No Accumulation of Peak Anti-Xa Activity of Tinzaparin in Elderly Patients with Moderate to Severe Renal Impairment: A Substudy of IRIS Clinical Trial.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 172-172 ◽  
Author(s):  
Virginie Siguret ◽  
Alain Leizorovicz ◽  
Eric Pautas ◽  
Isabelle Gouin-Thibault
Keyword(s):  
Infectious Disease ◽  
Clinical Trial ◽  
Molecular Weight ◽  
Renal Impairment ◽  
Elderly Patients ◽  
Creatinine Clearance ◽  
Severe Renal Impairment ◽  
Renal Elimination ◽  
Significant Difference ◽  
The Mean

Abstract Abstract 172 The “Innohep® in Renal Insufficiency Study” (IRIS) was an international, multicentre, open, randomized, parallel group clinical trial with a primary objective to compare the safety of tinzaparin and unfractionated heparin in terms of clinically relevant bleeding (CRB) in elderly patients with impaired renal function for initial treatment of acute deep vein thrombosis. In the elderly, concerns have been raised about the risk of an accumulation effect and/or overdose due to the renal elimination of low molecular weight heparins (LMWH). In a subset of centres participating in the IRIS study, we conducted a substudy in order to assess whether there was an accumulation of anti-Xa activity and whether there was any relationship between anti-Xa activity and age, weight, creatinine clearance or clinical outcomes in patients treated with tinzaparin (175 IU/kg/24h) for venous thromboembolism. Plasma anti-Xa activity was to be analysed at peak level (4–6 hours after injection) on Day 2 or Day 3 and on Day 5 or at visit S (VS: day of visit at end of SC treatment) using a chromogenic assay (Rotachrom® heparin, Diagnostica Stago®). Of the complete IRIS study population who received tinzaparin (n=268), data from 87 patients (32%) were analysed. The patient characteristics (mean age 83±5 years [75–99 years], mean creatinine clearance (Cockcroft-Gault) 40.8 mL/min (SD 11.7, range 14–59) were consistent with those of the overall population of IRIS study. Of note, 24.1% had severe renal impairment (creatinine clearance < 30 mL/min). The mean peak anti-Xa activities, which were 0.86 (SD 0.34) and 0.87 (SD 0.31) IU/mL on Day2/3 and Day5/VS, respectively, were found close to the mean 0.85 IU/mL reported in the literature in patients receiving tinzaparin at therapeutic dose. There was no correlation between the anti-Xa activity and age, weight, or creatinine clearance. There was no significant difference in the anti-Xa levels between patients with, versus those without, severe renal impairment. The mean accumulation ratio (defined as anti-Xa activity on Day5/VS divided by the anti-Xa activity on Day2/3) was 1.06 (SD 0.30, 90% CI:1.01–1.11): as the 90% CI of the accumulation did not exceed the pre-defined upper limit of 1.25, no significant accumulation was detected. The mean anti-Xa activity did not differ significantly between the 8 patients experiencing a CRB during tinzaparin treatment and the 79 who did not experience a CRB during tinzaparin treatment. Among the 8 patients who had a CRB, one had an anti-Xa activity > 2.0 IU/mL (considered above therapeutic level) whereas the seven others had anti-Xa < 1.5 IU/mL. Interestingly, we found that the mean anti-Xa activities were significantly lower in the 12 patients with infectious disease at baseline compared to the patients without infectious disease: 0.66 (SD 0.18) vs 0.8 (SD 0.35) IU/mL on Day2/3, p=0.007; 0.62 (SD 0.23) vs 0.91 (SD 0.30) IU/mL on Day5/VS, p=0.002). These numbers are small but may require further investigation. There was no statistically significant difference in anti-Xa levels when comparing patients with versus those without ongoing malignancy. In conclusion, an IRIS substudy demonstrated no accumulation of anti-Xa activity in elderly patients with moderate to severe renal impairment receiving unadjusted recommended full dose of tinzaparin and confirms previous pharmacokinetic studies in similar populations. The high proportion of higher molecular weight moieties in tinzaparin may account for reduced dependence on renal elimination of the anti-Xa activity seen in elderly patients with renal impairment. Disclosures: Siguret: Leo-Pharma: this work was supported by a grant from Leo-Pharma. Leizorovicz:GSK: Consultancy. Gouin-Thibault:Leo-Pharma: this work was supported by a grant from Leo-Pharma.

