Adjustment Of Drug Therapy Research Articles

PO-04-227 CHARACTERISTICS AND OUTCOMES OF PREGNANT WOMEN WITHOUT STRUCTURAL HEART DISEASE PRESENTING WITH VENTRICULAR ARRHYTHMIAS

Ventricular arrhythmias (VA) are rare in pregnancy especially in women without a history of cardiac disease. We aimed to describe the characteristics of women without structural heart disease presenting with VA during pregnancy, and the maternal and fetal outcomes. Pregnant women without known structural heart disease referred to a specialized pregnancy program for VA during pregnancy were retrospectively reviewed. VA were defined as 1) high burden PVCs (PVC>500/24 hours), 2) non sustained VT (NSVT, 3 or more beats at a rate>100 bm lasting for less than 30 s) or 3) sustained VT (ventricular tachycardia at a rate>100 bm lasting for more than 30 minutes). Holter recordings, ECGs and telemetry strips were reviewed. Baseline characteristics and maternal and fetal outcomes were collected. Of 81 women referred for VA, 63 had documented VA during pregnancy and were included in the study. Mean age was 34±5 years and 28 (44%) were nulliparous. A total of 20 (32%) women presented for high PVC burden, 18 (28%) for NSVT, and 22 (35%) for both. Three patients (5%) presented with sustained VT requiring emergent intervention. The median Holter PVC burden was 12% (min-max range 1-66%); the median NSVT length was 10 beats± 8 and the median rate was 178±38 bpm. Most of the VA occurred during the second trimester (mean week 24 ±8). Nine (14%) women had an abnormal ECG at baseline. A total of 40 women had documentation of the VA morphology from the 12-lead-ECG and 18 (45%) of them had an origin from the right ventricular outflow tract (RVOT, Figure 1). A total of 41(66%) were treated with betablockers (29 with metoprolol, 3 bisoprolol, 2 nadolol, 5 with propranolol), 2 with verapamil, 2 with flecainide and 1 with amiodarone. Eleven (18%) women required hospital admission (Table 1) and initiation or adjustment of drug therapy. Three patients had thromboembolic events. Of the three patients who presented with sustained arrhythmias, one had symptomatic heart failure and one died during pregnancy. Eight babies and 6 twins (total 14) had a birthweight <2500 gr, four babies were born preterm and 4 required resuscitation at birth. No fetal deaths occurred. Ventricular arrhythmias from the RVOT are common in pregnant women without structural heart disease. Most of the women with non-sustained arrhythmias have favorable outcomes, however, careful fetal and maternal monitoring in a specialized pregnancy program is required.Tabled 1Table 1: Details of hospital admissions (PO-04-227)Patient numberAge at deliveryGA (weeks)SymptomsVA detailsRVOT morphologyTreatmentOutcomes1232329SyncopePre-syncopePVCs, NSVTYesMetoprolol 37.5 mg TIDTransition from verapamil 120 mg TID to flecainide 50 mg TIDDischarged home23512Pre-syncopePVCs, NSVTNo (polymorphic)Metoprolol titration from 50 mg bid to 75 mg BIDDischarged home33512Pre-syncope/palpitationsSustained VTNo (RBBB, QRS axis +60ˆ)IV procainamide+ IV metoprololFlecainide 150 BID+ nadolol 120 ODDischarged home44024Palpitations/shortness of breathPVCs, NSVTYesTransition from metoprolol 25 mg BID to verapamil 240 mg BIDDischarged home53835SyncopeNSVTYesMetoprolol 50 TIDDischarged home63529Pre-syncope/palpitationsSustained VTNo (LBBB, superior axis)Esmolol IV infusionMetoprolol 125 TIDAmiodarone 400 mg ODDischarged home73424Cardiac arrestSustained VTNo (LBBB, QRS axis -30ˆ)CPR + epinephrineDeath83929PalpitationsPVCs, NSVTNo (RBBB, inferior axis)None (patient refused)Discharged home93924PalpitationsNSVTUnknownPropranolol 20 TIDDischarged home103835PalpitationsPVCsYesNone (patient refused)Discharged home113113Pre-syncope/palpitationsNSVTNo (LBBB, superior axis)Metoprolol 37.5 mg TIDDischarged home Open table in a new tab

Spontaneous Pulmonary Hematoma: Case Report of a Giant Post-COVID-19 Hematoma and Literature Review.

