Drugs - Real World Outcomes最新文献

Background: Oral mucositis (OM) is a frequent and debilitating complication of chemotherapy, yet little is known about its burden and management in Sudan. Therefore, this study aimed to determine the prevalence, characteristics, management, and factors associated with OM.

Methods: A hospital-based cross-sectional study was conducted from April to June 2022 at Khartoum Oncology Hospital, Sudan, among chemotherapy patients, with OM severity graded per the World Health Organization criteria. The data were analyzed using SPSS version 27.

Results: Among the 340 patients, 258 (75.9%) were female, and 128 (37.6%) were aged 45-59 years. OM occurred in 127 (37.4%) patients, mostly with generalized lesions (96; 75.6%) and Grade 3 severity (76; 59.8%). Common complications included inability to eat (75; 59.1%) and taste changes (69; 54.3%). Only 36 (28.3%) patients received prescription medication, mainly miconazole gel (17; 47.2%); pain management was provided to 12 (11.5%) patients, and dental interventions were provided to two (0.6%) patients. In multivariable logistic regression, age (p = 0.035) and number of chemotherapy doses (p < 0.001) remained independent predictors, with lower odds for four to six doses (aOR (adjusted odds ratio) 0.152; 95% CI (confidence interval) 0.087-0.268), seven to ten doses (aOR 0.033; 95% CI 0.009-0.121), and more than ten doses (aOR 0.045; 95% CI 0.004-0.484) than for one to three doses.

Conclusion: OM is moderately prevalent but often severe among Sudanese chemotherapy patients, with inadequate management and poor adherence to evidence-based practice. Implementing standardized oral care, clinician training, and patient education could reduce its burden and improve outcomes.

Background: Hyperthyroidism during pregnancy is associated with maternal, obstetric and fetal complications. Antithyroid drugs (ATDs) including carbimazole (CMZ), methimazole (MMI) and propylthiouracil (PTU) are the main pharmacotherapies for hyperthyroidism. Exposure to CMZ and MMI during the first trimester was associated with birth defects, while PTU is assumed to be the safer alternative.

Objective: To calculate the prescription prevalences of ATDs in women of childbearing age over time and to describe pregnancies occurring after or during ATD use.

Methods: Using the GePaRD database (claims data; 20% of the German population), we conducted year-wise cross-sectional studies for the period 2004-2020 to calculate prescription prevalences of CMZ, MMI and PTU in females aged 13-49 years. In longitudinal analyses, we included all women with any ATD dispensing between 2005 and 2020 aged 13-49 years at the first dispensing. We identified pregnancies occurring in this cohort and described ATD use before and during pregnancy.

Results: The age-standardized prescription prevalence of ATDs decreased by 32.1% between 2004 (2.71 per 1000) and 2020 (1.84 per 1000). This decrease was attributable to CMZ (2004: 1.40 per 1000; 2020: 0.76 per 1000; relative decrease: 45.7%) and MMI (2004: 1.25 per 1000; 2020: 0.99 per 1000; relative decrease: 20.8%). In the cohort including 9723 women, 13,586 pregnancies were observed, of which 67% (n = 9140) occurred after ATD use. In 16.2% of the pregnancies (n = 2203), ATD use overlapped with pregnancy onset. The proportion exposed to CMZ/MMI at pregnancy onset decreased from 30.7% in 2005 to 10.9% in 2020. In 16.5% of pregnancies (n = 2243), ATD use was started during pregnancy.

Conclusion: The prescription prevalence of ATD overall and specifically of CMZ/MMI in girls and women of childbearing age decreased between 2005 and 2020 in Germany. The decrease in exposure to CMZ/MMI at pregnancy onset indicates that physicians became increasingly aware of the potential risks of CMZ/MMI to the unborn child.

Background: Hypertension is a major global health burden associated with significant cardiovascular morbidity and mortality. Fixed-dose combinations (FDC) may improve blood pressure (BP) control and prevent associated complications. This study aimed to evaluate the effectiveness and safety of telmisartan and amlodipine FDC in Indian patients with hypertension.

Methods: This prospective, multicenter (n = 982), observational, real-world study enrolled patients aged ≥ 18 years diagnosed with hypertension and prescribed telmisartan and amlodipine FDC. The primary outcome was the mean change in systolic blood pressure (SBP) from baseline to 8 weeks. Safety was assessed on the basis of the incidence of adverse events reported by patients or observed by clinicians.

