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AIM: To determine the short-term biochemical effects and clinical tolerability of intermittent fasting (IF) in adults with type 2 diabetes mellitus (T2DM). METHODS: We describe a three-phase observational study (baseline 2 wk, intervention 2 wk, follow-up 2 wk) designed to determine the clinical, biochemical, and tolerability of IF in community-dwelling volunteer adults with T2DM. Biochemical, anthropometric, and physical activity measurements (using the Yale Physical Activity Survey) were taken at the end of each phase. Participants reported morning, afternoon and evening self-monitored blood glucose (SMBG) and fasting duration on a daily basis throughout all study stages, in addition to completing a remote food photography diary three times within each study phase. Fasting blood samples were collected on the final days of each study phase. RESULTS: At baseline, the ten participants had a confirmed diagnosis of T2DM and were all taking metformin, and on average were obese [mean body mass index (BMI) 36.90 kg/m2]. We report here that a short-term period of IF in a small group of individuals with T2DM led to significant group decreases in weight (-1.395 kg, P = 0.009), BMI (-0.517, P = 0.013), and at-target morning glucose (SMBG). Although not a study requirement, all participants preferentially chose eating hours starting in the midafternoon. There was a significant increase (P < 0.001) in daily hours fasted in the IF phase (+5.22 h), although few attained the 18-20 h fasting goal (mean 16.82 ± 1.18). The increased fasting duration improved at-goal (< 7.0 mmol/L) morning SMBG to 34.1%, from a baseline of 13.8%. Ordinal Logistic Regression models revealed a positive relationship between the increase in hours fasted and fasting glucose reaching target values (χ2 likelihood ratio = 8.36, P = 0.004) but not for afternoon or evening SMBG (all P > 0.1). Postprandial SMBGs were also improved during the IF phase, with 60.5% readings below 9.05 mmol/L, compared to 52.6% at baseline, and with less glucose variation. Neither insulin resistance (HOMA-IR), nor inflammatory markers (C-reactive protein) normalized during the IF phase. IF led to an overall spontaneous decrease in caloric intake as measured by food photography (Remote Food Photography Method). The data demonstrated discernable trends during IF for lower energy, carbohydrate, and fat intake when compared to baseline. Physical activity, collected by a standardized measurement tool (Yale Physical Activity Survey), increased during the intervention phase and subsequently decreased in the follow-up phase. IF was well tolerated in the majority of individuals with 6/10 participants stating they would continue with the IF regimen after the completion of the study, in a full or modified capacity (i.e., every other day or reduced fasting hours). CONCLUSION: The results from this pilot study indicate that short-term daily IF may be a safe, tolerable, dietary intervention in T2DM patients that may improve key outcomes including body weight, fasting glucose and postprandial variability. These findings should be viewed as exploratory, and a larger, longer study is necessary to corroborate these findings.

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STUDY OBJECTIVE: To test a brief intervention for preventing statin nonadherence among community pharmacy patrons. DESIGN: Prospective, cluster-randomized, controlled trial (the Community Pharmacists Assisting in Total Cardiovascular Health [CPATCH] trial). SETTING: Thirty community pharmacies in Saskatchewan, Canada. PATIENTS: Participating pharmacies were randomized to 15 intervention pharmacies where a brief statin adherence intervention was delivered by pharmacists (intervention group [907 patients]) or 15 usual care pharmacies where no statin adherence intervention was delivered (usual care group [999 patients]) to new users of statins (defined as less than 1 yr of statin therapy). INTERVENTION: Staff (pharmacy managers, staff pharmacists, and technicians) from intervention pharmacies attended a 2.5-hour workshop on the CPATCH program that prepared pharmacists to deal with the adherence barriers most likely associated with statin use (e.g., safety, cost, patient-provider relationship, and tolerability). Intervention pharmacists screened for new statin users and assessed these adherence barriers. Pharmacists were then instructed to tailor their follow-up plan based on the individual patient's situation. Investigators contacted the intervention pharmacies monthly to assess their compliance with the protocol and to offer additional support to motivate ongoing participation. MEASUREMENTS AND MAIN RESULTS: The primary outcome was mean difference in statin adherence between the intervention and usual care groups. Adherence was measured by the proportion of days covered (PDC) between 6 and 12 months following the original prescription fill date. General estimating equations were used to evaluate the difference in mean adherence between groups. Secondary outcomes included the percentage of new statin users exhibiting optimal adherence (defined as PDC of 80% or higher) and the percentage exhibiting nonpersistence (defined as the cessation of all statin dispensations within 3 mo of the first dispensation). Among 1906 eligible patients, no significant differences in mean adherence were observed between those receiving the intervention and those receiving usual care (71.6% vs 70.9%, p=0.64), the percentage of patients achieving optimal adherence (57.3% vs 55.9%, p=0.51), or the percentage exhibiting nonpersistence (9.4% vs 8.3%, p=0.41). However, compliance to the study protocol was extremely low in several intervention pharmacies. In a post hoc analysis, a higher level of protocol compliance among intervention pharmacies was significantly associated with higher adherence (p<0.01 for trend). Pharmacies falling in the highest tertile of compliance to the study protocol exhibited higher mean adherence among their patients compared with those in the usual care group (ß = 0.056, 95% confidence interval [CI] 0.010-0.101, p=0.01), and a significantly higher percentage of patients achieving optimal adherence (odds ratio 1.32, 95% CI 1.08-1.61; p<0.01); however, nonpersistence did not significantly differ between the two groups (5.5% vs 8.3%, p=0.27). CONCLUSION: The CPATCH intervention was ineffective for improving patient adherence to statin therapy in community pharmacies. However, poor effectiveness may have resulted from a failure to deliver the protocol consistently in several intervention pharmacies.