scholarly journals Tinzaparin Safety in Patients With Cancer and Renal Impairment: A Systematic Review

2021 ◽  
Vol 27 ◽  
pp. 107602962097959
Author(s):  
I. A. Vathiotis ◽  
N. K. Syrigos ◽  
E. P. Dimakakos
Keyword(s):  
Systematic Review ◽  
Molecular Weight ◽  
Renal Impairment ◽  
Creatinine Clearance ◽  
Cancer Patients ◽  
Major Bleeding ◽  
Severe Renal Impairment ◽  
Special Populations ◽  
Low Molecular Weight ◽  
Patients With Cancer

Low-molecular-weight heparins are approved for primary and secondary venous thromboembolism prevention. Tinzaparin is the low-molecular-weight heparin with the highest average molecular weight. The purpose of this systematic review is to provide an update regarding the safety profile of tinzaparin, prescribed either as a prophylactic or as a therapeutic regimen for venous thromboembolism in special populations, including cancer patients and patients with renal impairment. We identified prospective studies up to August 2020 reporting safety outcomes for cancer patients and patients with renal impairment on tinzaparin regimens. In patients with cancer major bleeding rates fluctuated between 0.8% and 7%. Patients on tinzaparin exhibited significantly lower rates of clinically relevant nonmajor bleeding events in comparison with those on vitamin K antagonists. Bioaccumulation of tinzaparin was not correlated with age, body weight or creatinine clearance. Periodic administration of either prophylactic or therapeutic doses of tinzaparin did not result in bioaccumulation, even in patients with severe renal impairment and creatinine clearance < 20 ml/min. Major bleeding rates for non-cancer patients with renal impairment on prophylactic tinzaparin regimens were 0%. Non-cancer patients with renal impairment on therapeutic tinzaparin regimens exhibited major bleeding in 0 to 3.4% of cases; major bleeding rates were higher for cancer patients with renal impairment on therapeutic tinzaparin regimens (4.3 to 10%). Tinzaparin can be used without dose adjustment in patients with severe renal impairment and creatinine clearance > 20 ml/min. Tinzaparin represents a safe choice for special populations at increased risk for thrombosis and bleeding.

scholarly journals Effect of ageing on plasma lipoprotein(a) levels

2002 ◽  
Vol 39 (3) ◽  
pp. 237-240 ◽  
Author(s):  
Harukuni Akita ◽  
Miyao Matsubara ◽  
Hitoshi Shibuya ◽  
Hirotoshi Fuda ◽  
Hitoshi Chiba
Keyword(s):  
Molecular Weight ◽  
Coronary Heart Disease ◽  
Risk Factor ◽  
Heart Disease ◽  
The Elderly ◽  
Low Molecular Weight ◽  
Lipoprotein A ◽  
Significant Difference ◽  
The Mean ◽  
Japanese Subjects

Background Lipoprotein(a) [Lp(a)] is a risk factor for atherosclerosis and increases with age. The purpose of this study was to determine the effect of ageing on Lp(a) for three different apo(a) phenotypes. Methods We measured plasma Lp(a) concentrations in 551 unrelated Japanese subjects (20-88 years of age). We performed statistical analyses separately for three apo(a) phenotypes: the low-molecular-weight (LMW) phenotype with the F, B or S1 isoform, the intermediate-molecular-weight (IMW) phenotype with the S2 isoform and the high-molecular-weight (HMW) phenotype with the S3 or S4 isoform. Results For each phenotype, the mean plasma Lp(a) concentration and the frequency of Lp(a) concentrations ≥ 250 mg/L increased with age. Further, a statistically significant difference was always found between the younger subjects (20-39 years of age) and the elderly (over 60 years). The frequency of coronary heart disease increased with age, particularly for the LMW and IMW phenotypes. Conclusions We conclude that ageing elevates plasma Lp(a) concentrations, which may have a role in the prevalence of coronary heart disease in the elderly, especially those with the LMW or IMW phenotypes.

scholarly journals Assessment of decrease in renal function associated with hypothyroidism

2021 ◽  
Vol 12 (1) ◽  
pp. 275-286
Author(s):  
Ayesha Ammar ◽  
Kahkashan Bashir Mir ◽  
Sadaf Batool ◽  
Noreen Marwat ◽  
Maryam Saeed ◽  
...  
Keyword(s):  
Renal Function ◽  
Confidence Interval ◽  
Creatinine Clearance ◽  
Confidence Intervals ◽  
Standard Error ◽  
Radioactive Iodine ◽  
T Test ◽  
Euthyroid State ◽  
Significant Difference ◽  
The Mean

