Use of interrupted time series methods in drug utilization research has increased, particularly in recent years. Despite methodological recommendations, there is large variation in reporting of analytic methods. Developing methodological and reporting standards for interrupted time series analysis is important to improve its application in drug utilization research, and we provide recommendations for consideration.
Objective To determine the association between use of sulphonylureas and risk of hypoglycaemia in relation to renal function and sulphonylurea metabolic group compared with use of metformin.Design Population based cohort study using routinely collected data from general practices in England.Setting Clinical Practice Research Datalink (CPRD) database, 2004-12.Participants 120 803 new users of a non-insulin antidiabetic agent with at least one prescription and aged 18 years or more. The first prescription defined start of follow-up. Patients were followed until the end of data collection, a record for hypoglycaemia, or a blood glucose level of less than 3.0 mmol/L.Main outcome measures Associations between sulphonylurea dose, renal impairment, type of sulphonylurea used, and risk of hypoglycaemia, were determined using Cox proportional hazard models. Adjustments were made for age, sex, lifestyle, comorbidity, and drug use.Results The risk of hypoglycaemia in current users of sulphonylureas only was significantly increased compared with current users of metformin only (adjusted hazard ratio 2.50, 95% confidence interval 2.23 to 2.82). The higher risk in current users of sulphonylureas only was further increased in patients with an estimated glomerular filtration rate of less than 30 mL/min/1.73 m2 (4.96, 3.76 to 6.55). The risk of hypoglycaemia was also significantly higher in patients with a high sulphonylurea dose (3.12, 2.68 to 3.62) and in current users of glibenclamide (7.48, 4.89 to 11.44). Gliclazide, the sulphonylurea of first choice, showed a similar risk of hypoglycaemia compared with other sulphonylureas.Conclusions Sulphonylurea treatment in patients with a renal function of less than 30 mL/min/1.73 m2 should be considered with caution. Moreover, an increased risk of hypoglycaemic events was observed among all users of sulphonylureas. This contrasts with several guidelines that recommend gliclazide as first choice sulphonylurea, and therefore requires further investigation.
Use of the case-crossover design in pharmacoepidemiology has increased rapidly in the last decade. As the application of the case-crossover design continues to increase, it is important to develop standards of practice, especially for display of data.
Purpose of the review-Osteoporosis is a major public health issue resulting in considerable fracture-related morbidity. Although effective treatment exists, adherence to osteoporosis pharmacotherapy is suboptimal and linked to reduced drug effectiveness. Interventions are thus needed to reduce the burden of fractures associated with poor treatment adherence.Recent findings-Most patients will stop osteoporosis pharmacotherapy, yet the majority who discontinue will reinitiate treatment after an extended gap. The key to improving adherence to osteoporosis pharmacotherapy is to reduce the number and length of gaps in treatment. Multifaceted and individualized interventions may help to improve adherence. New strategies aimed at identifying patients likely to stop therapy may also facilitate the development of targeted interventions.Summary-Adherence to osteoporosis pharmacotherapy is suboptimal with short periods of persistence and lengthy gaps in therapy. Regular communication regarding the importance of continued therapy is critical. More research to help identify risk profiles of patients likely to become non-adherent, targeted multifaceted interventions to maximize adherence to therapy, and data to support when patients may safely consider a physician directed drug holiday is needed.
Glucagon-like Peptide-1 receptor agonists (GLP1-ra) are a relatively new class of anti-hyperglycemic drugs which may positively affect bone metabolism and thereby decrease (osteoporotic) bone fracture risk. Data on the effect of GLP1-ra on fracture risk are scarce and limited to clinical trial data only. The aim of this study was to investigate, in a population-based cohort, the association between the use of GLP1-ra and bone fracture risk. We conducted a population-based cohort study, with the use of data from the Clinical Practice Research Datalink (CPRD) database (2007–2012). The study population (N = 216,816) consisted of all individuals with type 2 diabetes patients with at least one prescription for a non-insulin anti-diabetic drug and were over 18 years of age. Cox proportional hazards models were used to estimate the hazard ratio of fracture in GLP1-ra users versus never-GLP1-ra users. Time-dependent adjustments were made for age, sex, lifestyle, comorbidity and the use of other drugs. There was no decreased risk of fracture with current use of GLP1-ra compared to never-GLP1-ra use (adjusted HR 0.99, 95 % CI 0.82–1.19). Osteoporotic fracture risk was also not decreased by current GLP1-ra use (adjusted HR 0.97; 95 % CI 0.72–1.32). In addition, stratification according to cumulative dose did not show a decreased bone fracture risk with increasing cumulative GLP1-ra dose. We showed in a population-based cohort study that GLP1-ra use is not associated with a decreased bone fracture risk compared to users of other anti-hyperglycemic drugs. Future research is needed to elucidate the potential working mechanisms of GLP1-ra on bone.
SummaryWe completed a systematic review of the literature to examine the impact of pharmacist interventions in improving osteoporosis management. Results from randomized controlled trials suggest that pharmacist interventions may improve bone mineral density testing and calcium intake among patients at high risk for osteoporosis.IntroductionPharmacists play a key role in many healthcare systems by helping patients manage chronic diseases. We completed a systematic review of the literature to identify randomized controlled trials (RCTs) that have examined the impact of pharmacy interventions in narrowing two gaps in osteoporosis management: identifying at-risk individuals and improving adherence to therapy.MethodsWe searched the electronic databases of EMBASE, HealthStar, International Pharmaceutical Abstracts, MEDLINE, and PubMed from database development to April 2010, examined grey literature, and completed manual searches of reference lists to identify English-language research that examined osteoporosis management interventions within pharmacy practice. Results from RCTs were abstracted and assessed for bias.ResultsWe identified 25 studies that examined pharmacist interventions in osteoporosis management: 16 cohort, 5 cross-sectional, 1 historical/ecological control, and 3 RCTs. RCT interventions included osteoporosis educational and counseling programs, screening by pharmacists based on risk factor assessment or bone mineral density testing, and physician contact or recommendations for patients to follow-up with a general practitioner. Results from the three RCTs suggest that pharmacist interventions may improve bone mineral density testing (targeted screening) and calcium intake among patients at high risk for osteoporosis. However, two of the three RCTs had high risk of bias, and no study examined the impact of pharmacist intervention on osteoporosis treatment adherence.ConclusionsData support the potential role for pharmacists to help reduce gaps in osteoporosis management through improved identification of high-risk patients. More research is needed to examine pharmacist interventions on osteoporosis treatment adherence.
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