspepsia: a comparison of "PPI-start" and "H2-RA-start" management strategies in primary care - The CADET-HR Study. Aliment Pharmacol Ther. 2005;21(10):1189-202. PMID: 15882239; doi: 10.1111/j.1365-2036.2005.02466.x. https://doi.org/10.1111/j.1365-2036.2005...
|
ADR: Diarrhea, taste disorders and dyspepsia |
Patients infected with H. pylori with abdominal disorders (323) |
Manes et al., 20053838. Manes G, Pieramico O, Perri F, et al. Twice-daily standard dose of omeprazole achieves the necessary level of acid inhibition for Helicobacter pylori eradication. A randomized controlled trial using standard and double doses of omeprazole in triple therapy. Dig Dis Sci. 2005;50(3):443-8. PMID: 15810623.
|
ADR: Nasopharyngitis, upper respiratory tract inflammation, diarrhea, headache, arthralgia, back pain, insomnia, cystitis, abdominal pain and hyperglycemia |
Japanese patients with recurrent reflux esophagitis (119) |
Ohkusa et al., 20056767. Ohkusa T, Maekawa T, Arakawa T, et al. Effect of CYP2C19 polymorphism on the safety and efficacy of omeprazole in Japanese patients with recurrent reflux oesophagitis. Aliment Pharmacol Ther. 2005;21(11):1331-9. PMID: 15932363; doi: 10.1111/j.1365-2036.2005.02486.x. https://doi.org/10.1111/j.1365-2036.2005...
|
ADR: Allergic reaction |
Patients with lymphocytic gastritis (51) |
Madisch et al., 20066868. Madisch A, Miehlke S, Neuber F, et al. Healing of lymphocytic gastritis after Helicobacter pylori eradication therapy - A randomized, double-blind, placebo-controlled multicentre trial. Aliment Pharmacol Ther. 2006;23(4):473-9. PMID: 16441467; doi: 10.1111/j.1365-2036.2006.02778.x. https://doi.org/10.1111/j.1365-2036.2006...
|
ADR/TI: Headache, somnolence and diarrhea |
HIV-negative, healthy patients (19) |
Schöller-Gyüre et al., 20083232. Schöller-Gyüre M, Kakuda TN, De Smedt G, et al. A pharmacokinetic study of etravirine (TMC125) co-administered with ranitidine and omeprazole in HIV-negative volunteers. Br J Clin Pharmacol. 2008;66(4):508-16. PMID: 18492125; doi: 10.1111/j.1365-2125.2008.03214.x. https://doi.org/10.1111/j.1365-2125.2008...
|
ADR: Headache and gastrointestinal disorders |
Patients with burning in the stomach or reflux (55) |
Howden et al., 20096969. Howden CW, Ballard ED, Koch FK, Gautille TC, Bagin RG. Control of 24-hour intragastric acidity with morning dosing of immediate-release and delayed-release proton pump inhibitors in patients with GERD. J Clin Gastroenterol. 2009;43(4):323-6. PMID: 18758373; doi: 10.1097/MCG.0b013e31818a386e. https://doi.org/10.1097/MCG.0b013e31818a...
|
ADR: Increased weight, increased ferritin level, increased death related to cardiac disorders and non-fatal heart attack |
Patients with esophageal reflux (310) |
Lundell et al., 20097070. Lundell L, Miettinen P, Myrvold HE, et al. Comparison of outcomes twelve years after antireflux surgery or omeprazole maintenance therapy for reflux esophagitis. Clin Gastroenterol Hepatol. 2009;7(12):1292-8; quiz 1260. PMID: 19490952; doi: 10.1016/j.cgh.2009.05.021. https://doi.org/10.1016/j.cgh.2009.05.02...
|
ADR: Omeprazole reduced antiplatelet effects |
Unmedicated male patients (24) |
Ferreiro et al., 20107171. Ferreiro JL, Ueno M, Capodanno D, et al. Pharmacodynamic effects of concomitant versus staggered clopidogrel and omeprazole intake: results of a prospective randomized crossover study. Circ Cardiovasc Interv. 2010;3(5):436-41. PMID: 20858862; doi: 10.1161/CIRCINTERVENTIONS.110.957829. https://doi.org/10.1161/CIRCINTERVENTION...