Objective: Study was aimed to see the effects of hypothyroidism on GFR as a renal function. Material and methods: Total of Fifty-eight patients were included in the study. Out of those forty-eight patients were female and the rest were male. Out of fifty eight patients, fifty three patients were of thyroid cancer in which hypothyroidism was due to discontinuation of thyroxine before the administration of radioactive iodine for Differentiated thyroid cancer.Moreover, remaining five patients were post radioactive iodine treatment (for hyperthyroidism) hypothyroid. All of the patients were above eighteen years of age with TSH value > 30µIU/ml. Pregnant and lactating females were excluded.Renal function tests (urea/creatinine, creatinine clearance) and serum electrolytes followed by Tc-99m-DTPA renal scan for GFR assessment (GATES’ method) were carried out in all subjects twice during the study, One study during hypothyroid state (TSH > 30 µIU/ml) and other during euthyroid state (TSH between 0.4 to 4µ IU/ml). The results of Student’s t-test showed significant difference in renal functions (Urea, creatinine, creatinine clearance, GFR values) in euthyroid state and hypothyroid state (p-value <0.05). RESULTS: In case of creatinine the paired t test reveal the mean 1.014±0.428, with standard error of 0.669 within 95% confidence interval, for creatinine clearance 80.11±14.12 with standard error of 1.94 within 95% confidence intervals, for urea the mean 28±12.13 with standard error of 1.607 within 95% confidence intervals and for GFR for individual kidney is 38.056±8.56 with standard error of 1.3717 within 95% confidence interval. There was no difference in the outcome of the 2 groups. Conclusion: Hypothyroidism impairs renal function to a significant level and hence needs to be prevented and corrected as early as possible.

scholarly journals The Effect of Urtica Dioica Extract on Blood Lipids Profile in Patients with Type 2 Diabetes: A Randomized Double-blinded Clinical Trial

2021 ◽  
Author(s):  
Roya Khajeh Mehrizi ◽  
Hassan Mozaffari-Khosravi ◽  
Parisa Aboee
Keyword(s):  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Clinical Trial ◽  
Total Cholesterol ◽  
Density Lipoprotein ◽  
Urtica Dioica ◽  
Significant Difference ◽  
The Mean ◽  
Double Blinded

Background: Diabetes is an endocrine disorder that is strongly associated with cardiovascular disease. The use of alternative therapy has recently increased and medicinal plants are one of the alternative therapies for diabetic patients. This study aimed to evaluate the protective effect of Urtica dioica (Nettle) on lipid profile in patients with type 2 diabetes (T2D). Method: This parallel randomized double-blinded clinical trial was conducted on 60 men and women with T2D for an 8-week period. The participants were randomly assigned to received 100mg/kg/day extract of Urtica Dioica (UG) and the placebo group (PG). Blood triglyceride (TG), total cholesterol (TC), low density lipoprotein cholesterol (LDLc) and high density lipoprotein cholesterol (HDLc) were measured at baseline and end of the study. The data were analyzed using SPSS 16.0 and P < 0.05 was considered significant. Results: The mean difference of total cholesterol showed no significant difference in the UG compared to the PG which were -10.56±40.5 and -19.5± 35.9 (P = 0.14), respectively. The study also showed no significant difference between TG and LDLc in the UG compared to the PG (-39.8±171.5 vs. -23.37±72.3 (P = 0.68) and -3.16±33.4 vs. -11.2±35.6 (P = 0.15), respectively). The mean difference of HDLc in the UG and PG were -2.68±8.11 and 2.62±10.6 (P = 0.05), respectively, indicating a significant increase in the UG compared to the PG. Conclusion: The results demonstrated that consumption of 100mg/kg/day extract of UD for 8 weeks by increasing HDL concentration can decrease the risk of cardiovascular disease in patients with T2D.

scholarly journals Effectiveness of a Need-Based Program in Relieving Psychological Distress of Family Caregivers of Leukemia Patients: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Mehrdad Abdullahzadeh ◽  
Narjes Khosravi
Keyword(s):  
Clinical Trial ◽  
Psychological Distress ◽  
Family Caregivers ◽  
Psychological Needs ◽  
Anxiety And Depression ◽  
Study Group ◽  
Control Groups ◽  
Significant Difference ◽  
The Mean ◽  
And Control

