Drugs - Real World Outcomes最新文献

Background: Ailments such as diarrhoea and antibiotic-associated gut symptoms are generally self-managed using probiotics. Real-world data on reasons behind self-medication with over-the-counter (OTC) products and patient-reported outcomes can be investigated strategically by the pharmacists.

Objective: This study evaluates the use of Bacillus clausii (Enterogermina^®) at the Italian community pharmacies among self-medicating patients, their treatment habits and perceived benefits.

Design: This is a multicentre, prospective, non-interventional study which included two visits [at screening (T0) and end of the study (T1) when symptoms had subsided, ≤ 30 days from T0]. Patients who were already inclined to buy B. clausii were enrolled and instructed to complete a questionnaire at T0 and T1. The primary objective was to evaluate the reasons for taking B. clausii. Secondary objectives assessed treatment duration, perceived effectiveness, quality of life (QoL), treatment satisfaction and safety outcomes.

Results: Overall, 268 patients were enrolled; 99.6% of them were evaluated at T0 and 97.4% at T1, and safety was evaluated in 97.8% who had ≥ 1 dose of B. clausii. At T0, mean age was 50.7 years and majority were females (62.2%). In the interview, main reason stated for using B. clausii at T0 was diarrhoea (56.93%), followed by other gastrointestinal symptoms. Treatment duration was shorter in those with diarrhoea or abdominal pain versus those with constipation or abdominal tension. More than 90% perceived their symptoms to have improved or improved very much. Overall QoL improved in all the aspects measured. Treatment satisfaction was reported by nearly 90% of patients as satisfied, very satisfied or extremely satisfied. No adverse events were reported.

Conclusion: This is the first pharmacy-based study in Italy that evaluated the real-world usage of an OTC probiotic containing B. clausii among self-medicating adults. Diarrhoea was the most common reason for use, with high-level of perceived effectiveness and patient satisfaction with B. clausii.

Background: The antifibrotic drugs, nintedanib and pirfenidone, inhibit the decline in forced vital capacity in patients with idiopathic pulmonary fibrosis (IPF). Nintedanib also inhibits the onset of acute exacerbation and reduces the risk of all-cause mortality. However, their effectiveness in real-world practice remains unclear. Our study aimed to investigate the changes in forced vital capacity, survival period, causes of death, and risk factors for mortality in patients with IPF receiving antifibrotic drugs.

Methods: This retrospective study enrolled Japanese patients who visited Toho University Sakura Medical Center who were diagnosed with IPF and received antifibrotic drugs.

Results: We included 102 patients [mean age ± standard deviation (SD): 71.8 ± 7.5 years], of whom 76 were males. The decline in forced vital capacity (mean ± SD) during the antifibrotic therapy period was - 154 ± 259 mL/year, which was significantly lower than before the antifibrotic therapy period (- 484 ± 589 mL/year; n = 80, p = 0.003). Altogether, 52 deaths were confirmed, and the median survival time from antifibrotic therapy initiation was 38.0 months (95% confidence interval: 25.9-50.1 months). Acute exacerbation accounted for 9.6% of all deaths (95% confidence interval: 1.6-17.6). The decline in forced vital capacity during antifibrotic therapy was a risk factor for mortality.

Conclusions: In actual clinical practice in Japan, antifibrotic drugs suppressed the gradual decline in forced vital capacity, which is a risk factor for mortality. However, the median survival period remained poor at 38 months.

Background: Real-world Indian studies evaluating effectiveness of dapagliflozin as an add-on to other oral antidiabetic drugs (OAD) in patients with type 2 diabetes mellitus (DM) are scarce.

Methods: An electronic medical record (EMR)-based, retrospective, multicentre study was conducted to evaluate the effectiveness of dapagliflozin as add-on therapy in adult patients with inadequately controlled DM on metformin with or without other OAD. Baseline characteristics (visit 1: metformin or metformin plus OAD treatment for at least 30 days) and treatment-related outcomes (visit 2: follow-up) considered between 60 and 140 days after adding/switching dapagliflozin [glycated haemoglobin (HbA1c), body mass index (BMI), systolic blood pressure (SBP) and diastolic blood pressure (DBP)] were analysed.

