CoAprovel (irbesartan hydrochlorothiazide) / Sanofi - LARVOL DELTA

A comprehensive, population level evaluation of previously reported drug triggers of pemphigus highlights immunomodulatory capacity as a common characteristic. (PubMed, Front Immunol) - "In this series of observational, retrospective, case-control, pharmacovigilance analyses of the FDA Adverse Event Reporting System, the odds of reporting the adverse event pemphigus were significantly elevated among individuals exposed to 11/36 previously reported trigger drugs namely, gold sodium thiomalate, penicillamine, piroxicam, rifampin, hydroxychloroquine, imiquimod, hydrochlorothiazide, irbesartan, lisinopril, nivolumab, and nifedipine. Our findings reinforce the need for larger, more definitive studies to confirm these associations and to explore the mechanisms by which these drugs may contribute to PV development. Finally, these findings underscore the importance of considering environmental factors in the development and course of PV in genetically susceptible individuals."

Journal • Observational data • Retrospective data • Dermatology • Immunology • Pemphigus Vulgaris

Incidental Diagnosis of Lymphoplasmacytic Lymphoma in a Patient with CKD (KIDNEY WEEK 2024) - "His medication regimen included irbesartan, hydrochlorothiazide, nifedipine, levothyroxine, atorvastatin, and multivitamins. He was referred to hematology/oncology for further evaluation and treatment, receiving six cycles of Rituximab, Bendamustine, and Neulasta, resulting in normalized IgM levels and creatinine remained stable at 1.46 mg/dl. LPL in the kidney is exceedingly uncommon, with few case reports available. This case emphasizes the significance of renal biopsy in patients with stable renal function and unidentified causes of CKD, highlighting its utility in revealing unusual pathologies even when initial evaluations are inconclusive."

Clinical • B Cell Lymphoma • Cardiovascular • Chronic Kidney Disease • Genito-urinary Cancer • Hematological Disorders • Hematological Malignancies • Hypertension • Lymphoma • Lymphoplasmacytic Lymphoma • Monoclonal Gammopathy • Nephrology • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Solid Tumor • Thyroid Gland Carcinoma • Waldenstrom Macroglobulinemia • MYD88

The first description of mucous membrane pemphigoid induced by enalapril maleate: a case report. (PubMed, BMC Oral Health) - "ABID induced by antihypertensive drugs have been reported, and enalapril maleate has been implicated as an antihypertensive agent that may trigger AIBDs, such as MMP. This case highlights the potential relationship between antihypertensive drugs and MMP, of which clinicians should be aware to accurately diagnose and promptly relieve patients' pain."

Journal • Cardiovascular • Hypertension • Immunology • Pain

Methodology for risk assessment of nitrosamine drug substance related impurities in sartan and hydrochlorothiazide co-formulated products (ACS-Fall 2024) - "Factors contributing to genotoxic nitrosamine contaminants in Sartans, including tetrazole ring-containing molecules and nitroso group-complex forming molecules, are investigated alongside conditions necessary for nitrosamine formation.The methodology employs the N-Nitroso Acid Precursor (NAP) test, recommended by the WHO in 1978 with some modification to generate NDSRIs with selectivity, where individual glass vials containing drug substances are subjected to acidic conditions supplemented with NaNO2...Valsartan exhibits contamination by two distinct N-nitroso products, Losartan and Telmisartan each display contamination by three, while Olmesartan, Irbesartan, and HCTZ are found to be contaminated by one such product each. These findings, previously unreported, underscore the importance of robust risk assessment and mitigation strategies in safeguarding the integrity of combination antihypertensive drug products.In conclusion, this methodology provides a comprehensive..."

A Vector Theory of Assessing Clinical Trials: An Application to Bioequivalence. (PubMed, J Cardiovasc Dev Dis) - "In this work, VBC is applied to bioequivalence studies of three anti-hypertensive drugs: amlodipine, irbesartan, and hydrochlorothiazide. The results suggest that VBC is a reproducible, easily applicable method allowing for the discrimination and utilization of the endpoint component expressing different attributes. All clinical characteristics are assessed with increased statistical power, without inflation of type I error."

