Opioid Analgesics and the Risk of Fractures in Older Adults with Arthritis: OPIOIDS AND FRACTURES IN OLDER ADULTS

To compare the risk of fracture associated with initiating opioids vs. non-steroidal anti-inflammatory drugs (NSAIDs), and the variation in risk by opioid dose, duration of action, and duration of use

A Cohort Study of Thiazolidinediones and Fractures in Older Adults with Diabetes

Context: Thiazolidenediones (TZDs) are selective ligands of peroxisome-proliferator-activated receptor-␥ and have been shown to reduce bone mineral density. Recent results from several randomized controlled trials find an increased risk of fracture with TZDs compared with other oral antidiabetic agents. Objective: The aim of the study was to determine the association between TZD use and fracture risk among older adults with diabetes. Design: We conducted a cohort study. Participants: Medicare beneficiaries with at least one diagnosis of diabetes initiating monotherapy for an oral hypoglycemic agent participated in the study. Main Outcome: We measured the incidence of fracture within the cohort. Results: Among the 20,964 patients with diabetes eligible for this study, 686 (3.3%) experienced a fracture during the median follow-up of approximately 10 months. Although not statistically significant, patients using only a TZD were more likely to experience a fracture than those using metformin (adjusted relative risk, 1.31; 95% confidence interval, 0.98 -1.77; P ϭ 0.071) or a sulfonylurea (adjusted relative risk, 1.21; 95% confidence interval, 0.94 -1.55; P ϭ 0.12). Each individual TZD was associated with an increased risk, with confidence intervals overlapping unity, compared with both metformin and sulfonylureas. The adjusted risk of any fracture associated with TZD use compared with metformin was elevated for non-insulin-using patients, women and men. If TZD use is associated with fractures, the number needed for one excess fracture when comparing TZD users to sulfonylurea users was 200, and the number was 111 when comparing TZDs with metformin. Conclusions: As has been found with other analyses, our data suggest that TZDs may be associated with an increased risk of fractures compared with oral sulfonylureas and metformin

The Prevalence and Cost of Unapproved Uses of Top-Selling Orphan Drugs

Introduction: The Orphan Drug Act encourages drug development for rare conditions. However, some orphan drugs become top sellers for unclear reasons. We sought to evaluate the extent and cost of approved and unapproved uses of orphan drugs with the highest unit sales. Methods We assessed prescription patterns for four top-selling orphan drugs: lidocaine patch (Lidoderm) approved for post-herpetic neuralgia, modafinil (Provigil) approved for narcolepsy, cinacalcet (Sensipar) approved for hypercalcemia of parathyroid carcinoma, and imatinib (Gleevec) approved for chronic myelogenous leukemia and gastrointestinal stromal tumor. We pooled patient-specific diagnosis and prescription data from two large US state pharmaceutical benefit programs for the elderly. We analyzed the number of new and total patients using each drug and patterns of reimbursement for approved and unapproved uses. For lidocaine patch, we subcategorized approved prescriptions into two subtypes of unapproved uses: neuropathic pain, for which some evidence of efficacy exists, and non-neuropathic pain. Results: We found that prescriptions for lidocaine patch, modafinil, and cinacalcet associated with non-orphan diagnoses rose at substantially higher rates (average monthly increases in number of patients of 14.6, 1.45, and 1.58) than prescriptions associated with their orphan diagnoses (3.12, 0.24, and 0.03, respectively (p75%). Increases in lidocaine patch use for non-neuropathic pain far exceeded neuropathic pain (10.2 vs. 3.6 patients, p<0.001). Discussion In our sample, three of four top-selling orphan drugs were used more commonly for non-orphan indications. These orphan drugs treated common clinical symptoms (pain and fatigue) or laboratory abnormalities. We should continue to monitor orphan drug use after approval to identify products that come to be widely used for non-FDA approved indications, particularly those without adequate evidence of efficacy

Associations of Kidney Function with Cardiovascular Medication Use after Myocardial Infarction

Background and objectives: It is unknown whether adherence to recommended medications after myocardial infarction (MI) differs by kidney function

Deficits and Disparities in Early Uptake of GLP-1 Receptor Agonists and SGLT2 Inhibitors among Medicare-insured Adults Following a New Diagnosis of Cardiovascular Disease or Heart Failure

   Objective: To examine the association of race/ethnicity and socioeconomic deprivation with initiation of guideline-recommended diabetes medications with cardiovascular benefit (glucagon-like peptide-1 receptor agonists (GLP1-RA) and sodium-glucose co-transporter-2 inhibitors (SGLT2i)) among older adults with type 2 diabetes (T2D) and either incident atherosclerotic cardiovascular disease (ASCVD) or congestive heart failure (CHF). Research Design and Methods: Using Medicare data (2016-2019), we identified 4,057,725 individuals over age 65 with T2D and either incident ASCVD or CHF. We estimated incidence rates (IR) and hazard ratios (HR) of GLP1-RA or SGLT2i initiation within 180 days by race/ethnicity and zip code-level Social Deprivation Index (SDI) using adjusted Cox proportional hazards models.  Results: IRs of GLP1-RA or SGLT2i initiation increased over time but remained low ( Conclusions: Among older adults with T2D and either ASCVD or CHF, initiation of GLP1-RA or SGLT2i was low, suggesting a substantial deficit in delivery of guideline-recommended care or treatment barriers. Individuals of Black and Other race/ethnicity and those with higher area-level socioeconomic deprivation were less likely to initiate these medications.</p

The effects of initial drug choice and comorbidity on antihypertensive therapy compliance: results from a population-based study in the elderly.

Approximately half of all elderly patients have elevated blood pressure, and proper treatment of this disorder leads to decreased cardiovascular morbidity in patients 65 and older. This study examined the effect of initial drug choice and comorbidity on medication compliance. We conducted a retrospective follow-up of 8643 outpatients aged 65 to 99 with newly prescribed antihypertensive therapy (AHT) from 1982 to 1988 in the New Jersey Medicaid and Medicare programs. Compliance was measured in terms of the number of days in which AHT was available to the patient during the 12 months following the initiation of therapy. Odds ratios (OR) and 95% confidence intervals (CI) for the outcome of good compliance (\u3e or =80%) were calculated. In a logistic regression model, good compliance (\u3e or =80%) was significantly associated with use of newer agents such as angiotensin converting enzyme inhibitors (OR 1.9, 95% CI 1.6 to 2.2) and calcium channel blockers (OR 1.7, 95% CI 1.5 to 2.1) as compared to thiazides, the presence of comorbid cardiac disease (OR 1.2, 95% CI 1.1 to 1.2), and multiple physician visits (OR 2.2, 95% CI 1.8 to 2.5). Good compliance was inversely associated with use of multiple pharmacies (OR 0.4, 95% CI 0.4 to 0.5) and number of medications prescribed overall (OR 0.8, 95% CI 0.7 to 0.9). Drug choice, comorbidity, and health services utilization were significantly associated with AHT compliance and represent important considerations in the management of high blood pressure. Noncompliance may be an important cause of treatment failure in elderly hypertensives