GI Drugs Research Articles

A pilot study: Drug utilization pattern and prevalence of micro and macrovascular complication in type 2 diabetes patient

Background: Diabetes mellitus is a chronic metabolic disorder resulting from the deficiency of insulin secretion and insulin resistance. Currently, there is a death of nationwide data regarding the prevalence of micro and macro complications and drug utilization patterns. This study will help health-care professionals approach management more aggressively to prevent complications. Objectives: To assess the risk factors associated with complications in diabetes patients, and to determine the pattern of drug prescription among type-2 DM patients patterns at Virudhunagar Medical College & Hospital. Methods: This is a Prospective, prescription-based, and observational study. A sample size of 50 was selected systematically. Data were collected from patient case records and Prescriptions. The obtained data were entered in the structured patient profile form, and the filled forms were analyzed. Results: Out of the total 50 cases evaluated, 60 (60%) were males and 20(40%) were females. The 28 patients (56%) had a family history of diabetes. The prevalence of the associated diabetic complications was as follows viz. Hypertension (17.65%), IHD (1.47%), retinopathy (17.65%), nephropathy (7.35%), Neuropathy (47.06%), Stroke (5.88%) and CHF (2.94%). The overall utilization pattern of drugs were as follows viz. anti-diabetics (28%), anti-hypertensive (9%), antiplatelets (4%), lipid lowering agents (7%), vitamins and minerals (17%),GI drugs (14%), antimicrobials(6%). Among anti-diabetic drugs 48(96%) biguanides and 44(88%) of sulfonylureas classes of antidiabetic drugs were utilized. Likewise, preferred drugs for the management of hypertension, IHD, dyslipidemia, and neuropathy were Diuretics (25.93%), Clopidogrel (66.66%), Atorvastatin (100%), and Acetominophine (67.74%) respectively. Conclusion: The prevalence of micro and macro complications among type 2 diabetic patients was found to be high. Although polypharmacy was observed, drug utilization patterns can be rational owing to the higher prevalence of complications. Patient are not aware of the severity of the disease so complication makes the therapeutic more challenging. Patient education on disease severity and healthcare professionals need more focus on disease complications and severity to treat the disease earlier to improve patient health outcomes.

A Study on Prescription Pattern and Assessment of Smoking as a Risk Factor among COPD Patients in a Tertiary Care Hospital

Abstract: Aim: The aim is to study the prescription pattern and to assess whether smoking is a major risk factor among COPD patients in a tertiary care hospital. Materials and Methods: A prospective observational study was conducted for 6 months. All the data were collected, documented and analysed based on standard protocol. Data collected were entered and statistically analysed using Microsoft Excel. Results: 120 patients (83 male and 37 female) were included in the study. COPD was more common in the age group of 61-70 years with an average age of 66.8 years. Hypertension ((38.33%) was the most common comorbidity followed by diabetes mellitus. Smoking (66.6%) was a major risk factor followed by indoor pollution (16.60%) outdoor pollution, family history and asthma respectively. Among smokers, 61.25% were ex-smokers. 46.25% of smoking patients had pack years of 11-20. Most commonly prescribed drugs were Bronchodilators (98.30%), antibiotics (85.80%) and corticosteroids (70%). Deriphylline was the most commonly prescribed bronchodilator. Beta lactam antibiotics were most commonly prescribed antibiotics. Among other drugs, GI drugs were commonly prescribed. Parenteral route was mostly preferred, followed by inhalation and oral respectively. Conclusion: The study provides insight into the prescription pattern and shows that smoking is a major risk factor among COPD patients. In this study, bronchodilators were the most commonly used drug followed by antibiotics and corticosteroids. Smoking is a major risk factor followed by indoor pollution, outdoor pollution, family history and asthma respectively. Keywords: Chronic obstructive pulmonary disease, Comorbidities, Prescription pattern, Smoking, Risk factors.

Gastrointestinal medication burden among persons with the Ehlers-Danlos syndromes.

