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Interventions for enhancing medication adherence (Review)

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Abstract

Background People who are prescribed self administered medications typically take only about half their prescribed doses. Efforts to assist patients with adherence to medications might improve the benefits of prescribed medications. Objectives The primary objective of this review is to assess the effects of interventions intended to enhance patient adherence to prescribed medications for medical conditions, on both medication adherence and clinical outcomes. Search methods We updated searches of The Cochrane Library, including CENTRAL (via http://onlinelibrary.wiley.com/cochranelibrary/search/), MEDLINE, EMBASE, PsycINFO (all via Ovid), CINAHL (via EBSCO), and Sociological Abstracts (via ProQuest) on 11 January 2013 with no language restriction. We also reviewed bibliographies in articles on patient adherence, and contacted authors of relevant original and review articles. Selection criteria We included unconfounded RCTs of interventions to improve adherence with prescribed medications, measuring both medication adherence and clinical outcome, with at least 80% follow-up of each group studied and, for long-term treatments, at least six months follow-up for studies with positive findings at earlier time points. Data collection and analysis Two review authors independently extracted all data and a third author resolved disagreements. The studies differed widely according to medical condition, patient population, intervention, measures of adherence, and clinical outcomes. Pooling results according to one of these characteristics still leaves highly heterogeneous groups, and we could not justify meta-analysis. Instead, we conducted a qualitative analysis with a focus on the RCTs with the lowest risk of bias for study design and the primary clinical outcome. Main results The present update included 109 new RCTs published since the previous update in January 2007, bringing the total number of RCTs to 182; we found five RCTs from the previous update to be ineligible and excluded them. Studies were heterogeneous for patients, medical problems, treatment regimens, adherence interventions, and adherence and clinical outcome measurements, and most had high risk of bias. The main changes in comparison with the previous update include that we now: 1) report a lack of convincing evidence also specifically among the studies with the lowest risk of bias; 2) do not try to classify studies according to intervention type any more, due to the large heterogeneity; 3) make our database available for collaboration on sub-analyses, in acknowledgement of the need to make collective advancement in this difficult field of research. Of all 182 RCTs, 17 had the lowest risk of bias for study design features and their primary clinical outcome, 11 from the present update and six from the previous update. The RCTs at lowest risk of bias generally involved complex interventions with multiple components, trying to overcome barriers to adherence by means of tailored ongoing support from allied health professionals such as pharmacists, who often delivered intense education, counseling (including motivational interviewing or cognitive behavioral therapy by professionals) or daily treatment support (or both), and sometimes additional support from family or peers. Only five of these RCTs reported improvements in both adherence and clinical outcomes, and no common intervention characteristics were apparent. Even the most effective interventions did not lead to large improvements in adherence or clinical outcomes. Authors' conclusions Across the body of evidence, effects were inconsistent from study to study, and only a minority of lowest risk of bias RCTs improved both adherence and clinical outcomes. Current methods of improving medication adherence for chronic health problems are mostly complex and not very effective, so that the full benefits of treatment cannot be realized. The research in this field needs advances, including improved design of feasible long-term interventions, objective adherence measures, and sufficient study power to detect improvements in patient-important clinical outcomes. By making our comprehensive database available for sharing we hope to contribute to achieving these advances.
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... These factors make early diagnosis and proper management essential. According to the American Academy of Ophthalmology (2021), early and effective self-management of the disease outside hospitals can slow its progression [2]. Additionally, it can reduce its negative impact on patients' daily lives. ...
... Additionally, it can reduce its negative impact on patients' daily lives. This includes adherence to medication, early recognition of symptoms, regular visits to the ophthalmologist, and proper use of eye drops [2]. However, many patients find it difficult to adequately manage their condition. ...
