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Selected AbstractsProspects for therapeutic vaccination with glatiramer acetate for neurodegenerative diseases such as Alzheimer's diseaseDRUG DEVELOPMENT RESEARCH, Issue 2 2002Michal Schwartz Abstract Neurodegenerative diseases, whatever their primary causes, are characterized by certain common features, one of which is their self-perpetuating nature. The ongoing progression of the disorder is due to the effects of destructive self-compounds, whose presence in the tissues is an outcome of the early phase of the disease and which gradually destroy remaining functional neurons. Studies in our laboratory have led to the recent formulation of a novel concept of protective autoimmunity as the body's mechanism of defense against these destructive self-compounds. This autoimmune response to central nervous system (CNS) insults is mediated by T-cells and presumably operates by activating and regulating local microglia and infiltrating macrophages (inflammatory response) to carry out their function of clearing destructive material from the tissue at risk. We suggest that a well-controlled autoimmunity counteracts and overcomes the destructive effects of the potentially harmful self-compounds, at the cost of some loss of tissue. An additional risk to the individual is the induction of an autoimmune disease, which is likely to occur if the autoimmune response is malfunctioning. An optimal balance of the various factors will lead to an outcome of maximal benefit at minimal cost to the tissue. A procedure for safely boosting the autoimmune response, by vaccination with a weak self-crossreactive antigen such as glatiramer acetate (also known as Cop-1) was found to protect rats from glutamate toxicity, a major mediator of the spread of damage and a well-known causative factor in neurodegenerative disorders. Cop-1, when administered according to a different regimen, is an FDA-approved drug for the treatment of multiple sclerosis. Different formulations of the same drug can therefore be used to treat two extreme manifestations of chronic degenerative diseases of the CNS. Drug Dev. Res. 56:143,149, 2002. © 2002 Wiley-Liss, Inc. [source] Continuation and long-term maintenance treatment with Hypericum extract WS® 5570 after successful acute treatment of mild to moderate depression , rationale and study designINTERNATIONAL JOURNAL OF METHODS IN PSYCHIATRIC RESEARCH, Issue 3 2004Chairman, S. Kasper Professor Abstract Unipolar major depression is often a chronic disease that may require lifelong prophylaxis. Recovery from an acute episode is followed by 4-6 months of relapse prevention. After that, long-term maintenance treatment is administered to avoid recurrence. We present the rationale and design of an ongoing double-blind, randomized, placebo-controlled trial investigating the efficacy of Hypericum extract WS® 5570 in relapse prevention in recurrent unipolar depression. An estimated sample of 425 adults with recurrent, mild to moderate major depression (ICD-10 and DSM-IV criteria), ,3 previous episodes (last 5 years) and a total score ,20 points on the 17-item Hamilton Rating Scale for Depression (HAMD) will be included. After a one-week wash out patients receive 3 × 300 mg/day WS® 5570 single-blind for 6 weeks. Responders are randomized to 26 weeks of double-blind continuation treatment with 3 × 300 mg/day WS® 5570 or placebo. Patients completing continuation treatment without relapse enter 52 weeks of double-blind maintenance treatment, where those treated with WS® 5570 are re-randomized to 3 × 300 mg/day WS® 5570 or placebo. The primary outcome measure is the time to relapse during continuation treatment (HAMD ,16, clinical diagnosis of depression, or premature treatment termination for inefficacy). Hypericum extract, with its favourable tolerability profile, could be an interesting option for long-term prophylaxis. The trial was designed according to current consensus and guidance. Notably, it includes long-term prophylactic treatment with the same drug and the same therapeutic dose applied during acute treatment, uses well-defined outcome measures and provides a clear distinction between relapse and recurrence. Copyright © 2004 Whurr Publishers Ltd. [source] Publication bias perpetuates use of ineffective drugs in strokeINTERNATIONAL JOURNAL OF STROKE, Issue 3 2009K. Prasad Drugs approved and used for treatment of stroke vary from country to country. This is, at least, partly because of variation in the standards of evidence that is required for approval of drugs across countries. For example, some countries, usually low and middle income ones, approve a drug on the basis of a small positive study or post hoc subgroup analysis in a overall negative study, while others, usually high income