Results: A total of 3616 patients were screened from 478 centres. Most patients had received dapagliflozin (D) + metformin (M) + at least one other OAD [D + M + OAD, n = 2907 (80.4%), 408 followed-up with HbA1c reported], while 709 patients (19.6%, 138 followed-up with HbA1c reported) received dapagliflozin + metformin (D + M). Treatment with dapagliflozin as an add-on therapy resulted in significant change in HbA1c (-1.1 ± 1.44%; p < 0.05 for HbA1c subgroup ≥ 7.5%; -1.6 ± 1.41%; p < 0.05 for HbA1c subgroup ≥ 8%) at visit 2 compared with visit 1. Significant change in body weight (-1.4 ± 3.31 kg; p < 0.05 for HbA1c subgroup ≥ 7.5%; - 1.5 ± 3.22 kg; p < 0.05 for HbA1c subgroup ≥ 8%) was observed at visit 2. Similarly, a significant change in BMI was noted for the HbA1c subgroup ≥ 7.5% (-1.0 ± 8.38 kg/m²). However, the change in BMI in the HbA1c subgroup ≥ 8% was noted to be -1.4 ± 10.4 kg/m², which was not statistically significant (p = 0.08). In the overall study population, significant change in the SBP (-4.5 ± 14.9 mmHg; p < 0.05 for HbA1c subgroup ≥ 7.5%; -4.5 ± 15.1 mmHg; p < 0.0001 for HbA1c subgroup ≥ 8%) was observed at visit 2 compared with visit 1. On identical lines, significant change in DBP (-1.5 ± 8.94 mmHg; p < 0.05 for HbA1c subgroup ≥ 7.5%; -1.4 ± 8.91 mmHg; p < 0.05 for HbA1c subgroup ≥ 8%) was noted.

Conclusions: Dapagliflozin showed significant improvement in glycemic parameter, BMI and BP when added to metformin, with or without other OADs in a real-world scenario.

Background and objective: The term triple whammy (TW) refers to the concomitant use of non-steroidal anti-inflammatory drugs, diuretics, and angiotensin system inhibitors; this combination significantly increases the risk of acute kidney injury (AKI). To prevent this serious complication, we developed an electronic algorithm that detects TW prescriptions in patients with additional risk factors such as old age and impaired kidney function. The algorithm alerts a clinical pharmacist who then evaluates and forwards the alert to the prescribing physician.

Methods: We evaluated the performance of this algorithm in a retrospective observational study of clinical data from all adult patients admitted to the Cantonal Hospital of Aarau in Switzerland in 2021. We identified all patients who received a TW prescription, had a TW alert, or developed AKI during TW therapy. Algorithm performance was evaluated by calculating the sensitivity and specificity as a primary endpoint and determining the acceptance rate among clinical pharmacists and physicians as a secondary endpoint.

Results: Among 21,332 hospitalized patients, 290 patients had a TW prescription, of which 12 patients experienced AKI. Overall, 216 patients were detected by the alert algorithm, including 11 of 12 patients with AKI; the algorithm sensitivity is 88.3% with a specificity of 99.7%. Physician acceptance was high (77.7%), but clinical pharmacists were reluctant to forward the alerts to prescribers in some cases.

Conclusion: The TW algorithm is highly sensitive and specific in identifying patients with TW therapy at risk for AKI. The algorithm may help to prevent AKI in TW patients in the future.

Background: Approximately a decade has passed since the addition of venous thromboembolism to the list of significant adverse reactions of antipsychotic drugs. However, only a few studies have investigated the relationship between antipsychotic use and venous thromboembolism in the Japanese population.

Purpose: We aimed to evaluate the risk of recurrent venous thromboembolism in users of antipsychotic drugs and update the evidence on venous thromboembolism in the Japanese population.