The Ehlers-Danlos syndromes (EDSs) are a group of heritable disorders of connective tissue associated with an increased prevalence of both structural and functional GI conditions. We used 10years (2005-2014) of administrative claims data comprised of 4294 people with clinician-diagnosed EDS, aged 5-62years, and compared their frequency of GI drug prescription claims to their age-, sex-, state of residence-, and earliest claim date-matched controls. We categorized the GI medications into the following groups: acid suppressants, anti-emetics, irritable bowel syndrome drugs, and visceral hypersensitivity (VHS) medications. Compared to controls, a significantly higher proportion of persons with EDS had prescription claims for at least one GI drug group, as well as for drugs in each of the four GI drug groups included in our study. By age-group, 25.7% children and 45.1% adults with EDS had prescription claims for at least one GI drug group compared with only 7.4% and 21.0% of controls, respectively (p<0.0001). By gender, 44.0% of women and 25.3% of men with EDS had prescription claims for at least one class of GI drugs compared with 19.2% and 9.6% of controls, respectively (p<0.0001). Predominant medication burden occurs among women with EDS, beginning peri-pubertally for anti-emetics and VHS drugs. High GI medication burden underscores previous evidence that GI dysmotility is common among persons with EDS.

P: 20 EID-UL-AZHA (Muslim's Festival of Sacrifice): Increased Frequency of Spontaneous Encephalopathy, Whether This Is Secondary to Consumption of High Protein Diet?

BACKGROUND: Protein restricted diet once was the cornerstone of the management of Hepatic encephalopathy, latter no evidence showed significant benefits. However sub group of cirrhotics are intolerant to dietary proteins, especially animal proteins. We compared precipitants of encephalopathy and effect of animal proteins consumption during the festival of EID-UL-AZHA METHODS: A retrospective comparative cross sectional study was conducted and analyzed hospital data of AIMS (Asian institute of medical sciences, Hyderabad, Pak.). Patients of cirrhosis were enrolled with clinically diagnosed hepatic encephalopathy in two groups. Group A was categories with patients admitted 15 days before EID-Ul-AZHA and Group B includes patients admitted on EID UL AZHA day and up to 15 days afterward. Patients with neurological deficit and suspected CNS infection were excluded. Patient of both groups were assessed to compare precipitant factors for encephalopathy that includes infections, electrolytes imbalance, upper GI bleed, constipation, AKI and drugs. Dietary history regarding normal protein diet and high protein diet (animal proteins &gt; 1.5 g/kg/day) were also collected and compared in both groups. RESULTS: Out of 378 screened patients, 92 were presented with encephalopathy. All patients were Muslims with mean age 54.36 ± 11 yrs. Majority 66.3% were males and 33.7% were females. Precipitating factors were identified in 70.2% and 62.9% in group A and B respectively. Precipitating factor remain unidentified in 29.8% patients in group A and 37.1% in group B. 98.2% patients in group A were taking usual diet, only 1.8% consumed high (animal) protein diet, while in group B 51.4% patients were on usual diet and 48.6% consumed high (animal) protein diet. A comparable rise in frequency of spontaneous hepatic encephalopathy (without an identified precipitating factors) was observed in group B and 76.9% patients out of them were consuming high (animal) protein diet. CONCLUSIONS: A comparable rise in frequency spontaneous hepatic encephalopathy was observed during and/or post event of EID-UL-AZHA, majority had consumed high (animal) proteins. Consumption of meat (animal proteins) could be the possible contributing factor. Generally protein restriction is not recommended in cirrhotics but, still in sub group of cirrhotics who are protein intolerant, protein restriction or substitution of source of protein is inevitable. A further multicenter study is necessary at a larger scale to find out characteristic of patients who are intolerant to animal proteins.

Effects of medicines used to treat gastrointestinal diseases on the pharmacokinetics of coadministered drugs: a PEARRL Review.

