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Interventions for enhancing medication adherence (Review)
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.
... 10 However, multiple pieces of evidence have reported contradictory effects of behavioral interventions. 11,12 Another interventional plan is the integrated care intervention. The integrated care plan's goal is to increase the patient's quality of life by improving the efficiency of work by the health care providers. ...
Co-morbidities are characterized by the presence of multiple chronic diseases within a single individual. They pose an escalating healthcare challenge and managing this growing burden, particularly with non-communicable diseases, has become a major concern. However, a significant impediment to effective management lies in medication nonadherence. The importance of medication adherence has long been a focus of healthcare literature, yet many comorbid patients tend to underestimate its significance, leading to health deterioration. Research studies indicate alarmingly low adherence rates in comorbid patients. To address this issue, patient education and healthcare campaigns have become essential tools in enhancing adherence. The research, which commenced on October 19, 2023, was initiated after an exhaustive review of existing academic literature. Multiple databases, such as PubMed, Web of Science, and Cochrane, were employed for this comprehensive literature review, utilizing a wide array of medical terminology combinations. The study aims to shed light on potential strategies and educational approaches to enhance medication adherence in comorbid patients. Findings from this research have the potential to influence healthcare policy, the design of tailored interventions, and overall healthcare delivery improvements for co-morbid patients, ultimately leading to enhanced health outcomes, reduced costs, and an improved quality of life.
... Continuity of care is considered an important determinant of medication adherence (Yao et al., 2022). While complex interventions involving healthcare professionals have been effective in combatting medication non-adherence (Simoni et al., 2009;Chung et al., 2011) research must be conducted to determine specific roles and tasks within the team for a seamless transition of care (Nieuwlaat et al., 2014). The first step in this process is to establish the current patterns of care from the perspectives of HCPs, and its perceived shortcomings (Hill et al., 2009). ...
Background: Medications play an essential role in the management of patients who have experienced a stroke. Despite the recognised importance and widespread availability of secondary prevention guidelines, Irish research has shown a continuous failure to meet secondary prevention targets upon discharge. While complex interventions involving healthcare professionals (HCPs) such as Speech and Language Therapists (SLT), Occupational Therapists (OTs) and Pharmacists have been effective in combatting medication non-adherence, community multidisciplinary teams (MDTs) are not as well defined as in the acute setting, leading to wide variation in patient care. Therefore, this study aims to investigate the knowledge, attitudes, beliefs, and challenges faced by HCPs in the continuity of care post-discharge from a hospital stroke ward, and its impact on medication adherence.
Methods: Semi-structured interviews and one focus group with HCPs were conducted, and data were analysed using Braun & Clarke’s reflexive Thematic Analysis.
Results: Fourteen HCPs (6 Pharmacy, 4 SLT, 4 OTs) participated in this study. Participants discussed their views under two main themes 1) continuity of care and 2) medication adherence. Sub-themes observed regarding continuity of care include management and organisation, interpersonal continuity, and informational continuity. Themes generated which impact medication adherence post-discharge include condition-related factors, medication-related factors, systemic and HCP factors, and patient-related factors.
Discussion: Additional resources are required to bring community healthcare in line with the standard of acute care. Increased channels of communication must be established across contexts and disciplines, and may be achieved using interprofessional training through continuous professional development or third-level education, a more clearly defined community team structure, and discharge summaries completed to relevant quality standards. While suboptimal continuity of care was reported as contributing to medication non-adherence, HCPs also acknowledged the complexities of medication management post-stroke.
... Given the clinical and societal significance of therapeutic adherence, studies have examined a wide range of interventions aimed at addressing some of these factors and improving medication adherence. One review sought to analyze the efficacy of a number of interventions [18] among a total of 182 medication-adherence randomized clinical trials. Of these, 17 focused specifically on methods for improving antihypertensive adherence. ...
Medication non-adherence is a major healthcare barrier, especially among diseases that are largely asymptomatic, such as hypertension. The impact of poor medication adherence ranges from patient-specific adverse health outcomes to broader strains on health care system resources. The Centers for Disease Control (CDC) Wide-ranging Online Data for Epidemiologic Research (WONDER) database was used to retrieve Centers for Medicare and Medicaid Services’ data pertaining to blood pressure (BP) medication adherence, socio-economic variables, and cardiovascular (CV) outcomes across the United States. Multivariable linear regression models were used to estimate the change in total CV deaths as a function of non-adherence to BP medications. For every percent increase in the non-adherence rate, the total number of CV deaths increased by 7.13 deaths per 100,000 adults (95% CI: 6.34–7.92), even after controlling for the percentage of residents with access to insurance, the percentage of residents who were eligible for Medicaid, the percentage of residents without a college education, median home value, income inequality, and the poverty rate (p < 0.001). There is a significant association between non-adherence to BP medications and total CV deaths. Even a one percent increase in the adherence rate in the United States could result in tens of thousands of preventable CV deaths. Based on recently published CDC data, this could also have a tremendous impact on health care costs. This provides compelling evidence for increased efforts to improve adherence.