Methods: A cross-sectional retrospective analysis of data from a large Japanese claims database, managed by Medical Data Vision Co. Ltd., was conducted. Adult patients who experienced venous thromboembolism between October 2014 and September 2018 in acute care hospitals were identified. The risk of recurrent venous thromboembolism was evaluated with logistic regression using demographic variables. The data of patients using antipsychotic drugs within specific therapeutic classes were also evaluated.

Results: We included 8960 patients (mean age, 69 years; 59.2% female). Recurrent venous thromboembolism was observed in 686 patients (7.7%). The risk of recurrent venous thromboembolism was significantly higher in younger patients [< 65 years: reference; 65-74 years: odds ratio (OR) 0.81, 95% confidence interval (CI) 0.66-0.99, p = 0.04; ≥ 75 years: OR 0.77, 95% CI 0.64-0.94, p = 0.01], those with history of surgery (OR 1.39, 95% CI 1.18-1.65, p = 0.01), and anticoagulant users (OR 2.25, 95% CI 1.46-3.48, p = 0.01) and was significantly lower in the presence of comorbidities (OR 0.68, 95% CI 0.58-0.81, p< 0.01) and fractures (OR 0.49, 95% CI 0.26-0.94, p = 0.03). Long-term antipsychotic drug prescriptions (> 14 days) were associated with a higher risk of venous thromboembolism than short-term prescriptions (≤ 14 days) (OR 1.56, 95% CI 1.04-2.34, p = 0.03).

Conclusions: In patients with a history of venous thromboembolism, particular attention should be paid to recurrence in younger patients. If antipsychotic drugs are prescribed for > 14 days to patients with a history of venous thromboembolism, they should be administered carefully, guided by reported findings. Further evaluations using different databases or populations are required to generalize the findings of this study.

Background: Isotretinoin, indicated for severe acne, is a potent teratogen and therefore contraindicated in pregnancy. Thus, the pregnancy prevention program (PPP) for isotretinoin has been introduced.

Objectives: The aim of this study was to assess the concomitant use of isotretinoin and effective contraception and the rate of potential isotretinoin-exposed pregnancies in females of childbearing age in 2017-2020 in Estonia. In addition, we aimed to evaluate whether compliance with the PPP has improved compared with the previous study conducted in Estonia covering the period of 2012-2016.

Methods: This retrospective, nationwide study using prescription and healthcare claims data included 2575 females aged 15-45 years who started using isotretinoin between 2017 and 2020.

Results: For 64.7% of females of childbearing age, no concurrent use of an effective contraceptive was detected while using isotretinoin. A moderately higher contraceptive coverage (35.3%) was observed compared with the previous study (29.7%) (p < 0.001). Complete contraception coverage was highest in females aged 30-39 years with an adjusted OR of 12.8 (p < 0.001) compared with the age group 15-19 years and 2.47 (p < 0.001) compared with the age group 20-29 years. 17 pregnancies coincided with the isotretinoin treatment-related period. The risk for potential isotretinoin-exposed pregnancy was 6.6 (95% CI 3.9-10.5) per 1000 treated females of childbearing age over the 4-year observation period. The risk for potential isotretinoin-exposed pregnancies per 1000 treated females was 1.0 in females aged 15-19 years, 11.6 in females aged 20-29 years, 8.8 in females aged 30-39 years, and 7.4 in females aged 40-45 years (p = 0.009).

Conclusion: A slight improvement in complete contraceptive coverage during isotretinoin use has not resulted in a decrease in the risk of isotretinoin-exposed pregnancies. The contraceptive usage and risk for pregnancy vary greatly across age groups, suggesting the need for a more targeted approach to improve the effectiveness of the PPP.

Objective: Drug non-adherence in primary preventive cardiovascular therapy is one of the most important modifiable drivers of cardiovascular events. The effect of deductibles in healthcare cost-sharing plans (the amount that has to be paid for healthcare services before the insurance company starts to pay) on such non-adherence in a European setting is unknown. Therefore, we estimated the association between deductibles and the adherence to primary preventive antihypertensive and antihyperlipidemic medication.

