Current medical research and opinion
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Aim: Midazolam like other benzodiazepines is supposed to be neurotoxic in small children and to represent a risk factor for the development of delirium. The aim of this study was to evaluate whether a modified analgesia and sedation protocol is feasible and effective to reduce the requirement of midazolam in neonates and young infants after cardiac surgery. Methods: Patients aged 6 months or younger who underwent surgery for congenital heart disease with cardiopulmonary bypass were enrolled and divided into a pre-modification group (January-December 2016) and after adjusting our sedation protocol into a post-modification group (January-December 2018). ⋯ The number of patients receiving midazolam and the cumulative dose of midazolam could be successfully reduced. The sedation scores were still within the desired target range for adequate sedation without any negative side effects. Conclusions: It is feasible and safe to reduce the use of midazolam in infants after cardiac surgery maintaining sedation goals based on a modified nurse-driven analgesia and sedation protocol.
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Objective: To assess the impact of age on the safety and tolerability of ALO-02, an abuse-deterrent opioid formulation consisting of oxycodone hydrochloride and sequestered naltrexone hydrochloride, in patients with chronic pain. Methods: Data from two clinical studies in patients with chronic low back pain or chronic non-cancer pain were analyzed. Patients aged ≥18 years who required continuous around-the-clock opioid analgesia for an extended period were grouped into ≥65 years and <65 years age groups. ⋯ One patient aged ≥65 years experienced an AE of opioid withdrawal. Conclusions: The safety and tolerability of ALO-02 is similar in those aged ≥65 years and those aged <65 years with chronic pain. ClinicalTrials.gov identifiers: NCT01571362, NCT01428583.
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Objective: Uncontrolled asthma is associated with considerable clinical burden and costs to payers and patients. US economic models evaluating biologics using data from clinical trials demonstrate high incremental cost-effectiveness ratios (ICERs), but the cost-effectiveness based on real-world treatment patterns is unknown. This analysis used real-world evidence to assess the cost-effectiveness of adding omalizumab to standard of care (SOC). ⋯ One-way and multivariate sensitivity analyses confirmed that the base case outcome was robust to variation in inputs. Conclusions: Based on real-world outcomes, omalizumab may be cost-effective for uncontrolled asthma from the US payer perspective. Including broader evidence on treatment discontinuation, caregiver burden, and oral corticosteroid reduction from real-world studies may better reflect the effects and value of omalizumab for all healthcare stakeholders.
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Objective: The impact of cytomegalovirus (CMV) infection on healthcare resource utilization (HCRU) and costs post-allogeneic hematopoietic stem cell transplant (allo-HSCT) has not been well studied in the US. This retrospective, observational cohort study examined such outcomes in the first year following allo-HSCT. Methods: The IBM MarketScan administrative claims database was used to identify adults who underwent a first allo-HSCT between 1 January 2010 and 30 April 2015. ⋯ Valganciclovir (59.8%) and ganciclovir (33.7%) were the most commonly utilized anti-viral agents in patients with CMV. Conclusions: CMV infection was associated with significantly higher healthcare resource utilization and costs during the first year post-allo-HSCT. Additional research is warranted to further evaluate the consequences of post-HSCT CMV infection, as well as cost-effective measures to minimize its occurrence.
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Observational Study
Predicting initiation of preventive migraine medications: exploratory study in a large U.S. medical claims database.
Objective: Despite guidelines that identify potential patients eligible for preventive migraine medications, their underutilization leaves patients at risk of acute medication overuse, disease progression, and higher healthcare resource utilization and disability. This exploratory, retrospective, observational study aimed to identify which factors predict preventive migraine medication initiation. Demographics and initiation of acute medication use were hypothesized to be predictive of initiation of preventive migraine medication. ⋯ Results: Study population included 147,923 patients: 43,660 preventive migraine medication initiators and 104,263 non-preventive migraine medication patients. Best-fit model for predicting preventive migraine medication initiation included: female gender (odds ratio = 1.181 [95% CI = 1.144,1.218]; measured at date of first migraine diagnosis); headache diagnosis prior to migraine diagnosis (odds ratio = 1.538 [95% CI = 1.498,1.579]; measured 1-year before first migraine diagnosis); and sleep disorder (odds ratio = 1.206 [95% CI = 1.161,1.252]), headache/migraine-specific Emergency Department (ED) visit (odds ratio = 1.224 [95% CI = 1.168,1.283]), neurologist visit (odds ratio = 1.502 [95% CI = 1.459,1.547]), and acute medication refills with <90-day gap (odds ratio = 1.509 [95% CI = 1.470,1.549]) each measured at 1-year before first preventive migraine medication. Conclusions: In addition to consistent acute medication refills, specific comorbidity diagnoses, headache/migraine-specific ED utilization, and neurologist care are predictive of preventive migraine medication initiation in the 1-year post-incident migraine diagnosis.