Clinician's dilemma: Naproxen-induced liver injury

Naproxen is a widely used nonsteroidal anti-inflammatory drug (NSAID) in pediatric population, used for mild-to-moderate pains, arthritis, and other immune-mediated disorders. It rarely causes clinically apparent liver injury in the adult population taking high doses of the drug over a prolonged period and is reported even rarer in pediatric population. We present a case of drug-induced liver injury (DILI) in a 13-year-old girl taking naproxen in therapeutic doses for juvenile rheumatoid arthritis. There was a complete recovery of liver function following discontinuation of naproxen therapy.

Maintained activity in ankylosing spondylitis patients treated with TNFi and/or NSAID for at least 12 weeks: a cross-sectional study in Brazil

Abstract Background The aim of this study was to evaluate disease activity among patients with axial spondyloarthritis (AS) treated with tumor necrosis factor inhibitors (TNFi) and/or nonsteroidal anti-inflammatory drugs (NSAIDs) for at least 12 weeks in private outpatient settings in Brazil. Methods This was a cross-sectional, real-world study conducted in 17 Brazilian private health care institutes. Patients were selected if diagnosed with AS or axial radiographic spondyloarthritis (AxSpA) and treated with NSAIDs or TNFi for at least 12 weeks within the last 26 weeks prior to enrollment. The data were collected from interviewed-based and self-administered questionnaires from patients and physicians. Disease activity was defined as active (≥ 4), low /suboptimal (≥ 2 and < 4) and inactive (< 4) by Bath AS Disease Activity Index (BASDAI) and/or very high (≥ 3.5), high (≥ 2.1 to < 3.5), low (≥ 1.3 to < 2.1), and inactive (< 1.3) by AS Disease Activity Score (ASDAS-CRP). Both patients and physicians' perceptions of disease control were assessed using a numeric rating scale (NRS; 0—inactive to 10—very active disease). Results The cohort included 378 patients with a mean age of 46 years, and the median time since diagnosis until enrollment was 5.4 years (interquartile range 2.7-10.5). Most patients were treated with TNFi alone (74%), followed by TNFi in combination with NSAID (15%), and NSAID alone (11%). About half AS patients showed active disease and 24% of patients showed low activity/suboptimal disease control despite having been treated for at least 12 weeks. Although TNFi showed better disease control than NSAID, inactive disease was experienced by few patients. The NRS (mean [standard deviation]) score for disease perception was 4.24 (3.3) and 2.85 (2.6) for patients and physicians, respectively. Conclusion This real-world study showed that most AS patients on TNFi and/or NSAID had not achieved an adequate disease control, as almost 75% of them exhibited active disease or low activity/suboptimal disease control. There remains a need for improved disease management among patients with AS.

New topical microemulsions of etofenamate as sufficient management of osteoarthritis

Abstract In this study, microemulsions containing etofenamate were prepared and evaluated as dermal delivery carriers. The developed microemulsions consist of oleic acid, Span 80, Tween 20, Cremophor EL, Transcutol and ethanol. The percentage of etofenamate loading in the microemulsions was 5% (w/w). The characterization of formulations included droplet size, zeta potential, pH, conductivity, PDI, refractive index and viscosity. Moreover, ex vivo penetration study was carried out using mice abdominal skin. The developed formulations were analyzed for their cytotoxicity via MTT assay and tested for their anti-inflammatory properties opposed to LPS-stimulated nitrite prοduction in RAW 264.7 cells. As ideal formulation, M2ETF, was chosen due to its greater permeation, lower penetration as well as higher anti-inflammatory

Bioequivalence Study Comparing Meloxicam 15mg Tablet of Pascual Laboratories, Inc. with Meloxicam (Mobic®) 15mg Tablet of Boehringer Ingelheim in Healthy Male Filipino Subjects under Fasting Conditions

