Avaluació de l’efectivitat i la seguretat del cinacalcet en pacients amb malaltia renal crònica i hiperparatiroïdisme secundari sense tractament renal substitutiu

[cat] INTRODUCCIÓ: L’hiperparatiroïdisme secundàri (HPTS) és una complicació freqüent de la malaltia renal crònica (MRC), caracteritzat per un increment de la síntesi i secrecció de l’hormona paratiroïdal (PTH). La seva sobreproducció a llarg termini incrementa el risc de fractures òssies i la morbi-mortalitat cardiovascular. Es recomana iniciar tractament en aquells pacients amb anormalitats bioquímiques suggestives d’HPTS, encara que es trobin en fases primerenques de la MRC i no requereixin tractament renal substitutiu (TRS). El cinacalcet és un calcimimètic que actua disminuint la síntesi i secrecció de PTH. Forma part de les opcions terapèutiques de l’HPTS, però no presenta indicació en pacients sense TRS, on el seu ús és controvertit. OBJECTIUS: L’objectiu principal va ser avaluar l’efectivitat i la seguretat del cinacalcet en pacients amb MRC i HPTS sense TRS, per poder establir la possibilitat d’una nova indicació terapèutica. MÈTODES: Es va es va dissenyar un estudi analític, observacional, retrospectiu i multicèntric. Es van incloure pacients adults amb MRC i HPTS sense TRS ni trasplantament renal (TR), que van recollir el cinacalcet en les unitats de dispensació ambulatòria durant els anys 2010 i 2011 i disposessin mínim d’un any de seguiment des de l’inici del cinacalcet fins el TRS. RESULTATS: Es van incloure 41 pacients, amb una edat mitjana de 66 ± 15 anys i una PTH basal mitjana de 445,32 ± 236,03 pg/ml. Un 34%, un 51% i un 15% es trobaven en estadi 3, 4 i 5 de MRC respectivament. Un 67% dels pacients va aconseguir reduir el valor de PTH com a mínim en un 30% (p0,001) i va incrementar els de fosfat en un 13% (p>0,001). Un 20% dels pacients van experimentar hipocalcèmia (IC95% 7%-32%) i es va produir un increment dels episodis d’hiperfosfatèmia del 15% al 39% (IC95% 23%-55%). Un 25% va suspendre el tractament amb cinacalcet abans de finalitzar els 12 mesos. A llarg termini, es va observar com, durant els 12 als 36 mesos, es van mantenir els resultats d’efectivitat. Els valors de calci van disminuir durant els primers 12 mesos, però després es van mantenir. Els valors de fosfat van incrementar durant els primers 12 mesos, amb tendència a mantenir-se posteriorment. CONCLUSIÓ: El cinacalcet, en les condicions avaluades, va ser efectiu en la disminució dels nivells de PTH, ja en els primers tres mesos de tractament, observant-se resultats similars als dels estudis en pacients amb MRC i HPTS en TRS. En pacients no dialitzats, el cinacalcet produeix disminució dels valors de calci i, a diferència dels pacients en TRS, increment dels valors de fosfat, produint episodis de hipocalcèmia i de hiperfosfatèmia. A llarg termini, els valors de reducció de PTH aconseguits en el primer any de tractament es mantenen, almenys fins als 36 mesos. Les alteracions dels valors del calci i del fosfat es produeixen majoritàriament durant els primers 12 mesos, mentre que posteriorment es mantenen. Tanmateix, els episodis d’hiperfosfatèmia incrementen.[eng] INTRODUCTION: Secondary hyperparathyroidism (SHPT) is a common complication of chronic kidney disease (CKD), that worsens as renal function deteriorates. Main consequences include an increase of bone fractures and cardiovascular morbi-mortality. Cinacalcet decreases PTH secretion and release but its use in patients not yet on dialysis is controversial. METHODS: Analytical, observational, multicentric, retrospective study to evaluate effectiveness and safety of cinacalcet in patients with CKD and SHPT not yet on dialysis. Patients were included if they had collected cinacalcet during 2010 and 2011 from pharmacy outpatient department, and had undergone at least a year of treatment before the beginning of renal replacement therapy. RESULTS: 41 patients, with CKD stage 3 (34%), 4 (51%) and 5 (15%) and mean baseline PTH value of 445,32 ± 236,03 mg/dl. At twelve months, a 67% of patients achieved a reduction in PTH values ≥ 30 % (p 300 pg/ml. A 30% of the patients treated with cinacalcet achieved NKF/K-DOQI PTH goals (p=0.001, CI 12,6%-47,4%). Mean serum calcium decreased by 6% and mean serum phosphorus increased by 13%. A 20% of patients experienced hypocalcemia episodes. Hyperphosphatemia episodes increase from 15% to 39%. A 25% stopped cinacalcet before 12 months. Cinacalcet maintained reduction of PHT values between 12 and 36 months as well as decrease in calcium values. Phosphate values increased in the first 12 months but maintained afterwards. CONCLUSION: Cinacalcet is effective in controlling PTH levels in patients not on dialysis, similar to hemodialysis studies. Effectiveness of cinacalcet is maintained at least up to 36 months. Cinacalcet produces an increase in phosphate values in the first 12 months unlike hemodialysis patients. Calcium and phosphate disturbances are maintained between 12 and 36 months