Results: Out of 8541 individuals screened, 6232 were enrolled. A significant reduction in mean SBP was observed, decreasing from 155.12 mmHg at baseline to 135.96 mmHg at week 8 (P < 0.0001). Similarly, a reduction in mean diastolic blood pressure (DBP) was seen from 104.47 mmHg at baseline to 88.45 mmHg at week 8 (P < 0.0001). Around 70% of patients achieved the target BP (< 140/90 mmHg). Within the context of the study design, the physicians' global efficacy assessment suggested that 51.35% were extremely satisfied and 48.01% were satisfied with the treatment outcomes. Similarly, the tolerability assessment indicated that 52.95% of physicians were extremely satisfied and 45.84% were satisfied, while only a small proportion (0.54-0.64%) reported neutrality.

Conclusions: Treatment with telmisartan and amlodipine FDC demonstrated significant antihypertensive effectiveness and was well-tolerated in the real-world among Indian patients with hypertension.

Background: Pediatric-inspired regimens (PIR) yield excellent outcomes for acute lymphoblastic leukemia (ALL). Despite national guidelines recommending PIR for adolescents and young adults (AYAs; aged 15-39 years), the use of guideline-concordant PIR in AYAs is inconsistent across treatment settings.

Methods: This retrospective observational study compared overall survival (OS) and stem cell transplant (SCT) use among AYAs treated with PIR versus non-PIR. Using a deidentified, geographically representative USA health claims database, we analyzed a cohort of AYAs with newly diagnosed ALL between 1 July 2007 and 30 September 2020.

Results: Among 599 patients who met the inclusion criteria, 187 (31%) received PIR, 303 (51%) received non-PIR, and for 109 (18%), treatment was undetermined. PIR and non-PIR groups were propensity score matched (n = 187 each). Using Kaplan-Meier methodology, OS was significantly higher for those treated with PIR versus non-PIR (log-rank P = 0.0001; hazard ratio [HR], 0.31; 95% confidence interval [CI], 0.18-0.55). For PIR and non-PIR, 1-, 3-, and 5-year survival estimates (95% CI) were 98.1% (95.3-99.3%) versus 88.3% (83.5-91.7%); 88.5% (82.6-92.5%) versus 69.1% (62.1-75.1%); and 87.3% (81.0-91.6%) versus 63.3% (55.2-70.3%). Sensitivity and subgroup analyses were consistent with primary results. By Kaplan-Meier methodology, SCT use was significantly lower among AYAs treated with PIR than non-PIR (log-rank P = 0.0004; HR, 0.46; 95% CI 0.30-0.71); use by 2 years was 16.5% (12.2-22.2%) and 33.4% (27.6-40.0%), respectively.

Conclusions: These results support the use of guideline-concordant PIR for AYA ALL.

Background: Major depressive disorder (MDD) affects over 332 million people globally. Although antidepressants are effective, adverse drug reactions (ADRs) may reduce adherence and quality of life (QoL). In Nepal, where mental health and pharmacovigilance (PV) systems are developing, assessing self-reported ADRs is essential. This study evaluated the antidepressant-induced ADRs among patients visiting the psychiatry outpatients department of a tertiary care hospital in Nepal.

Methods: A 3-month, single-center, cross-sectional study was conducted at the psychiatry outpatient department of Dhulikhel Hospital, Nepal. Using purposive sampling, 204 patients diagnosed with depression and receiving antidepressant therapy were assessed through structured interviews using validated tools like the Antidepressant Side-Effect Checklist (ASEC), Naranjo ADR Probability Scale, and Schumock and Thornton Criteria.

Results: Among 204 patients, the mean number of ADRs was 7.8 ± 6.2 per patient. Most participants were middle-aged (mean 42.8±11.2 years), urban residents (61.3%), and female (53.4%). Severe depression was the most frequent diagnosis (69.6%). Escitalopram (17.6%), amitriptyline (16.2%), and mirtazapine (14.7%) were most commonly prescribed. The most frequently reported ADRs were dry mouth (65.7%), blurred vision (61.3%), weight gain (59.8%), drowsiness (54.9%), and increased appetite (53.9%). Combination antidepressants therapy (26.9%) was associated with higher odds of increased appetite (adjusted odds ratio [AOR] 2.21, p < 0.05) and weight gain (AOR 1.87, p < 0.05). Naranjo assessment (mean score 2.1 ± 1.8) indicated that most ADRs were 'possible' (33.8%), a small proportion were 'probable' (3.4%), and none met criteria for 'definite' or 'doubtful'. All ADRs were predictable Type A reactions. The ASEC-based severity assessment showed most ADRs were mild (23.6%) to moderate (26.5%) with a lower proportion being severe (15.5%); thus, no treatment adjustments were made but counselling was provided as ADRs were clinically manageable through routine monitoring and counselling.