Abstract PurposeThe family of leukemia patients, due to their caring role, often feel psychological distress. This paper describes the efficacy of a designed family-need-based program on relieving depression, anxiety, and stress of family caregivers of leukemia patients by meeting the specific psychological needs of caregivers.MethodsIn this clinical trial, 64 family caregivers of leukemia patients referring to a medical center in Iran were recruited by convenience sampling and divided into study and control groups randomly. The study group attended a designed need-based program. The control group did not receive the intervention. Stress, anxiety, and depression before, right after, and one month after the intervention in family caregivers were compared using DASS-42. Data were analyzed using descriptive and inferential statistics; the significance level adopted was 5%.ResultsBefore the intervention, the mean score of depression, anxiety, and stress scale in both study and control groups showed no considerable difference (P > 0.05). After the intervention, the mean score of DASS-42 revealed a significant difference between the two groups and the study group did better on outcomes (P < 0.001).ConclusionThis family-need-based program can decrease the level of stress, anxiety, and depression of the family caregivers of leukemia patients and may potentially alleviate the psychological distress of family caregivers over their caring role.Trial registration number: IRCT2013093011895N2. Date of registration: 2014-05-06

scholarly journals Effect of Acupressure on Stress and Anxiety of Patients with Multiple Sclerosis: A Sham-controlled Randomized Clinical Trial

2020 ◽  
Vol 10 (3) ◽  
pp. 270-283
Author(s):  
Mohammad Ali Nahayati ◽  
◽  
Seyed Abolfazl Vaghar Seyyedin ◽  
Hamid Reza Bahrami-Taghanki ◽  
Zahra Rezaee ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Test Scores ◽  
Sham Group ◽  
Applied Pressure ◽  
Intervention Group ◽  
T Test ◽  
Significant Difference ◽  
The Mean

Objective: Stress and anxiety are common in patients with Multiple Sclerosis (MS). These complications exacerbate the symptoms of MS. This study aims to evaluate the effect of acupressure on stress and anxiety of MS patients. Methods: In this randomized clinical trial, participants were 106 MS Patients referred to Multiple Sclerosis Society in Mashhad, Iran. After signing an informed consent form, they completed a demographic form and stress, and the Depression Anxiety Stress Scale - 42 items (DASS-42). Then, they were randomly assigned into intervention and sham groups by tossing a coin. Participants in the intervention group were asked apply a pressure on the Shenmen and Yin Tang acupoints for one month (once per day for 15 minutes), while the sham group applied pressure 2.5 cm below the Shenmen acupoint and 3 cm above the Yin Tang acupoint. Participants in each group were then completed the DASS-42 again one hour after the final session. Data were analyzed using chi-square test, Kolmogorov-Smirnov test, independent t-test, and Paired t-test. Results: In the intervention and sham groups, there was no statistically significant difference between the mean pre-test scores of stress (34.73±5.80 vs. 33.06±6.42) and anxiety (27.09±6.99 vs. 25.31±6.88), and neither between the mean post-test scores of stress (29.20±6.21 vs. 33.73±9.44) and anxiety (22.79±5.68 vs. 25.21±6.72) (P>0.05). However, comparison of DASS-42 scores between groups showed that the mean scores of stress and anxiety in the intervention group were significantly lower than in the sham group (P< 0.05). Conclusion: It seems that acupressure can be used along with other therapeutic and pharmacological interventions to reduce stress and anxiety in patients with MS.

scholarly journals Tinzaparin in Cancer and Renal Impairment: A Systematic Review Focusing on Safety

2020 ◽  
Author(s):  
Ioannis Vathiotis ◽  
Nikolaos Syrigos ◽  
Evangelos Dimakakos
Keyword(s):  
Systematic Review ◽  
Renal Impairment ◽  
Creatinine Clearance ◽  
Cancer Patients ◽  
Major Bleeding ◽  
Severe Renal Impairment ◽  
Vitamin K Antagonists ◽  
Bleeding Events ◽  
Increased Risk ◽  
Therapeutic Doses