Journal

Comparing the adsorption of micropollutants on activated carbon from anaerobically stored, organics-depleted, and nitrified urine. (PubMed, Water Res) - "The urine solutions were spiked with 19 pharmaceuticals: amisulpride, atenolol, atenolol acid, candesartan, carbamazepine, citalopram, clarithromycin, darunavir, diclofenac, emtricitabine, fexofenadine, hydrochlorothiazide, irbesartan, lidocaine, metoprolol, N4-acetylsulfamethoxazole, sulfamethoxazole, trimethoprim, venlafaxine, and two artificial sweeteners, acesulfame and sucralose. In addition, we showed that the relative pharmaceutical removal in all solutions was independent of the initial pharmaceutical concentration unless the background organics matrix changed considerably. We conclude that removal of micropollutants in GAC columns from organics-depleted urine can be performed without clogging, but with the drawback of a higher carbon usage compared to removal from nitrified urine."

Journal

Impact of China's National Volume-Based Procurement on Medication Adherence and Clinical Outcomes Among Patients With Hypertension (ISPOR 2024) - "The study included users of originator antihypertensive medications covered by the first pilot NVBP, including amlodipine, irbesartan, losartan, and irbesartan hydrochlorothiazide combination formulations. NVBP had no negative effect on cardiovascular clinical outcomes in hypertensive patients and improved medication adherence."

Adherence • Clinical • Clinical data • Cardiovascular • Hypertension • Myocardial Infarction

Alcohol consumption and antihypertensive treatment effect in male patients with hypertension. (PubMed, Am J Hypertens) - "Alcohol drinkers compared with non-drinkers required a higher dosage of antihypertensive drug treatment to achieve similar blood pressure control."

Journal • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders

Efficacy of single-pill combination in uncontrolled essential hypertension: A systematic review and network meta-analysis. (PubMed, Clin Cardiol) - "The results of the network meta-analysis showed that a total of 11 single-pill combination antihypertensive drugs were included, namely: Amlodipine/valsartan, Telmisartan/amlodipine, Losartan/HCTZ, Candesartan/HCTZ, Amlodipine/benazepril, Telmisartan/HCTZ, Valsartan/HCTZ, Irbesartan/amlodipine, Amlodipine/losartan, Irbesartan/HCTZ, and Perindopril/amlodipine. Based on Ranking Plot of the Network, we can conclude that single-pill combination antihypertensive drugs are superior to monotherapy, and ARB/CCB combination has better advantages than other SPC in terms of systolic blood pressure, diastolic blood pressure, blood pressure control rate, and diastolic response rate. However, due to the small number of some drug studies, the lack of relevant studies has led to not being included in this study, which may impact the results, and readers should interpret the results with caution."

Journal • Retrospective data • Review • Cardiovascular • Hypertension

Amlodipine-induced gingival hypertrophy, a less known side effect to dermatologists (WCD 2023) - "BACKGROUND: Multiple factors may lead to Gingival hypertrophy (GH), including taking certain drugs (Phenytoin, Ciclosporin) but is uncommon for calcium channel blockers (CCB)...OBSERVATIONS: A 73-year-old man followed for basal cell carcinoma of the zygomatic region, touching the facial nerve, is in complete remission after partial excision and Vismodegib...We advise on replacing the CCB by Irbesartan / Hydrochlorothiazide and dental care...The prevalence of GH on calcium channel blocker varies according to the type of CCB, Amlodipine being estimated between 1.1 and 3.3% compared to 20% for Nifedipine...The earliest possible detection of GH is desirable. CCBs must therefore be known to dermatologists as being responsible for GH"

Adverse events • Basal Cell Carcinoma • Dental Disorders • Dermatology • Non-melanoma Skin Cancer • Oncology

Insidious mole, an infrequent collision tumor (WCD 2023) - "History of diabetes mellitus treated with Metformin 500mg/d, hypertension treated with Hydrochlorothiazide and Irbesartan 12.5mg/150mg. Immunohistochemistry with HMB45, marked positivity of neoplastic cells distributed throughout the thickness of the epidermis and surgical margins free of neoplasia. KEY MESSAGE: We present the first case reported worldwide of malignant melanoma in situ on a long-standing cherry angioma, an infrequent collision tumor, and its successful treatment using a Hughes Tarsoconjunctival flap and upper eyelid skin graft"

Cardiovascular • Dermatology • Diabetes • Genetic Disorders • Hypertension • Melanoma • Metabolic Disorders • Oncology • Pain • Pruritus • Skin Cancer • Solid Tumor

A rheumatologist in the ICU (EULAR 2023) - "Immunosuppressive treatment with cyclophosphamide (initial dose: 0.5gr/m2 of body surface), maintaining the rest of the treatment...Before admission, he was treated with vitamin K antagonists (VKAs), irbesartan and hydrochlorothiazide...A viral myo-pericarditis was suspected and a treatment with colchicine was initiated...A triple therapy with unfractionated heparin, steroids (3 pulses of 1 gram of Methylprednisolone then 1 mg/kg/day of prednisone for a few days with rapid tapering) and intravenous immunoglobulins (1 gram/kg/day for 3 days) allowed a dramatic improvement of the clinical status and biological abnormalities...The only persisting sequel was adrenal insufficiency. After three years of follow up, the patient is still well-controlled with VKAs and glucocorticoid supplementation."

