Use of potentially inappropriate medications and medications of concern in older adults with multiple myeloma / Utilização de medicamentos potencialmente inapropriados e medicamentos que requerem cautela em idosos com mieloma múltiplo

Objetivo: Analisar o uso de medicamentos potencialmente inapropriados (MPIs) e o uso de medicamentos usados em terapia de suporte que requerem cautela em idosos com câncer (MTSRCICs), determinando os fatores associados. Visou-se também determinar a concordância entre os critérios explícitos empregados na identificação de MPI. Metodologia: Estudo transversal com indivíduos com mieloma múltiplo (MM), idade ≥ 60 anos em tratamento ambulatorial. Os MPI foram identificados de acordo com os critérios AGS Beers 2019, PRISCUS 2.0 e o Consenso Brasileiro de Medicamentos Potencialmente Inapropriados (CBMPI). Os MTSRCIC foram definidos de acordo com a National Comprehensive Cancer Network. Os fatores associados ao uso de MPI e MTSRCIC foram identificados por regressão logística múltipla. O grau de concordância entre os três critérios explícitos empregados no estudo foi mensurado pelo coeficiente kappa Cohen. Resultados: As frequências de MPI foram 52,29% (AGS Beers 2019), 62,74% (CBMPI), 65,36% (PRISCUS 2.0) e 52,29% (MTSRCICs). As concordâncias entre AGS Beers 2019 com PRISCUS 2,0 e com CBMPI foram altas, enquanto a concordância entre CBMPI e PRISCUS 2.0 foi excelente. No modelo final de regressão logística polifarmácia foi associada positivamente ao uso de MPI por idosos para os três critérios explícitos utilizados, além de associado à utilização de MTSRCICs. Conclusões: A frequência do uso de MPI e de MTSRCIC foi elevada. A concordância em relação ao uso de MPI entre os critérios AGS Beers 2019, CBMPI e PRISCUS 2.0 foi alta ou excelente. A polifarmácia apresentou associação independente e positiva com uso de MPIs e de MTSRCICs por pacientes idosos com MM. (AU)

Objectives: To analyze the use of potentially inappropriate medications (PIMs) and medications used in supportive therapy that require caution in older adults with cancer, in addition to determining associated factors the agreement between criteria sets used to identify PIMs. Methods: This cross-sectional study included individuals with multiple myeloma aged ≥ 60 years who were undergoing outpatient treatment. PIMs were identified according to American Geriatric Society Beers 2019, PRISCUS 2.0, and Brazilian Consensus on Potentially Inappropriate Medicines criteria. Medications of concern were defined according to National Comprehensive Cancer Network criteria. Factors associated with the use of PIMs and medications of concern were identified using multiple logistic regression. The degree of agreement between the 3 criteria sets was measured using Cohen's kappa coefficient. Results: The frequency of PIM use was 52.29% according to American Geriatric Society Beers criteria, 62.74% according to Brazilian Consensus criteria, and 65.36% according to PRISCUS criteria, while 52.29% of the patients were using medications of concern. Agreement between American Geriatric Society Beers, PRISCUS, and Brazilian Consensus criteria was high, while it was excellent between Brazilian Consensus and PRISCUS criteria. In the final logistic regression model, polypharmacy was associated with PIM use according to each criteria set, as well as the use of medications of concern. Conclusions: The frequency of PIMs and medications of concern was high. Agreement about PIM use between the American Geriatric Society Beers, Brazilian Consensus, and PRISCUS criteria was high or excellent. There was an independent association between polypharmacy and the use of PIMs and medications of concern by older patients with multiple myeloma. (AU)

Incidence and reasons for discontinuation of first-line therapy in patients with multiple myeloma: results from a historical cohort, Brazil 2009-2020.

Multiple myeloma (MM) is an incurable hematological cancer requiring multiple lines of anti-myeloma regimens to promote disease remission and increase patient survival. The study assessed the incidence and reasons for discontinuation of first-line therapy in outpatients who started MM therapy in Belo Horizonte, Brazil from 2009 to 2020. A historical cohort study in which patients were followed from treatment initiation until discontinuation of first-line therapy. Discontinuation of first-line therapy was characterized as (i) discontinuation followed by a second-line therapy, and (ii) discontinuation that prevented patients from receiving a subsequent line of treatment. Non-parametric competing risk analysis with a 95% confidence interval estimated the cumulative incidences of discontinuation followed by a second-line therapy. The probability of discontinuation was compared according to selected variables using the Gray's test at a significance level of 5%. Approximately half of the participants (n = 260) were female and younger than 65 years. Discontinuation of first-line therapy followed by a second-line therapy accounted for 50.4% of the patients and occurred up to 30th month. The main reason for discontinuation not qualifying patients for receiving second-line therapy was to achieve a response to treatment. The maximum times for discontinuation not followed by a second-line therapy ranged from 12 to 20 months due to deaths or response to treatment. The probability of receiving second-line therapy was higher among patients initiating therapy in 2009-2014 and those not undergoing transplantation. In conclusion, discontinuation of first-line therapy followed by second-line treatment occurred as likely as the discontinuation not followed by a subsequent line.