Pulmonary hematomas are a rare pathology. Although they are usually reported post-traumatically, there are also spontaneous forms in pulmonary pathologies or during drug therapy. In these spontaneous entities, primitive forms are rarely described, although the contributory local pulmonary pathological terrain or a specific associated medication has not yet been identified. We present the case of a patient who developed a giant pulmonary hematoma that appeared spontaneously during recovery from COVID-19 infection. It appeared in one of the two bullae-like cystic lung lesions developed during secondary COVID-19 infection. The clinical impact was major, with hypotension and anemia being observed, requiring hemodynamic support and the adjustment of drug therapy. The clinical course was favorable, with a quasi-complete resolution of both the hematoma and a second cystic lesion being observable at 8 months by pulmonary remodeling. Spontaneous pulmonary hematomas may constitute a pathological entity associated with a post-COVID-19 remodeling process of the lung and the related anticoagulant treatment, which should be recognized, especially in the actual COVID-19 pandemic or in the widespread use of anticoagulant treatment. Conservative treatment is the method of choice, even in giant lung forms.

Problems and prospects of it in healthcare in Russia: modern realities

Information and communication technologies penetrate into all areas of everyday life of modern society, learning, helping and replacing human labor. Without information technologies, it is already impossible to imagine the field of medical science: at present and in the near future, they will improve the continuity of health monitoring, take over the prediction of the risks of complications, the adjustment of drug therapy during life and many other processes.&#x0D; The article is devoted to the problems and prospects of information technologies in healthcare in Russia. The general model of information technologies, problems and ways of solving the restrictions from Western campaigns are highlighted. In view of the digitalization of the healthcare system in our country, the article talks about the need to ensure the continuity and independence from external influence of information technology systems in its full cycle: from client terminals, communication systems, to data storage and processing servers.&#x0D; The most important factor that allows us to speak with confidence about the development of specialized information technologies solutions in the healthcare system of the Russian Federation is an effective state policy in ensuring the digitalization of the economy: national projects, government programs, changes in legislation, roadmaps for achieving key indicators.

Treatment strategies in diabetic nephropathy - Update 2022

A new classification of patients with diabetes mellitus into so-called clusters can be used to assess the risk of developing diabetic nephropathy. Up to date treatment of patients with diabetic nephropathy includes not only glycemic control, but focuses on a holistic approach with prevention of (progression of) secondary diabetic complications and reduction of the patient's cardiovascular mortality. To achieve this treatment goals, it requires comprehensive management of the patient to implement lifestyle interventions (regarding diet, physical activity, weight loss, smoking cessation) and selection of the medication with the greatest individual benefit. Part of lifestyle intervention is adherence to a dietary regimen that has again been shown in recent studies to be relevant in inhibiting progression of chronic kidney disease and reducing cardiovascular risk. In particular, this includes protein restriction with preference for plant sources of protein, and salt restriction. Adjustment of drug therapy is no longer based on antihyperglycemic effects alone, but takes into account inhibition of progression of nephropathy and cardiac risk, as well as support of body weight control. For this purpose, in addition to RAAS inhibitors from the field of antihypertensives, the antidiabetic classes of SGLT2 inhibitors and GLP-1 receptor agonists as well as the non-steroidal aldosterone antagonist finerenone are now available.

Public Knowledge About How Common Chronic Diseases Affect Wound Healing Postoperatively in Aseer Region.

Background Wound healing has classically been described to occur in three phases, regardless of the mechanism of injury. These phases are the inflammatory, proliferative, and remodeling phases. Chronic diseases adversely affect the wound healing process, and more needs to be done for different policies, such as adjustment of drug therapy, diet, or behavior to help rapid wound healing. Diabetes, auto-immune diseases, obesity, malnutrition, cardiovascular disease, chronic renal disease, and cancers are the frequent co-morbidities affecting wound healing. Aim To assess the public knowledge about how common chronic diseases affect wound healing postoperatively in Aseer Region. Methodology A descriptive cross-sectional study targeting the general population living in the Aseer region for at least a year. Data were collected using a pre-structured electronic questionnaire initiated by the researchers after an intense literature review and experts' consultation. The study questionnaire covered participants' data, smoking and medical history, surgical history, and participant knowledge items. A questionnaire was used as a digital survey and distributed to all participants in a private and anonymous process. Results A total of 502 participants completed the study questionnaire. Participants' ages ranged from 18 to 60 years, with a mean age of 34.6 ± 12.9 years old. A total of 294 (58.6%) participants were males, and 341 (67.9%) were university graduates. Exact 430 (85.7%) know that Supervision and control of Diabetes Mellitus help in wound healing, 369 (73.5%) reported that Chronic diseases delay wound healing, and 449 (89.4%) think that commitment to therapeutic and preventive plans before and after any surgical procedure contributing in rapid wound healing for chronic diseases patients. As for the effect of chronic diseases on a surgical wound, 320 (63.7%) reported delayed wound healing, 241 (48%) knew it may increase the infection, and 186 (37.1%) reported it might Decrease blood supply to the site of a wound. Conclusions In conclusion, the study revealed that more than half of the population in Aseer regions were knowledgeable regarding the effect of chronic diseases on post-optative wound healing, especially for the benefit of a commitment to therapeutic and preventive plans before and after any surgical procedure.

