DOI: 10.61873/rcpp.40.e207786

Authors: Martín Roberto Basile-Alvarez, Erick André Escalante-Buendía, Karen A. Palacios-Aguirre, Alejandro Ortega Desio, Omar Yaxmehen Bello-Chavolla

Abstract: To evaluate current therapies for diabetic macular edema (DME), with emphasis on durability, safety, access, and the evidence supporting aflibercept 8 mg. An expert-selected narrative synthesis of primary clinical trials, pharmacologic studies, regulatory documents, and selected real-world evidence published from January 1, 2000, through August 8, 2026, was performed. Anti-vascular endothelial growth factor therapy remains first-line treatment for most center-involved DME with visual impairment, but observation or focal/grid laser is reasonable for selected eyes with good visual acuity. In PHOTON, aflibercept 8 mg every 12 or 16 weeks after three monthly doses was noninferior to aflibercept 2 mg every 8 weeks for visual acuity at week 48; durability and similar safety were maintained through week 96 with fewer injections. Faricimab, brolucizumab, dexamethasone and fluocinolone implants, and the ranibizumab Port Delivery System offer alternative durability profiles with distinct evidence and risks. Aflibercept 8 mg provides an effective option for extending treatment intervals while maintaining visual and anatomical outcomes; however, no single therapeutic strategy is optimal for all patients. Treatment should therefore be individualized according to visual and anatomical response, ocular and systemic characteristics, patient preference, treatment burden, access, and local health-system constraints.

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DOI: 10.61873/rcpp.40.e196749

Authors: Arbind Kumar Choudhary

Abstract: Background: Gastroesophageal reflux disease (GERD) is a prevalent chronic acid-related disorder that substantially impairs patient quality of life. Proton pump inhibitors (PPIs) are established therapy; however, first-generation agents such as omeprazole show clinically relevant inter-individual variability related in part to cytochrome P450 2C19 (CYP2C19) metabolism. Ilaprazole, a newer PPI with predominant cytochrome P450 3A4 (CYP3A4) metabolism and a longer elimination half-life, may provide more consistent acid suppression, but direct comparative data in Indian patients with GERD and erosive gastritis using validated quality-of-life tools remain limited. Aim: To compare the clinical efficacy, health-related quality-of-life outcomes, and safety of ilaprazole 10 mg once daily versus omeprazole 20 mg once daily over eight weeks in patients with symptomatic GERD and endoscopically confirmed erosive gastritis. Erosive esophagitis was not required for inclusion and was not the primary condition studied. Methodology: A prospective, single-center, single-blind, comparative clinical study was conducted at VMKVMC&H, Salem, Tamil Nadu. Sixty patients fulfilling the inclusion criteria were randomly assigned in a 1:1 ratio to either ilaprazole 10 mg (n=30) or omeprazole 20 mg (n=30) once daily before breakfast for eight weeks. Participants were blinded to treatment allocation, while treating investigators were aware of allocation for dispensing and safety monitoring. Primary outcomes were change in GERD symptom count and health-related quality of life assessed using the 25-item QOLRAD questionnaire across five domains: Emotional distress, sleep disturbance, food/drink problems, physical/social functioning, and vitality. The theoretical QOLRAD total score range is 25-175, with higher scores indicating better quality of life. Adverse drug reactions, adherence, and concomitant/rescue medication use were assessed at follow-up visits. Baseline imbalances in symptom count and choking sensation were taken into account when analysing efficacy outcomes. Results: The groups were comparable in age (35.8±6.3 vs 37.2±4.8 years; p=0.352), and sex distribution was similar but not identical (male 53.3% vs 50.0%; p=1.000). Baseline QOLRAD total scores were comparable (34.07±9.10 vs 33.13±7.73; p=0.965). Baseline symptom count was higher in the omeprazole group (7.90±0.61 vs 7.10±0.96; p<0.001), and choking sensation was present only in the omeprazole group (36.7% vs 0%); therefore, we analysed symptom-count findings with caution, focusing on change from baseline. By week 8, ilaprazole was associated with a higher QOLRAD total score than omeprazole (146.57±4.14 vs 103.63±32.26; p<0.001; Cohen's d=1.706; mean difference 42.94, 95% CI 30.81-55.07). Mean GERD symptom count declined from 7.10±0.96 to 0.67±0.48 with ilaprazole (90.6% reduction) versus 7.90±0.61 to 3.10±1.18 with omeprazole (60.8% reduction). At week 8, ilaprazole showed higher point-in-time symptom resolution for epigastric pain, nausea, irritating throat sensation, belching, and loss of appetite. The week 4-to-week 8 nausea pattern was clarified as point-in-time symptom status, because symptoms could recur or be re-reported at the final visit. Adverse drug reactions were mild and comparable between groups (10.0% vs 13.3%; p>0.05), with no serious adverse events in either arm. Conclusion: Ilaprazole 10 mg once daily was associated with greater improvement in GERD symptom burden and health-related quality of life than omeprazole 20 mg once daily over eight weeks, with a comparable safety profile. However, because this was a small, single-center, single-blind study with baseline symptom imbalance and without CYP genotyping, pharmacokinetic assessment, intragastric pH monitoring, or repeat endoscopy, we regard these findings as preliminary and requiring confirmation in larger, methodologically rigorous trials. Pharmacogenomic and pharmacological explanations should be regarded as plausible hypotheses rather than proven mechanisms.

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DOI: 10.61873/jzpr9600

Authors: Kyriakoula Manaridou, Jost Eberlein, Olympia Konstantakopoulou, Alexandra Skitsou, Petros Galanis, Georgios Charalambous, Charalambos Dokos

Abstract: Background: Prescription errors (PE) in psychiatric hospitals can compromise treatment and patient safety. While well studied in general healthcare, evidence from psychiatric settings, particularly in Germany, remains scarce. Aim: This preliminary study investigates the prevalence, types, and severity of PE in a German psychiatric hospital over 12 months. Methodology: A prospective observational study was conducted at St. Josef AMEOS Psychiatric Hospital, Oberhausen, Germany (2023–2024). All 6,020 paper-based therapeutic plans were screened. From these, 150 cases of PE were identified for interim analysis. Errors were categorized using adapted EQUIP methodology and classified by severity (minor, major, serious, potentially fatal) and by drug group according to the British National Formulary (BNF). Results: Of the 150 cases, 93.3% were minor, 5.0% were major, and 1.7% were serious; no potentially fatal errors were observed. Writing errors were most common (38%). Errors most frequently involved musculoskeletal medications (BNF 10; 36.7%), followed by gastrointestinal (BNF 1; 18.7%) and CNS/psychotropics (BNF 4; 14.7%). Most errors occurred in inpatient settings and were primarily attributed to residents and consultants. Significant associations were found between error type and drug class, and between error type and severity (p<0.05). Conclusion: These interim results suggest that PE in psychiatric hospitals are mostly minor, with somatic medications more often affected than psychotropics. Given the small interim sample (150 of 6,020 plans), findings should be interpreted cautiously and considered hypothesis-generating. Larger, multi-center studies and evaluation of electronic prescribing systems are needed to confirm these patterns and guide interventions.

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