Conclusion: Given the high frequency of predictable Type A ADRs and the increased metabolic effects observed with combination therapy, these findings emphasize the need for routine monitoring and strengthened PV practices to improve antidepressant safety in resource-limited settings like Nepal.

Background and objectives: Respiratory tract infections and skin and soft-tissue infections are some of the most common causes of outpatient visits. Upper respiratory tract infections (URTIs) are the most common type of infection globally, as well as in India. In 2019, its global incidence was 17.2 billion. Additionally, the Infectious Diseases Society of America 2012 guidelines for the management of Group A streptococcal pharyngitis strongly recommend penicillin or amoxicillin for individuals without penicillin allergy. Therefore, we conducted this study to assess the real-world safety and efficacy of a fixed-dose combination of cephalexin extended release and clavulanate potassium (cephalexin CV) in patients with URTIs and uncomplicated skin and soft-tissue infections (uSSTIs).

Methods: In this phase IV, multicentre, open-label, single-arm study, patients with URTIs and uSSTIs were prescribed cephalexin CV (375 mg + 125 mg or 750 mg + 125 mg for severe infection) orally twice daily for 10 days. Patients were assessed for adverse events (AEs), clinical success defined as a clinical cure or clinical improvement, and microbiological success defined as a microbiological outcome of documented eradication or presumed eradication at the end of the study.

Results: A total of 230 patients were enrolled, 115 patients each with URTIs and uSSTIs. Only eight AEs were reported; seven were treatment-emergent AEs. In the URTI group, 1/115 (0.9%) patients reported one treatment-emergent AE and in the uSSTI group, 6/115 (5.2%) patients reported six treatment-emergent AEs. The most commonly reported treatment-emergent AE was diarrhoea. Three events of diarrhoea were related to the treatment (one in the URTI group and two in the uSSTI group). All AEs were of mild intensity and no serious AEs were reported. All patients with URTIs and 113 (98.3%) patients with uSSTIs showed clinical success; 16 (100%) patients with URTIs and 59 (96.7%) patients with uSSTIs showed microbiological success.

Conclusions: In this real-world study, the fixed-dose combination of cephalexin CV was safe, well tolerated and efficacious in terms of clinical and microbiological success for the treatment of URTIs and uSSTIs. In the current era of antimicrobial resistance, the fixed-dose combination of cephalexin CV can be an alternative therapeutic option.

Clinical trial registration: This study was prospectively registered on Clinical Trials Registry, India [CTRI/2022/07/044190] on 20 July, 2022; URL: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzA4MTA=&Enc=&userName= .

Background: Vulvovaginal candidiasis (VVC) is a common gynecological complaint. Ibrexafungerp (brand name: Brexafemme®) is a new, first-in-class oral antifungal medication approved as a 1-day treatment for VVC and as a monthly treatment to reduce frequency of recurrent VVC.

Objective: This article describes characteristics of patients who received ibrexafungerp and potential ibrexafungerp-related side effects in order to help inform optimal future use of this medication.

Methods: We used a large, national commercial health insurance claims database (the Merative^TM MarketScan® Commercial/Medicare Database) to identify female patients with one or more outpatient ibrexafungerp prescription during 1 July 2021 to 31 December 2023. We examined patient demographic characteristics, medical conditions and medications, type of healthcare provider seen, diagnostic testing performed, and potential ibrexafungerp side effects.

Results: Among 1368 female patients who received ibrexafungerp, most were also prescribed fluconazole or topical antifungals (84.7%) or had one or more vaginitis/vulvitis-related healthcare visit (76.9%) in the previous year. Few patients (2.9%) experienced a potential ibrexafungerp-related side effect.

Conclusions: Our results suggest that ibrexafungerp was generally used as non-first-line treatment for VVC.

Background and objectives: Oropharyngeal dysphagia (OD), a dysfunction in swallowing food or drink, can result from various diseases and adverse drug reactions. OD is a risk factor for aspiration pneumonia (AP). However, the specific drugs causing OD and their incidence rates are not fully understood. This study aimed to identify drugs associated with OD, their incidence rates, and AP risk factors in patients taking these drugs on the basis of the information provided in package inserts.