Drug Interaction Management in Critically Ill Patient

Drug interaction in critically ill patient is very common and affecting patients Physically, Mentally and Financially. There are various measures which has been taken to minimize this burden on patient, such as books being prepared which include various drug interaction, maintain websites and database that provides information regarding drug interactions. With the use of these website and databases the drug interaction can be managed. It is common practice that side effects of drug interaction are being managed by additional drugs, the main reason behind it could be non-availability of alternative drugs or costlier alternative. These factors remain the main cause of treatment failure in majority of patients leading to prolong. The current study was performed for the duration of 12 months, from this study it was identified that 113 types of major drug interactions commonly found in total 250 prescriptions which were evaluated and managed accordingly. Suggestions being prescribed by various sites were, avoid concomitant use of drug, use alternative therapy, and monitor closely for any adverse effect. During suggestion made by the Clinical Pharmacist, for the same drug interactions it was identified that more of drug therapy adjustment can be done then provided by the online database. The parameter on which the drug interactions management are being suggested were focused on just type of drug interaction and its effect, it does not include the actual pharmacodynamic and pharmacokinetic changes in therapy. The suggestion made by the clinical pharmacist were includes drug removal, drug dosage changes, alternative therapy, alternative route of administration, change in time interval etc. From this study it was concluded that the drug interaction management can be done at various stages of treatment with proper therapy modification by the clinical pharmacist, and if done properly it will improve the overall outcome of patient health care.

Correct use of non-indexed eGFR for drug dosing and renal drug-related problems at hospital admission

PurposeTwo to seven percent of the German adult population has a renal impairment (RI) with an estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2. This often remains unrecognized and adjustment of drug therapy is lacking. To determine renal function in clinical routine, the CKD-EPI equation is used to calculate an indexed eGFR (ml/min/1.73m2). For drug dosing, it has to be individualized to a non-indexed eGFR (ml/min) by the patient’s body surface area. Here, we investigated the number of patients admitted to urological wards of a teaching hospital with RI between July and December 2016. Additionally, we correctly used the eGFRnon-indexed for drug and dosage adjustments and to analyse the use of renal risk drugs (RRD) and renal drug-related problems (rDRP).MethodsIn a retrospective observational study, urological patients with pharmacist-led medication reconciliation at hospital admission and eGFRindexed (CKD-EPI) of 15–59 ml/min/1.73m2 were identified. Indexed eGFR (ml/min/1.73m2) was recalculated with body surface area to non-indexed eGFR (ml/min) for correct drug dosing. Medication at admission was reviewed for RRD and based on the eGFRnon-indexed for rDRP, e.g. inappropriate dose or contraindication.ResultsOf 1320 screened patients, 270 (20.5%) presented with an eGFRindexed of 15–59 ml/min/1.73m2. After readjustment, 203 (15.4%) patients had an eGFRnon-indexed of 15–59 ml/min. Of these, 190 (93.6%) used ≥ 1 drugs at admission with 660 of 1209 (54.7%) drugs classified as RRD. At least one rDRP was identified in 115 (60.5%) patients concerning 264 (21.8%) drugs.ConclusionRenal impairment is a common risk factor for medication safety in urologic patients admitted to a hospital. Considerable shifts were seen in eGFR-categories when correctly calculating eGFRnon-indexed for drug dosing purposes. The fact that more than half of the study patients showed rDRP at hospital admission underlines the need to consider this risk factor appropriately.