|
DI: Increased levels of leukocytes and platelets and increased incidence of cardiac and cerebral adverse events |
Patients with stent implantation (38) |
Hudzik et al., 20107272. Hudzik B, Szkodzinski J, Danikiewicz A, et al. Effect of omeprazole on the concentration of interleukin-6 and transforming growth factor-ß1 in patients receiving dual antiplatelet therapy after percutaneous coronary intervention. Eur Cytokine Netw. 2010;21(4):257-63. PMID: 21084246; doi: 10.1684/ecn.2010.0213. https://doi.org/10.1684/ecn.2010.0213...
|
ADR: Diarrhea, tiredness, dizziness, abdominal pain and headache |
Patients with typical symptoms of reflux more than twice a week (200) |
Miwa et al., 20117373. Miwa H, Inoue K, Ashida K, et al. Randomised clinical trial: efficacy of the addition of a prokinetic, mosapride citrate, to omeprazole in the treatment of patients with non-erosive reflux disease - a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2011;33(3):323-32. PMID: 21118395; doi: 10.1111/j.1365-2036.2010.04517.x. https://doi.org/10.1111/j.1365-2036.2010...
|
Cohort studies (17) |
ADR: Thrombosis, hyperthyroidism, complete retinal detachment, ulcerative colitis and skin rash |
Patients with persistent reflux esophagitis and who did not respond to treatment with H2 receptor antagonists (178) |
Klinkenberg-Knol et al., 19947474. Klinkenberg-Knol EC, Festen HP, Jansen JB, et al. Long-term treatment with omeprazole for refractory reflux esophagitis: efficacy and safety. Ann Intern Med. 1994;121(3):161-7. PMID: 8017742.
|
ADR: Death due to cardiovascular, cerebrovascular, respiratory and postoperative problems, carcinomas, urinary tract infections and suicide |
Diagnosed with colitis due to C. difficile (140) |
Cadle et al., 20071313. Cadle RM, Mansouri MD, Logan N, Kudva DR, Musher DM. Association of proton-pump inhibitors with outcomes in Clostridium difficile colitis. Am J Health Syst Pharm. 2007;64(22):2359-63. PMID: 17989446; doi: 10.2146/ajhp060629. https://doi.org/10.2146/ajhp060629...
|
ADR: Myocardial infarction, stroke, cardiovascular death and unstable angina |
Patients using clopidogrel after percutaneous coronary intervention (16,690) |
Kreutz et al., 20107575. Kreutz RP, Stanek EJ, Aubert R, et al. Impact of proton pump inhibitors on the effectiveness of clopidogrel after coronary stent placement: the clopidogrel Medco outcomes study. Pharmacotherapy. 2010;30(8):787-96. PMID: 20653354; doi:10.1592/phco.30.8.787. https://doi.org/10.1592/phco.30.8.787...
|
DI: Inhibition of the effect of clopidogrel |
Patients using clopidogrel (18,139) |
van Boxel et al., 20107676. van Boxel OS, van Oijen MG, Hagenaars MP, Smout AJ, Siersema PD. Cardiovascular and gastrointestinal outcomes in clopidogrel users on proton pump inhibitors: results of a large Dutch cohort study. Am J Gastroenterol. 2010;105(11):2430-6; quiz 2437. PMID: 20736935; doi: 10.1038/ajg.2010.334. https://doi.org/10.1038/ajg.2010.334...
|
DI: Increased anticoagulant effect of acenocoumarol |
Patients that used acenocoumarol for at least 42 days in the study period (2,755) |
Teichert et al., 20117777. Teichert M, van Noord C, Uitterlinden AG, et al. Proton pump inhibitors and the risk of overanticoagulation during acenocoumarol maintenance treatment. Br J Haematol. 2011;153(3):379-85. PMID: 21418179; doi: 10.1111/j.1365-2141.2011.08633.x. https://doi.org/10.1111/j.1365-2141.2011...
|
TI: Cardiovascular death, myocardial infarction and stroke |
Patients who underwent coronary intervention (13,144) |
Kimura et al., 20117878. Kimura T, Morimoto T, Furukawa Y, et al. Association of the use of proton pump inhibitors with adverse cardiovascular and bleeding outcomes after percutaneous coronary intervention in the Japanese real world clinical practice. Cardiovasc Interv Ther. 2011;26(3):222-33. PMID: 24122589; doi: 10.1007/s12928-011-0063-2. https://doi.org/10.1007/s12928-011-0063-...