@#<p style="text-align: justify;"><strong>Objective.</strong> Proof of bioequivalence is important for the interchangeability of pharmaceutically equivalent drug products. This study aimed to compare the rate and extent of absorption of meloxicam 15 mg tablet of Pascual Laboratories, Inc. (Test) with meloxicam 15 mg tablet (Mobic) of Boehringer Ingelheim (Reference) in healthy Filipino men. In addition, the study also determined the safety and tolerability of single doses of the said medications, under the same conditions.</p><p style="text-align: justify;"><strong>Methods.</strong> This was a randomized, open label, blind-endpoint analysis, truncated, crossover study with single drug doses administered in the fasting condition in each of the two treatment periods, separated by a two-week washout period. Pharmacokinetic blood sampling was performed up to 72 h post-dose. Plasma samples were analyzed using a validated liquid chromatography with tandem mass spectrometry technology. The primary endpoints were: area under plasma-concentration-time curve from time zero to the last observed concentration at time 72 h (AUC0-72) and maximum plasma concentration (Cmax) for meloxicam.</p><p style="text-align: justify;"><strong>Results.</strong> Eighteen men (mean age 21.5 years; mean body mass index 22.9 kg/m2) completed the study. When administered one meloxicam 15 mg tablet, the ratios of the geometric means of the primary endpoints AUC0-72 and Cmax, were within the established bioequivalence limits of 80% to 125% compared with Mobic 15 mg tablet: 104.07% (90% Confidence Interval [CI]: 100.26, 108.03), and 103.34% (90% CI: 96.22, 110.97), respectively. No adverse event was reported.</p><p style="text-align: justify;"><strong>Conclusion.</strong> Meloxicam 15 mg tablet of Pascual Laboratories, Inc. and the innovator Mobic 15 mg tablet are bioequivalent. Single doses of both products were safe and well tolerated.</p>

Comparative effectiveness of S-adenosylmethionine and etoricoxib in newly diagnosed patients of knee osteoarthritis

Background: Knee osteoarthritis is an important cause for morbidity in elderly people. Therapy is largely symptomatic with nonsteroidal anti-inflammatory drugs which pose risk in the elderly. Methionine is natural body constituent with novel property of blunting S-adenosylmethionine (SAMe) inflammatory process and cartilage degradation. The aim of this study was to compare effectiveness of SAMe, with standard etoricoxib therapy in newly diagnosed knee osteoarthritis cases.Methods: 127 newly diagnosed knee osteoarthritis patients were randomized into two groups. 55 participants received treatment of etoricoxib 600 mg extended release once daily for 90 days (group 1) and 72 received etoricoxib 600 mg extended release once daily and SAMe 400 mg twice daily for initial 15 days followed by SAMe once daily 400 mg as maintenance dose for next 75 days (group 2). The outcomes were measured by knee injury and osteoarthritis outcome score (KOOS). Pre and post treatment KOOS scores of all cases were separately pooled to define the median for whole as well as components of KOOS parameters. Relative frequencies of cases with values around respective medians were compared by MOODS median test. Patient characteristics, disease characteristics were also examined for bearing on outcomes besides the treatment.Results: SAMe treatment was associated with significantly greater improvement in symptoms, activities of daily life, spontaneous recreational activities and the quality of life compared to etoricoxib therapy. The therapy was well-tolerated.Conclusions: The study confirms SAMe as superior therapeutic option in osteoarthritis. SAMe indeed has been reported to have specific anti-arthritic effects and promotive to general well-being.