Abstract Purpose: Low-molecular-weight heparins are approved for primary and secondary venous thromboembolism prevention. The purpose of this systematic review is to provide an update regarding the safety profile of tinzaparin sodium, prescribed either as a prophylactic or as a therapeutic regimen for VTE in cancer patients and individuals suffering from renal impairment. Method: We identified and studied clinical studies from 2000 until 2020, reporting safety outcomes for cancer patients and individuals with renal impairment receiving either prophylactic or therapeutic doses of tinzaparin. Results: In patients with cancer major bleeding rates fluctuate between 0.8% and 7%; reported major bleeding rates for non-cancer patients with renal impairment on prophylactic tinzaparin regimens were 0%. Non-cancer patients on therapeutic tinzaparin regimens exhibited major bleeding in 0 to 2.3% of cases; major bleeding rates were higher for cancer patients with renal impairment receiving therapeutic doses of tinzaparin (4.3 to 10%). Patients on tinzaparin exhibit significantly lower rates of clinically relevant nonmajor bleeding events in comparison with those on vitamin K antagonists. Bioaccumulation of tinzaparin is not correlated with age, body weight or creatinine clearance. Periodic administration of either prophylactic or therapeutic doses of tinzaparin does not result in bioaccumulation, even in patients with severe renal impairment and creatinine clearance < 20 ml/min. Conclusion: Tinzaparin is safe and can be used without dose adjustment in patients with severe renal impairment and creatinine clearance > 20 ml/min. Tinzaparin represents a thoroughly studied and safe choice for special populations at increased risk for thrombosis and bleeding.

Compare the effect of aromatherapy using lavender and Damask rose essential oils on the level of anxiety and severity of pain following C-section: A double-blinded randomized clinical trial

2020 ◽  
Vol 17 (3) ◽  
Author(s):  
Ali Abbasijahromi ◽  
Hamed Hojati ◽  
Saeid Nikooei ◽  
Hossein Kargar Jahromi ◽  
Hamid Reza Dowlatkhah ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Essential Oil ◽  
Essential Oils ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Content Type ◽  
Gate Control Theory ◽  
Significant Difference ◽  
The Mean ◽  
Damask Rose

AbstractBackgroundAnxiety is the most common psychological reaction in women during labor. Similar to numerous other surgeries, postoperative pain is also reported following cesarean section (C-section). According to the (Gate) Control Theory, there is a relationship between pain and psychological problems such as anxiety. Accordingly, the present study aimed to compare the effect of aromatherapy using lavender and Damask rose essential oils on the level of anxiety and severity of pain following C-section.MethodsThis triple-group randomized clinical trial was performed on 90 mothers who visited Motahari Hospital of Jahrom, Iran, for C-section in 2017. The incidence and severity of pain and anxiety were measured and recorded for all three groups prior to intervention. The intervention groups underwent aromatherapy with lavender and Damask rose essential oils. Patients were asked to inhale cotton balls, separately stained with three drops of each essential oil at a distance of 10 cm for 30 mins. The severity of pain and anxiety was measured using the visual analogue scale (VAS) and the Spielberger State-Trait Anxiety Inventory (STAI) 5 min after the specified process, respectively. The control group underwent aromatherapy in a similar fashion with normal saline. Finally, data were analyzed using descriptive statistical indices and ANOVA and Kruskal–Wallis tests in SPSS 21.ResultsThere was no significant difference between the three groups in the mean severity of pain and anxiety before the intervention (p>0.05). The mean severity of pain and overt anxiety in the lavender and Damask rose aromatherapy groups was significantly different than the control group after the intervention (p<0.001). In addition, no significant difference was observed between the overt and overall anxiety levels of the two intervention groups after the intervention (p>0.05).ConclusionsThe findings suggested that inhalation aromatherapy can reduce the severity of overt anxiety and pain after C-section, with Damask rose essential oil showing a larger effect than lavender.

Tinzaparin and enoxaparin given at prophylactic dose for eight days in medical elderly patients with impaired renal function

2007 ◽  
Vol 97 (04) ◽  
pp. 581-586 ◽  
Author(s):  
Manvel Aghassarian ◽  
Ludovic Drouet ◽  
Claire dit-Sollier ◽  
Karine Lacut ◽  
Jean-Jacques Heilmann ◽  
...  
Keyword(s):  
Renal Function ◽  
Body Weight ◽  
Elderly Patients ◽  
Creatinine Clearance ◽  
Impaired Renal Function ◽  
The Body ◽  
Accumulation Factor ◽  
Renal Elimination ◽  
Prophylactic Dose ◽  
Accumulation Effect