Long-term effectiveness of cinacalcet in non-dialysis patients with chronic kidney disease and seconday hyperparathyroidism

Background: secondary hyperparathyroidism (SHPT) is a common complication of chronic kidney disease (CKD). Cinacalcet use is controversial in non-dialysis patients. Methods: this retrospective observational study recruited patients receiving cinacalcet (off-label use) in 2010 and 2011. Patients were followed for three years from the beginning of treatment using an intention-to-treat approach. Results: forty-one patients were studied: 14 CKD stage 3 (34.1%), 21 CKD stage 4 (51.2%), and 6 CKD stage 5 (14.6%). Median baseline parathyroid hormone (PTH) was 396 (101-1,300) pg/mL. Upon cinacalcet treatment (22 ± 12 months), PTH levels decreased by ≥ 30% in 73.2% of patients (P < 0.001; 95% confidence interval [CI], 59-87%), with a mean time for response of 18.7 months (95% CI, 15.4-22.1). Sixteen patients were followed for 36 months and treated for 32 ± 9 months. Mean reduction in their PTH levels was 50.1% (P < 0.001; 95% CI, 33.8-66.4%) at 36 months, with 62.5% of patients (P < 0.001; 95% CI, 35.9-89.1%) presenting reductions of ≥ 30%. Serum calcium levels decreased from 9.95 ± 0.62 mg/dL to 9.21 ± 0.83 and 9.12 ± 0.78 mg/dL at 12 and 36 months, respectively (P < 0.001). Serum phosphorus levels increased from 3.59 ± 0.43 to 3.82 ± 0.84 at 12 months (P = 0.180), remaining so at 36 months (P = 0.324). At 12 and 36 months, 2 (12.5%) patients experienced hypocalcemia. Meanwhile, 1 (6.3%) and 4 (25.0%) patients reported hyperphosphatemia at 12 and 36 months, respectively. Conclusion: Cinacalcet remained effective for at least 36 months in non-dialysis patients with SHPT. Electrolytic disturbances were managed with concurrent use of vitamin D and its analogs or phosphate binders

Effectiveness of Cinacalcet in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Not Receiving Dialysis.

Background Secondary hyperparathyroidism (SHPT) is a common complication in chronic kidney disease (CKD) patients. Cinacalcet could be a therapeutic option although its use is controversial in patients not receiving dialysis. Thus, the aim of this study is to assess the effectiveness and safety of cinacalcet in patients with CKD and SHPT without renal replacement treatment (RRT) and without renal transplantation (RT). Methods A retrospective observational study was conducted. Patients were included if they had collected cinacalcet, under off-label use, during 2010 and 2011. Patients selected were followed from the beginning of cinacalcet therapy for one year of treatment. Results A total of 37 patients were included with CKD stage 3 (38%), 4 (51%) and 5 (11%). Baseline mean PTH value was 400.86 ± 168.60 mg/dl. At 12 months, a 67% of patients achieved at least a 30% reduction in their PTH value (p<0.001; CI 49.7-83.6), and the overall mean reduction of PTH values was 38% (p< 0.001; IC -49.1, -27.5). A 28% of the patients achieved KDOQI PTH goals (p = 0.003, CI 12%-50%). At 12 months, mean serum calcium values decreased by 6% and mean serum phosphorus values increased by 13%. A 19% of patients experienced hypocalcemia episodes while an increase of 24% in hyperphosphatemia episodes was observed. A 25% of patients finished cinacalcet before a year of treatment. Main withdrawal reasons were: gastrointestinal and other discomfort (8%), hypocalcaemia (8%), non-compliance (3%), interactions (3%) and excess of efficacy (3%). Conclusions Cinacalcet was effective in patients with CKD and SHPT not receiving dialysis. Electrolytic imbalances could be managed with administration of vitamin D and analogues or phosphate binders