Drugs used to treat gastrointestinal diseases (GI drugs) are widely used either as prescription or over-the-counter (OTC) medications and belong to both the 10 most prescribed and 10 most sold OTC medications worldwide. The objective of this review article is to discuss the most frequent interactions between GI and other drugs, including identification of the mechanisms behind these interactions, where possible. Current clinical practice shows that in many cases, these drugs are administered concomitantly with other drug products. Due to their metabolic properties and mechanisms of action, the drugs used to treat gastrointestinal diseases can change the pharmacokinetics of some coadministered drugs. In certain cases, these interactions can lead to failure of treatment or to the occurrence of serious adverse events. The mechanism of interaction depends highly on drug properties and differs among therapeutic categories. Understanding these interactions is essential to providing recommendations for optimal drug therapy. Interactions with GI drugs are numerous and can be highly significant clinically in some cases. While alterations in bioavailability due to changes in solubility, dissolution rate, GI transit and metabolic interactions can be (for the most part) easily identified, interactions that are mediated through other mechanisms, such as permeability or microbiota, are less well-understood. Future work should focus on characterising these aspects.

Concomitant Drug Use in Patients on Methadone Maintenance Therapy

Background: Methadone maintenance therapy (MMT) is considered as an efficient and effective treatment in management of high risk opioids addiction; although, concomitant use of other drugs may interfere with treatment course and outcome in MMT cases. This study aimed at evaluating patterns of drug use along with methadone based on self reported and urine analysis data in two MMT clinics. Methods: 135 patients on MMT recruited for this cross-sectional study which was conducted from March to September 2014. Data were obtained of MMT clinic of Imam Reza (p) hospital, Mashhad, Iran. After completing a written informed consent, a questionnaire including demographic information, duration of MMT, methadone dose, concomitant medication and other related information was fulfilled. Data were analyzed by SPSS software version 16. Results: Mean (SD) age of patients was 42.8 (12.2). All patients were taking medication along with methadone. The most prevalent drug classes were antidepressants (32%) and benzodiazepines (BNZD) (25%). The next three drug groups were analgesics, GI and cardiovascular drugs respectively. Antidepressant and benzodiazepine use was more prevalent in patients who were on MMT for at least 7 months compared with shorter courses. Antidepressant use was more common in patients on maximum dose of 30 mg/day methadone while BNZD use was more frequent in patients on doses higher than 30 mg/d. Conclusion: Psychiatric drug use is common in opioid addicted cases. BNZD and antidepressant drugs were two most consumed drugs in cases on MMT based on our study. Psychiatric drug consumption was more common in patients on higher length of methadone use. Dosage of methadone may affect kind of concomitant drug use. Physicians should be aware of interactions between psychiatric medications and opioids.

Trends in United States Drug Shortages for Medications Used in Gastroenterology

Introduction Drug shortages have become more severe in recent years; however, data describing how such shortages impact gastroenterology (GI) drugs are limited. We characterize longitudinal trends of drug shortages in the USA within the scope of GI practice. Methods Drug shortage data from the University of Utah Drug Information Service were analyzed from January 2001 to December 2014. A board certified gastroenterologist, an internal medicine physician, and a clinical pharmacist identified drug shortages within the scope of GI practice, whether they are used for high-acuity conditions, availability, formulation, or therapeutic category. Trends in the length of shortages for GI drugs were described using standard descriptive statistics and regression analysis. Results A total of 1,774 drug shortages were reported over the 14-year period. Of those, 253 shortages (14.3%) were classified within the scope of GI practice. The number of newly-reported GI drug shortages increased from 15 in 2001 to 44 in 2014. The majority of GI drugs (55.7%) were parenteral and 102 shortages (40.3%) were single source drugs. By the end of the study period, 44 (17.4%) GI drugs remained on active shortage with a median duration of 24.3 months (interquartile range [IQR] 6.9–32.1). The median duration for resolved shortages of GI drugs was 7.7 months (IQR 2.9–17.6). Conclusions There was a significant increase in shortages of drugs used in GI practice from 2001 to 2014. Many of these drugs were used for high-acuity conditions and alternative agents were also impacted. Gastroenterologists must be cognizant of current shortages in order to mitigate impact on patient care.