countries, require confirmatory or replication studies before approving the same drug. Needless to say that such confirmatory or replication studies need to be published and adequately disseminated as soon as possible so that approval decisions can be revised in the light of additional evidence. However, this does not always happen. The new evidence often remains hidden in the form of nonpublication or abbreviated publication. Sometimes, it is published but with undue delay. What is worrisome is that these problems occur more often when the new evidence does not favor the new drugs than when it favors them, a manifestation of what is called ,publication bias.' This bias is well documented in the stroke research literature (1, 2). [source] Structure determination of diclofenac in a diclofenac-containing chitosan matrix using conventional X-ray powder diffraction dataJOURNAL OF APPLIED CRYSTALLOGRAPHY, Issue 2 2004Nongnuj Muangsin The structure determination of diclofenac embedded in a diclofenac-containing chitosan matrix using conventional X-ray powder diffraction data is demonstrated. It reveals that sodium diclofenac, the starting material in the preparation of a controlled-release diclofenac-containing chitosan matrix, changes to diclofenac acid in space group C2/c in the matrix. Simple methods were employed for handling the sample to obtain X-ray powder diffraction data of sufficiently high quality for the determination of the crystal structure of diclofenac embedded in chitosan. These involved grinding and sieving several times through a micro-mesh sieve to obtain a suitable particle size and a uniformly spherical particle shape. A traditional technique for structure solution from X-ray powder diffraction data was applied. The X-ray diffraction intensities were extracted using Le Bail's method. The structure was solved by direct methods from the extracted powder data and refined using the Rietveld method. For comparison, the single-crystal structure of the same drug was also determined. The result shows that the crystal structure solved from conventional X-ray powder diffraction data is in good agreement with that of the single crystal. The deviations of the differences in bond lengths and angles are of the order of 0.030,Å and 0.639°, respectively. [source] Adding sufentanil to levobupivacaine or ropivacaine intrathecal anaesthesia affects the minimum local anaesthetic dose requiredACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 9 2009R. PARPAGLIONI Background: We carried out this prospective, randomized, double-blind study in order to evaluate whether the intrathecal addition of sufentanil 3.3 mcg affects both the minimum local anaesthetic dose (MLAD) of spinal levobupivacaine and ropivacaine for a caesarean section and enhances the spinal block characteristics. Methods: One hundred and eighty women were randomly allocated into four groups: levobupivacaine (Group L), levobupivacaine plus sufentanil (Group L+S), ropivacaine (Group R) and ropivacaine plus sufentanil (Group R+S). Each received 3 ml of the study solution intrathecally as part of a combined spinal/epidural technique. The initial dose was 12 mg for Groups L and L+S, and 15 mg for Groups R and R+S. The test solution was required to achieve a visual analogue pain score (VAPS) of 30 mm or less to be considered effective at skin incision, uterine incision, birth, peritoneal closure and at the conclusion of surgery. Effective or ineffective responses determined a 0.5 mg decrease or increase of the same drug, respectively, for the next patient in the same group, using an up,down sequential allocation. Results: Using the Dixon and Massey formula, the MLAD was 10.65 mg [confidence interval (CI) 95%: 10.14,11.56] in Group L, 4.73 mg (CI 95%: 4.39,5.07) in Group L+S, 14.12 mg (CI 95%: 13.50,14.60) in Group R and 6.44 mg (CI 95%: 5.86,7.02) in Group R+S. Conclusions: The addition of sufentanil reduced the MLAD of both the local anaesthetics. It did not affect their potency ratio significantly and resulted in enhanced spinal anaesthesia. [source] Systematic review of the efficacy of antiretroviral therapies for reducing the risk of mother-to-child transmission of HIV infectionJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 3 2007N. Suksomboon PhD Summary Objective:, To evaluate the efficacy of antiretroviral therapies in reducing the risk of mother-to-child transmission of HIV infection. Methods:, Systematic review and meta-analysis of randomized controlled trials. Clinical trials of antiretrovirals were identified through electronic searches (MEDLINE, EMBASE, BIOSIS, EBM review and the Cochrane Library) up until November 2006. Historical searches of reference lists of relevant randomized controlled trials, and systematic and narrative reviews were also