Utilidad de las redes sociales en farmacovigilancia. Situación actual y perspectivas de futuro

Las redes sociales (RRSS) son una herramienta de transmisión de información, y hacen uso de ella la mayoría de las instituciones para diseminar información sobre medicamentos y productos sanitarios, incluyendo información sobre alertas de efectos adversos de medicamentos. Cabe destacar que, para este objetivo, existe una gran variedad de fuentes de información en RRSS para pacientes y sanitarios. Es fundamental conocer no sólo cuáles son las cuentas de interés para mantenerse informado, sino también aquellas que permiten la posibilidad de poder obtener datos de seguridad de medicamentos conforme a lo que se publica espontáneamente por parte de este sistema. El objetivo del presente trabajo es revisar las cuentas profesionales de las diferentes RRSS que pueden ser útiles para la obtención pasiva de la información sobre los efectos adversos de los medicamentos. Además de introducir las posibilidades de las RRSS como fuente para generar datos de seguridad de medicamentos y sus perspectivas en el futuro. Palabras clave: Farmacovigilancia, redes sociales, profesionales sanitarios

Effectiveness of Cinacalcet in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Not Receiving Dialysis.

BACKGROUND:Secondary hyperparathyroidism (SHPT) is a common complication in chronic kidney disease (CKD) patients. Cinacalcet could be a therapeutic option although its use is controversial in patients not receiving dialysis. Thus, the aim of this study is to assess the effectiveness and safety of cinacalcet in patients with CKD and SHPT without renal replacement treatment (RRT) and without renal transplantation (RT). METHODS:A retrospective observational study was conducted. Patients were included if they had collected cinacalcet, under off-label use, during 2010 and 2011. Patients selected were followed from the beginning of cinacalcet therapy for one year of treatment. RESULTS:A total of 37 patients were included with CKD stage 3 (38%), 4 (51%) and 5 (11%). Baseline mean PTH value was 400.86 ± 168.60 mg/dl. At 12 months, a 67% of patients achieved at least a 30% reduction in their PTH value (p<0.001; CI 49.7-83.6), and the overall mean reduction of PTH values was 38% (p< 0.001; IC -49.1, -27.5). A 28% of the patients achieved KDOQI PTH goals (p = 0.003, CI 12%-50%). At 12 months, mean serum calcium values decreased by 6% and mean serum phosphorus values increased by 13%. A 19% of patients experienced hypocalcemia episodes while an increase of 24% in hyperphosphatemia episodes was observed. A 25% of patients finished cinacalcet before a year of treatment. Main withdrawal reasons were: gastrointestinal and other discomfort (8%), hypocalcaemia (8%), non-compliance (3%), interactions (3%) and excess of efficacy (3%). CONCLUSIONS:Cinacalcet was effective in patients with CKD and SHPT not receiving dialysis. Electrolytic imbalances could be managed with administration of vitamin D and analogues or phosphate binders

Safety of Short-Term Treatments with Oral Chloroquine and Hydroxychloroquine in Patients with and without COVID-19: A Systematic Review