Predictors of Discontinuation of Adjuvant Hormone Therapy in Patients With Breast Cancer.

To identify predictors of discontinuation of adjuvant hormone therapy in patients with breast cancer. We conducted a record-linkage study based on data from Stockholm-Gotland Breast Cancer Register, Swedish Prescribed Drug Register, and self-reported questionnaire. Women diagnosed with breast cancer between 2005 and 2008 in Stockholm, Sweden, were prospectively followed for 5 years until 2013, starting from their first prescription of tamoxifen or aromatase inhibitors (N = 3,395). Family history of ovarian cancer (hazard ratio [HR], 1.55; 95% CI, 1.19 to 2.02); younger (< 40 years; HR, 1.39; 95% CI, 1.08 to 1.78) and older (≥ 65 years; HR, 1.15; 95% CI, 1.03 to 1.28) age; higher Charlson comorbidity index (≥ 2 v 0; HR, 1.35; 95% CI, 1.03 to 1.76); and use of analgesics (HR, 1.33; 95% CI, 1.16 to 1.52), hypnotics/sedatives (HR, 1.24; 95% CI, 1.07 to 1.43), GI drugs (HR, 1.25; 95% CI, 1.08 to 1.43), and hormone replacement therapy (HR, 1.27; 95% CI, 1.08 to 1.49) were identified as baseline predictors for hormonal treatment discontinuation. Use of analgesics (HR, 1.22; 95% CI, 1.08 to 1.37), hypnotics/sedatives (HR, 1.21; 95% CI, 1.07 to 1.37), antidepressants (HR, 1.22; 95% CI, 1.06 to 1.40), or GI drugs (HR, 1.27; 95% CI, 1.13 to 1.43), and switching therapy between tamoxifen and aromatase inhibitors (HR, 1.50; 95% CI, 1.23 to 1.83) during the first year of hormonal treatment were associated with increased risk of discontinuation during the next 4 years. Predictors identified in our study can be used in developing targeted intervention to prevent adjuvant hormone therapy discontinuation and subsequently to improve breast cancer outcomes.

A cross-sectional study of factors related to gastrointestinal drug use in Korean adolescents

Adolescence is critical in the habituation of diverse lifestyles and is a base for future physical well-being. Although gastrointestinal disorders are frequently reported in adolescents, studies related to GI drug use or related factors in Korean adolescents are rare. Thus, this study examined Korean adolescents for the use of GI drugs for abdominal symptoms and analyzed the associated factors. This cross-sectional study was done with a total of 2,416 students who completed a given questionnaire. The health-related questions included GI medication intake, smoking, alcohol, caffeine, regular exercise, self-cognitive health level, GI symptom, non-steroidal anti-inflammatory drugs (NSAIDs) intake, and sleep problems. In questions about GI medication intake, drugs included digestives and antacids. And the intake of GI drugs more than once during the past 1 month was regarded as taking GI drugs. The sociodemographic questions included age, gender, grade, number of close friends, extracurricular activities, and school performance. The overall prevalence for taking GI drugs, including antacids and digestives, was 17.4 %. When students taking GI drugs were compared with those not taking GI drugs, the former group showed higher rates of girls (P < 0.001) and participants in extracurricular activities (P < 0.05) than the latter group. Factors including alcohol, caffeine, self-cognitive health levels, and GI symptoms showed statistical significance with the rate of GI drug intake. The rate of GI drug intake in NSAID users was 2.7 times higher than that in non-users (P < 0.001). The prevalence rate of every sleep problem was higher in students taking GI medications except snoring, witnessed apnea, and teeth grinding. From the multiple regression, it was found that gender (female), extracurricular activities, alcohol intake, self-cognitive health levels, NSAIDs intake, and nightmares were related factors to GI drug intake. Based on the results, it was conclude that encouragement to build healthy lifestyle habits in adolescents is very important for their academic performances and health status in adulthood.