|
ADR: Increased levels of chromogranin A |
Patients with increased levels of chromogranin A that could not be caused by neuroendocrine tumors (196) |
Korse et al., 20117979. Korse CM, Muller M, Taal BG. Discontinuation of proton pump inhibitors during assessment of chromogranin A levels in patients with neuroendocrine tumours. Br J Cancer. 2011;105(8):1173-5. PMID: 21989216; doi: 10.1038/bjc.2011.380. https://doi.org/10.1038/bjc.2011.380...
|
ADR: Hypergastrinemia |
Patients with moderate to severe peptic esophagitis |
Ligumsky et al., 20118080. Ligumsky M, Lysy J, Siguencia G, Friedlander Y. Effect of long-term, continuous versus alternate-day omeprazole therapy on serum gastrin in patients treated for reflux esophagitis. J Clin Gastroenterol. 2001;33(1):32-5. PMID: 11418787.
|
TI: Omeprazole failed to control the gastric acidity of some patients |
Patients who underwent kidney transplantation |
David-Neto et al., 20124949. David-Neto E, Takaki KM, Agena F, et al. Diminished mycophenolic acid exposure caused by omeprazole may be clinically relevant in the first week posttransplantation. Ther Drug Monit. 2012;34(3):331-6. PMID: 22549498; doi: 10.1097/FTD.0b013e31824d6e8e. https://doi.org/10.1097/FTD.0b013e31824d...
|
DI: Inhibition of the effect of clopidogrel |
Patients with acute coronary syndrome (37,099) |
Lin et al., 20128181. Lin CF, Shen LJ, Wu FL, Bai CH, Gau CS. Cardiovascular outcomes associated with concomitant use of clopidogrel and proton pump inhibitors in patients with acute coronary syndrome in Taiwan. Br J Clin Pharmacol. 2012;74(5):824-34. PMID: 22364155; doi: 10.1111/j.1365-2125.2012.04250.x. https://doi.org/10.1111/j.1365-2125.2012...
|
ADR: Increased risk of fractures |
Patients who underwent medical consultations in the last two years (61,916) |
Soriano et al., 20141616. Cea Soriano L, Ruigómez A, Johansson S, García Rodríguez LA. Study of the association between hip fracture and acid-suppressive drug use in a UK primary care setting. Pharmacotherapy. 2014;34(6):570-81. PMID: 24634193; doi: 10.1002/phar.1410. https://doi.org/10.1002/phar.1410...
|
ADR: Increased risk of dementia |
Elderly people over 75 years old (73,679) |
Gomm et al., 20164444. Gomm W, von Holt K, Thomé F, et al. Association of Proton Pump Inhibitors with Risk of Dementia. A Pharmacoepidemiological Claims Data Analysis. JAMA Neurol. 2016; 73(4):410-416. doi: 10.1001/jamaneurol.2015.4791. https://doi.org/10.1001/jamaneurol.2015....
|
ADR: Increased risk of first-time ischemic stroke |
- (396,296) |
Yi et al., 20174747. Yi X, Zhou Q, Wang C, et al. Concomitant Use of Proton Pump Inhibitors and Clopidogrel Is Not Associated with Adverse Outcomes after Ischemic Stroke in Chinese Population. J Stroke Cerebrovasc Dis. 2016; 25(12):2859-2867. doi: 10.1016/j.jstrokecerebrovasdis.2016.08.00. https://doi.org/10.1016/j.jstrokecerebro...
|
ADR: Increased serum creatinine levels |
Inpatient patients (419) |
Varallo et al., 20184141. Varallo FR, Nadai TR, Oliveira ARA, et al. Potential Adverse Drug Events and Nephrotoxicity Related to Prophylaxis with Omeprazole for Digestive Disorders: A Prospective Cohort Study. Clin Therapeutics. 2018, 40(6)973-982. PMID: 29759903; doi: 10.1016/j.clinthera.2018.04.013. https://doi.org/10.1016/j.clinthera.2018...
|
ADR: Increased risk of metabolic syndrome and hepatic steatosis |
Patients with a recent diagnosis of celiac disease (301) |
Imperatore et al., 20184545. Imperatore N, Tortora R, Testa A, et al. Proton pump inhibitors as risk factor for metabolic syndrome and hepatic steatosis in coeliac disease patient on gluten-free diet. J Gastroenterol. 2018;53(4):507:516. PMID: 28823009; doi: 10.1007/s00535-017-1381-7 https://doi.org/10.1007/s00535-017-1381-...