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Background: Glaucoma is one of the leading causes of blindness that can be mitigated through early recognition and effective management. Specifically, early and effective self-management outside hospitals can slow disease progression and reduce its negative daily impact. This includes adherence to medication, high levels of health literacy (requires patients to be able to find, understand, and use relevant health information), early recognition of symptoms, regular visits to ophthalmologists, etc. However, there is a lack of empirical evidence regarding levels of adherence to medication and health literacy in glaucoma patients in Greece. This study aimed to assess health literacy and self-management activation levels in glaucoma patients and explore the relationship between these factors. Materials and Methods: A total of 312 glaucoma patients were recruited from outpatient ophthalmology clinics in Heraklion, Greece, between November 2023 and May 2024 through convenience sampling. The Greek versions of the Patient Activation Measure-13 (PAM-13) and the European Health Literacy Survey Questionnaire 16 (HLS-EU-16) evaluated self-management activation and health literacy, respectively. Results: Patients exhibited low self-management activation (level 1: disengaged and overwhelmed, =40.7, SD: ±29.9) and sufficient health literacy (=10.7, SD: ±3.7). No significant association was found between health literacy and self-management activation (p = 0.602). Conclusions: Glaucoma patients had low to moderate levels of self-management activation and health literacy, without a significant association between them. Therefore, multifaceted strategies are needed to enhance these patients’ activation and health literacy. Further research, using larger, multi-center samples, is needed to clarify the link between these variables.
... Despite extensive research and various interventions designed to improve adherence to treatment of chronic conditions, medication non-adherence persists among patients with diabetes, including those prescribed insulin, leading to poor health outcomes [1,[23][24][25][26]. Nonadherence is attributed to several complex intertwined factors [24,27]. These include the complexity of the medication regimens, the social stigma from injecting in public, weight gain, fear of side effects, their costs especially if high co-payments alongside economic difficulties, inconsistent hospital visits, health literacy, and individual health beliefs regarding medication use [17,20,24,26,[28][29][30][31]. ...
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Background Diabetes mellitus (DM) is a global health problem. Adherence to intensive insulin therapy is necessary to achieve better glycemic control in types 1 and 2 DM. This study aimed to evaluate the extent of adherence to insulin therapy, its predictors and to identify barriers to its adherence. Method This was a cross-sectional survey among adult (≥18 years) diabetic patients who are currently using insulin, either alone or in combination with an oral antidiabetic regimen, and seeking primary care at Kwame Nkrumah University of Science and Technology Hospital in Ghana. A total of one hundred and eight-six patients were conveniently sampled, and interviewed. Insulin adherence was determined using the Medication Adherence Reporting Scale-5. Descriptive statistics, a chi-square test of independence, and a multiple logistic regression analysis were performed using STATA version 14 (StataCorp, TX USA). Results The majority of the patients interviewed were over 60 years (40.32%); female (61.83%); married (68.82%); and had completed secondary education (48.39%). 67.20% of the patients were adherent to insulin therapy. Adherence level was associated with age (p = 0.020), marital status (p = 0.001), employment status (p = 0.012), type of DM (p<0.001), regular follow-up (p = 0.007) and comorbidities (p = 0.002) and was only predicted by the type of DM (aOR = 14.82 C.I 1.34–163.50, p-value = 0.028). Conclusion Adherence to insulin therapy among our study population was suboptimal, which is a concern considering the associated increased risk of complications. Adherence assessment and counselling by healthcare professionals to address barriers to poor adherence must be continually undertaken to achieve optimal glycemic control. Impact of findings on practice statements Continuous adherence assessment and counselling must be offered to all diabetes mellitus patients on insulin therapy as part of their ambulatory care to help improve outcomes. Using the Medication Adherence Reporting Scale-5 to determine patient adherence levels is an easy-to-use and an inexpensive method; however, it should be used with caution due to the potential for misclassification. Efforts must be made to provide appropriate strategies to deal with barriers to insulin adherence at ambulatory care clinics as part of the individualized comprehensive diabetic care to reduce diabetic complications.