Effect of therapeutic regimens and polypharmacy on health-related quality of life of people with multiple myeloma: a cross-sectional study in Belo Horizonte, Brazil.

OBJECTIVE: Multiple myeloma (MM) is an incurable hematological cancer and its treatment is geared to promote better Health-Related Quality of Life (HRQoL). We aimed to assess HRQoL and compare scores between variables on therapeutic regimens and polypharmacy in MM patients. METHODS: This cross-sectional study was performed from April/2019 to February/2020 in Belo Horizonte, Brazil. HRQoL scores were obtained by the QLQ-C30 and QLQ-MY20 instruments. Data were retrieved from interviews and medical records. Therapeutic regimens were grouped into thalidomide-containing regimens; bortezomib-containing regimens; bortezomib and thalidomide-containing regimens; other therapeutic regimens, and remission group. We performed univariate analyses by the Mann-Whitney method and adopted the Kruskal-Wallis test for multiple comparisons. Robust multiple linear regression was used to determine the association between independent variables and the HRQoL scores. RESULTS: The sample included 225 participants and most patients (65.3%) were on active treatment and had worse scores concerning future perspective. Polypharmacy was associated with worse scores on all scales in the univariate analyses. We observed a difference in the global health and body image (p < .05) scales in the multiple comparisons with therapeutic regimens. The global health scale difference was found between groups with other regimens and the remission group (p < .05). The difference between the bortezomib and thalidomide-containing regimens and remission group was not statistically significant (p = .077) in the body image scale. The multiple linear regression maintained the association of polypharmacy with worse HRQoL scores. CONCLUSION: We identified an independent association between HRQoL and polypharmacy in MM patients. However, there was no difference between the evaluated regimens, suggesting they are equivalent in Brazil about HRQoL.

Use of fall risk-increasing drugs in older adults with multiple myeloma: A cross-sectional study.

OBJECTIVE: To investigate the use of fall risk-increasing drugs (FRIDs) and associated factors and to assess the use of medicines that induce neuropathy in older adults with multiple myeloma (MM). METHODS: Cross-sectional study with older adults with MM treated at the outpatient oncology and hematology services in a southeastern Brazilian capital. FRIDs were classified according to the Screening Tool of Older Persons Prescription in older adults with high fall risk (STOPPFall). The high risk of falling was defined using the Medication Fall Risk Score scale, and the medicines that induce neuropathy were identified according to Vilholm et al. (2014) and Jones et al. (2019). Univariate and multivariate analyses were performed to verify the association between variables. RESULTS: Approximately 54.2% of the 153 older adults included in the study were female, and the median age was 70.9 years (IQR = 13; min = 60 and max:92). Around 71.3% used FRIDs, and diuretics (25.6%), antidepressants (20.5%), and opioids (19.9%) were the most used. A total of 32.7% had a high risk of falling. Polypharmacy was associated with a higher risk of using FRIDs. Statins used concomitantly with immunomodulators or bortezomib were the most used neuropathyinducing drugs, increasing fourfold the likelihood of reporting peripheral neuropathy. CONCLUSION: The frequency of use of FRIDs is high in older adults with MM and is positively associated with polypharmacy.

Adherence to thalidomide in patients with multiple myeloma: A cross-sectional study in a Brazilian metropolis.

PURPOSE: The treatment of multiple myeloma (MM) has advanced with the introduction of immunomodulators (IMiDS). Thalidomide is the IMiD available in Brazil with free access to MM patients. Adherence to treatment with IMiDs is essential for a successful therapy. The study proposed to describe adherence to thalidomide treatment in patients diagnosed with MM in onco-hematological outpatient clinics. METHODS: This is a cross-sectional study with patients over 18 years of age diagnosed with MM undergoing thalidomide treatment. Adherence was measured by the Proportion of Days Covered (PDC), which is an indirect method of measuring adherence that uses database-related medication dispensing information. Patients with PDC ≥90 were classified as adherent. The association between adherence and independent variables was assessed in univariate and multivariate analyses using logistic regression. RESULTS: A total of 65 patients with a median age of 62.6 years were identified. The median PDC was 93.7%. The frequency of adherence to thalidomide was 56.9%. Adherence to thalidomide showed a negative association with hospitalization in the last 12 months (OR = 0.202; 95% CI = 0.060-0.687) and with higher schooling (OR =0.161; 95% CI = 0.039-0.667) and a positive association with higher income (OR = 5.115; 95% CI = 1.363-19.190). CONCLUSION: Most patients from onco-hematological outpatient clinics in a metropolitan region of southeastern Brazil showed high adherence to thalidomide, which was independently associated with higher income, hospitalization, and higher schooling. More studies are required to understand better the determinants of adherence to thalidomide in the country.