... The limitation inherent to this study design is related to the source of the data. Researchers have used systematic reviews to investigate the association between medication regime complexity and adherence using data from RCTs, cross-sectional, cohort, or case-control studies with conclusive results [41][42][43]. Identifying the risks that can negatively impact the success of the study population, treatment pattern, outcome measurement, or motivations for patients to adhere to study drugs is necessary. Adherence data can influence the interpretation of trial results, affecting the magnitude of an observed treatment efficacy [44]. ...
... 6 Medication adherence is a complex behaviour and identifying appropriate adherence interventions should be underpinned by behaviour change theory. 8 A measure of the modifiable determinants of medication adherence, with each determinant being linked to an evidence-based behaviour change technique, offers a scalable approach to practitioners delivering evidence-based interventions tailored to individual patient need. ...
Purpose
To validate the Identification of Medication Adherence Barriers Questionnaire (IMAB-Q) as a tool to guide practitioners to identify patients who require support to take their medicines as prescribed, their key barriers to adherence and select relevant behaviour change techniques.
Patients and Methods
Adults prescribed medication for cardiovascular disease prevention were recruited from nine community pharmacies in England. Participants completed the IMAB-Q comprising 30 items representing potential barriers to adherence developed from our previous mixed methods study (scoping review and focus groups) underpinned by the Theoretical Domains Framework. Participants also self-reported their adherence on a visual analogue scale (VAS) ranging from perfect adherence (100) to non-adherence (1). A subgroup of 30 participants completed the IMAB-Q twice to investigate test-retest reliability using weighted Kappa. Mokken scaling was used to investigate IMAB-Q structure. Spearman correlation was used to investigate IMAB-Q criterion validity compared to the VAS score.
Results
From 1407 invitations, 608 valid responses were received. Respondents had a mean (SD) age of 70.12 (9.9) years and were prescribed a median (IQ) 4 (3, 6) medicines. Worry about unwanted effects (n = 212, 34.5%) and negative emotions evoked by medicine taking (n = 99, 16.1%) were most frequently reported. Mokken scaling did not organise related IMAB-Q items according to the TDF domains (scalability coefficient H = 0.3 to 0.6). Lower VAS self-reported adherence correlated with greater IMAB-Q reported barriers (rho = −0.14, p = 0.001). Test-retest reliability of IMAB-Q items ranged from kappa co-efficient 0.9 to 0.3 (p < 0.05).
Conclusion
The IMAB-Q is valid and reliable for identifying people not adhering and their barriers to adherence. Each IMAB-Q item is linked to a TDF domain which in turn is linked to relevant behaviour change techniques. The IMAB-Q can therefore guide patients and practitioners to select strategies tailored to a patient’s identified barriers.
... Both of these factors can indirectly contribute to better medication adherence [24]. Previous studies have suggested that ease of access to medications, reduced costs, and timely delivery can indeed improve adherence [24,25]. Also, satisfaction with labeling and packaging reflects the commitment to patient safety and the provision of clear instructions, which are crucial for therapeutic success. ...
Objective
To evaluate the efficacy of ADHD medication adherence interventions and explore the pathways to effectiveness.
Methods
A systematic review was conducted using multiple databases to identify relevant randomized controlled trials (RCTs). Pooled effect sizes were calculated for medication adherence and ADHD symptom outcomes. Qualitative Comparative Analysis (QCA) was used to identify pathways to effectiveness.
Results
Six RCTs were included. The interventions significantly improved medication adherence (OR = 2.39, 95% CI [1.19, 4.79]) and ADHD symptoms (Hedges’ g = −0.96, 95% CI [−1.38, −0.54]). Multi-regression analysis showed a positive relationship between medication adherence and ADHD symptom reduction. QCA revealed two paths for effectiveness: (1) Presence of ADHD drug education and absence of reminder and (2) Presence of tracking and absence of reminder.