Evaluation of 0.1% Olopatadine Hydrochloride versus 0.5% Ketorolac Tromethamine Solution in the Management of Allergic Conjunctivitis

Introduction: The term “allergic conjunctivitis” refers to a group of hypersensitivity disorders of eye. This is a commonocular condition which presents with itching, redness, tearing, swelling, burning, fullness in the eye, leading to rubbing ofthe eye, and blurred vision. Histamine, prostaglandins, and mast cell degranulation are important mediators responsiblefor the signs and symptoms of seasonal and perennial allergic conjunctivitis. Olopatadine is a novel drug with dual actionof mast cell stabilizer with blocking of histamine H1 receptors. Ketorolac tromethamine 0.5% ophthalmic solution is a verypotent nonsteroidal anti-inflammatory drug (NSAID) that inhibits the enzyme cyclooxygenase and decreases the synthesisof prostaglandins.Objectives: The objectives of the study were to compare the clinical efficacy and therapeutic effects of 0.1% olopatadinehydrochloride to that of 0.5% ketorolac tromethamine ophthalmic solution with different pharmacological mechanisms in themanagement of seasonal allergic conjunctivitis.Materials and Methods: This was a comparative study that was conducted on patients with allergic conjunctivitis attendingophthalmology outpatient department in a tertiary health-care center during the study period of 1 year. A total of 100 patientswere chosen by purposive sampling method and randomized into two groups. Group A patients were treated with olopatadineand Group B patients were treated with ketorolac and the drugs were instilled twice daily. Patients were evaluated for clinicalsigns and symptoms at baseline and at 30 min, 2 days, 7 days, and 14 days of application of eye drops.Results: The mean age in our study was 27.81 years and had male predominance. There was a significant reduction in thefrequency of all ocular signs and symptoms of hyperemia and itching following initiation of medication. The percentage of nonresponders was comparable between both the groups. Three patients showed increase in hyperemia signs at 30 min postapplication of ketorolac. Adverse reaction was observed in three patients in the ketorolac group.Conclusion: The topical dual-action drug-olopatadine and NSAID-ketorolac both have an attenuating and equivocal effect onthe clinical signs and symptoms of allergic conjunctivitis.

Bromfenac as Adjunctive Treatment with Intravitreal Bevacizumab in Branch Retinal Vein Occlusion of Macular Edema

PURPOSE: To evaluate the effectiveness of 0.1% topical bromfenac as an adjunctive treatment with intravitreal bevacizumab (IVB) injection for branch retinal vein occlusion (BRVO) patients.METHODS: We retrospectively evaluated 68 eyes of 68 patients with macular edema (ME) secondary to BRVO who were treated with IVB injection and followed up for at least 12 months. Of the 68 eyes, 38 were treated with IVB combined with 0.1% topical bromfenac and 30 were treated with IVB alone. IVB reinjection was performed in cases of recurrence. The primary outcome measurement was the number of IVB injections. Changes in the best-corrected visual acuity (BCVA) and central foveal thickness (CFT) during the 12-month follow-up were compared.RESULTS: There was no significant difference in the BCVA or CFT between the two groups at the initial and final examinations. However, the number of IVB injections was significantly lower in the 0.1% bromfenac-treated eyes (p < 0.01) than in the control eyes (4.1 ± 0.7 vs. 5.0 ± 0.6 times).CONCLUSIONS: Compared to IVB monotherapy, topical bromfenac as an adjunctive treatment with IVB injection of eyes with ME secondary to BRVO did not affect visual outcomes, but it reduced the number of IVB injections.

Nonsteroidal anti-inflammatory drugs induced diaphragm disease: a report of 3 cases and literature review

Multiple strictures of small bowel induced by nonsteroidal anti-inflammatory drugs (NSAIDs), were known as diaphragm disease. The purpose of these case reports is to present 3 cases of diaphragm disease of small bowel and summarize the clinical features of this disease entity. A 34-year-old man, a 63-year-old man, and a 66-year-old woman were admitted to Daegu Catholic University Medical Center because of recurrent intestinal obstructions. Two of these patients had taken heavy NSAIDs use. Capsule endoscopy was performed in all cases and the all capsules were retained by circumferential strictures of the ileum. Segmental resection of the strictures was performed in 2 patients and 1 underwent just enterotomy and capsule removal. In conclusion, clinicians should be aware that diaphragm disease might be a cause of small bowel obstruction especially in patients receiving long term NSAIDs therapy.