Methods: This study identified candidate dysphagia-inducing drugs (CDIDs) from Japanese package inserts that listed OD as an adverse reaction. The age, sex, medications, and comorbidities of patients taking CDIDs were analyzed using the JammNet insurance database, purchased from JammNet Co., Ltd. (Tokyo, Japan).

Results: Overall, 54 ingredients were identified as CDIDs. Out of 24,276 patients taking CDIDs, 146 (0.6%) were diagnosed with OD and 76 (0.3%) with AP. Among those with AP, 23 patients (30%) also had OD. OD or AP occurred in patients taking 28 (52%) of the 54 target ingredients. In addition, 13 ingredients had an adverse reaction incidence of 1% or greater for either condition. The top five CDIDs with the highest incidence rates for each diagnosis were clobazam, baclofen, zonisamide, tiapride hydrochloride, and topiramate. Incidence rates of OD and AP were significantly higher with multiple CDIDs than with a single drug (p < 0.05). Logistic regression analysis showed that AP occurrence was significantly associated with males, late-stage elderly individuals, a diagnosis of OD, and constipation.

Conclusions: The results of this study suggest that careful attention should be given to the risk of AP when prescribing CDIDs, particularly for elderly male patients.

Introduction: Pulmonary arterial hypertension (PAH) is a rare, chronic and progressive disease with a significant clinical, social, and economic impact. Despite available therapies, none address the underlying cause but rather focus on symptom management.

Objectives: This study aims to estimate the economic and social burden of PAH in Italy, including direct healthcare costs, direct nonhealthcare costs, and indirect costs related to productivity loss.

Methods: A bottom-up prevalence-based cost-of-illness model was developed using epidemiological data and healthcare resource consumption from national and international literature, validated by a panel of expert clinicians with extensive experience in the management of the condition across different regions of Italy. The analysis was conducted from a societal perspective over a 1-year horizon. The economic burden included direct healthcare costs (hospitalization, pharmaceuticals, and specialist care), direct nonhealthcare costs, and indirect costs related to productivity loss.

Results: In Italy, the prevalent population of patients with PAH is estimated between 2100 and 3500 individuals, with 2-5% in functional class (FC) I, 28-31% in FC II, 53-57% in FC III, and 7-11% in FC IV. The total annual expenditure for treatment and management is estimated between 263 million and 438 million euros, with 74% attributable to direct healthcare costs, 9% to direct nonhealthcare costs, and 17% to indirect costs. The mean annual cost per patient is approximately 125,000 € and increases with disease severity, ranging from 46,303 € for FC I to 252,176 € for FC IV.

Conclusions: PAH has a substantial economic burden, increasing with disease severity. Early diagnosis and targeted interventions could improve patient outcomes, reduce complications, and optimize resource allocation for the National Health Service and society.

Background: Chronic obstructive pulmonary disease (COPD) is a significant public health concern, and inhalation therapy is a critical component of its management. However, using an inhaler is challenging, especially for patients with COPD, who are often elderly and experience reduced dexterity, visual and cognitive impairment, and difficulty synchronizing inhalation with dose actuation. Synchrobreathe^® is an easy-to-use, breath-actuated inhaler that releases medication during inhalation, addressing these challenges. Although its use in asthma is well documented, evidence in COPD is limited.

Methods: This prospective, multicenter, observational study carried out during August 2021 and August 2022 evaluated the clinical outcomes of the budesonide/formoterol combination (BUD/FORM) delivered through Synchrobreathe^® in patients with COPD in India. The primary endpoint was disease control, that is, change from baseline in COPD Assessment Test (CAT) score at 12 weeks. Secondary endpoints included changes in CAT and modified Borg Dyspnea Scale (mBDS) scores and device usability. Adverse events were monitored over 12 weeks.

Results: In the study population (N = 250), significant reductions from baseline were observed in mean CAT (-6.56 ± 0.33; p < 0.001) and mBDS (-1.60 ± 0.09; p < 0.0001) scores at 12 weeks. Almost all (98%) patients were satisfied with Synchrobreathe^® and preferred it over their previous inhalers. No significant adverse events were reported.

Conclusion: BUD/FORM delivered through Synchrobreathe^® significantly improved CAT and mBDS scores, with no reported serious adverse events in patients with COPD. Its simple usage makes it an effective option for this patient population.