... Prior attempts at behavioral and educational interventions achieved only limited success. These one-size-fits-all approaches did not effectively address the varied reasons why individuals did not adhere to recommended guidelines, which often differ greatly from person to person [8]. ...
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Low medication adherence poses a great risk of poor treatment outcomes among patients with chronic diseases. Recently, mobile applications (apps) have been recognized as effective interventions, enabling patients to adhere to their prescriptions. This study aimed to establish the effectiveness of mobile app interventions for medication adherence, affecting features, and dropout rates by focusing on previous randomized controlled trials (RCTs). This study conducted a systematic review and meta-analysis of mobile app interventions targeting medication adherence in patients with chronic diseases. Electronic searches of eight databases were conducted on April 21, 2023, for studies published between 2013 and 2023. Comprehensive meta-analysis software was used to estimate the standardized mean difference (SMD) of pooled outcomes, odds ratios (ORs), and confidence intervals (CIs). Subgroup analysis was applied to investigate and compare the effectiveness of the interventional strategies and their features. The risk of bias of the included RCTs was evaluated by applying the risk of bias tool. Publication bias was examined using the fail-safe N method. Twenty-six studies with 5,174 participants were included (experimental group 2603, control group 2571). The meta-analysis findings showed a positive impact of mobile apps on improving medication adherence (OR = 2.371, SMD = 0.279). The subgroup analysis results revealed greater effectiveness of interventions using interactive strategies (OR = 2.652, SMD = 0.283), advanced reminders (OR = 1.849, SMD = 0.455), data-sharing (OR = 2.404, SMD = 0.346), and pill dispensers (OR = 2.453). The current study found that mobile interventions had significant effects on improving medication adherence. Subgroup analysis showed that the roles of stakeholders in health providers’ interactions with patients and developers’ understanding of patients and disease characteristics are critical. Future studies should incorporate advanced technology reflecting acceptability and the needs of the target population.
... Furthermore, post-surgical body image changes and the impact of chemotherapy can contribute to low self-esteem and depression among breast cancer patients, further affecting medication adherence [13]. As demonstrated by numerous previous studies, poor medication adherence significantly increases the risk of cancer recurrence and mortality [14]. Therefore, investigating the factors influencing medication adherence in breast cancer patients undergoing hormonal therapy is crucial. ...
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Background Given the global prevalence of breast cancer and its high mortality rate, adherence to long-term anti-hormonal therapy is crucial for preventing recurrence and improving survival outcomes. Previous research demonstrates how psychological factors including depression and empowerment impact medication adherence. However, comprehensive studies remain limited, especially in Korea. This study explores the effects of depression and empowerment on medication adherence among patients with breast cancer undergoing anti-hormonal therapy. Methods This descriptive survey involved 183 patients with breast cancer from one hospital in South Korea; participants were recruited using convenience sampling. Self-reported questionnaires were used to assess medication adherence, depression levels using the Korean version of the Beck Depression Inventory-II, and empowerment levels using a tool developed for women with breast cancer. Hierarchical regression explored relationships and influences between variables. Results Participants demonstrated an average depression score of 19.67 ± 11.25, with medication adherence measured at 18.06 ± 5.15 and empowerment at 106.40 ± 18.15, revealing that, among patients with breast cancer, many experienced depression with varying levels: 16.9% mild, 27.3% moderate, and 21.9% severe. Medication adherence levels were distributed, with 58.5% of patients categorized as non-adherent and 41.5% categorized as adherent. The results indicated a significant negative correlation between depression and medication adherence and a positive correlation between empowerment and medication adherence. Higher empowerment levels were associated with improved adherence. Conversely, high depression levels were associated with low medication adherence. Conclusions This study enhances understandings of psychosocial factors influencing medication adherence in patients with breast cancer, highlighting patient empowerment as crucial for healthcare interventions. Thus, healthcare providers should implement targeted interventions including educational programs to inform patients about their treatment regimens, provide counseling services addressing mental health concerns such as depression, and establish support groups fostering a sense of community and shared experiences among patients. By integrating these strategies into patient care, healthcare professionals can significantly enhance patient empowerment and improve medication adherence toward better health outcomes for breast cancer patients. Future research could explore the long-term effects of these interventions on adherence and overall patient well-being.
