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Alberto Montanari, Davide Lazzeroni, Giovanna Pelà, Antonio Crocamo, Yuliya Lytvyn, Luisa Musiari, Aderville Cabassi, David Z I Cherney
AIMS: To investigate whether blockade of calcium channels (CCs) or Angiotensin II Type 1 receptors 1 (AT1R) modulates renal responses to nitric oxide synthesis inhibition (NOSI) in humans. METHODS: Fourteen sodium replete healthy volunteers underwent 90 minute infusions of 3.0 μ NG-nitro-L-arginine methylester (L-NAME), on 3 occasions, preceded by 3 days of either placebo (PL), 10 mg Manidipine (MANI), or 50 mg losartan (LOS). At each phase, mean arterial pressure (MAP), glomerular filtration rate (GFR, inulin), renal blood flow (RBF, p-aminohippurate), urinary sodium (UNaV) and 8-isoprostane (U8-iso-PGF2αV - an oxidative stress marker) were measured...
February 8, 2017: American Journal of Physiology. Renal Physiology
Luca Monaco, Mauro Melis, Chiara Biagi, Monia Donati, Ester Sapigni, Alberto Vaccheri, Domenico Motola
BACKGROUND: In July 2012 a new European legislation (Directive 2010/84/EU and Regulation No. 1235/2010) regarding pharmacovigilance has become effective. It has boosted the activity of Signal Detection through a monthly analysis of potential safety signals on EudraVigilance (EV). Our aim is to describe the procedure of signal detection on EV data and to present results obtained by the our pharmacovigilance centre. METHOD: Data are extracted from EV database, which collects suspected Adverse Drug Reactions (ADRs) of medicinal products in Europe...
March 2017: Expert Opinion on Drug Safety
Margarita Saiz-Satjes, Francisco Javier Martinez-Martin, Alex Roca-Cusachs
AIMS: In AMANDHA trial, the addition of manidipine, but not amlodipine, in diabetic patients with uncontrolled hypertension, microalbuminuria and preserved renal function resulted in a large decrease of urinary albumin excretion (UAE) despite similar blood pressure (BP) reductions. Factors associated with the reduction of UAE were analyzed. METHODS: For this purpose, a multivariable analysis was performed. RESULTS: Although after 6 months of treatment, manidipine and amlodipine decreased BP to a similar extent, reductions of UAE were higher with manidipine...
November 25, 2016: Future Cardiology
Benchawan Chamsai, Sontaya Limmatvapirat, Srisagul Sungthongjeen, Pornsak Sriamornsak
CONTEXT: Manidipine (MDP) is generally used clinically as an antihypertensive agent; however, the bioavailability of orally administered MDP is limited due to their very low water solubility. OBJECTIVE: The objectives of this research were, therefore, to increase the solubility of MDP by the formation of ternary solid dispersions (tSD) with polyethylene glycol 4000 (PEG4000) and copovidone and to improve their stability. METHODS: Solid ternary phase diagram was constructed to find homogeneous solid dispersion region after melting and solidifying at low temperature with different quenching substances...
March 2017: Drug Development and Industrial Pharmacy
Niloy Bhattacharjee, Sujata Barma, Nandita Konwar, Saikat Dewanjee, Prasenjit Manna
Diabetic nephropathy (DN), a chronic complication of diabetes, is charecterized by glomerular hypertrophy, proteinuria, decreased glomerular filtration, and renal fibrosis resulting in the loss of renal function. Although the exact cause of DN remains unclear, several mechanisms have been postulated, such as hyperglycemia-induced renal hyper filtration and renal injury, AGEs-induced increased oxidative stress, activated PKC-induced increased production of cytokines, chemokines, and different inflammatory and apoptotic signals...
November 15, 2016: European Journal of Pharmacology
Margarita Saiz Satjes, Francisco J Martinez-Martin
Renin-angiotensin system inhibitors should be considered as the first-line therapy in the treatment of patients with hypertension and diabetes. However, most of the diabetic subjects with hypertension require at least two drugs to achieve blood pressure targets. The ACCOMPLISH trial suggested that the best combination in the treatment of high-risk hypertensive patients should include a renin-angiotensin system inhibitor and a dihydropyridine. However, not all dihydropyridines block the same receptors. Those dihydropyridines that block T-type calcium channel blockers may provide additional advantages...
July 2016: Future Cardiology
Papapit Tuchinda, Kanokvalai Kulthanan, Sakunee Khankham, Kowit Jongjarearnprasert, Naruemon Dhana
BACKGROUND: Previous studies have shown that calcium channel blockers can cause cutaneous adverse reactions; however, the amounts of data collected are limited. Recently, there have been new drugs available for which only a few reports have been published with regard to cutaneous adverse reactions. OBJECTIVE: The purpose of our study was to estimate the rate and to study clinical patterns of cutaneous adverse drug reactions to calcium channel blockers. METHODS: Medical records of patients who had cutaneous adverse reactions to calcium channel blockers between January 2004 and December 2010, at the Adverse Drug Reaction Center of Siriraj hospital, Mahidol University, Bangkok, Thailand were reviewed...