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In many clinical practice settings, individual pharmaceutical care practitioners have thousands of patients who may receive their service. However, the pharmaceutical care approach provides virtually no guidance regarding how patients should be identified or prioritized by practicing pharmacists. We believe that pharmacists need to be "officially" accountable to specific patient groups at high risk for drug- or disease-induced morbidity within their practice. Consequently, the current definition of pharmaceutical care and its associated care processes need to be modified to ensure the activities of pharmacists are being focused on high-priority patients on a consistent basis.

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BACKGROUND: Community pharmacies vary widely in terms of ownership structures, location, and dispensing policies. It is unknown if an association exists between the type of community pharmacy and the degree of medication adherence exhibited by patrons-patients. OBJECTIVE: To describe adherence to statin therapy among subjects patronizing different types of community pharmacy categories (department- mass merchandise, chain-franchise, and independent-banner) in Saskatchewan, Canada, between 2000 and 2005. METHODS: Study data were obtained from the Saskatchewan Drug Plan and Extended Benefits database, which is maintained by the government of Saskatchewan, Canada. The study included all subjects who (a) filled a statin prescription within selected community pharmacies between January 1, 2000, and December 31, 2005; (b) had no record of statin prescriptions during the year prior to the first statin prescription, according to the records of the Saskatchewan Drug Plan and Extended Benefits; and (c) demonstrated active utilization in the drug plan database for at least 1 year after the first statin prescription. The proxy criterion for activity was any dispensing record for statin or nonstatin medications at least 1 year following the index claim. Statin adherence level was estimated as tablets per day, defined as the total number of tablets dispensed divided by the total number of days of observation. Each subject's observation period began on the index date and ended on the earlier of (a) 30 days after the last recorded fill for any type of prescription medication (statin or nonstatin), or (b) December 31, 2005. The primary end point was the proportion of subjects within each pharmacy category who maintained an adherence level of 80% or greater during their individual observation period. Additional adherence calculations were performed for each of 3 time periods, beginning on the index date and ending on days 365, 729, and 1094 (i.e., 1, 2, and 3 years). Patients were included in the analysis for each time period if they met a proxy criterion for availability for observation, defined as the dispensing of any drug at least 1 day after the end date of each period. Pearson chi square tests were used to assess the significance of differences in baseline characteristics and adherence proportions, comparing pharmacy categories. Logistic regression analysis estimated the odds of an adherence level of at least 80% during the individual observation period, adjusting for pharmacy category, sex, age 65 years or older, known low-income drug coverage, number of distinct drug classes filled concurrently during the first year of observation, loyalty to index pharmacy, and length of observation. Using similar methods, we also estimated "pharmacy loyalty" by calculating the proportion of subjects who refilled 75% or more of their statin prescriptions at the pharmacy that dispensed their first statin prescription. RESULTS: From an initial sample of 12,818 subjects who had at least 1 pharmacy claim for a statin in the period from January 1, 2000, through December 31, 2005, 8699 subjects met the inclusion criteria. Subjects were observed for a mean (SD, range) of 3.7 (1.7, 1.0-7.0) years after the index statin prescription. During the first year following the index claim, statin adherence rates were at least 80% for 1799 of 3761 (47.8%) patrons of department-mass merchandise, 1778 of 3235 (55.0%) patrons of chain-franchise, and 921 of 1703 (54.1%) patrons of independent-banner stores (P < 0.001). Measured from the index date through day 1094, 869 of 2292 (37.9%), 874 of 1887 (46.3%), and 457 of 975 (46.9%) subjects in the department-mass merchandise, chain-franchise, and independent banner categories, respectively, had a statin adherence level of at least 80% (P < 0.001). In logistic regression analysis, pharmacy category type was significantly associated with statin adherence; subjects in the chain franchise and independent-banner categories were more likely to be adherent to their statin medications during their observation periods than were those in the department-mass merchandise category (adjusted odds ratio [OR] = 1.36, 95% CI = 1.23-1.50, P < 0.001 and OR = 1.39, 95% CI = 1.24-1.57, P < 0.001, respectively). From the index date through day 1094, 1752 of 2292 (76.4%), 1475 of 1887 (78.2%), and 795 of 975 (81.5%) subjects remained pharmacy-loyal in the department-mass merchandise, chain franchise, and independent-banner categories, respectively (P = 0.006). Controlling for several potential confounders using logistic regression, independent-banner pharmacy patrons were more likely to remain pharmacy- loyal during their observation periods than were those patronizing department-mass merchandise (adjusted OR = 1.34, 95% CI = 1.16-1.54, P < 0.001) or chain-franchise stores (adjusted OR = 1.22, 95% CI = 1.06-1.42, P = 0.009). CONCLUSION: One year after their first statin fill, subjects demonstrated low rates of adherence, ranging from 48% to 55%, regardless of the type of pharmacy they patronized. Although the differences by type of pharmacy reached statistical significance, their clinical importance is not evident, reinforcing the fact that the problem of nonadherence appears to exist among all types of community pharmacies, regardless of their categorization.

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