Influenza Vaccination and Outcome in Heart Failure

Influenza virus infection is associated with significant morbidity and mortality in patients with chronic diseases including heart failure (HF). Annual influenza vaccination is recommended to prevent infection during the winter months. Data regarding its clinical benefit in HF patients are sparse. The purpose of the study was to evaluate the effect of influenza vaccination on clinical outcome in patients with HF. Consecutive patients with HF at a health maintenance organization were evaluated for influenza vaccination status during the winter season of 2017/2018 and its association with cardiac-related hospitalizations and death during 1-year after vaccination. The study cohort included 6,435 HF patients. A total of 4,440 patient were vaccinated during the winter season (69% of the HF cohort). The vast majority (96%) were vaccinated before the winter months (September to November). Patients vaccinated were older patients with more co-morbidities. Cox regression analysis after adjustment for clinically significant predictors demonstrated that vaccination was associated with reduced mortality (hazard ratio [HR] 0.77, 95% confidence interval [CI] 0.65 to 0.91, p <0.01) as well as reduced death and cardiovascular hospitalizations (HR 0.83 95% CI 0.76 to 0.90, p <0.001). Adjustment for drug therapy demonstrated a similar result with improved outcome with influenza vaccine. Propensity score matched control analysis demonstrated that vaccination was associated with improved survival (HR 0.80, 95% CI 0.67 to 0.95, p <0.01) and reduced death and cardiovascular hospitalizations (HR 0.86, 95% CI 0.79 to 0.94, p <0.001). In conclusion, Influenza vaccination in patients with HF was associated with improved clinical outcome including improved survival and reduced death and hospitalizations.

Genetic Polymorphisms of CYP2D6: Prevalence in Healthy Kurds

Background: Identifying the genetic polymorphisms of drug metabolizing enzyme CYP2D6 is useful in pharmacogenomics. Unfortunately, until today, the prevalence of the CYP2D6 polymorphisms among Kurds is scarce. Objective: In this study, we explored the CYP2D6 polymorphisms among Kurds. Methods: Four hundred and fifty-nine unrelated healthy Kurds were recruited for the study. DNA was extracted from whole blood and was then used for genotyping CYP2D6*3, *4, *5, *6, *9, *10, *17, *114 and gene duplication using the nested allelespecific multiplex Polymerase Chain Reaction (PCR). Conclusion: The data add to our knowledge of CYP2D6 alleles, the genotypes and the distributions of predicted phenotypes in Kurds. Majority of the observed variant alleles confer no function and gene duplication. CYP2D6 polymorphisms were found to be very heterogeneous in relation to genotype frequencies. Further study in relation to the evaluation of drug therapy adjustment based on CYP2D6 genotype may help to understand the clinical consequences of CYP2D6 polymorphisms.

Screening for impaired liver function as a risk factor for drug safety at hospital admission of surgical patients.

Background Hepatic insufficiency can affect patient safety and should therefore be considered during drug therapy. Hospital admission offers an ideal point to screen for patients at risk and to adjust drug therapy accordingly. Objective To assess the number of patients admitted to hospital with clinically elevated liver parameters. To identify high-risk patients in need of potential drug therapy adjustment to liver function by calculation of liver scores. Finally, to investigate whether pre-hospital medication needed adjustment to liver function. Setting Patients admitted to surgical wards of a tertiary teaching hospital. Method Surgical patients were included in a 3-month retrospective study. A pharmacist-led screening process, including recording of elevated liver parameters and calculation of liver scores (Child-Pugh-score, Model of End-stage Liver Disase [MELD], MELDNa), was used to assess frequency of hepatic insufficiency and patients potentially needing medication adjustment. Additionally, pre-hospital medication was checked for contraindications and correct dosage with regard to liver function. Main outcome measure Percentage of surgical patients with clinically elevated liver parameters at admission, percentage of patients with hepatic insufficiency potentially needing drug therapy adjustment, and percentage of pre-hospital drug intakes not adjusted to liver function. Results Of 1200 patients, 130 (11%) had at least one clinically relevant elevated liver parameter at hospital admission. Of these, need for drug adjustment to liver function was found for 16-36%, depending on the liver score used (equivalent to 2-4% of all patients), with the highest number of patients detected by the MELD- and MELDNa-score. Pre-hospital medication concerned 719 drug intakes and was contraindicated in 2%, dosage not adjusted in 3%, and evaluation not possible in 44% of all drug intakes due to lack of information on the drug. Conclusion A significant proportion of patients admitted for surgery have clinically elevated liver parameters and potentially need medication adjustment. A pharmacist-led screening already at hospital admission can support the identification of patients with clinically relevant elevated liver parameters and patients at risk by calculating liver scores under routine conditions. Evaluation of drug adjustment to liver function is challenging, since no data are available in routine resources for a considerable number of drugs.