Role of Nonsteroidal Anti-inflammatory Drug in Treatment of Extra-abdominal Desmoid Tumors

BACKGROUND: We retrospectively reviewed the outcomes of patients who had been treated with meloxicam for the extra-abdominal desmoid tumors and evaluated the correlation between clinical outcome and clinic pathological variables. METHODS: Twenty patients treated with meloxicam were followed up every 3 to 6 months. Meloxicam administration was planned at 15 mg/day orally for 6 months. RESULTS: Of the 20 patients evaluated, according to Response Evaluation Criteria in Solid Tumors criteria, there were five patients with partial response (25.0%), eight with stable disease (40.0%), and seven with tumor progression (35.0%). The cumulative probability of dropping out from our nonsurgical strategy using meloxicam was 35.0% at 1 year and 35.0% at 5 years. CONCLUSIONS: The present study suggests that conservative treatment would be a primary treatment option for this perplexing disease even though we were not able to determine that the use of a cyclooxygenase-2 inhibitor would have an additional influence on the natural course of a desmoid tumor.

Role of Topical Nepafenac and Topical Dexamethasone in Postoperative Inflammation after Cataract Surgery: A Comparative Study.

Background: To study the role of nonsteroidal anti-inflammatory Nepafenac 0.1% topically in comparison to topical steroid for controlling postoperative inflammation after cataract surgery. Methods: Prospective randomized controlled trials were given and double blind study was done. In both groups, similar baseline parameters were taken into consideration. Postoperative inflammation, intraocular pressure and visual acuity following routine small incision cataract surgery were assessed in both groups in first 21 days. Parameters were graded according to severity. Results: There was not much difference statistically in two groups in the treatment of any of the signs, including ciliary congestion, aqueous cells, flare, descemet’s folds, visual acuity and intraocular pressure (p 0.001) however, there was apparent improvement with corticosteroids when aqueous flare was considered but with Nepafenac there was no side effect and was well tolerated. Conclusion: Nepafenac is equally effective as topical steroid and can safely be used in routine postoperative inflammation after uncomplicated cataract surgery.

Comparison of 1% Prednisolone and 0.1% Bromfenac Solutions for Preventing Macular Edema after Cataract Surgery

PURPOSE: To compare the clinical effectiveness of 1% Prednisolone acetate ophthalmic solution and 0.1% Bromfenac sodium hydrate ophthalmic solution on prevention of cystoid macular edema after cataract surgery. METHODS: A retrospective chart review of 349 patients who received phacoemulsification with intraocular lens implantation in Severance Hospital from July 2013 to January 2016 was performed. In these patients, 192 eyes received 1% Prednisolone acetate ophthalmic solution, and 157 eyes were treated with topical 0.1% Bromfenac sodium hydrate ophthalmic solution. The incidence and severity of cystoid macular edema (CME) were evaluated by retinal foveal thickness on optical coherence tomography for patients who showed best corrected visual acuity (BCVA) less than 0.5 (log MAR ≥ 0.3). RESULTS: There was no significant difference between the two groups in age (p = 0.708), sex (p = 0.977), or the side of operated eye (p = 0.443). The two groups showed BCVA 0.04 ± 0.09 (Steroid group) and 0.03 ± 0.07 (nonsteroidal anti-inflammatory drug [NSAID] group) at 1 month after the surgery and the difference was not significant (p = 0.947). One eye in the topical steroid group had cystoid macular edema, and 3 eyes in the steroid group showed elevated intraocular pressure (IOP) over 30 mm Hg. There were no IOP elevations or macular edema in the NSAID group. CONCLUSIONS: The results showed that 0.1% Bromfenac sodium hydrate ophthalmic solution had a similar effect to 1% Prednisolone acetate ophthalmic solution on preventing CME after cataract surgery. This indicates that topical NSAID can be considered along with topical steroids in order to prevent CME after cataract surgery.

