Risk Factors For Side Effects Research Articles

Risk factors for side effects due to the use of antituberculous drugs in elderly patients

This study was designed to evaluate incidence of clinical risk factors for side effects due to the use of antituberculous drugs. We retrospectively analyzed clinical records of 229 elderly patients with tuberculosis treated at our hospital. Temporary stop of antituberculous therapy proved to be needed because of side effects in 77 patients (33.6%). Adverse effects leading to drug discontinuation were liver dysfunction (15.7%), gastrointestinal dysfunction (7.0%), and skin rash (5.7%); other effects accounted for discontinuation in 5.2%. Risk factors for liver dysfunction according to Cox proportional hazards regression analysis were complications of HCV infection (hazard ratio or HR, 2.97; 95% confidence interval or CI, 1.20 to 7.38; p=0.019); hepaocellular injury present at admission (HR, 3.37; 95% CI, 1.56 to 7.29; p=0.002); and dose of isoniazid (per mg/kg, HR, 1.40; 95% CI, 1.05 to 1.85; p=0.02). Body mass index was a risk factor for gastrointestinal dysfunction (per kg/m2, HR, 0.83; 95% CI, 0.70 to 0.98; p=0.026). Such identification of risk factors for side effects from antituberculous therapy in elderly tuberculosis patients would minimize adverse effects.

Cardiotoxic effects of trastuzumab.

Breast cancer with overexpression of the HER2 receptor is an aggressive type of breast cancer with poor prognosis. Trastuzumab (Herceptin) is a monoclonal antibody that binds to the HER2 receptor on the cell surface blocking the signals that promote cell-growth proliferation. Trastuzumab treatment has almost halved the risk of relapse, when given as an adjuvant, and has improved the overall survival in metastatic breast cancer. However, when given alone or in combination with cardiotoxic chemotherapy, especially anthracyclines, trastuzumab may lead to congestive heart failure of varying severity. The article is a non-systematic review of articles from clinical trails, basic research, and recommendations by Norwegian and international expert panels. The cardiotoxic effects of trastuzumab and anthracycline in combination were already reported in the pivotal trials. Over ten years of research have revealed the mechanisms of cardiotoxicity with trastuzumab. Risk factors have been identified and recommendations drawn up for cardiac surveillance and treatment of patients with signs of heart failure. By following these recommendations the incidence of heart failure is reduced to approximately five per cent of treated patients. In summary, the favourable effects of trastuzumab are convincing, but cardiotoxicity is a significant challenge in treatment. Risk factors for side effects indicate extra vigilance, but the side effects are unpredictable and all patients treated with trastuzumab must undergo regular cardiac surveillance.

Neoadjuvant targeting of glioblastoma multiforme with radiolabeled DOTAGA–substance P—results from a phase I study

Complete surgical resection beyond tumor margins cannot be achieved in glioblastoma multiforme (GBM) because of infiltrative nature. In several cancers, neoadjuvant treatment has been implemented to reduce the risk of tumor cell spreading during resection. In GBM, the objective of a neoadjuvant approach is reduction of tumor cells within the main tumor mass and beyond in the infiltration zone. Such an approach can only be performed if elevated intracranial pressure can be medically controlled. In a previous study with recurrent gliomas, we showed that local intratumoral injection of radiolabeled DOTAGA-substance P substantially inhibited further growth and led to radionecrotic transformation of the tumor (CCR 2006). We have now examined this modality as neoadjuvant treatment for GBM, primarily assessing feasibility, toxicity, the extent of resection, and functional outcome. After diagnosis of GBM, 17 patients were included in a prospective phase I study. Repetitive intratumoral injections of radiolabeled DOTAGA-substance P were performed, followed by surgical resection. Chemical synthesis, radiolabeling, and local injection of the peptidic vector [90Yttrium]-DOTAGA-substance P were described previously. Neoadjuvant injection of [90Y]-DOTAGA-substance P was feasible without decompensation of intracranial pressure. Prolonged application of corticosteroids was identified as the main risk factor for side effects. Fifteen patients stabilized or improved their functional status. The mean extent of resection in subsequent surgery was 96%. Neoadjuvant therapy of GBM using locally injected radiolabeled DOTAGA-substance P was feasible and of low toxicity. The high extent of resection and concomitant irradiation of tumor cells in the infiltration zone may be prognostically relevant.