Conclusion
ADHD medication adherence interventions have a positive impact on both medication adherence and ADHD symptoms. Interventions should consider including ADHD drug education or tracking to maximize effectiveness.
Background
Pelvic floor dysfunction is a public health issue, with 1 in 3 women experiencing symptoms at some point in their lifetime. The gold standard of treatment for pelvic floor dysfunction is supervised pelvic floor muscle training (PFMT); however, adherence to PFMT in women is poor. Mobile apps are increasingly being used in the National Health Service to enable equity in the distribution of health care and increase accessibility to services. However, it is unclear how PFMT mobile apps influence PFMT adherence in women.
Objective
We aimed to identify which behavior change techniques (BCTs) have been used in PFMT mobile apps, to distinguish the core “capability, opportunity, and motivation” (COM) behaviors targeted by the BCTs used in PFMT mobile apps, and to compare the levels of PFMT adherence in women between those using PFMT mobile apps and those receiving usual care.
Methods
We conducted a scoping review of the literature. Published quantitative literature that compared the use of a PFMT mobile app to a control group was included to address the objectives of the study. The electronic bibliographic databases searched included MEDLINE, CINAHL, Scopus, Web of Science, and PEDro, along with CENTRAL. Studies were also identified from reference searching of systematic reviews. Original articles written in English from 2006 onward were included. Nonexperimental quantitative studies, qualitative studies, studies that use male participants, case studies, web-based interventions, and interventions that use vaginal probes were excluded. Narrative synthesis was conducted on eligible articles based on the aims of the study.
Results
Of the 114 records retrieved from the search, a total of 6 articles met the eligibility and inclusion criteria. The total number of participants in the studies was 471. All PFMT mobile apps used the BCT “prompts and cues.” Opportunity was the core COM behavior targeted by the PFMT mobile apps. Higher levels of adherence to PFMT were observed among women using PFMT mobile apps.
Conclusions
Digital “prompts and cues” are a BCT commonly used in PFMT mobile apps, and further research is required to practically assess whether a future randomized controlled trial that investigates the effectiveness of digital “prompts and cues” on PFMT adherence in women can be conducted.
Objective
A high level of adherence to antiretroviral therapy is required for complete suppression of HIV replication, immunological and clinical effectiveness. We investigated whether cognitive behaviour therapy can improve medication adherence.
Design
Prospective randomized 1-year trial.
Setting
Collaboration of HIV university outpatient clinic and psychotherapists in private practice.
Participants
60 HIV-infected persons on stable anti-retroviral combination therapy and viral load below 50 copies/ml.
Intervention
Cognitive behaviour intervention in individual patients, in addition to standard of care.
Main outcome measures
Feasibility and acceptance of intervention; adherence to therapy assessed using medication event monitoring system (MEMS) and self-report questionnaire; virological failure; psychosocial measures.
Results
The median number of sessions for cognitive behaviour intervention per patient during the 1-year trial was 11 (range 2–25). At months 10–12, mean adherence to therapy as assessed using MEMS was 92.8% in the intervention and 88.9% in the control group ( P=0.2); the proportion of patients with adherence ≥95% was 70 and 50.0% ( P=0.014), respectively. While there was no significant deterioration of adherence during the study in the intervention arm, adherence decreased by 8.7% per year ( P=0.006) in the control arm. No differences between the intervention group and standard of care group were found regarding virological outcome. Compared with the control group, participants in the intervention group perceived a significant improvement of their mental health during the study period.
Conclusions
Cognitive behavioural support in addition to standard of care of HIV-infected persons is feasible in routine practice, and can improve medication adherence and mental health.
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.