Methods: Using the claims database of Menzis Health Insurer in the Netherlands, we applied ordered beta regression mixed modelling to estimate the association between deductibles and adherence taking several demographic and social-economic factors, repeated measurements and within-patient variation into account.

Results: All in all, 106,316 patients starting primary preventive antihypertensive or antihyperlipidemic monotherapy were eligible for analysis. At index date, mean age of the study population was 58 years and 52% were male. Reaching the deductible limit and no need to pay for medication anymore increased the adherence [relative adherence ratio (RAR) 1.03, 95% confidence interval (95% CI): 1.00-1.05] for antihyperlipidemic therapy and 1.02 (95% CI: 1.00-1.04) for antihypertensive therapy. A larger deductible amount decreases the adherence of antihyperlipidemic and antihypertensive therapy (RAR 0.83; 95% CI: 0.69-1.00 and RAR 0.85, 95% CI: 0.74-0.98, respectively).

Conclusion: Independent of other risk factors for non-adherence, presence of deductibles in health insurance is associated with a small negative effect on the adherence to both primary preventive antihypertensive as well as antihyperlipidemic therapy. Further study is needed on the potential health-economic consequences.

Background: Parkinson's disease is now one of the fastest-growing neurodegenerative disorders in the developed world, with an increasing prevalence and associated socioeconomic costs. Progression of the disease leads to a gradual deterioration in patients' quality of life, despite optimal treatment, and both medical and societal needs increase, often with the assistance of paid and/or unpaid caregivers.

Objective: We aimed to quantify the incremental economic burden of Parkinson's disease by disease severity in a real-world setting across differing geographic regions.

Methods: Demographics, clinical characteristics, health status, patient quality of life, caregiver burden, and healthcare resource utilization data were drawn from the Adelphi Parkinson's Disease Specific Program™, conducted in the USA, five European countries, and Japan.

Results: A total of 563 neurologists provided data for 5299 individuals with Parkinson's disease; 61% were male, with a mean age of 64 years. Approximately 15% of individuals were deemed to have advanced disease, with significantly more comorbidities, and a poorer quality of life, than those with non-advanced disease. Overall, the mean annual healthcare resource utilization increased significantly with advancing disease, and resulted in a three-fold difference in the USA and Europe. The main drivers behind the high economic burden included hospitalizations, prescription medications, and indirect costs.

Conclusions: People with Parkinson's disease, and their caregivers, incur a higher economic burden as their disease progresses. Future interventions that can control symptoms or slow disease progression could reduce the burden on people with Parkinson's disease and their caregivers, whilst also substantially impacting societal costs.

Background: In Japan, daily, twice weekly, and weekly formulations of teriparatide (TPD) and monthly formulations of romosozumab (ROMO) are available as osteogenesis promoters for the treatment of osteoporosis with a high risk for fracture.

Objective: To compare the effects of three TPD preparations and ROMO on fracture healing and low back pain after a fresh vertebral fracture.

Methods: This was a retrospective observational study. Patients presenting with fresh osteoporotic vertebral fractures were treated subcutaneously with TPD daily (DTPD), twice weekly (2/WTPD), weekly (WTPD), or with ROMO monthly. Bone union, vertebral height changes, and low back pain in the injured vertebra were compared after 6 months of treatment.

Results: Bone union and pain improvement were more frequent among those who received daily and twice weekly administration of TPD compared with those who received WTPD and ROMO administration. A comparison for multiplicity between the groups using the Steel-Dwass test showed significant differences between the DTPD and ROMO groups (p = 0.0029) and WTPD and ROMO groups (p = 0.0490), suggesting superior bone fusion in the DTPD and WTPD groups. Similarly, significant differences were noted between the DTPD and ROMO groups (p = 0.0001), WTPD and ROMO groups (p = 0.0341), and 2/WTPD and ROMO groups (p = 0.0009), indicating a higher degree of pain improvement in the DTPD, WTPD, and 2/WTPD groups compared with that in the ROMO group.

Conclusions: Daily, weekly, and twice-weekly administration of TPD may be superior to ROMO for promoting fresh vertebral fracture healing.