A11719 pulse-cor registry

Objectives: Arterial stiffness evaluating is a modern method of target organ damage assessing, but there is a lack of data on pulse wave velocity dynamics in the arteries of the elastic type (PWVe). Methods: We included initially 1558 subjects: 779 (50%) with arterial hypertension (AH) and 779 (50%) normotensive. 728 (46,7%) were women and 830 (53,3%) were men. Among hypertensive subjects 278 were naïve to treatment, other was on study drugs, 143 had good BP control, registered on the first visit, other had referred for drug therapy adjustment. PWV and CSBP in all subject were measured with SphygmoCor (AtCor, Australia). 229 subjects ( ∼ 14,7%) came back after 1 month, 111 subjects ( ∼ 7,1%) – after 3 m, 200 ( ∼ 12,8%) – after 6 m, 120 subjects ( ∼ 7,7%) – after 12 m and 45 ( ∼ 2,8%) after 35 m of follow-up. Antihypertensive treatment was prescribed using ESC/ESH guidelines. Results: The percentage of those referred for the follow-up visit may be explained by that it was predominantly subjects with arterial hypertension or those who wanted underwent additional diagnostics. After 1 month of treatment office SBP (oSBP) decreased significantly from142,6 ± 1,6 to132,6 ± 1,7 mmHg (p < 0,001), while PWVe dynamics was not significant (NS), after 3m oSBP was 129,6 ± 1,9 mmHg (p = 0,02), PWVe dynamics – still NS, after 6m oSBP was 129,8 ± 2,1 (p < 0,001), PWV dynamics – still NS. Those who came after 6m had oSBP 133,3 ± 2,4 (NS compared with baseline), but PWVe dynamics was significant (12,2 ± 0,3 vs 10,4 ± 0,2, p = 0,003), it was more pronounced after 12m and 36 m (10,1 ± 0,3, p = 0,006 and 9,8 + 0,2, p = 0,002) while oSBP dynamic remained NS comparing with baseline. Conclusion: We have found that before 6m of therapy there was no significant dynamics in PWVe, arterial elasticity improved only after 12 and 36m, which was not dependent on final SBP

Características basales y cambios en el tratamiento tras el periodo de optimización de los pacientes incluidos en el estudio EFICAR

ObjectivesTo describe the baseline date and drugs therapy changes during treatment optimization in patients with heart failure with depressed systolic function included in the EFICAR study. DesignMulticenter randomized clinical trial. LocationSeven Health Centers. Participants150 patients (ICFSD) age 68±10years, 77% male. MeasurementsSociodemographic variables, comorbidities (Charlson index), functional capacity and quality of life. Drug therapy optimization was performed. ResultsThe main etiology was ischemic heart disease (45%), with 89% in functional classii. The Charlson index was 2.03±1.05. The ejection fraction mean was 37%±8, 19% with ejection fraction <30%. With the stress test 6.3±1.6 mean was reached, with the 6minutes test 446±78 meters and the chair test 13.7±4.4seconds. The overall quality of life with ejection fraction was 22.8±18.7 and with the Short Form-36 Health Survey, physical health 43.3±8.4 and mental health 50.1±10.6. After optimizing the treatment, the percentage of patients on drugs therapy and the dose of angiotensin converting enzyme inhibitors, angiotensinii receptor antagonists and beta-blockers were not changed. ConclusionsThe majority of the subjects are in functional classii, with functional capacity and quality of life decreased and comorbidity index high. A protocolized drug therapy adjustment did not increase the dose or number of patients with effective drugs for heart failure with depressed systolic function

Associations between the 2007 Medicare reimbursement reduction for bone mineral density testing and osteoporosis drug therapy patterns of female Medicare beneficiaries.

ObjectiveTo examine how drug therapy patterns for osteoporosis have changed after the Medicare Physician Fee Schedule (MPFS) reimbursement reduction in 2007, in relation to follow-up bone mineral density (BMD) testing status.MethodsWe used a retrospective temporal shift design to examine changes in drug therapy patterns before (Phase 1: January 1, 2005–December 31, 2006) and after (Phase 2: July 1, 2007–June 30, 2009) the MPFS reimbursement reduction in 2007, Cleveland, OH, USA. Participants were osteoporotic older women in Phase 1 (n=1,340) and Phase 2 (n=1,437). The main outcomes were a) adherence, b) adjustment, c) occurrence of an extended gap, and d) restarting drug therapy after an extended gap. Follow-up BMD testing status by study phase and location were also analyzed.ResultsBMD testing rates at physicians’ offices decreased from 64.5% in Phase 1 to 58.4% in Phase 2 (P=0.02); however, testing rates in hospital outpatient settings increased (from 20.8% to 24.5%). There were also decreases in drug therapy adjustment from 15.9% in Phase 1 to 11.6% in Phase 2 (odds ratio [OR]: 0.73; P<0.01) and in restarting drug therapy after an extended gap (55.4% in Phase 1 and 43.6% in Phase 2; OR: 0.76; P<0.01).ConclusionThere were no changes in the overall rate of follow-up BMD testing. The rates of drug adjustments and restarting drug therapy after an extended gap did decrease. These decreases were more evident when follow-up BMD testing was not performed.