undertaken. Studies were included if they were (i) randomized controlled trials of any antiretroviral therapy aimed at decreasing the risk of mother-to-child transmission of HIV infection, (ii) reporting outcomes in terms of HIV infection in infant, infant death, stillbirth, premature delivery, or low birth weight. The data were extracted by a single investigator and checked by a second investigator. Disagreements were resolved through discussion or a third investigator. The efficacy was estimated using relative risk (RR), risk difference (RD) and number needed to treat (NNT) together with 95% confidence intervals. Results:, Fifteen trials were included in the systematic review. Based on five placebo-controlled trials, a zidovudine regimen reduced the risk of mother-to-child transmission by 43% (95% CI: 29,55%). The incidence of low birth weight seems to be decreased with zidovudine (pooled RR 0·75, 95% CI: 0·57,0·99). The efficacy of short-short course of zidovudine was comparable with that of the long-short course. Nevirapine monotherapy given to mothers and babies as a single dose reduced the risk of vertical transmission compared with an intrapartum and post-partum regimen of zidovudine (RR 0·60, 95% CI: 0·41,0·87). Zidovudine plus lamivudine was effective in reducing the risk of maternal-child transmission of HIV (RR 0·63, 95% CI: 0·45,0·90). Adding zidovudine to single-dose nevirapine in babies was no more effective than nevirapine alone (pooled RR 0·88, 95% CI: 0·47,1·63), nor was there any significant difference between zidovudine plus lamivudine and nevirapine. In mothers who were treated with standard antiretroviral therapy, no additional benefit was observed with the addition of a single dose of nevirapine in mothers and newborns. In addition, for mothers who received zidovudine prophylaxis, a two-dose intrapartum/newborn nevirapine reduced the risk of HIV infection and death of babies by 68% (95% CI: 39,83%) and 80% (95% CI: 10,95%), respectively, when compared with placebo. Conclusions:, The available evidence suggests that zidovudine alone or in combination with lamivudine and nevirapine monotherapy is effective for the prevention of mother-to-child transmission of HIV. They may also be beneficial in reducing the risk of infant death. Different antiretroviral regimens appear to be comparably effective in reducing HIV transmission from mothers to babies. In mothers already receiving zidovudine prophylaxis, adding a single dose of nevirapine to mothers during labour and giving the same drug to infants may further decrease the risk of vertical transmission and infant death. [source] Differential sensitivity to the effects of nicotine and bupropion in adolescent and adult male OF1 mice during social interaction testsAGGRESSIVE BEHAVIOR, Issue 4 2008M.C. Gómez Abstract Few studies have compared the action of both nicotine (NIC) and bupropion (BUP), an antidepressant used to treat NIC dependence, on social and aggressive behavior at different ages. This study aims to determine whether these drugs produce differential effects in adolescent (postnatal day: 36,37) and adult (postnatal day: 65,66) mice that have been housed individually for 2 weeks in order to induce aggressive behavior. Mice received BUP (40, 20, or 10,mg/kg), NIC (1, 0.5, and 0.25,mg/kg as base), or vehicle earlier to a social interaction test. BUP (40,mg/kg) decreased social investigation and increased nonsocial exploration in both adolescent and adult mice. The same effects were also observed in adult mice administered with a lower dose of the same drug (20,mg/kg). In adolescents, NIC (1,mg/kg) decreased social investigation, but this effect did not reach statistical significance in adults. In conclusion, a differential sensitivity to the effects of NIC or BUP emerged in some of the behavioral categories when the two age groups were compared. Aggr. Behav. 34:369,379, 2008. © 2008 Wiley-Liss, Inc. [source] Eudragit RL100 nanoparticle system for the ophthalmic delivery of cloricromeneJOURNAL OF PHARMACY AND PHARMACOLOGY: AN INTERNATI ONAL JOURNAL OF PHARMACEUTICAL SCIENCE, Issue 7 2004Claudio Bucolo A Eudragit RL100 polymer nanoparticle system loaded with cloricromene was prepared and characterized on the basis of physicochemical properties, stability and drug release features. To investigate the ocular bioavailability of cloricromene after inclusion in the polymer matrix, the new nanoparticle system was topically administered in the rabbit eye and compared with an aqueous solution of the same drug. The nanoparticle system showed interesting size distribution and surface charge values, suitable for ophthalmic application. The results indicated that the dispersion of cloricromene within Eudragit RL100 polymer nanoparticles increased its ocular bioavailability and