Chloroquine (CQ) and hydroxychloroquine (HCQ) have recently become the focus of global attention as possible treatments for Coronavirus Disease 2019 (COVID-19). The current systematic review aims to assess their safety in short treatments (≤14 days), whether used alone or in combination with other drugs. Following the PRISMA and SWiM recommendations, a search was conducted using four health databases for all relevant English-, Chinese-, and Spanish-language studies from inception through 30 July 2021. Patients treated for any condition and with any comparator were included. The outcomes of interest were early drug adverse effects and their frequency. A total of 254 articles met the inclusion criteria, including case and case-control reports as well as cross-sectional, cohort, and randomised studies. The results were summarised either qualitatively in table or narrative form or, when possible (99 studies), quantitatively in terms of adverse event frequencies. Quality evaluation was conducted using the CARE, STROBE, and JADAD tools. This systematic review showed that safety depended on drug indication. In COVID-19 patients, cardiac adverse effects, such as corrected QT interval prolongation, were relatively frequent (0–27.3% and up to 33% if combined with azithromycin), though the risk of torsade de pointes was low. Compared to non-COVID-19 patients, COVID-19 patients experienced a higher frequency of cardiac adverse effects regardless of the regimen used. Dermatological adverse effects affected 0–10% of patients with autoimmune diseases and COVID-19. A broad spectrum of neuropsychiatric adverse effects affected patients treated with CQ for malaria with variable frequencies and some cases were reported in COVID-19 patients. Gastrointestinal adverse effects occurred regardless of drug indication affecting 0–50% of patients. In conclusion, CQ and HCQ are two safe drugs widely used in the treatment of malaria and autoimmune diseases. However, recent findings on their cardiac and neuropsychiatric adverse effects should be considered if these drugs were to be proposed as antivirals again

Supplementary_Table – Supplemental material for Hydroxyurea-Induced Pneumopathy in a Patient With Myeloproliferative Syndrome

<p>Supplemental material, Supplementary_Table for Hydroxyurea-Induced Pneumopathy in a Patient With Myeloproliferative Syndrome by Oriol Plans Galván, Hipólito Pérez Moltó, Ariadna Fabià-Mayans, Blanca Xicoy, José Luis Mate and Pilar Ricart Martí in Clinical Medicine Insights: Case Reports</p

Effectiveness of Cinacalcet in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Not Receiving Dialysis.

Background Secondary hyperparathyroidism (SHPT) is a common complication in chronic kidney disease (CKD) patients. Cinacalcet could be a therapeutic option although its use is controversial in patients not receiving dialysis. Thus, the aim of this study is to assess the effectiveness and safety of cinacalcet in patients with CKD and SHPT without renal replacement treatment (RRT) and without renal transplantation (RT). Methods A retrospective observational study was conducted. Patients were included if they had collected cinacalcet, under off-label use, during 2010 and 2011. Patients selected were followed from the beginning of cinacalcet therapy for one year of treatment. Results A total of 37 patients were included with CKD stage 3 (38%), 4 (51%) and 5 (11%). Baseline mean PTH value was 400.86 ± 168.60 mg/dl. At 12 months, a 67% of patients achieved at least a 30% reduction in their PTH value (p<0.001; CI 49.7-83.6), and the overall mean reduction of PTH values was 38% (p< 0.001; IC -49.1, -27.5). A 28% of the patients achieved KDOQI PTH goals (p = 0.003, CI 12%-50%). At 12 months, mean serum calcium values decreased by 6% and mean serum phosphorus values increased by 13%. A 19% of patients experienced hypocalcemia episodes while an increase of 24% in hyperphosphatemia episodes was observed. A 25% of patients finished cinacalcet before a year of treatment. Main withdrawal reasons were: gastrointestinal and other discomfort (8%), hypocalcaemia (8%), non-compliance (3%), interactions (3%) and excess of efficacy (3%). Conclusions Cinacalcet was effective in patients with CKD and SHPT not receiving dialysis. Electrolytic imbalances could be managed with administration of vitamin D and analogues or phosphate binders

Supplementary_Figure – Supplemental material for Hydroxyurea-Induced Pneumopathy in a Patient With Myeloproliferative Syndrome

<p>Supplemental material, Supplementary_Figure for Hydroxyurea-Induced Pneumopathy in a Patient With Myeloproliferative Syndrome by Oriol Plans Galván, Hipólito Pérez Moltó, Ariadna Fabià-Mayans, Blanca Xicoy, José Luis Mate and Pilar Ricart Martí in Clinical Medicine Insights: Case Reports</p

Patient baseline caractheristics.

<p>Patient baseline caractheristics.</p