Study objective: to compare two antihypertensive medications (lisinopril, an ACE-inhibitor and atenolol, a cardioselective β-blocker) for tolerance and patient compliance in a general practice setting and to investigate the impact of a patient package insert (PPI) on patient compliance. Design: randomized, open, comparative trial with a one week washout period and 8 weeks of active treatment in two trial groups (without and with PPI) each divided into two subgroups (atenolol or lisinopril). Setting: recruitment by volunteer family physicians in routine practice. Patients: sequential sample of 74 patients older than 21 years and younger than 65 years, presenting with mild to moderate hypertension, currently not treated or under treatment but not controlled [sitting diastolic blood pressure (DBP) >90 mmHg] or not tolerating current treatment. Three patients were excluded from analysis because of possible fraud by one investigator, and three patients because of protocol violations. Fifty patients completed the trial. Interventions: patients were randomized to one group which received a hybrid PPI, containing information on both drugs; the other group received no written patient information. Each group was randomized to one of two subgroups receiving either atenolol 100 mg o.d or lisinopril 20 mg o.d. Measurements and main results: to measure compliance, the Medication Event Monitoring System (MEMS®, Aprex)) was used. This is a vial with a microcircuitry inside the cap, able to record time and data of each opening and closing of the vial. Some physicians appeared to choose younger patients to distribute the packages of atenolol, introducing 'selection bias'. Eighteen patients (26.5%) dropped out, 13 with adverse events, five without adverse event. Both drugs were equally effective in reducing the DBP. Data from the MEMS-device were available for 46 patients (4 missing data). 22% had at least one drug holiday 54% had at least one dosing interval exceeding 1800 min. Twenty-one of 23 patients (91%) under lisinopril and 15 of 29 patients (65%) under atenolol were perfect compliers. Discussion: using the MEMS-device in a clinical trial may contribute to quality control by detecting cases of fraudulent data as rogue investigators have difficulty maintaining a daily routine of opening/closing electronically monitored medication vials in order to compile a false record of dose-taking. In clinical trials involving drugs with actions readily perceptible by patients, it can be hypothesized that patient compliance and the perception and attribution of adverse reactions will probably be influenced by written patient information, resulting in differential occurrence of dosing irregularity, drug holidays or drop-out.
Background
Multidisciplinary heart failure programs including patient education and self‐management strategies such as daily recording of body weight and use of a patient diary decrease hospital readmissions and improve quality of life. However, the degree of uptake of individual components of these programs and their contribution to patient benefit are uncertain.
Methods
Patients with heart failure admitted to Auckland Hospital were randomised into the management or usual care groups of the Auckland heart failure management study (AHFMS). Patients in the management group were given a heart failure diary for the recording of daily weights, attended a heart failure clinic and were encouraged to attend three education sessions. Patients in the usual care group received routine clinical care, mainly from general practitioners. Patients were followed to 12 months. This study investigated the uptake of self‐management by assessing diary use and self‐weighing behaviour in the group receiving the heart failure intervention, and compared the level of knowledge of heart failure self‐management of the management group to the control group after 12 months.
Results
Of the 197 patients in the AHFMS, 100 patients were included in the management group and received a diary and education about heart failure self‐management including monitoring weight daily. Of these patients, 76 patients used the diary. These patients were on more medication; were more likely to attend the education sessions, heart failure clinic, and primary care, and had a lower mortality rate over the course of the study. Variables independently associated with use of the diary included less severe symptoms (OR 15, 95% confidence intervals 1.7, 144), frequent attendance at the heart failure clinic (OR 15, 95% CI 3, 78) and attendance at an education session (OR 8, 95% CI 1.5, 42). Of the 76 patients who used the diary, 51 weighed themselves regularly. More of these patients owned scales at home; they were also more likely to attend the education sessions, and experienced fewer hospital admissions than those patients who did not weigh themselves regularly. Variables independently associated with regular self‐weighing included the presence of scales at home (OR 6.3, 95% CI 1.7, 14.1), left ventricular ejection fraction >30% (OR 4.3, 95% CI 1.1, 17.5), and attendance at the education session(s) (OR 6.3, 95% CI 1.7, 14.1). Patients in the management group exhibited higher levels of knowledge at 12 months of follow‐up and were more likely to monitor their condition using daily weighing, compared to the control group.
Conclusions
At 12 months of follow‐up, implementation of self‐management strategies including daily weight monitoring and level of education on self‐management was significantly higher in the management group than the control group. For the patients in the management group, not using the diary or inability to perform daily weighing were associated with less frequent attendance at the heart failure clinic and education sessions and poorer health outcomes. In this study, attendance at the education sessions was associated with the adoption of self‐management, underlining the importance of education in multidisciplinary heart failure programmes. Self‐weighing could be increased by provision of scales to all patients. The subset of patients who did not adopt self‐management strategies in this study were at high risk of death or readmission.
A comparative, randomized, open clinical study, comparing the efficacy of two cimetidine dosage regimens, 400 mg b.i.d. versus 300 mg q.i.d., in the treatment of symptomatic duodenal ulcer was performed in three centers on 51 patients with endoscopically confirmed ulcers. Results indicate that both treatments are equally effective. Rates of healing and duration of treatment necessary to obtain endoscopic healing and complete disappearance of symptoms are comparable. The 400 mg b.i.d. dosage regimen has the advantages of a smaller total daily dose and a patient compliance easier to enforce.
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.
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.
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.
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.
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.