Fatal anaphylactoid reaction following ioversol administration

We report a fatal intravenous ioversol administration in a 60-year old male patient. Although the introduction of new low-osmolar non-ionogenic contrast media with a more favourable efficacy-toxicity balance has diminished the side-effects significantly, everyone involved in radiodiagnostic procedures should be aware of the potential life-threatening effects. Especially patients with risk factors for side-effects should be monitored carefully.

Effets secondaires psychiatriques des médicaments non psychotropes

Many drugs, from various therapeutic classes, may induce side-effects of possible psychiatric origin. Awareness of such effects is paramount in terms of therapy and prognosis. The problem of imputability when the drug itself is a psychotropic compound raises complex issues; in other cases, when the suspected drug is not a psychotropic compound, causality is easier to substantiate. Authors try to review psychiatric side-effects of non psychotropic drugs. Results are presented in tables following algorithms of the Vidal TM physician desk reference dictionary, in order to remain closer to daily practice, in psychiatry or other specialties. The most frequently reported side-effect is clouding of consciousness (confusion, delirium), but phenomenological descriptions often remain vague. Information defining circumstances or risk factors for side-effects are given as often as possible. Data presented here originate from 3 different reference books and a recent literature search. General considerations on imputability and specific methodological problems are beyond the scope of this review.

Risk factors for side effects during first infusion of rituximab-definition of a low risk group.

Side effects from the first infusion of the monoclonal anti-CD20 antibody, rituximab, 375 mg/m2 was documented in 47 treatments (37 patients) and correlated to tumour mass and interval to previous cytostatic treatment. A significant correlation was found with less side effects in patients with a low tumour mass and/or if chemotherapy was recently administered. It is difficult to differ between these two parameters as they covariate, i.e. the majority of patients without or with a minimal tumour burden were recently treated with cytostatics. The reason why these patients have no or minimal side effects may be due to low numbers of CD20 positive cells in the circulation. The finding of a low-risk group for side effects from the first infusion of rituximab; has practical clinical implications, for example, hospitalization can be avoided. Concerning side effects, it may be an advantage to give rituximab after the introduction of successful chemotherapy.

Risk factors for side effects during patient controlled epidural analgesia

Risk factors for side effects during patient controlled epidural analgesia

Patient-controlled epidural analgesia with bupivacaine and fentanyl on hospital wards: prospective experience with 1,030 surgical patients.

The efficacy and safety of patient-controlled epidural analgesia (PCEA) for postoperative analgesia on hospital wards was studied. Postoperative analgesia was provided for 1,030 patients with PCEA using 0.05% bupivacaine and fentanyl, 4 microg/ml, in a standardized manner. Patients were seen at least twice a day by the staff of the anesthesia pain management service. Prospectively gathered data included verbal pain scores at rest and activity (0-10); consumption of bupivacaine and fentanyl; and incidences of pruritus, nausea, sedation, hypotension, motor block, and respiratory depression. Descriptive statistics were used. Risk factors for side effects were determined using logistic regression. The study included 552 women and 477 men who underwent a median (mode) of 3 (2) days of PCEA. Their mean age was 59 +/- 16 yr and their mean weight was 76 +/- 19 kg. There were 454 abdominal, 165 gynecologic, 126 urologic, 108 vascular, 90 thoracic, 83 orthopedic, and 4 plastic surgical procedures. Median (mode) pain scores were 1 (0) at rest and 4 (5) with activity on postoperative day 1. Incidences of side effects were 16.7% (pruritus), 14.8% (nausea), 13.2% (sedation), 6.8% (hypotension), 2% (motor block), and 0.3% (respiratory depression). Reasons for termination of PCEA were elective (82%), displaced epidural catheter (12%), anticoagulation (3%), infection (1%), side effects (1%), inadequate analgesia (1%), and other (<1%). Risk factors for side effects were female sex, patient weight <73 kg, patient age <58 yr, bupivacaine and fentanyl consumption >9 ml/h, use of analgesic adjuncts, and lumbar placement of epidural catheters. Patient-controlled epidural analgesia provides effective and safe postoperative analgesia on hospital wards.