|
ADR: Hypomagnesemia |
Hospitalized patients with Torsades de pointes (48) |
Lazzerini et al., 20184242. Lazzerini PE, Bertolozzi I, Finizola F, et al. Proton Pump Inhibitors and serum magnesium levels in patient with torsades de pointes. Front Pharmacol. 2018;9:1-10. doi: 10.3389/fphar.2018.00363. https://doi.org/10.3389/fphar.2018.00363...
|
ADR: Increased risk of fibrosis progression, cirrhosis, hepatic decompensation and development of hepatocellular carcinoma |
Patients with hepatitis C virus (HCV) infection. |
Li et al., 20184848. Li DK, Yan P, Abou-Samra AB. Proton pump inhibitors are associated with accelerated development of cirrhosis, hepatic decompensation and hepatocellular carcinoma in noncirrhotic patients with chronic hepatitis C infection: results from ERCHIVES. Aliment Pharmacol Ther. 2018; 47(2):246-258. PMID: 29105111doi: 10.1111/apt.14391. https://doi.org/10.1111/apt.14391...
|
Quasi-experimental studies (4) |
ADR: Diarrhea and ringing in the ears |
Patients with burning in the stomach, erosive esophagitis or non-erosive reflux disease (108) |
Tsuzuki et al., 20118282. Tsuzuki T, Okada H, Kawahara Y, et al. Proton pump inhibitor step-down therapy for GERD: a multi-center study in Japan. World J Gastroenterol. 2011;17(11):1480-7. PMID: 21472108; doi: 10.3748/wjg.v17.i11.1480. https://doi.org/10.3748/wjg.v17.i11.1480...
|
ADR: Respiratory infection, otitis media, pharyngitis, change in bowel habit, fever and rhinitis |
Patients with cured reflux esophagitis (64) |
Hassall et al., 20128383. Hassall E, Shepherd R, Koletzko S, et al. Long-term maintenance treatment with omeprazole in children with healed erosive oesophagitis: a prospective study. Aliment Pharmacol Ther. 2012;35(3):368-79. PMID: 22176465; doi: 10.1111/j.1365-2036.2011.04950.x. https://doi.org/10.1111/j.1365-2036.2011...
|
ADR: Nausea, vomiting, constipation, diarrhea, metallic taste in the mouth, headache, abdominal pain, loss of appetite, drowsiness, weakness, dizziness and dry mouth |
Patients with H. pylori (134) |
Sezgin et al., 20143434. Sezgin O, Barlas IO, Üçbilek E, Yengel E, Altintas E. Modified sequential Helicobacter pylori eradication therapy using high dose omeprazole and amoxicillin in the initial phase in the extensive metaboliser Turkish patients for CYP2C19 polymorphism is ineffective. Acta Gastroenterol Belg. 2014;77(1):3-7. PMID: 24761684.
|
ADR: Myocardial infarction or heart failure with or without consequent death |
Patients who were hospitalized due to myocardial infarction within 12 weeks after starting use of proton-pump inhibitors (5,550) |
Juurlink et al., 20138484. Juurlink DN, Dormuth CR, Huang A, et al. Proton pump inhibitors and the risk of adverse cardiac events. Plos One. 2013;8(12):e84890. PMID: 24386430; doi: 10.1371/journal.pone.0084890. https://doi.org/10.1371/journal.pone.008...
|
Case-control studies (2) |
ADR: Maculopapular rash, angioedema and/or urticaria, Steven-Johnson’s syndrome, erythema multiforme, eczematous eruption and urticarial vasculitis |
Patients with dyspepsia, gastroesophageal reflux disease and upper gastrointestinal tract bleeding; prevention of ulcers induced by nonsteroidal anti-inflammatory drugs, stress and prednisolone (170) |
Chularojanamontri et al., 20128585. Chularojanamontri L, Jiamton S, Manapajon A, et al. Cutaneous reactions to proton-pump inhibitors: a case-control study. J Drugs Dermatol. 2011;11(10):e43-7. PMID: 23134998.
|
ADR: Low sperm motility |
Men who were planning to have children (955) |
Heijgen et al., 20164646. Heijgen NA, de Ridder MA, Verhamme KM, et al. Are proton-pump inhibitors harmful for the semen quality of men in couples who are planning pregnancy? Fertil Steril. 2016;106(7):1666-1672. 27743698; doi: 10.1016/j.fertnstert.2016.09.010. https://doi.org/10.1016/j.fertnstert.201...