Treating Rheumatoid Arthritis to Target

Recently, many countries, including Canada, evaluated rheumatologists' acceptance and agreement with a set of 10 Treat to Target (T2T) recommendations for rheumatoid arthritis (RA), developed by an international task force. In this study, the Canadian T2T steering committee evaluated how Canadian patients with RA perceive these recommendations. The objectives of this study were to assess the current state of RA management in Canada from a patient perspective and to assess whether and to what extent Canadians with RA agree with each of the 10 T2T recommendations and to compare the results with a previous survey completed by physicians. Participating rheumatologists were asked to invite consecutive RA patients to complete a 20-question survey. The survey was designed to assess relevant sociodemographic variables, the current treatment, and the approach to RA management as seen from the patient's perspective, as well as their agreement with the T2T recommendations. A total of 959 patients (77% were female) were recruited by 22 participating rheumatologists from 6 Canadian provinces. Patients had a mean age of 59.1 years and mean disease duration of 12.9 years. Approximately 72% of patients were on methotrexate (76.1% combination therapy), and 36.7% were treated with biologics (6.4% monotherapy, 30.3% combination therapy). The agreement with T2T recommendations ranged from 8.6 for recommendation 4 (frequency of adjustment of drug therapy) to 9.5 for recommendation 8 (maintenance of treatment targets). These results are comparable to a previous physicians' survey except that there was more acceptance on the part of patients for more frequent visits (recommendation 5; patient agreement score was 9.06 vs physician agreement score of 6.92) and evaluations for adjustments of therapy (recommendation 6 patient agreement score was 9.39 vs physician agreement score of 7.49) to achieve the stated goal. The results of this survey showed that Canadian patients are being treated for their RA according to the published treatment recommendations with combination disease-modifying antirheumatic drugs and biologics and a small percentage with oral corticosteroids. The majority of patients seems to be satisfied with their management and is in agreement with the T2T recommendations, although they tended to place greater emphasis than did physicians on flexibility of visit frequency and detailed assessments.

Pharmacist-led monitoring program for patients on sunitinib for metastatic renal-cell carcinoma: A Canadian experience.

479 Background: Sunitinib is a standard of care for first-line treatment of metastatic clear cell renal-cell carcinoma (mRCC). Despite having a relatively good safety profile, Sunitinib does have several clinically important toxicities. With the rapid rise in the use of Sunitinib and other oral cancer agents, we instituted a pharmacist-led monitoring program in the ambulatory care setting to prospectively document, monitor, and manage toxicities in our Canadian province. Methods: The pharmacist-led monitoring program consisted of patient assessments in clinic with the oncology team combined with a call back program. The program consisted of a patient assessment in the oncology clinic on day 1 of a Sunitinib cycle followed with a call back on day 14. A chart review of consecutive patients who were prospectively monitored by this progam after receiving Sunitinib for mRCC was conducted. Treatment specific data for the first six cycles of therapy included dose reductions, therapy delays/interruptions, therapy discontinuation, and reason for each was recorded. Toxicity data including the occurrence and severity grade was collected. The time to treatment failure (TTF) defined as the time from therapy initiation to treatment discontinuation for any reason was measured. Results: Fifty six patients are included in the study cohort. Of these, 52 (92.86%) started at the standard 50 mg once daily and the remainder at a reduced dose. Additionally, 15 patients experienced hypertension requiring drug therapy adjustment or additional antihypertensive therapy. Two patients required drug therapy for hypothyroidism. There were a total of 39 dose reductions in this patient population over a six cycle period. The majority of dose reductions (46.2%) and therapy interruptions (34.5%) occurred during cycle one. The time to treatment failure for the 45 patients that discontinued therapy was 9.72 months. Conclusions: Pharmacist-Led monitoring of oral cancer therapies is a practical and feasible method of monitoring patients on Sunitinib for mRCC. The success has led to its implementation with other agents and disease sites.

