Efficacy and Safety of Pantoprazole versus Ranitidine in the Treatment of Patients with Symptomatic Gastroesophageal Reflux Disease

Abstract

Background/Aim: Gastroesophageal reflux disease (GERD) is a prevalent disease associated with a high symptom burden and a reduced quality of life. This multicenter, randomized, double-blind study compared relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) and from other gastrointestinal symptoms (epigastric pain, vomiting, nausea, flatulence, retching, and retrosternal feeling of tightness) and safety profiles of the proton pump inhibitor pantoprazole and the H₂ antagonist ranitidine in patients suffering from symptomatic GERD. Methods: The patients [338 intention-to-treat (ITT) population; 284 per-protocol (PP) population] received 20 mg pantoprazole (once daily in the morning) plus ranitidine placebo (once daily in the evening; ITT n = 167, PP n = 136) or pantoprazole placebo (once daily in the morning) plus 300 mg ranitidine (once daily in the evening; ITT n = 171, PP n = 148) for 28 days. The primary efficacy criterion (ITT and PP populations) was relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) after 28 days of treatment. Secondary criteria (PP) included relief from key GERD symptoms on day 14, relief from all gastrointestinal symptoms on days 14 and 28, and relief from key GERD symptoms on days 14 and 28. Safety evaluations included adverse events and laboratory assessments. Results: Significantly more pantoprazole-treated patients were free from key GERD symptoms at day 28 (68.3%, n = 114) as compared with ranitidine-treated patients (43.3%, n = 74; 95% confidence interval for odds ratio 1.84–4.51). Pantoprazole was also significantly more efficacious in controlling all gastrointestinal symptoms of GERD. By day 28, 51.5% (n = 70) of the pantoprazole-treated patients were completely symptom free versus 31.1% (n = 46) of the ranitidine-treated patients (95% confidence interval for odds ratio1.45–3.83). Both treatments were well tolerated. Conclusion: Pantoprazole is significantly superior to ranitidine in the treatment of key and associated gastrointestinal symptoms of GERD and is well tolerated.

Treatment of gastroesophageal reflux disease

“…Ademais, em relação à segurança da droga, vários efeitos adversos, como infecção do trato respiratório superior, vômito, diarréia, pneumonia, lesão cutânea, fadiga e tremor foram observados. Por outro lado, estudos em adultos comprovaram a superioridade dos IBP sobre os IH2 na cicatrização de esofagite grave 30,31 . Séries de casos com essa classe de drogas em crianças têm selecionado pacientes a partir da falha terapêutica com IH2, alcançando grandes taxas de alívio de sintomas e cicatrização de mucosa esofágica [32][33][34][35] .…”

“…A terapia de inibição ácida com IBP é capaz de impedir a evolução da estenose e de reduzir a necessidade de dilatações endoscópicas 2,31 .…”

Gastroesophageal Reflux Disease (GERD): Is There More to the Story?

“…Although more effective than other current commercially available treatment methods, the use of PPIs can result in a number of known rare side effects, including nausea, diarrhea, headache, insomnia, and anaphylaxis. [27,31,32] The first-generation PPIs that are currently used have also shown significant interpatient variability and in many cases may adversely interact with other drugs. [16] Cholecystokinin 2 receptor antagonists The CCK 2 receptor antagonists ( Figure 6) are a new class of drugs designed to block the CCK 2 receptors, thereby inhibiting gastric acid secretion.…”

Tratamento da doença do refluxo gastroesofágico

“…On the other hand, studies on adults have confirmed the superiority of PPI over H2RA for healing severe esophagitis. 30,31 Studies with this class of drugs in children have primarily selected patients based on treatment failure with H2RA, achieving high rates of symptom relief and esophageal mucosa healing. [32][33][34][35] Cucchiara et al compared both drugs in children.…”