|
Cross-sectional studies (2) |
ADR: Proliferative changes |
Patients who underwent endoscopy and who had been using proton-pump inhibitors for at least 2 months (22) |
Menegassi et al., 201055. Menegassi VS, Czeczko LEA, Czeczko LSG, et al. Prevalência de alterações proliferativas gástricas em pacientes com uso crônico de inibidores de bomba de próton [Prevalence of gastric proliferative changes in patients with chronic use of proton pump inhibitor agents]. ABCD, Arq Bras Cir Dig. 2010;23(3):145-9. doi: 10.1590/S0102-67202010000300003. https://doi.org/10.1590/S0102-6720201000...
|
ADR: Decreased serum levels of vitamin B12 |
Patients with diagnosis of gastrointestinal disease in the consumption of proton pump inhibitors (109) |
Mindiola et al., 20174040. Mindiola AL, Fernandéz HM, Arciniegas DR, et al. Vitamin B 12 Deficiency Associated with Consumption of Proton Pump Inhibitors. Col Gastroenterol. 2017;32 (3):197-201. doi: 10.22516/25007440.150. https://doi.org/10.22516/25007440.150...
|
No clinical outcomes |
Clinical trials (12) |
Many conditions |
Yamamoto et al., 19958686. Yamamoto I, Fukuda Y, Okui M, Tamura K, Shimoyama T. Proton pump inhibitor for Helicobacter pylori eradication in patients with peptic ulcer. J Clin Gastroenterol. 1995;20 Suppl 1:S38-42. PMID: 7673613.; Goh et al., 19958787. Goh KL, Parasakthi N, Peh SC, Anderson PE, Tan KK. Prolonged treatment with omeprazole does not improve the eradication rate of Helicobacter pylori infection--a short report [corrected]. Singapore Med J. 1995;36(6):619-20. PMID: 8781634.; Soga et al., 19993737. Soga T, Matsuura M, Kodama Y, et al. Is a proton pump inhibitor necessary for the treatment of lower-grade reflux esophagitis? J Gastroenterol. 1999;34(4):435-40. PMID: 10452673.; Noordzij et al., 20018888. Noordzij JP, Khidr A, Evans BA, et al. Evaluation of omeprazole in the treatment of reflux laryngitis: a prospective, placebo-controlled, randomized, double-blind study. Laryngoscope. 2001;111(12):2147-51. PMID: 11802014; doi: 10.1097/00005537-200112000-00013. https://doi.org/10.1097/00005537-2001120...
; Zhou et al., 20024343. Zhou Y, Qiao L, Wu J, Hu H, Xu C. Comparison of the efficacy of octreotide, vasopressin, and omeprazole in the control of acute bleeding in patients with portal hypertensive gastropathy: A controlled study. J Gastroenterol Hepatol. 2002;17(9):973-9. PMID: 12167118.; van Zanten et al., 20053535. Veldhuyzen Van Zanten SJ, Chiba N, Armstrong D, et al. A randomized trial comparing omeprazole, ranitidine, cisapride, or placebo in Helicobacter pylori negative, primary care patients with dyspepsia: the CADET-HN Study. Am J Gastroenterol. 2005;100(7):1477-88. PMID: 15984968; doi: 10.1111/j.1572-0241.2005.40280.x. https://doi.org/10.1111/j.1572-0241.2005...
; Fujiwara et al., 20058989. Fujiwara Y, Higuchi K, Nebiki H, et al. Famotidine vs. omeprazole: a prospective randomized multicentre trial to determine efficacy in non-erosive gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2005;21 Suppl 2:10-8. PMID: 15943841; doi: 10.1111/j.1365-2036.2005.02468.x. https://doi.org/10.1111/j.1365-2036.2005...
; Liu et al., 20139090. Liu BL, Li B, Zhang X, et al. A randomized controlled study comparing omeprazole and cimetidine for the prophylaxis of stress-related upper gastrointestinal bleeding in patients with intracerebral hemorrhage. J Neurosurg. 2013;118(1):115-20. PMID: 23061387; doi: 10.3171/2012.9.JNS12170. https://doi.org/10.3171/2012.9.JNS12170...
; Miner JR et al., 20109191. Miner PB, McKean LA, Gibb RD, et al. Omeprazole-Mg 20.6 mg is superior to lansoprazole 15 mg for control of gastric acid: A comparison of over-the-counter doses of proton pump inhibitors. Aliment Pharmacol Ther. 2010;31(8):846-51. PMID: 20146702; doi: 10.1111/j.1365-2036.2010.04258.x. https://doi.org/10.1111/j.1365-2036.2010...