OC.08.1: RANDOMISED MULTICENTRE PILOT DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF EVALUATING THE EFFICACY AND SAFETY OF MESALAZINE IN THE PREVENTION OF RECURRENCE OF DIVERTICULITIS: INTERIM ANALYSIS AFTER 24-MONTH FOLLOW-UP

Background and aim: Recurrence of diverticulitis occurs in 19-54% of patients within 5 years after uncomplicated first attack. A few open clinical trials suggested the usefulness of 5-ASA compounds in these patients. We have undertaken a multicentre randomized pilot placebo-controlled study to evaluate the prophylactic role of mesalazine in preventing recurrence of diverticulitis as well as its effects on symptoms associated to diverticular disease. Material and methods: 105 patients with uncomplicated diverticulitis in the previous 6 months were randomized to receive in a double-blind fashion for 24 months: (a) mesalazine 800 mg bid for 10 days every month or (b) matching placebo. The primary efficacy endpoints were the diverticulitis recurrence at ITT analysis and the time of relapse (TTR). Clinical evaluations were performed using the Therapy Impact Questionnaire (TIQ) for physical condition and quality of life at admission and at 3-month-intervals. Treatment tolerability and use of additional GI-drugs were also evaluated at baseline visit and every 6 and 3 months, respectively. Results: 96 patients (mean-age 61.5 years), 47 on mesalazine and 49 on placebo, were analyzed. Relative risk (RR) of diverticulitis relapse in mesalazine vs placebo group was 1.04, 0.87, 0.69 and 0.48 at 6, 12, 18 and 24 months, respectively (p: ns). The average time-to-relapse was 219 days for mesalazine-treated-group and 370 days for the placebo-group (p: ns). Mean values of TIQ for physical condition at 24 months was significantly better in mesalazine than in placebo group (p =0.021); average additional drug consumption was also significantly lower (-20.4%, p=0.028) during mesalazine than placebo treatment. No significant difference in the development of side effects or changes of the laboratory parameters were recorded in the two groups. Conclusions: Intermittent prophylactic treatment with mesalazine reduces the relative risk of diverticulitis recurrence after 24 months (0.48, 95%CI 0.201.15). Patient physical conditions are significantly improved by mesalazine, with a significant reduction of the additional consumption of other GI drugs.

Medicines that are less suitable for prescribing — GI drugs

Medicines that are less suitable for prescribing — GI drugs

Ex-drinking may be a surrogate for unmeasured risk factors for upper gastrointestinal bleeding: reappraisal and an additional survey of subjects from a case–control study in Japan

In our recent case-control study on the association between non-steroidal anti-inflammatory drugs (NSAIDs) and upper gastrointestinal bleeding (UGIB), the risk of UGIB was higher in non-drinkers than in heavy-drinkers. To explore this unexpected finding, we re-analyzed the data to test whether non-drinking represented risk factors for UGIB and also conducted an additional survey to find any disagreement with the original study that might suggest information bias. In the re-analysis, we estimated odds ratios (ORs) of UGIB by classifying 183 non-drinkers in the original study into 39 ex- and 144 never-drinkers. We also measured the prevalence of potential risk factors of UGIB in controls. In the new survey, we sent a self-administered questionnaire on previous alcohol consumption. In the re-analysis, the OR for ex-drinking (5.4) was higher and the OR for never-drinking (2.6) was lower than the OR for non- (ex- plus never-) drinking (3.2) in the original study. Ex-drinkers had higher prevalence of H. pylori infection, history of previous ulcer and use of GI drugs than other types of drinkers. The answers on their previous alcohol consumption were consistent between the original and new surveys both in cases (kappa = 0.74) and controls (kappa = 0.73). Ex-drinking may represent unmeasured risk factors for UGIB such as undiagnosed ulcer. In an observational study of UGIB, ex-drinking may be distinguished from never-drinking as a potential surrogate for UGIB risk. When prescribing an NSAID to an ex-drinker in clinical practice, one may make sure to explore whether an ex-drinker has a history of ulcer.