September 2014: Asian Pacific Journal of Allergy and Immunology
Christos V Rizos, Moses S Elisaf
Hypertension plays a major role in the development and progression of micro- and macrovascular disease. Moreover, increased blood pressure often coexists with additional cardiovascular risk factors such as insulin resistance. As a result the need for a comprehensive management of hypertensive patients is critical. However, the various antihypertensive drug categories have different effects on glucose metabolism. Indeed, angiotensin receptor blockers as well as angiotensin converting enzyme inhibitors have been associated with beneficial effects on glucose homeostasis...
July 26, 2014: World Journal of Cardiology
Annalisa Zoppi, Amedeo Mugellini, Paola Preti, Andrea Rinaldi, Aldo Celentano, Emma Arezzi, Marco Alberici, Roberto Fogari
BACKGROUND: Failure to achieve good blood pressure (BP) control is probably the most important reason for high rates of morbidity and mortality in patients with hypertension. Combination therapy has been shown to increase the percentage of patients in whom BP control is achieved. One combination is a calcium channel blocker (CCB) and an angiotensin-converting enzyme inhibitor (ACE-I). OBJECTIVE: The aim of this study was to assess the effects of the fixed combination of the CCB manidipine and the ACE-I delapril in the treatment of hypertensive patients already given monotherapy with either component but with poor results (ie, insufficient BP control or adverse events [AEs])...
July 2003: Current Therapeutic Research, Clinical and Experimental
Vítor Todeschini, Maximiliano da Silva Sangoi, Alianise da Silva Meira, Diogo Miron, Alini Dall Cortivo Lange, Nadia Maria Volpato
A stability-indicating micellar electrokinetic chromatography (MEKC) method was developed and validated for simultaneous analysis of delapril (DEL) and manidipine (MAN) using salicylic acid as an internal standard. The MEKC method was performed using a fused-silica capillary (effective length of 72 cm) with 50 mM of borate buffer and 5 mM of anionic surfactant sodium dodecylsulfate at pH 9.0 as the background electrolyte. The separation was achieved at 25 kV applied voltage and 35 degrees C. The injection was performed at 50 mbar for 5 s, with detection at 208 nm...
January 2014: Journal of AOAC International
Fernanda Malaquias Barboza, Willian Moreira Machado, Luiz Renato Olchanheski Junior, Josiane Padilha de Paula, Sônia Faria Zawadzki, Daniel Fernandes, Paulo Vitor Farago
Microparticles of poly(ε-caprolactone) (PCL) and poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV) containing manidipine dihydrochloride (MAN) were successfully prepared by the simple emulsion/solvent evaporation method. All formulations showed loading efficiency rates greater than 80% and average particle size less than 8 μm. Formulations had spherical shape with smooth and porous surface for PCL and PHBV, respectively. According to Fourier-transform infrared spectroscopy, initial components were not chemically modified during microencapsulation...
2014: TheScientificWorldJournal
Vítor Todeschini, Amanda Thomas Barden, Leticia Lenz Sfair, Maximiliano da Silva Sangoi, Nadia Maria Volpato
A first-order derivative spectrophotometric (1D-UV) method was developed and validated for simultaneous determination of delapril (DEL) and manidipine (MAN) in tablets. The 1D-UV spectra were obtained using change lambda = 4.0 nm and wavelength set at 228 nm for DEL and 246 nm for MAN. The method was validated in accordance with the ICH requirements, involving the specificity, linearity, precision, accuracy, robustness and limits of detection and quantitation. The method showed high specificity in the presence of two drugs and formulation excipients and was linear over the concentration range of 18-54 microg mL(-1) (r2 = 0...
2013: Acta Chimica Slovenica
Loreley Betancourt-Castellanos, Esther Ponz-Clemente, M Sol Otero-López, Conchita Blasco-Cabañas, Dolors Marquina-Parra, Manuel García-García
Turbid acellular peritoneal fluid of a non-infectious aetiology is an uncommon entity in peritoneal dialysis and is characterised by a high concentration of triglycerides in the peritoneal fluid. The most common causes include cancer, lymphatic obstructions, pancreatitis, trauma, and even the use of certain medications such as calcium antagonists. The largest studies concerning this entity have been carried out in patients of Asian descent. We recently diagnosed 4 cases of turbid acellular peritoneal fluid at our institution in relation to the use of calcium antagonists...
2013: Nefrología: Publicación Oficial de la Sociedad Española Nefrologia
A J García Ruiz, J A Divisón Garrote, N García-Agua Soler, F Morata García de la Puerta, A C Montesinos Gálvez, L Avila Lachica
OBJECTIVE: The aim of this study is to compare the efficiency of different fixed-dose combinations of renin-angiotensin-aldosterone system (RAAS) blockers and calcium channel blockers, to use it as a guide to assist the rational prescribing in antihypertensive therapy. METHODS: The efficacy of each drug was obtained from intervention studies randomized, double-blind, made with these combinations and a utility-cost modeling from the model proposed and used by NICE...