enhanced the biopharmaceutical profile. The new cloricromene-loaded nanoparticle system described here may be useful in clinical practice. [source] Adverse drug reactions in medical intensive care unit of a tertiary care hospital,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2009Lisha Joshua MBBS Abstract Purpose Patients in the intensive care unit (ICU) have multiorgan dysfunction as well as altered pharmacokinetic parameters. Hence they are susceptible to adverse drug reactions (ADRs). The objective of the study is to assess the characteristics of ADRs among inpatients in the medical ICU and to compare the same with patients who have not experienced ADRs. Methods Prospective, observational study for a period of 1 year in medical ICU of a tertiary care hospital. Relevant data of patients with ADRS were analysed. Characteristics of patients with and without ADRs were compared. Results Of 728 patients admitted in medical ICU, 222 (28.4%) had ADRs. Multiple ADRs (38.7%) implicated by the same drug and serious ADRs (37%) were noticed. Renal/electrolyte system (21%) was most commonly involved. Clinical spectrum included acute renal failure (ARF, 11.4%), hepatic injuries (5.4%), haematological dysfunction (4.2%), seizures (3.3%), upper gastrointestinal bleed (3.3%) and cutaneous ADRs (3.3%). Antimicrobials (27%) were the commonly implicated drug class. The most commonly implicated drug was furosemide (6.8%). Infrequently reported ADRs included azithromycin-induced erythema multiforme, leflunamide-induced erythema multiforme and vasculitis, ceftazidime-induced seizures and ceftriaxone-induced hepatitis. Co-morbidity, polypharmacy and duration of stay were significantly higher in patients with ADRs compared to those who have not experienced ADRs. Three patients died. Conclusion High incidence of serious and multiple ADRs noticed. A wide clinical spectrum of ADRs and infrequently reported ADRs to newer drugs were also observed. Copyright © 2009 John Wiley & Sons, Ltd. [source] Estimation and Inference for a Spline-Enhanced Population Pharmacokinetic ModelBIOMETRICS, Issue 3 2002Lang Li Summary. This article is motivated by an application where subjects were dosed three times with the same drug and the drug concentration profiles appeared to be the lowest after the third dose. One possible explanation is that the pharmacokinetic (PK) parameters vary over time. Therefore, we consider population PK models with time-varying PK parameters. These time-varying PK parameters are modeled by natural cubic spline functions in the ordinary differential equations. Mean parameters, variance components, and smoothing parameters are jointly estimated by maximizing the double penalized log likelihood. Mean functions and their derivatives are obtained by the numerical solution of ordinary differential equations. The interpretation of PK parameters in the model and its flexibility are discussed. The proposed methods are illustrated by application to the data that motivated this article. The model's performance is evaluated through simulation. [source] GSTT1 and GSTM1 gene deletions are not associated with hepatotoxicity caused by antitubercular drugsJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 4 2010S. Chatterjee MD Summary Background and objective:, Susceptibility to antitubercular drug (ATD)-induced hepatotoxicity may be genetically mediated, with variant alleles of genes such as N -acetyltransferase (NAT2) and CYP2E1 reported as risk factors. Two studies of Asian populations have reported that GSTM1*0/*0 (null) genotype was a likely predictor of hepatotoxicity, whereas another of a Caucasian population implicated GSTT1*0/*0. We undertook a prospective case,control study to investigate whether GSTM*0/*0 and GSTT1*0/*0 were risk factors for ATD-induced hepatotoxicity. Methods:, Pulmonary tuberculosis patients on isoniazid, rifampicin and pyrazinamide who developed hepatotoxicity using defined criteria were prospectively identified. These cases were then matched with at least one control subject on the same drugs but without hepatotoxicity. Genotyping for GSTM1 and GSTT1 was performed by multiplex PCR on genomic DNA. The odds ratios for the frequency of specific GSTM1 and GSTT1 homozygotes in the case and control subjects were calculated to test for association between the genotypes and hepatotoxicity. Results and discussion:, Hundred and fifty-one subjects (51 cases, 100 controls) were enrolled. Odds ratio for GSTM1 null genotype was 1·00 (95% CI 0·51,1·97) and GSTT1 null was 2·02 (95% CI 0·39,10·39), respectively, showing that these genotypes are not associated with hepatotoxicity. Conclusion:,GSTM1 *0/*0 or GSTT1 *0/*0 or both null genotypes, do not appear to be associated with ATD-induced hepatotoxicity in our Indian population. [source] Neuronal