SummaryLow-molecular-weight heparins (LMWHs) accumulate in patients with impaired renal function. As this accumulation depends on heparin chain length and subsequent reticulo-endothelial/renal elimination, LMWHs might have different pharmacodynamic profiles. The primary objective was to examine if any accumulation effect of two LMWHs, enoxaparin and tinzaparin, occurred after repeated administration of a prophylactic dose over eight days in elderly patients (age >75 years) with creatinine clearance between 20 and 50 ml/min and body weight <65Kg. Patients were openly randomized to two groups (enoxaparin 4,000 IU or tinzaparin 4,500 IU once daily). Anti-Xa was measured on day 1 and day 8. Blood samples were taken at 0, 2, 4, 5, 6, 9, 12, 16 and 24 hours. The primary end point was the accumulation factor calculated as a ratio between the maximal anti-Xa activity on day 1and day 8. Fifty-five patients were included (mean age 87.9 ± 5.5 ).The creatinine clearance was 34.7 ± 11.4 ml/min; the body weight was 52.3 ± 8.6 kg. The accumulation factor defined was not significant for tinzaparin (1.05, p=0.29) while it was significantly enhanced for enoxaparin (1.22, p <0.0001). In this pharmacodynamic study performed in elderly patients with impaired renal function, a statistically significant accumulation effect was observed after eight days of prophylactic treatment with enoxaparin but not with tinzaparin, which are two LMWHs with different chain lengths. Trials based on clinical end points should be conducted to evaluate the clinical relevance of these observations.

Elderly Patients Treated with Tinzaparin (Innohep®) Administered once Daily (175 Anti-Xa IU/kg): Anti-Xa and Anti-IIa Activities over 10 Days

2000 ◽  
Vol 84 (11) ◽  
pp. 800-804 ◽  
Author(s):  
E. Pautas ◽  
M. Février ◽  
C. Wipff ◽  
B. Durand-Gasselin ◽  
M. Laurent ◽  
...  
Keyword(s):  
Renal Impairment ◽  
Elderly Patients ◽  
Creatinine Clearance ◽  
Ex Vivo ◽  
Day Treatment ◽  
Peak Level ◽  
Repeated Administration ◽  
Once Daily ◽  
Age Related ◽  
Pharmacodynamic Profile

SummarySince low molecular weight heparins (LMWH) are partly eliminated by renal excretion, their pharmacodynamic profile may be modified in very elderly patients with age-related renal impairment. The aim of this prospective study was to determine whether tinzaparin (Innohep®) 175 anti-Xa IU/kg administered subcutaneously once daily over 10 days does accumulate in hospital patients greater than 70 years of age. Plasma anti-Xa and anti-IIa amidolytic levels and APTT were determined prior to the first injection (day 0), and then, at peak level i.e. 5 h after the second injection (day 2) and subsequently on days 5, 7 and 10.Thirty consecutive inpatients (6 men, 24 women) requiring LMWHs at a curative dose for acute thromboembolic disease were included. Patients’ characteristics (mean ± SD) were: age 87.0 ± 5.9 years (range 71–96), body weight 62.7 ± 14.6 kg (range 38-90) and creatinine clearance 40.6 ± 15.3 mL/min (range 20–72). The mean actual dose of tinzaparin delivered was 174.8 anti-Xa IU/kg. Since no patient had an anti-Xa activity above 1.5 IU/mL, the dose of tinzaparin remained fixed over 10 days.Anti-Xa and anti-IIa peak levels measured on day 2 were 0.66 ± 0.20 IU/mL (range 0.26–1.04) and 0.33 ± 0.10 IU/mL (range 0.18–0.55), respectively. Ex vivo anti-Xa/anti-IIa ratios were close to 2.1. APTT ratios (patient/control) were strongly correlated with anti-IIa activity (p <0.01). There was no progressive increase of the anti-Xa and anti-IIa activities after repeated administration of tinzaparin over the 10 day treatment period. No correlation was found between anti-Xa and anti-IIa activities and age, weight, or creatinine clearance. No major bleeding occurred during the study and only one minor haematoma at the injection site was reported. No thromboembolic complication or death occurred.Tinzaparin may thus be administered safely at a treatment dose (175 anti-Xa IU/kg) in older patients with age-related renal impairment. Neither dose adjustment, nor serial anti-Xa activity monitoring seems to be required in patients with creatinine clearance above 20 mL/min during the first ten day treatment.

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