Etiology of Non-variceal Bleeding of upper Gastrointestinal System: A Brief Review.

Upper gastrointestinal bleeding (UGB) has important morbidity and mortality risk and these risk increases when co-morbidities exist. Nonsteroidal anti-inflammatory drugs use and Helicobacter Pylori infection are risk factors for peptic ulcer bleeding. Peptic ulcer disease is the most common cause of non variceal UGB. However, other rare causes should be responsible for UGB especially in treatment resistant cases.

Nonsteroidal anti-inflammatory drug (NSAID) associated fixed drug eruption (FDE) in children attending dermatology OPD of a tertiary care hospital of Eastern India: a cross-sectional observational study.

Background: Although extensively studied in adults, Nonsteroidal anti-inflammatory drug (NSAID) hypersensitivity in children, especially in young children, remains a poorly defined area in both its clinical and epidemiologic aspects. Methods: The present observational study was conducted in the department of Dermatology of a tertiary care hospital in Eastern India. Twenty children (20) were screened with suspected NSAID-associated fixed drug eruption (FDE) in the outpatient department. A thorough history taking and clinical examination was performed for each of the cases of FDE. These cases were then managed conservatively after discontinuation of the suspected medication. Rechallenge with the putative offending drug was not done due to ethical reasons. WHO-UMC Causality Assessment criteria and Naranjo probability scale were used for causality assessment of each of the cases of FDE. The severity of reported reactions was assessed by using Modified Hartwig and Siegel Scale and Preventability of the ADRs was assessed by Modified Schumock and Thornton Scale. Results: Patients aged between 5 to 12 years and with a male preponderance of 3:2. The offending NSAID was ibuprofen for 8 of the patients, paracetamol and diclofenac for 4 each and ketorolac for 4 of the patients. These patients were prescribed the offending drugs for fever, rheumatoid arthritis and minor trauma. For each patient, history and clinical signs was consistent with the diagnosis of drug-induced FDEs. Causality assessment for each of the cases revealed ‘possible’ association predominantly (80%). Severity of the suspected ADR (adverse drug reaction) assessed using Modified Hartwig and Siegel Scale, revealed that the ADRs were mild(30%) to moderate (70%) in severity and of ‘probable’ preventibility (90%). Conclusions: 20 new cases of NSAID-induced FDEs over a period of 6 months suggest that this is not a rare entity as was presumed. There is a growing need for a strict monitoring of such off label offending drugs, known to cause ADRs especially among pediatric patients to ensure safe and rational therapeutics.

Use of nonsteroidal antiinflammatory drugs in patients with cardiovascular disease / 中国药学杂志

OBJECTIVE: To provide appropriate guidelines to optimize the rational use of nonsteroidal anti-inflammatory drugs (NSAIDs) for patients with established cardiovascular disease (CVD). METHODS: Mechanisms of increased CVD risk due to NSAIDs were elaborated. Results of clinical researches and Meta-analysis for different NSAIDs in CVD risk were reviewed. RESULTS: All NSAIDs are associated writh an increased risk of cardiovascular adverse effects. The degree of selectivity for cyclooxygenase-2 and the interaction with low-dose aspirin may contribute to the CVD risk of different NSAIDs. CONCLUSION: Physicians should weigh the benefits against risks for individual patients with CVD. NSAIDs should be used in strict accordance with indications and contraindications. Appropriate class of NSAIDs should be selected and interaction with aspirin should be avoided in patients with CVD. After the prescription of NSAIDs, the patients should be monitored to minimize the adverse effects.