nitric oxide synthase does not contribute to the modulation of pulmonary vascular tone in fetal lambs with congenital diaphragmatic hernia (nNOS in CDH lambs),PEDIATRIC PULMONOLOGY, Issue 4 2008Anthony S. de Buys Roessingh MD Abstract Aim The aim of this study was to determine the presence of the neuronal nitric oxide synthase (nNOS) in near full-term lambs with congenital diaphragmatic hernia (CDH) and its role in the modulation of pulmonary vascular basal tone. Methods We surgically created diaphragmatic hernia on the 85th day of gestation. On the 135th, catheters were used to measure pulmonary pressure and blood flow. We tested the effects of 7-nitroindazole (7-NINA), a specific nNOS antagonist and of N -nitro- l -arginine (l -NNA), a nonspecific nitric oxide synthase antagonist. In vitro, we tested the effects of the same drugs on isolated pulmonary vessels. The presence of nNOS protein in the lungs was detected by Western blot analysis. Results Neither 7-NINA nor l -NNA modified pulmonary vascular basal tone in vivo. After l -NNA injection, acetylcholine (ACh) did not decrease significantly pulmonary vascular resistance (PVR). In vitro, l -NNA increased the cholinergic contractile-response elicited by electric field stimulation (EFS) of vascular rings from lambs with diaphragmatic hernia. Conclusion We conclude that nNOS protein is present in the lungs and pulmonary artery of near full-term lamb fetuses with diaphragmatic hernia, but that it does not contribute to the reduction of pulmonary vascular tone at birth. Pediatr Pulmonol. 2008; 43:313,321. © 2008 Wiley-Liss, Inc. [source] Familial cases of Henoch-Schönlein purpura in eight familiesPEDIATRICS INTERNATIONAL, Issue 6 2005Osamu Motoyama AbstractBackground:,Familial cases of Henoch-Schönlein purpura (HSP) have rarely been reported. Methods:,Familial cases of HSP were reviewed by medical records of 418 children with HSP. Results:,Two members developed HSP in eight families. HSP occurred in a mother and her daughter in one family and in siblings, including one pair of twin sisters, in seven other families. Four pairs of patients developed HSP at the same age. Three pairs presented HSP within 1 month of each other and the other pairs presented HSP between 9 months and 5 years. Seven patients had a history of allergic diseases. The clinical courses of 12 patients were reviewed. Upper respiratory tract infection preceded HSP in 10 patients, two of whom had elevated antistreptolysin-O titers. No pairs of patients in a family received the same drugs before the onset of HSP. Abdominal pain was noted in eight patients, arthralgia in six and nephritis in four. Severity of skin lesions, presence of abdominal pain and nephritis, and serum IgA levels at the acute stage varied among family members of HSP. Conclusions:,The incidence of HSP in family members of children with HSP seems to be high. Onset at the same age and onset of HSP within 1 month in siblings have not previously been reported. There were no characteristic or similar findings between two patients of the same family. No trigger or genetic factor causing HSP was identified. [source] Fast and automated functional classification with MED-SuMo: An application on purine-binding proteinsPROTEIN SCIENCE, Issue 4 2010Olivia Doppelt-Azeroual Abstract Ligand,protein interactions are essential for biological processes, and precise characterization of protein binding sites is crucial to understand protein functions. MED-SuMo is a powerful technology to localize similar local regions on protein surfaces. Its heuristic is based on a 3D representation of macromolecules using specific surface chemical features associating chemical characteristics with geometrical properties. MED-SMA is an automated and fast method to classify binding sites. It is based on MED-SuMo technology, which builds a similarity graph, and it uses the Markov Clustering algorithm. Purine binding sites are well studied as drug targets. Here, purine binding sites of the Protein DataBank (PDB) are classified. Proteins potentially inhibited or activated through the same mechanism are gathered. Results are analyzed according to PROSITE annotations and to carefully refined functional annotations extracted from the PDB. As expected, binding sites associated with related mechanisms are gathered, for example, the Small GTPases. Nevertheless, protein kinases from different Kinome families are also found together, for example, Aurora-A and CDK2 proteins which are inhibited by the same drugs. Representative examples of different clusters are presented. The effectiveness of the MED-SMA approach is demonstrated as it gathers binding sites of proteins with similar structure-activity relationships. Moreover, an efficient new protocol associates structures absent of