Glycaemic control and implementation of the ADA/EASD-2006 consensus algorithm in type 2 diabetes mellitus patients in primary care in Spain

In 2006, the American Diabetes Association and the European Association for the Study of Diabetes established a consensus algorithm (ADA/EASD-2006) for the adjustment of drug therapy for type 2 diabetes mellitus (T2DM). To study glycaemic control in T2DM patients and the implementation of the ADA/EASD-2006 recommendations in primary care centres in Spain. Prospective observational study in 1194 patients with T2DM conducted in 250 primary care centres in Spain. Patients were assessed at study inclusion (V0) and at 3 (V1) and 6 months (V2) post baseline. Information was collected at the level of DM control, HbA(1c) < 7% (HbC) and implementation of the ADA/EASD-2006 guidelines. Type 2 diabetes mellitus patients (53% women; mean age 64.9 years) had a mean (SD) HbA(1c) 7.8 (1.4)% and HbC 25.2% at baseline, 95% of them were receiving oral antihyperglycaemic agents (AAs) only. At V1, HbA(1c) was 7.3 (1.1)% and HbC was 38.1%; 65.0% of patients were receiving oral AAs, 5.6% insulin and 27.9% oral AAs plus insulin. At V2, HbA(1c) was 7.1 (0.9)% and HbC was 48.0%; 57.1% of patients were receiving oral AAs, 5.0% insulin and 36.9% oral AAs plus insulin. The ADA/EASD-2006 algorithm was adhered to in 33% patients up to study month 3, vs. 17.2% throughout the entire 6-month period. In patients with T2DM seen in primary care, the HbA1c target was met in 48.0% after adjusting their AAs. However, this is not reflected in greater implementation of the ADA/EASD-2006 guidelines, which are adhered to in only 17%.

The high prevalence of malnutrition in elderly diabetic patients: implications for anti‐diabetic drug treatments

Type 2 diabetes usually occurs in the context of obesity and associated insulin resistance. Current treatment recommendations are based on lifestyle modifications and incremental drug therapy. However, this approach could lead to inappropriate priorities upon ageing, when diabetes may be compounded by malnutrition and reduced insulin resistance. We prospectively evaluated glycaemic and nutritional parameters in 146 consecutive diabetic patients (age 82.5 +/- 7.3 years, mean +/- sd) admitted to our geriatric service. We also implemented nutritional support therapy and a drug therapy adjustment protocol. Oral hypoglycaemic agent withdrawal was attempted in cases of good glycaemic control (HbA(1c) < 7.5% (<47 mmol/mol) or fasting blood glucose < 7.5 mmol/l). Mean BMI and HbA(1c) were 29.6 +/- 7.1 kg/m(2) and 6.9 +/- 1.2% (52 +/- 9 mmol/mol), respectively. Of the patients, 51.4% were taking 1-3 oral hypoglycaemic agents, 30.8% were on insulin and 9.6% on were on insulin and oral hypoglycaemic therapy. Low Mini Nutritional Assessment scores and serum marker levels indicated a high prevalence of malnutrition and/or chronic disease, even in obese patients. Mini Nutritional Assessment scores were positively associated with HbA(1c) values. Among patients treated by oral hypoglycaemic agents, complete drug withdrawal was achieved in 65.8%, much more often than new treatments were added (P = 0.002). Glycaemic control did not worsen after approximately 30 days, despite in-hospital nutritional therapy. Successful oral hypoglycaemic therapy withdrawal was associated with lower Mini Nutritional Assessment scores. Malnutrition is highly prevalent in elderly diabetic inpatients and, paradoxically, contributes to 'good' glycaemic control. Malnutrition should be screened for in these patients and, when present, should prompt a revision in diet and drug therapy. In particular, the possibility of reducing unnecessary drug therapy should be considered.

New understanding of the problem of management of type 2 diabetes mellitus - novel prospects (ADA/EASD consensus, 2008)

Type 2 diabetes mellitus is a severe progressive disease associated with the high incidence of complications. The worldwide incidence of type 2 diabetes mellitus is known to be steadily growing which makes the management of this disease a topical medical problem. The majority of the patients all over the world fail to achieve recommended treatment end-points. The scientifically-sound choice of an adequate pharmacotherapeutic modality based on the available data on type 2 diabetes pathophysiology is of utmost importance under conditions of real clinical practice. The new updated ADA/EASD consensus of 2008 provides a well-grounded practical algorithm for the initiation and further adjustment of drug therapy in patients with type 2 diabetes mellitus. The HbA1c level of 7.0% or higher at any stage of the treatment should be regarded as a signal for active correction of the previous therapeutic regime. The early prescription of basal insulin contributes to the efficacious glycemic control and decreases the risk of long-term diabetic complications. Treatment with a combination of insulin and metformin is a highly effective approach to the management of patients with hyperglycemia and simultaneously slows down weight gain. The present algorithm enables clinicians to choose the most adequate hypoglycemic agents and combine different therapeutic modalities to the benefit of each individual patient.

Therapeutic drug monitoring in the treatment of tuberculosis.