Low-dose methotrexate in rheumatic diseases—Efficacy, side effects, and risk factors for side effects

Controlled trials and observational studies have shown low-dose methotrexate (MTX) to be a second-line agent of high potency with a favorable profile of safety and tolerability in the treatment of rheumatoid arthritis (RA). Its riskbenefit ratio in psoriatic arthritis is less well documented. Preliminary reports on its beneficial effects in other disorders, including the systemic manifestations of RA, other spondyloarthritides, and collagen vascular diseases, merit more detailed examination. Gastrointestinal intolerance and hepatic enzyme elevation are the most frequent side effects of MTX; life-threatening events such as severe hemocytopenia and MTX pneumonitis are rare and amenable to prevention by recognizing risk factors and premonitory signs. Hepatotoxicity does not appear to be a major limiting factor in RA patients over the first 2 to 3 years of MTX therapy; its impact on long-term tolerance remains to be clarified.

Incidence and risk factors for side effects of spinal anesthesia.

We prospectively studied 952 patients to identify the incidence of hypotension (systolic blood pressure less than 90 mmHg), bradycardia (heart rate less than 50 beats/min), nausea, vomiting, and dysrhythmia during spinal anesthesia. Historical, clinical, and physiologic data were correlated with the incidence of these side effects by univariate and multivariate analysis. Hypotension developed in 314 patients (33%), bradycardia in 125 (13%), nausea in 175 (18%), vomiting in 65 (7%), and dysrhythmia in 20 (2%). Variables conferring increased odds of developing hypotension include peak block height greater than or equal to T5 (odds ratio 3.8, P less than 0.001), age greater than or equal to 40 yr (2.5, P less than 0.001), baseline systolic blood pressure less than 120 mmHg (2.4, P less than 0.001), combination of spinal and general anesthesia (1.9, P = 0.01), spinal puncture at or above the L2-L3 interspace (1.8, P less than 0.001), and addition of phenylephrine to the local anesthetic (1.6, P = 0.02). Variables conferring increased odds of developing bradycardia include a baseline heart rate less than 60 beats/min (odds ratio 4.9, P less than 0.001), ASA physical status classification of 1 versus 3 or 4 (3.5, P less than 0.001), current therapy with beta-adrenergic blocking drugs (2.9, P less than 0.001), and peak block height greater than or equal to T5 (1.7, P = 0.02). Variables conferring increased odds of developing nausea or vomiting include addition of phenylephrine or epinephrine to the local anesthetic (3.0-6.3, P less than or equal to 0.003), peak block height greater than or equal to T5 (odds ratio 3.9, P less than 0.001), use of procaine (2.6-4.4, P less than or equal to 0.003), baseline heart rate greater than or equal to 60 beats/min (2.3, P = 0.03), history of carsickness (2.0, P = 0.01), and development of hypotension during spinal anesthesia (1.7, P = 0.009). Our results indicate that the incidence of side effects during spinal anesthesia may be reduced by 1) minimizing peak block height; 2) using plain solutions of local anesthetics; 3) performing the spinal puncture at or below the L3-L4 interspace; and 4) avoiding the use of procaine in the subarachnoid space.

Adverse Reactions to Amantadine Prophylaxis of Influenza in a Retirement Home

Controversy exists about the safety of following the recommendation of the Immunization Practice Committee of the Centers for Disease Control that nursing home residents be given amantadine prophylaxis during influenza outbreaks. This study was undertaken to define the incidence of adverse reactions to amantadine in the elderly and to identify risk factors for side effects. A retrospective cohort study. A retirement home which offered amantadine prophylaxis to its residents during a presumed influenza outbreak. Of the 96 elderly residents, 79 accepted the offer of amantadine prophylaxis. Attributable adverse health outcomes as assessed by chart review. 41% of the people receiving amantadine had attributable adverse reactions, of which 22% were classified as severe. Severe adverse reactions were associated with residence in the assisted living section of the facility (P = 0.002), a greater number of underlying diagnoses (P = 0.009), congestive heart failure (P = 0.02), and high serum creatinine (P = 0.02). A person with none of these risk factors had a 7% chance of having a severe adverse outcome compared to a 70% chance for someone with all four risk factors. The findings raise concern that the prophylactic administration of amantadine to all elderly residents of nursing and retirement homes may be associated with a high incidence of unacceptable reactions, particularly among less healthy residents.

Risk factors for side effects of long-term administration of 5-fluorouracil derivatives in patients with hepatocellular carcinoma associated with liver cirrhosis

Risk factors for side effects of long-term administration of 5-fluorouracil derivatives in patients with hepatocellular carcinoma associated with liver cirrhosis