Acute Kidney Injury • Cardiovascular • Complement-mediated Rare Disorders • Endocrine Disorders • Genetic Disorders • Hematological Disorders • Hypertension • Immunology • Infectious Disease • Inflammatory Arthritis • Nephrology • Novel Coronavirus Disease • Obesity • Obstructive Sleep Apnea • Pain • Pneumonia • Pulmonary Disease • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Rheumatology • Sjogren's Syndrome • Sleep Disorder • Thrombocytopenia • Vasculitis • Venous Thromboembolism • CRP

Amlodipine-induced gingival hypertrophy, a side effect less known to dermatologists (EADV-Sp 2023) - "Introduction: Multiple factors may lead to Gingival hypertrophy (GH), including taking certain drugs (Phenytoin, Ciclosporin) but is uncommon for calcium channel blockers (CCB)...Materials and A 73-year-old man followed for basal cell carcinoma of the zygomatic region, touching the facial nerve, is in complete remission after partial excision and Vismodegib...We advise on replacing the CCB by Irbesartan / Hydrochlorothiazide and dental care... Anterior, papillary localization with respect of the edentulous areas of the GH is a typical drug origin. The prevalence of GH on calcium channel blocker varies according to the type of CCB, Amlodipine being estimated between 1.1 and 3.3% compared to 20% for Nifedipine. Time to onset of GH is variable often being at 1 to 3 months after start of the treatment."

Adverse events • Basal Cell Carcinoma • Dental Disorders • Dermatology • Non-melanoma Skin Cancer • Oncology

Effect of administration of low-dose irbesartan and hydrochlorothiazide combined with levamlodipine at different times on the circadian rhythm of blood pressure and the levels of MMPs and TIMPs in non-dipper patients with grade 1 and 2 hypertension. (PubMed, J Clin Hypertens (Greenwich)) - "The percentage of the dipper type was higher in the night medication group than in the morning medication group, while the percentage of the non-dipper type was lower in the morning medication group (p < .05). Low-dose irbesartan and hydrochlorothiazide combined with levamlodipine at different times can effectively treat NDH, but bedtime dosing is more beneficial in reducing nocturnal blood pressure, reversing NDH, improving the circadian rhythm of blood pressure, left ventricular structure, regulating vascular endothelial function, increasing MMPs levels, and reducing TIMP levels."

Journal • Cardiovascular • Hypertension

Seasonal variation in the effect of antihypertensive treatment with the irbesartan/hydrochlorothiazide combination. (PubMed, Hypertens Res) - "Further subgroup analyses according to several baseline characteristics showed a greater between-season difference in the changes in systolic BP in patients aged ≥55 years than in those <55 years (n = 255, 12.6 mmHg vs. n = 246, 6.9 mmHg, P = 0.02), especially in patients who did not use antihypertensive medication at baseline (n = 94, 15.4 mmHg vs. n = 132, 5.4 mmHg, P = 0.006). In conclusion, there is indeed seasonality in the antihypertensive treatment effect, with a greater BP reduction in patients who commenced treatment in cold than warm seasons."

Journal • Cardiovascular • Hypertension

OBSERVATIONAL PROSPECTIVE STUDY OF AZILSARTAN MEDOXOMIL/ CHLORTALIDONE COMPARED WITH IRBESARTAN/ HYDROCHLOROTHIAZIDE COMBINATION THERAPY IN OBESE HYPERTENSIVES (PUZZLE). (PubMed, J Hypertens) - P=N/A | "Both fixed combinations of ARB and diuretic are safe and effective treatment of AH in obese patients, but long-term treatment with AZL-C allows to achieve more stable peripheral and central BP decrease."