Hypersensitivity to Aspirin and Nonsteroidal Anti-inflammatory Drugs / 대한내과학회지

Aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) are the most widely used medications, based on their antipyretic, analgesic, and anti-inflammatory effects. However, both aspirin and NSAIDs cause hypersensitivity reactions through immunologic as well as non-immunologic mechanisms. Except for the rare single-NSAID-induced reaction, most hypersensitivity reactions show cross-reactive features to other NSAIDs regardless of their chemical structure. An accurate correct medical history is the most important diagnostic approach, whereas the roles of blood and skin tests are limited in the majority of cases of NSAIDs hypersensitivity. Although able to confirm the presence of a hypersensitivity reaction, an oral or bronchial provocation test should be performed only under the supervision of a skilled physician at a well-equipped institution. Avoidance of the causative NSAID and all cross-reactive NSAIDs is the cornerstone of management. Patients who require treatment with aspirin or NSAIDs can undergo aspirin desensitization. Genetic predisposition to hypersensitivity to NSAIDs have been demonstrated, but a clear understanding of the pathophysiologic and phenotypic diversity of these hypersensitivity reactions requires further studies, including functional ones.

Paying attention to the correct application of non-steroidal anti-inflammatory drugs in the treatment of ocular surface inflammatory disease / 中华实验眼科杂志

Inflammation is a common ocular surface disease.Glucocorticoid drugs are effective on the ocular surface inflammation,but their long-term and massive application is prone to serious side effects.Nonsteroidal antiinflammatory drugs (NSAIDs) have anti-inflammatory,anti-allergic,analgesic effects.The topical application of NSAIDs for the prevention and treatment of ocular inflammatory disease is much safer than that of glucocorticoid.Therefore,NSAIDs have more and more concerns in the treatment of ocular surface inflammation in recent years.Although NSAID has good anti-inflammatory effectiveness and less adverse effects,it should be correctly administered.During the treatment process of inflammatory ocular surface diseases,the combination of NSAIDs with glucocorticoid drug can strengthen the curative effect and reduce the adverse reactions.

Effect of Non-Steroidal Anti-Inflammatory Drugs on Cystoid Macular Edema in Diabetic Patients after Cataract Surgery

PURPOSE: The present study analyzed the effect of non-steroidal anti-inflammatory drugs (NSAIDs) on cystoid macular edema in diabetic patients after cataract surgery. METHODS: Among 105 eyes of 84 diabetic patients, 43 patients who were administered Pranopulin(R) (JW pharmaceutical, Korea) starting 3 days before surgery comprised the experimental group. The control group included 41 patients who were not given Pranopulin(R). The results consisted of macular thickness measurements and total macular volume which were quantified by optical coherence tomography (OCT, Carl Zeiss Meditec). RESULTS: Macular thickness of the experimental group was 7.72 +/- 13.04 microm at postoperative 1 month, 7.15 +/- 13.62 microm at postoperative 2 months and was significantly thinner than in the control group (p < 0.05). Macular volume of the experimental group was 0.33 +/- 0.49 mm3 at postoperative 1 month, 0.31 +/- 0.43 mm3 at postoperative 2 months and was also significantly smaller than in the control group (p < 0.05). CONCLUSIONS: Using NSAIDs prophylactically before cataract surgery can effectively reduce the risk of postoperative cystoid macular edema in diabetic patients.

<b>The Difference in Analgesic Use of Acetaminophen between in Japan and Other Countries, and Possible Drug Cost Reduction </b><b>Caused by the Acetaminophen Prevalence in Japan </b> / 薬剤疫学