cocrystallized ligands to the purine clusters enabling those structures to be associated with a specific binding mechanism. Applications of this classification by binding mode similarity include target-based drug design and prediction of cross-reactivity and therefore potential toxic side effects. [source] Histopathological effects on epidural tissue of bolus or continuous infusions through an epidural catheter in ewesANAESTHESIA, Issue 5 2010H. Türe Summary This study was performed to evaluate the histopathological effects of epidural drug injection given either by intermittent bolus or continuous infusion through a catheter on epidural tissue. Fourteen ewes received intermittent bolus injections of morphine with bupivacaine, or a bolus of the same drugs followed by continuous infusion for 5 days. After 5 days, histopathological examination of the epidural space revealed mild to moderate inflammatory changes, and focal fibrosis surrounding the catheter in all ewes. The similarity of the inflammatory reaction in the control and drug treated groups seems to indicate that neither intermittent bolus or continuous infusion after a bolus dose caused histopathological changes in the epidural space beyond that caused by the catheter itself. [source] Six of the Best, Colorectal 21BRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue S1 2002I. Taylor Aims: Intrahepatic arterial (IHA) therapy should deliver higher doses of drug to the liver with reduced overall systemic exposure. An IHA regimen was designed which used the same drugs and schedule, and achieved similar toxicity and steady-state venous 5FU levels as the standard de Gramont IV regimen. Patients with advanced colorectal liver metastases were randomized to either IV or IHA. Methods: In total 290 patients were randomized from 16 centres in 6 years. The median age was 62 years, 70 per cent were male, 68 per cent had colon cancer. Of the 145 patients allocated to IV, 14 per cent did not receive any allocated therapy, but 78 per cent received six cycles of chemotherapy. Of the 145 IHA patients, 37 per cent did not start and only 35 per cent received six cycles. The additional problems in the IHA group were inability to insert the catheter, or infected, leaking, or blocked catheters. Of the patients who did not receive six cycles of IHA therapy, 52 per cent switched to IV therapy. Similar levels of toxicity and quality of life were reported in both arms. Results: There was no clear evidence of a difference in progression-free survival (HR 0.90, 95 per cent CI: 0.71,1.16; P = 0.42) or overall survival (HR 1.03, 95 per cent CI: 0.79,1.33; P = 0.85). From randomization median, and estimated 1- and 2-year survival were 14.1 months in both groups, and 60 and 57 per cent, and 26 and 22 per cent for IV and IHA, respectively. Conclusions: This trial suggests that there is no obvious role for this IHA regimen in the management of hepatic metastatic colorectal cancer. [source] Tolerability of High Doses of Lercanidipine versus High Doses of Other Dihydropyridines in Daily Clinical Practice: The TOLERANCE StudyCARDIOVASCULAR THERAPEUTICS, Issue 1 2008Vivencio Barrios The TOLERANCE study was aimed to compare the tolerability of high doses of lercanidipine (20 mg) with that of other frequently used dihydropyridines (amlodipine 10 mg/nifedipine GITS 60 mg) in the treatment of essential hypertension in daily clinical practice. It was an observational, transversal, multicentre study performed in a Primary Care Setting. A total of 650 evaluable patients with essential hypertension and age , 18 years were included. They had been treated with high doses of lercanidipine (n= 446) or amlodipine/nifedipine GITS (n= 204) during at least 1 month and previously with low doses (10 mg, 5 mg, and 30 mg, respectively) of the same drugs. The main objective was to compare the rates of vasodilation-related adverse events between both groups. Rates of signs and symptoms related to vasodilation were significantly higher (P < 0.001) in the amlodipine/nifedipine GITS group (76.8%, CI 95%[70.7; 82.9]) than in lercanidipine group (60.8%, [56.1;65.5]). Blood pressure control (< 140/90 mmHg or <130/80 for diabetics) and type of concomitant antihypertensive medications were similar in both groups. Treatment compliance was good (around 93%) and fairly comparable in both groups. Most adverse events with lercanidipine were mild (74.5% vs. 64% in amlodipine/nifedipine GITS group, P= 0.035) whereas severe adverse event rates did not differ significantly between groups (2.8% vs. 3.6%). In conclusion, treatment with lercanidipine at high doses is associated with a lower rate of adverse events related to vasodilation compared to high doses of amlodipine or nifedipine GITS in clinical practice. [source] | |||||||||||||||||||||||||