; Ummarino et al., 20123636. Ummarino D, Miele E, Masi P, et al. Impact of antisecretory treatment on respiratory symptoms of gastroesophageal reflux disease in children. Dis Esophagus. 2012;25(8):671-7. PMID: 22236501; doi: 0.1111/j.1442-2050.2011.01301.x. https://doi.org/0.1111/j.1442-2050.2011....
; Sakurada et al., 20129292. Sakurada T, Kawashima J, Ariyama S, et al. Comparison of adjuvant therapies by an H2-receptor antagonist and a proton pump inhibitor after endoscopic treatment in hemostatic management of bleeding gastroduodenal ulcers. Dig Endosc. 2012;24(2):93-9. PMID: 22348833; doi: 10.1111/j.1443-1661.2011.01176.x. https://doi.org/10.1111/j.1443-1661.2011...
; Solana et al., 20139393. Solana MJ, López-Herce J, Sánchez A, et al. 0.5 mg/kg versus 1 mg/kg of intravenous omeprazole for the prophylaxis of gastrointestinal bleeding in critically Ill children: a randomized study. J Pediatr. 2013;162(4):776-782.e1. PMID: 23149178; doi: 10.1016/j.jpeds.2012.10.010. https://doi.org/10.1016/j.jpeds.2012.10....
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Cohort studies (5) |
Many conditions |
Zairis et al., 20109494. Zairis MN, Tsiaousis GZ, Patsourakos NG, et al. The impact of treatment with omeprazole on the effectiveness of clopidogrel drug therapy during the first year after successful coronary stenting. Can J Cardiol. 2010;26(2):e54-7. PMID: 20151060.; Harjai et al., 20119595. Harjai KJ, Shenoy C, Orshaw P, et al. Clinical outcomes in patients with the concomitant use of clopidogrel and proton pump inhibitors after percutaneous coronary intervention: An analysis from the guthrie health off-label stent (GHOST) investigators. Circ Cardiovasc Interv. 2011;4(2):162-70. PMID: 21386091; doi: 0.1161/CIRCINTERVENTIONS.110.958884. https://doi.org/0.1161/CIRCINTERVENTIONS...
; Chen et al., 20142828. Chen WC, Li YD, Chiang PH, et al. Comparison of proton pump inhibitor and histamine-2 receptor antagonist in the prevention of recurrent peptic ulcers/erosions in long-term low-dose aspirin users: a retrospective cohort study. Biomed Res Int. 2014; 2014:693567. PMID: 25295267; doi: 10.1155/2014/693567. https://doi.org/10.1155/2014/693567...
; Galante et al., 20129696. Cappelletti Galante M, Garcia Santos V, Bezerra da Cunha GW. Assessment of the use of clopidogrel associated with gastroprotective medications in outpatients. Farm Hosp. 2012;36(4):216-9. PMID: 22115860; doi: 10.1016/j.farma.2011.06.011. https://doi.org/10.1016/j.farma.2011.06....
; Wang et al., 20179797. Wang YF, Chen YT, Luo GC, et al. Proton-Pump Inhibitor Use and the Risk of First-Time Ischemic Stroke in the General Population: A Nationwide Population-Based Study. Am J Gastroenterol. 2017 Jul;112(7):1084-93. PMID: 28397874; doi: 10.1038/ajg.2017.101. https://doi.org/10.1038/ajg.2017.101...
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Cross-sectional studies (2) |
Newborns with hypospadias born to mothers who had used proton-pump inhibitors during pregnancy (430,569) |
Erichsen et al., 20149898. Erichsen R, Mikkelsen E, Pedersen L, Sørensen HT. Maternal use of proton pump inhibitors during early pregnancy and the prevalence of hypospadias in male offspring. Am J Ther. 2014;21(4):254-9. PMID: 22314213; doi: 10.1097/MJT.0b013e3182456a8f. https://doi.org/10.1097/MJT.0b013e318245...
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Patients with stage 5 chronic kidney disease (CKD) on hemodialysis therapy and chronic use of proton pump inhibitors (37) |
Restrepo et al., 20179999. Restrepo CH et al. Impacto de los inhibidores de la bomba de protones en los niveles de vitamina B12 en pacientes con ERO estadio 5 en hemodiálisis. Experiencia de un centro en Manizales, Colombia. Acta Med Colomb [online]. 2017; 42(3):172-179.
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