Acetaminophen is commonly used as the global standard of analgesics. For example, the WHO lists acetaminophen as an essential drug and various clinical guidelines in many countries include acetaminophen as a first-line drug for pain relief because of it's efficacy and safety profile. In particular, there is not significant risk of such as gastrointestinal disorders, renal dysfunctions, bleeding, or cardiovascular events, and it is considered to be a safer option than non-steroidal anti-inflammatory drugs(NSAIDs). In Japan, however, NSAIDs are widely used to treat pain while the use of acetaminophen for pain relief is quite limited. This difference could be attributed to the low approved dose of acetaminophen in Japan, which is less than half of that used elsewhere. This lower approved dose causes difficulty in obtaining analgesic effect with acetaminophen. In January 2011, however, the approved dose of acetaminophen in Japan was increased to the world standard dose, making it easier to obtain an analgesic effect. In the near future, an increase in the use of acetaminophen for pain relief can be expected in Japan. NSAIDs are common drugs for pain in Japan, but often require co-prescription of a gastric mucosal protective agents, H₂- blockers, or proton pump inhibitors(PPI) to prevent gastrointestinal disorders. On the other hand, acetaminophen has much less risk of such adverse reactions and there is no need for co-prescription of digestive medicines. Thus, increased use of acetaminophen could decrease the cost for pain relief in Japan. (Jpn J Pharmacoepidemiol 2012; 17(2): 75-86)

High Recurrence Rate of Idiopathic Peptic Ulcers in Long-Term Follow-up

BACKGROUND/AIMS: Our aim was to compare the long-term clinical outcomes of idiopathic peptic ulcer disease (IPUD) with those of Helicobacter pylori-positive and nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcer disease (PUD). METHODS: Patients with endoscopically diagnosed PUD were retrospectively reviewed. According to their H. pylori-infection status and history of NSAIDs use, patients were categorized into three groups: H. pylori-positive PUD, NSAID-induced PUD, and IPUD. Clinical outcomes were analyzed, and the recurrence rate of PUD was compared among the three groups. RESULTS: A total of 238 patients were enrolled. Those with IPUD, NSAID-induced PUD, and H. pylori-positive PUD comprised of 56, 60, and 122 patients, respectively. The 5-year cumulative incidences of recurrent ulcers were 24.3% (95% confidence interval [CI], 11.6% to 37.0%) in IPUD, 10.9% (95% CI, 2.6% to 19.2%) in NSAID-induced PUD, and 3.8% (95% CI, 0.1% to 7.5%) in H. pylori-positive PUD (IPUD vs NSAID-induced PUD/H. pylori-positive PUD, p=0.43/p<0.001 by log-rank test). In the Cox-proportional hazards model, only IPUD remained as an independent risk factor associated with recurrent ulcers (hazard ratio, 5.97; 95% CI, 1.94 to 18.34; p=0.002). CONCLUSIONS: IPUD exhibited a higher recurrence rate than H. pylori-positive and NSAID-induced PUD in long-term follow-up and was an independent risk factor for ulcer recurrence.

Preemptive Analgesic Effect of Topical NSAIDS in Postoperative Pain Relief after LASEK

PURPOSE: To assess the preemptive analgesic effect of topical NSAIDs (0.5% ketorolac tromethamine, Acular) as postoperative pain relief in patients undergoing LASEK. METHODS: A prospective, randomized, placebo-controlled, paired eye study was performed. Patients undergoing LASEK were randomized to receive 0.5% ketorolac in one eye and 0.3% ofloxacin (placebo) in the contralateral eye at 30 minutes, 20 minutes, or ten minutes prior to LASEK. Pain was assessed using a visual analog scale of 0 to 10 in each eye 6, 12, 24, 36, 48 and 72 hours after surgery. Patients were also asked to assess the levels of glare, tearing and irritation using a visual analog scale from 0 to 10. RESULTS: A total of 62 eyes from 31 patients were enrolled in the present study. The mean postoperative pain score in the NSAID group was significantly lower than that in the placebo group at postoperative hours 6 (2.35 versus 4.97), 12 (2.52 versus 5.16), and 24 (3.84 versus 4.94) (p 0.05). Patients reported significantly less tearing and irritation in the NSAID-administered eye compared to those in the placebo eye after LASEK (p < 0.05). CONCLUSIONS: Preemptive administration of topical NSAIDs before LASEK was effective in reducing acute postoperative pain. Preemptive analgesia with topical NSAIDs may be a valuable treatment option for controlling postoperative pain following ocular surgery.