Therapeutic drug monitoring (TDM) is a standard clinical technique used for many disease states, including many infectious diseases. As for these other conditions, the use of TDM in the setting of tuberculosis (TB) allows the clinician to make informed decisions regarding the timely adjustment of drug therapy. Such adjustments may not be required for otherwise healthy individuals who are responding to the standard, four-drug TB regimens. However, some patients are slow to respond to treatment, have drug-resistant TB, are at risk of drug-drug interactions or have concurrent disease states that significantly complicate the clinical situation. Such patients may benefit from TDM and early interventions may preclude the development of further drug resistance. It is not possible to collect multiple blood samples in the clinical setting for logistical and financial reasons. Therefore, one typically is limited to one or two time points. When only one sample can be obtained, the 2-hour post-dose concentrations of isoniazid, rifampin, pyrazinamide and ethambutol are usually most informative. Unfortunately, low 2-hour values do not distinguish between delayed absorption (late peak, close to normal range) and malabsorption (low concentrations at all time points). A second sample, often collected at 6-hour post-dose, can differentiate between these two scenarios. The second time point can also provide some information about clearance and half-life, assuming that drug absorption was nearly completed by 2 hours. TDM requires that samples are promptly centrifuged, and that the serum is promptly harvested and frozen. Isoniazid and ethionamide, in particular, are not stable in human serum at room temperature. Rifampin is stable for more than 6 hours under these conditions. During TB treatment, isoniazid causes the greatest early reduction in organisms and is considered to be one of the two most important TB drugs, along with rifampin. Although isoniazid is highly active against TB, low isoniazid concentrations were associated with poorer clinical and bacteriological outcomes in US Public Health Services (USPHS) TB Trial 22. Several earlier trials showed a clear dose-response for rifampin and pyrazinamide, so low concentrations for those two drugs also may correlate with poorer treatment outcomes. At least in USPHS TB Trial 22, the rifampin pharmacokinetic parameters were not predictive of the outcome variables. In contrast, low concentrations of unbound rifapentine may have been responsible, in part, for the worse-than-anticipated performance of this drug in clinical trials. The 'second-line' TB drugs, including p-aminosalicylic acid, cycloserine and ethionamide, are relatively weak TB drugs. Under the best conditions, treatment with these drugs takes over 2 years, as opposed to 6 to 9 months with isoniazid- and rifampin-containing regimens. Therefore, TB centres such as National Jewish Medical and Research Center in Denver, CO, USA, measure serum concentrations of the 'second-line' TB drugs early in the course of treatment. That way, poor drug absorption can be dealt with in a timely manner. This helps to minimise the time that patients are sputum smear- and culture-positive with multidrug-resistant TB, and may prevent the need for even longer treatment durations. Patients with HIV are at particular risk for drug-drug interactions. Because the published guidelines typically reflect interactions only between two drugs, these guidelines are of limited value when the patient is treated with three or more interacting drugs. Under such complicated circumstances, TDM often is the best available tool for sorting out these interactions and placing the patient the necessary doses that they require. TDM is only one part of the care of patients with TB. In isolation, it is of limited value. However, combined with clinical and bacteriological data, it can be a decisive tool, allowing the clinician to successfully treat even the most complicated TB patients.

Intravenous iron supplementation for the treatment of the anemia of moderate to severe chronic renal failure patients not receiving dialysis

Iron deficiency may develop in hemodialysis patients, especially when erythropoietin is given. The role of iron deficiency in the anemia of predialysis chronic renal failure (CRF), however, is much less clear. We have intravenously (IV) administered iron as ferric saccharate in a total dose of 200 mg elemental iron monthly for 5 months to 33 CRF patients who remained anemic despite oral iron supplementation and who had no laboratory signs of iron overload. None was receiving erythropoietin therapy. In 22 of the patients there was an increase in the hematocrit values by the end of the study. These patients were considered responders to intravenous iron (IV Fe) therapy. In 11 patients the iron administration was not associated with improvement of the anemia (nonresponders). Before onset of the IV Fe therapy there were no differences between the responders and nonresponders with regard to degree of anemia, serum ferritin, iron saturation, renal function, or blood pressure. One additional patient was excluded from the study because of a mild reaction during an IV test dose before the study. No worsening of kidney function and no other side effects were noted. In four patients (three responders and one nonresponder) the control of blood pressure necessitated antihypertensive drug therapy adjustment. In conclusion, IV Fe supplementation in two thirds of anemic CRF patients not receiving dialysis resulted in a significant improvement of the anemia, thus avoiding the necessity of erythropoietin or blood administration. This could be achieved by increasing the plasma ferritin levels to 200 to 400 μg/L and/or increasing the iron saturation to 25% to 35%. Intravenous ferric saccharate appears to be a safe and effective method of administering iron for the correction of anemia in CRF patients not receiving dialysis.