... This includes simplifying prescribing regimens, implementing educational programs, fostering improved communication between patients and health care professionals, utilizing reminders and addressing treatment costs. [20][21][22] Studies have indicated that personalized patient education contributes to enhanced glycemic and weight control, accompanied by a reduced risk of hypoglycemia and long-term complications in individuals on SGLT2i therapy. 4,8,23 This Delphi consensus study aimed to identify the common adverse effects of SGLT2i and to establish the best clinical practices for patient education at the time of the first prescription of SGLT2i therapy, specifically tailored to the Indian context. ...
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Background: Sodium-glucose cotransporter 2 inhibitors (SGLT2i) directly inhibit the SGLT2 protein in kidney proximal tubules, leading to increased glucose excretion. Medication adherence ensures individuals receive intended therapeutic effects, optimizing overall treatment effectiveness. The primary objective of this consensus study was to pinpoint the prevalent adverse effects associated with SGLT2i and establish optimal clinical practices for educating patients during the initiation of therapy. Methods: A diverse panel of experts, consisting of 158 clinicians specializing in diabetes care across India, were invited to engage in a Delphi discussion following an initial online survey conducted via email. Throughout the process, panelists were actively encouraged to offer feedback on the compiled responses, allowing for adjustments in their perspectives. Subsequently, the outcomes of each meeting were consolidated to form final recommendations. Results: About 88.24% of participants identified initiating SGLT2i for type 2 diabetes with atherosclerotic cardiovascular disease, heart failure or chronic kidney disease. Considerations for prescribing include eGFR <25 mL/ min/1.73 m² (66.46%), a history of urinary tract infection (65.82%), and prior genital mycotic infections. Most (53.71%) preferred tips in prescriptions, and 63.92% consistently educated patients about SGLT2i use, with 64.15% strongly agreeing it alleviates clinical inertia; 68.35% strongly supported regional language education, and 79.11% endorsed QR-based patient education in smart prescriptions (Rx). Conclusion: Educating patients in regional languages, leveraging technology and providing printed literature are crucial strategies for overcoming clinical inertia and enhancing medication adherence.
... The first step in a collaborative effort toward improving diabetes care services and research would be creating (a) Short-term (within one year) 1. Train at least 1-2 doctors* in every health clinic to provide high-quality diabetes care, prevent/treat its comorbidities (hypertension and dyslipidaemia), and have the skills in managing obesity, metabolic syndrome and prediabetes from progressing to type 2 diabetes. All patients with sub-optimal control of diabetes (HbA1c > 8.5%) are to be seen at a shorter interval by these doctors [47][48][49] Patients within good control could be followed-up by other doctors but must be reviewed at least annually by these designated doctors. Patients who still do not meet the personalised disease targets after being under the care of these doctors for at most 6 months should be discussed with or referred to the FMSs † for further management. ...
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There are approximately 220 million (about 12% regional prevalence) adults living with diabetes mellitus (DM) with its related complications, and morbidity knowingly or unconsciously in the Western Pacific Region (WP). The estimated healthcare cost in the WP and Malaysia was 240 billion USD and 1.0 billion USD in 2021 and 2017, respectively, with unmeasurable suffering and loss of health quality and economic productivity. This urgently calls for nothing less than concerted and preventive efforts from all stakeholders to invest in transforming healthcare professionals and reforming the healthcare system that prioritizes primary medical care setting, empowering allied health professionals, improvising health organization for the healthcare providers, improving health facilities and non-medical support for the people with DM. This article alludes to challenges in optimal diabetes care and proposes evidence-based initiatives over a 5-year period in a detailed roadmap to bring about dynamic and efficient healthcare services that are effective in managing people with DM using Malaysia as a case study for reference of other countries with similar backgrounds and issues. This includes a scanning on the landscape of clinical research in DM, dimensions and spectrum of research misconducts, possible common biases along the whole research process, key preventive strategies, implementation and limitations toward high-quality research. Lastly, digital medicine and how artificial intelligence could contribute to diabetes care and open science practices in research are also discussed.