Validity and reliability of the QLQ-MY20 module for assessing the health-related quality of life in Brazilians with multiple myeloma.

PURPOSE: Multiple myeloma (MM) is a rare but treatable hematological cancer, which makes the health-related quality of life (HRQoL) an important patient-report outcome measure in clinical studies. The Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to measure HRQoL in people with MM. However, the Brazilian Portuguese version of QLQ-MY20 has not yet been validated for Brazil. This study aimed to evaluate the validity and reliability of the instrument for application in Brazilian patients with MM. METHODS: This is a cross-sectional methodological study with patients seen in health services in Belo Horizonte, Brazil. The variables were collected through face-to-face interviews with the QLQ-MY20 instrument and complemented with data from medical records. Content validity analyses (content validity coefficient [CVC]; correctness ratio), convergent and divergent validity (Spearman's correlation coefficient [CC]), internal consistency, and temporal reproducibility (test-retest; intraclass correlation coefficient [ICC]) were performed. RESULTS: 225 patients were included and 71.1% were older than 60. The analysis of the judging committee showed adequate content validity. We observed mainly a good internal consistency of the items and good discrimination power in the convergent and divergent validity. High ICC values were observed through the test-retest, and there was no difference in the scores between the two moments, which shows good temporal stability of the instrument. CONCLUSION: The study allowed us to conclude that the Brazilian version of the QLQ-MY20 module is valid and reliable, and thus suitable for application in Brazilians living with MM.

Validation of an Instrument for Measuring Adherence to Treatment With Immunomodulators in Patients With Multiple Myeloma.

Background: Validate the Treatment Adherence Measure (TAM) instrument in outpatients with MM concerning construct validity, reliability and the ceiling and floor effects. Methods: This cross-sectional study included patients diagnosed with MM previously treated with an immunomodulator for at least one month, aged 18 or over, and followed-up in the investigated outpatient clinics. Adherence to immunomodulators was measured by TAM. The TAM's reliability was assessed using Cronbach's alpha; The association between adherence and health-related quality of life was investigated to analyze the divergent and convergent construct, measured by the Quality of Life Questionnaire core (QLQ-C30) and the Quality of Life Questionnaire Multiple Myeloma module (QLQ-MY20). The presence of a ceiling or floor effect in the TAM was also analyzed. Results: Eighty-four patients were included in the study, achieving 97.6% adherence. Cronbach's alpha was 0.41, and the hypothesis of convergent construct validity was confirmed, with statistical significance, in contrast to the hypothesis of divergent construct validity. The presence of the ceiling effect in TAM suggested that this instrument does not allow changes to be detected in individuals concerning adherence to IMiDs. Conclusion: TAM instrument did not show satisfactory validity and reliability to measure MM's adherence. MM patients treated at oncohematological outpatient clinics in a metropolitan region of southeastern Brazil showed high adherence to IMiDs.

Adverse events in patients with leprosy on treatment with thalidomide.

INTRODUCTION: Thalidomide, used to treat erythema nodosum leprosum (ENL), is associated with severe adverse events (AEs) and is highly teratogenic. METHODS: A cross-sectional study was conducted on thalidomide-treated patients with ENL. AEs and selected variables were investigated through interviews and assessment of medical records. Odds ratios with 95% confidence intervals were estimated via logistic regression. RESULTS: Peripheral neuropathy symptoms and deep vein thrombosis (DVT) were the most common AEs reported. Although women of reproductive age used contraceptives, <50% of patients reported using condoms. Polypharmacy was associated with all endpoints, except DVT. CONCLUSIONS: Pharmacovigilance is crucial to prevent harmful thalidomide-associated AEs.

Adverse events in patients with leprosy on treatment with thalidomide

Abstract INTRODUCTION: Thalidomide, used to treat erythema nodosum leprosum (ENL), is associated with severe adverse events (AEs) and is highly teratogenic. METHODS: A cross-sectional study was conducted on thalidomide-treated patients with ENL. AEs and selected variables were investigated through interviews and assessment of medical records. Odds ratios with 95% confidence intervals were estimated via logistic regression. RESULTS: Peripheral neuropathy symptoms and deep vein thrombosis (DVT) were the most common AEs reported. Although women of reproductive age used contraceptives, <50% of patients reported using condoms. Polypharmacy was associated with all endpoints, except DVT. CONCLUSIONS: Pharmacovigilance is crucial to prevent harmful thalidomide-associated AEs.