Combination therapy • Journal • Observational data • Cardiovascular • Genetic Disorders • Hypertension • Obesity • Pulmonary Arterial Hypertension

"Hoy me encuentro con la sorpresa de que hay quiebre de stock en todas las cadenas de farmacias de #Santiago de #Chile del medicamento #coaprovel 150 /12.5 de @sanofi . Agotado también en V y IV región. Y yo sin medicamento de reemplazo porque NO existe." (@evelynpfeng)

"All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets by Lupin Pharmaceuticals: Recall - Due to Potential Presence of N-nitrosoirbesartan Impurity https://t.co/H5b7wn5292" (@FDAMedWatch)

Effect of Tripterygium wilfordii polyglycoside tablets on serum inflammatory factors and T cells in patients with chronic nephritis. (PubMed, Am J Transl Res) - "Treatment combined with Tripterygium wilfordii polyglycosides can significantly alleviate the inflammatory state of patients with chronic glomerulonephritis, reduce the level of proteinuria, and improve renal function. Tripterygium wilfordii polyglycosides can improve immune function of the body and has high safety."

Clinical • Journal • Glomerulonephritis • Lupus Nephritis • Nephrology • Ophthalmology • Renal Disease • CD4 • CD8 • CXCL8 • TNFA

Incident hyperuricemia in relation to antihypertensive therapy with the irbesartan/hydrochlorothiazide combination. (PubMed, Blood Press Monit) - "Thiazide-induced changes in serum uric acid or incident hyperuricemia were associated with the achieved SBP/DBP, being lower at the level of 130-139/<90 mm Hg."

Journal

An In Vitro-In Vivo Simulation Approach for the Prediction of Bioequivalence. (PubMed, Materials (Basel)) - "The predictability of the IVIVS procedure was evaluated through its application in the development process of a new generic product of amlodipine/irbesartan/hydrochlorothiazide. In this study, the IVIVS approach predicted successfully the BE outcome of the three drugs. During the development of generics, the IVIVS approach can save time and expenses."

Journal • Preclinical

A randomized controlled trial on home blood pressure monitoring and quality of care in stage 2 and 3 hypertension. (PubMed, Hypertens Res) - "The randomized patients in the HBPM (n = 96) and control groups (n = 405) had similar characteristics at baseline and similar use of higher dosages of irbesartan/hydrochlorothiazide (300 mg/12.5-25 mg) at 4 (9.4% vs. 12.2%, P = 0.45) and 8 weeks of follow-up (27.1% vs. 35.5%, P = 0.13). The proportion of patients who achieved the goal of clinic blood pressure control at 12 weeks of follow-up was significantly higher in the HBPM group than in the control group (66.7% vs. 55.1%, P = 0.04). In conclusion, HBPM improved treatment adherence and blood pressure control in patients with hypertension, despite similar antihypertensive treatment intensities."

Clinical • Journal • Hypertension • Metabolic Disorders

Simultaneous Determination of Hydrochlorothiazide and Irbesartan from Pharmaceutical Dosage Forms with RP-HPLC. (PubMed, Turk J Pharm Sci) - "Moreover, the suggested chromatographic technique was successfully applied for the determination of the drugs in human serum and pharmaceutical dosage forms with limit of detection values of 0.008 μg mL for IRBE and 0.012 μg mL for HCT. The proposed rapid analysis method of these antihypertensive drugs can be easily used and applied by pharmaceutical companies for which the analysis time is important."

Journal

[VIRTUAL] A Case of COVID-19-Associated Acute Pancreatitis (ACG 2020) - "Outpatient medications were irbesartan-hydrochlorothiazide, amlodipine and famotidine. Our case highlight that SARs-CoV-2 can also cause pancreatitis. In patients with COVID 19 and abdominal pain, pancreatitis should be considered."

Clinical • Acute Respiratory Distress Syndrome • Anorexia • Cardiovascular • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Hematological Disorders • Hypertension • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Pancreatitis • Pneumonia • Respiratory Diseases • Thrombosis • Venous Thromboembolism

[VIRTUAL] IgA Nephropathy in a Patient with Beta-Thalassemia Minor: A Case Report (KIDNEY WEEK 2020) - "He was treated initially, by another provider, with hydrochlorothiazide/irbesartan and carvedilol for hypertensive nephropathy...We managed successfully with irbesartan, amlodipine, NaHCO3 then furosemide...Significantly, at the time of biopsy, all cases had fibrosis in various degrees ranging from partial to global sclerosis with fibrous crescents. Notably, prior cases occurred in Asian ethnicities, were IgAN is prevalent; our case is the first Hispanic affected patient."

Clinical • Beta-Thalassemia • Cardiovascular • CNS Disorders • Diabetic Nephropathy • Fibrosis • Genetic Disorders • Glomerulonephritis • Hematological Disorders • Human Immunodeficiency Virus • Hypertension • Immunology • Infectious Disease • Ischemic stroke • Lupus Nephritis • Metabolic Disorders • Nephrology • Otorhinolaryngology • Psychiatry • Renal Disease