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Background: Patients’ adherence to antibiotic treatment and related prevention of AMR is significant. Understanding healthcare professionals’ strategies for advising and educating patients in primary care settings is crucial. Aim: From the perspectives of professionals and patients, to explore how physicians, pharmacists, and nurses educate patients about antibiotic use and antimicrobial resistance in primary care settings. Methods: A qualitative systematic literature review was conducted in MEDLINE, EMBASE, CINAHL Complete, Eric, SocINDEX, PsycInfo, Web of Science and Scopus. The study included 102 publications, followed PRISMA recommendations and was registered in PROSPERO (reg.no. CRD4202455761). The studies were screened and selected based on specific inclusion and exclusion criteria using Covidence. Quality appraisal followed the Critical Appraisal Skills Program (CASP) qualitative study checklist. Data were extracted, and the analysis consisted of a descriptive numerical summary analysis and a qualitative thematic analysis. Results: The analyzed studies spanned multiple countries and settings and included perspectives of primary care physicians, pharmacists, nurses and patients. Two main themes emerged: (1) Relationships between professionals and patients influenced educational strategies, showing that trust and rapport between healthcare professionals and patients played a crucial role in shaping educational strategies around antibiotic use; (2) The organizational structures challenged professionals in guiding and educating patients, highlighting how limited resources, time constraints, and system-level pressures hindered healthcare professionals’ ability to provide consistent and effective education. Often, structural challenges led to not educating the patients on the risks of antibiotic misuse and antimicrobial resistance. The use of delayed prescriptions emerged as a strategy for improved AMR stewardship and to meet patients’ expectations for antibiotic treatment, though it raised concerns about undermining professional responsibility and authority in ensuring appropriate antibiotic use. Conclusion: Healthcare professionals’ role in educating patients about antibiotic use and AMR in primary care settings was complex, with different challenges faced by nurses, pharmacists and primary care physicians. These challenges extended beyond the clinical level, including relational, social and structural factors. Power dynamics, trust issues, and time pressures often hindered effective education on antibiotic use. Addressing gaps in education on antibiotic use and AMR requires acknowledging these multifaceted challenges, with future efforts focusing on better supporting healthcare professionals in this context. Systematic review registration: https://www.crd.york.ac.uk/prospero/, identifier CRD4202455761.
Chapter
The challenge of poor medication adherence in the management of chronic diseases remains a pivotal issue, contributing significantly to the disparity between real-world effectiveness and clinical trial outcomes. Conventional strategies aimed at improving adherence through patient education and empowerment have often proven intricate and largely inefficacious. In contrast, long-acting (LA) medicines represent a transformative approach to overcoming the adherence barrier. LA formulations offer simplified dosing regimens, reduced treatment burdens, heightened patient acceptability, and broader public health benefits. This chapter focuses on currently approved LA medicines and their global utilization in the management of chronic conditions such as psychosis, contraception, chronic ocular diseases, and HIV-1 infection. Notably, LA medicines have demonstrated a positive impact on patient acceptability and adherence rates across diverse disease categories. Furthermore, this chapter sheds light on the underexplored potential of LA medicines in addressing other chronic ailments such as osteoporosis, viral hepatitis, and various chronic viral infections, as well as cardiovascular diseases and diabetes. Emphasizing the importance of cost-effective, self-administrable, discreet, and reversible LA medicines with improved pharmacokinetics featuring a shorter PK tail, we highlight the potential for these innovations to significantly enhance the global adoption and application of LA medicines.