March 2013: Semergen
Christian Ott, Markus P Schneider, Ulrike Raff, Martin Ritt, Kristina Striepe, Marco Alberici, Roland E Schmieder
AIMS: Intraglomerular pressure is one of the main drivers of progression of renal failure. Experimental data suggest that there are important differences between calcium channel blockers (CCBs) in their renal haemodynamic effects: manidipine reduces, whereas amlodipine increases intraglomerular pressure. The aim of this study was to investigate the effects of manidipine and amlodipine treatment on intragomerular pressure (P(glom)) in patients with mild to moderate essential hypertension...
January 2013: British Journal of Clinical Pharmacology
Evangelos N Liberopoulos, Elisavet Moutzouri, Christos V Rizos, Fotis Barkas, George Liamis, Moses S Elisaf
AIM: To compare the effect of manidipine 20 mg plus rosuvastatin 10 mg versus olmesartan 20 mg plus rosuvastatin 10 mg on markers of insulin resistance in patients with mixed dyslipidemia, hypertension, and impaired fasting glucose (IFG). METHODS: This study had a prospective, randomized, open-label, blinded endpoint (PROBE) design. A total of 40 patients with IFG, mixed dyslipidemia, and stage 1 hypertension were included. Following dietary intervention, patients were randomly allocated to rosuvastatin (10 mg/d) plus olmesartan (20 mg/d) or manidipine (20 mg/d)...
March 2013: Journal of Cardiovascular Pharmacology and Therapeutics
Y Uesawa, K Mohri
Quantitative structure-interaction relationship (QSIR) analyses of 1,4-dihydropyridine drugs were performed on grapefruit juice interaction potentials to characterize the interaction and evaluate drugs not yet tested in clinical research. AUC ratios of drugs with and without grapefruit juice ingestion were estimated as grapefruit juice interaction potentials from clinical studies on dihydropyridine drugs such as amlodipine, azelnidipine, benidipine, cilnidipine, felodipine, manidipine, nicardipine, nifedipine, nimodipine, nisoldipine, and pranidipine...
March 2012: Die Pharmazie
Yoshihiro Uesawa, Takahiro Takeuchi, Kiminori Mohri
Concomitant consumption of grapefruit juice (GFJ) causes increases in the plasma concentration of a variety of drugs due to inhibition of intestinal CYP3A enzyme. Dihydropyridine calcium channel blockers belong to the category of drugs that are most prone to undergo such interaction. Increases in area under the plasma concentration-time curve (AUC) due to GFJ differ greatly depending on the dihydropyridine administered. Therefore, a meta-analysis of each dihydropyridine was performed based on available literature...
July 2012: Current Pharmaceutical Biotechnology
Piero Ruggenenti, Giuseppe Lauria, Ilian Petrov Iliev, Anna Fassi, Aneliya Parvanova Ilieva, Stefano Rota, Carlos Chiurchiu, Drazenka Pongrac Barlovic, Angelo Sghirlanzoni, Raffaella Lombardi, Paola Penza, Guido Cavaletti, Maria Luisa Piatti, Barbara Frigeni, Marco Filipponi, Nadia Rubis, Greta Noris, Nicola Motterlini, Bogdan Ene-Iordache, Flavio Gaspari, Annalisa Perna, Jelka Zaletel, Antonio Bossi, Alessandro Roberto Dodesini, Roberto Trevisan, Giuseppe Remuzzi
To assess whether angiotensin-converting enzyme inhibitors and third-generation dihydropyridine calcium channel blockers ameliorate diabetic complications, we compared glomerular filtration rate (GFR; primary outcome), cardiovascular events, retinopathy, and neuropathy in 380 hypertensive type 2 diabetics with albuminuria <200 mg/min included in a multicenter, double-blind, placebo-controlled trial (DEMAND [Delapril and Manidipine for Nephroprotection in Diabetes]) and randomized to 3-year treatment with manidipine/delapril combination (10/30 mg/d; n=126), delapril (30 mg/d; n=127), or placebo (n=127)...
November 2011: Hypertension
Vítor Todeschini, Maximiliano da Silva Sangoi, Nadia Maria Volpato
A simple, specific, fast and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the simultaneous analysis of delapril (DEL) and manidipine (MAN) from their combination formulation was developed and validated using fesoterodine as the internal standard (IS). The LC-MS/MS method was carried out on a Luna C8 column (50 × 3.0 mm i.d., 3 µm) with a mobile phase consisting of methanol and 10 mmol L(-1) ammonium acetate (90 : 0, v/v), run at a flow rate of 0.25 mL min(-1). The mass spectrometry method was performed employing positive electrospray ionization operating in multiple reaction monitoring mode, monitoring the transitions of m/z 453...
2011: European Journal of Mass Spectrometry
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