A study of codispensing with sodium alendronate in Australia

To estimate the percentage of patients dispensed alendronate who were also dispensed another drug for treatment of an upper gastrointestinal disorder ('GI' drug). The Australian Health Insurance Commission (HIC) Pharmaceutical Benefits Scheme (PBS) database was searched to identify a cohort of patients for whom alendronate or calcitriol had been dispensed and had also been dispensed a GI drug. The number of patients dispensed a GI drug were 6.7% for alendronate and 7.5% for calcitriol with H(2)-receptor antagonists accounting for the majority of usage. This difference of - 0.8% (95% confidence interval -1.6, 0.1) is not significant. There was no excess use of GI drugs in patients taking alendronate compared with those taking calcitriol and the Australian HIC PBS database is useful for identifying large numbers of patients who have been dispensed combinations of drugs.

Fatores associados ao uso de medicamentos durante a gestação em seis cidades brasileiras

This report aims to compare the use of medication during pregnancy in Brazil according to socio-demographic variables in pregnant women who received prenatal care in Unified National Health System (SUS) facilities in six large cities. A structured questionnaire was applied to 5,564 pregnant women who attended prenatal care at SUS facilities, all of whom were participants in the Brazilian Study on Gestational Diabetes (1991-1995). The use of any type of medication presented a positive association with increases in schooling, age, and having a partner, and a negative association with an increase in the number of children. Multivitamin and digestive tract-related drug use showed a positive association with increased schooling and age and a negative association with increased number of children. The use of medication for anemia was negatively associated with increases in schooling and age. Use of multivitamins and GI drugs was associated with variables that characterize pregnant women with higher socioeconomic status, suggesting that medication during pregnancy is an expression of prenatal care.

Pharmacological Advances in Pain and Symptom Control for Digestive and Hepatic Disorder Patients

Major advances in the pharmacotherapy of gastrointestinal and hepatic disorders have occurred in recent years. Important adverse effects on the GI tract due to symptom control medications and on other systems due to GI drugs also have been identified. Digestive and hepatic disorders cause a constellation of symptoms, pain, and suffering often associated with significant morbidity and mortality. Recent pharmacological advances and improved understanding of disease pathogenesis have led to new therapeutic agents and revolutionized drug therapy for GI and hepatic disorders. To address these important advances, the Journal is initiating a series of articles which will review current practices and ongoing developments associated with digestive and hepatic disorders. Management of gastroesophageal reflux disease, Helicobacter pylori and peptic ulcer disease, inflammatory bowel disease, and viral hepatitis will be reviewed as well as the treatment of constipation, and nausea and vomiting unrelated to chemotherap...

Use of i.v. Cimetidine, Ranitidine, and Famotidine in 40 Hospitals

The drug experiences of 1200 patients receiving i.v. histamine H2-receptor antagonists were studied. Forty hospitals in five southeastern states participated in a drug-use evaluation (DUE). In addition to supplying background information, a pharmacist at each hospital used a standardized form to perform a concurrent review of 30 consecutive adult patients who had been started on i.v. cimetidine, ranitidine, or famotidine. In addition to the patient's age and the prescriber's medical specialty, specific DUE criteria included the reason given in the medical record for use; dosage regimen and adjustments made on the basis of the patient's renal function; other GI drugs taken concurrently; pharmacist intervention; simultaneous use of oral medications; occurrence of adverse events; H2-antagonist use with specified drug products known to affect serum drug concentrations of one or both medications; and use of gastric pH monitoring. Therapy with i.v. H2 antagonists was usually started by internal medicine specialists or surgeons, and most of the evaluated patients received such therapy for prevention of stress-related mucosal damage. According to estimated creatinine clearance, 34% of patients were in need of dosage adjustments, but such adjustments were made in only 49% of these. Forty percent of patients began therapy while taking at least one medication orally, and almost one fourth of patients were receiving an additional drug for the treatment of an acid-peptic or related indication. The occurrence of adverse events was similar for the three H2 antagonists studied. The findings identify several problematic areas in the way H2 antagonists are used in clinical practice.