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Background. Several previous studies have established that low treatment adherence is common among bipolar patients and may explain high rates of recurrence. On the other hand, some patients keep relapsing even when they strictly follow their prescribed somatic treatments. Psychological interventions such as psychoeducation may foster early recognition of prodromal symptoms and minimize the risk of relapse. To date, studies assessing the usefulness of psychoeducation in fully compliant patients are lacking. Method. This was a single-blind, randomized, prospective clinical trial on the efficacy of group psychoeducation in remitted fully compliant DSM-IV bipolar I patients (N = 25) who were compared with a group with similar characteristics (N = 25) who did not receive psychoeducation. All patients received naturalistic pharmacologic treatment. Recruitment began in 1997 and follow-up was completed in January 2002. The follow-up phase comprised 2 years during which all patients continued receiving naturalistic treatment without psychological intervention and were assessed monthly on several outcome measures. Results: At the end of the 2-year follow-up, 23 subjects (92%) in the control group fulfilled criteria for recurrence versus 15 patients (60%) in the psychoeducation group (p < .01). The number of total recurrences and the number of depressive episodes were significantly lower in psychoeducated patients. Conclusion: Although the present study has the limitation of small sample size, psychoeducation showed its efficacy in preventing relapses in bipolar I patients who were adherent to drug treatment. The action of psychoeducation seems to go beyond compliance enhancement and may support a tripod model composed by lifestyle regularity and healthy habits, early detection of prodromal signs followed by prompt drug intervention, and finally treatment compliance.
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Aim: This study assesses the impact of serum carboxy-terminal collagen crosslinks (CTX) bone marker feedback (BMF) on adherence to ibandronate treatment in Asian postmenopausal women with osteoporosis. Methods: This was a 12-month (6-monthly phased), randomized, prospective, open-label, multi-center study conducted in 596 (of 628 enrolled) postmenopausal women with osteoporosis (: 85 years old) who were naive, lapsed, or current bisphosphonate users. Patients were randomized into two arms: serum CTX BMF at 3 months versus no-BMF. Once-monthly 150 mg ibandronate tablet was administered for 12 months and adherence to therapy was assessed at 6 and 12 months. In addition, patient satisfaction and safety of ibandronate treatment were also assessed. Results: Serum CTX BMF at 3 months showed no impact on adherence. The proportions of adherent patients were comparable in the BMF versus no-BMF arms (92.6% vs. 96.0%, P = 0.16); overall, serum CTX levels were similar for adherent and non-adherent patients. However, BMF patients felt more informed about their osteoporosis (P < 0.001) and more satisfied (P < 0.01) than no-BMF patients. Conclusions: The Asian postmenopausal osteoporosis patients in this study had a high adherence rate to once-monthly ibandronate therapy. Use of serum CTX BMF had no further impact on increasing adherence, but increased treatment satisfaction.
Conference Paper
OBJECTIVE: The overall aims of the ADDITION study are to evaluate whether screening for prevalent undiagnosed Type 2 diabetes is feasible, and whether subsequent optimised intensive treatment of diabetes, and associated risk factors, is feasible and beneficial. DESIGN: Population-based screening in three European countries followed by an open, randomised controlled trial, SUBJECTS AND METHODS: People aged 40-69 y in the community, without known diabetes, will be offered a random capillary blood glucose screening test by their primary care physicians, followed, if equal to or greater than 5.5 mmol/l, by fasting and 2-h post-glucose-challenge blood glucose measurements. Three thousand newly diagnosed patients will subsequently receive conventional treatment (according to current national guidelines) or intensive multifactorial treatment (lifestyle advice, prescription of aspirin and ACE-inhibitors, in addition to protocol-driven tight control of blood glucose, blood pressure and cholesterol). Patients allocated to intensive treatment will be further randomised to centre-specific interventions to motivate adherence to lifestyle changes and medication. Duration of follow-up is planned for 5 y. Endpoints will include mortality, macrovascular and microvascular complications, patient health status and satisfaction, process-of-care indicators and costs.
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Non-compliance with treatment is a major problem, especially in psychiatric patients receiving a long-term medication. The aim of this study was to detect the extent of non-compliance with treatment of schizophrenic patients and assess the effectiveness of the intervention program. Compliance with treatment of 225 relapsed cases of Malay schizophrenia was assessed. About 73% of the patients were found to have poor compliance. Poor insight of the illness is the most common reason of poor compliance. Patients with poor compliance who were prescribed drug dosage of not more than twice per day throughout follow-up and underwent counseling to enhance treatment compliance had a significantly lower relapse rate than the controlled group at the end of 1 year of follow-up. The importance of family support and the role of pharmacists in health education and drug counseling was highlighted.
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This study was prospectively planned to compare the efficiacy of azithromycin which is a new antibacterial agent and cefuroxine axetile which is commonly used second-generation cephalosporin for the treatment of acute otitis media. Patients diagnosed with acute otitis media received three days of azithromycin (10 mg/kg/day in children, 500 mg/day in adults in single daily dose) or ten days of cefuroxime axetile (40 mg/kg/day in children, 500 mg/day in two divided doses). Clinical efficiacy was evaluated at the beginning and on days 4-6, 10-14 and 30 of the treatment. Microbiologic assessments were performed in patients provided informed consent. Fifty-six patients were enrolled in the study. Thirty-one patients received azithromycin and twenty-five cefuroxime axetile. There were no significant differences in symptoms and signs between the patient groups with acute otitis media (p>0.05). Microbiologic assessments were performed in thirty- seven ear samples and the primary pathogen was found to be Streptococcus pneumoniae. Four patients in azithromycin-treated group and three patients in cefuroxime axetile-treated group were excluded for lack of efficiacy. Moreover, nine patients in each group were excluded for inadequate follow- up; thus, the study which was started with fifty-six patients could be finished with thirty patients. Satisfactory clinical outcome observed in 82% of azithromycin-treated group and in 81% of cefuroxime axetile-treated group. The gastrointestinal complaints were the most common side effects. No patient discontinued treatment because of adverse events. Statistically significant difference between clinical responses in azithromycin-treated and in cefuroxime axetile-treated groups was not found. Compliance was better in azithromycin-treated patients than in cefuroxime axetile-treated patients.
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The broad-spectrum antibiotic clarithromycin has been shown to be safe and effective in the treatment of lower respiratory tract infections, including acute exacerbations of chronic bronchitis (AECB), when dosed at 250 or 500 mg twice daily. Because a once-daily schedule may improve compliance, a modified-release formulation of clarithromycin was developed. This prospective, double-blind, parallel-group, multicenter study randomized 239 patients to receive either clarithromycin modified-release tablets 500 mg once daily (CL MR) or clarithromycin tablets 250 mg twice daily (CL) for 7 to 14 days. At the end of treatment, 93% of evaluable and 91% of intent-to- treat (ITT) patients in the once-daily group and 95% and 90% of patients, respectively, in the twice-daily group achieved clinical success. At 21 days posttreatment, clinical success rates were 86% (evaluable) and 82% (ITT) with the once-daily formulation and 91% and 83% with the twice-daily formulation. Resolution or improvement of all symptoms occurred in 75% to 100% of patients in both groups. As measured by pill count, 96% and 94% of patients in the once- and twice-daily groups, respectively, were more than 90% compliant with their prescribed regimens. The most commonly reported adverse events were abdominal pain (9%) and diarrhea (4%) in the once-daily group and abdominal pain and headache (4% each) in the twice-daily group. CL MR is as effective as standard 250 mg CL given twice daily in the treatment of AECB. Both formulations were safe and well tolerated, and compliance with CL MR was slightly higher than with CL.