The Streptokinase Therapy Complications and its Associated Risk Factors in Patients with Acute ST Elevation Myocardial Infarction.

Acute myocardial infarction (AMI) is one of the main leading causes of mortality and morbidity. Despite the progress in the treatment of AMI, streptokinase is still being used in many countries. Because of the critical condition of patients with AMI and complications of streptokinase therapy, this study was performed to evaluate the pattern of adverse drug reaction (ADRs) induced by streptokinase and its associated risk factors in patients with acute ST elevation MI. A prospective cross-sectional study in a 14-month period was done at the university affiliated referral cardiovascular center. The Naranjo probability scale and Food and drug administration (FDA) criteria for severity of ADRs were performed for assessing the ADRs. The linear and logistic regression tests were used to evaluate the correlation between ADRs and study risk factors. During the study period, 217 patients who received streptokinase were entered. The majority of patients (n = 191) experienced at least one ADR. Six patients died in-hospital mainly because of cardiac causes. The history of drug allergy was the main predictor in occurring of ADRs (Odds ratio: 3.26; 95% CI: 1.48-457.6; p =0.026). The most serious ADR was hemorrhagic stroke with a 1.4% incidence. Hypotension was one of the most occurred ADR (n = 75). Anaphylactic shock was not detected in this study. In summary, our study showed that the history of drug allergy is the main predictor in occurring of ADRs by streptokinase. Furthermore, streptokinase therapy was associated with a higher rate of hemorrhagic stroke in Iranian population.

The Effect of Treatment of Vitamin D Deficiency on the Level of P-Selectin and hs-CRP in Patients With Thromboembolism: A Pilot Randomized Clinical Trial.

Despite the known role of vitamin D deficiency in development of thrombosis, no studies have evaluated the impact of treating of vitamin D deficiency on the markers of thrombosis. A pilot randomized clinical trial was done on 40 vitamin D-deficient patients with deep vein thrombosis (DVT) or pulmonary embolism (PE). The intervention group received an oral dose of 50,000 IU vitamin D3 every week for 8 weeks, followed by 1 pearl every 2 weeks for 4 weeks (a total of 3 months), while the control group did not receive vitamin D. Then, P-selectin and hs-CRP were measured at baseline and 1 and 3 months after the intervention. There was no significant decrease in hs-CRP in either group after 1 month (P = .955) or after 3 months (P = .525). Likewise, there was no significant decrease in P-selectin between the 2 groups after 1 month (P = .921) or 3 months (P = .795). The results indicated that treatment of vitamin D deficiency had no significant effect on hs-CRP or P-selectin after 3 months among DVT/PE patients. However, treatment of vitamin D deficiency in these patients resulted in the control of the international normalized ratio (INR) with the lower doses of warfarin. This observation is the first clinical report of enhancement of the anticoagulant effect of warfarin by the supplementing of vitamin D. Larger trials are needed to clearly show the effect of treating of vitamin D deficiency on thrombosis.

The randomized clinical trial of coenzyme Q10 for the prevention of periprocedural myocardial injury following elective percutaneous coronary intervention.

INTRODUCTION: Periprocedural myocardial injury (PMI) following elective percutaneous coronary intervention (PCI) is an important therapeutic concern with remaining some mortality and morbidity. To the best of our knowledge, there is no published study that investigates the potential benefit of CoQ10 in preventing PMI following elective PCI. METHODS: In a randomized, clinical trial, 100 patients who scheduled for elective PCI were allocated in to the intervention (n=50) and control group (n=50). The intervention received a 300 mg loading dose CoQ10 12 hours before procedure. The level of CK-MB and troponin-I was measured before procedure, and 8 and 24 hours after. Furthermore, hs-CRP was measured at baseline and 24 hours after. All patients were assessed for the incidence of major adverse cardiac effects (MACEs) after 1 month. RESULTS: The CK-MB elevation (above the upper limit normal) was occurred in 22% (n=11) of CoQ10 and 20% (n=10) of control (P=.806). The elevation of troponin-I was documented in 8% (n=4) of both groups. No significant change in the level of cardiac biomarkers was noted. However, the significant reduction in hs-CRP level was occurred in CoQ10 group (P=.032). CONCLUSION: The results showed that pretreatment with 300 mg CoQ10 12 hours before procedure could not reduce PMI following elective PCI, however, significantly decreased hs-CRP.

The Effect of High-Dose Vitamin D3 on Soluble P-Selectin and hs-CRP Level in Patients With Venous Thromboembolism: A Randomized Clinical Trial.

High plasma level of P-selectin is associated with the development of venous thromboembolism (VTE). Furthermore, supplementation of vitamin D could decrease thrombotic events. Hence, this study was designed to examine whether the administration of vitamin D can influence the plasma level of P-selectin in patients with VTE. In the randomized controlled trial, 60 patients with confirmed acute deep vein thrombosis and/or pulmonary embolism (PE) were randomized into the intervention (n = 20) and control (n = 40) groups. The intervention arm was given an intramuscular single dose of 300 000 IU vitamin D3 Plasma level of 25-hydroxy vitamin D, P-selectin, and high-sensitive C-reactive protein (hs-CRP) was measured at baseline and 4 weeks after. The plasma level of P-selectin (95% confidence interval = -5.99 to -1.63, P = .022) and hs-CRP (P = .024) significantly declined in vitamin D-treated group, while only hs-CRP was significantly decreased in the control group (P = .011). However, the magnitude of these reductions was not statistically significant. This study could not support the potential benefit of the high-dose vitamin D on plasma level of P-selectin and hs-CRP in patients with VTE.

A systematic review on comparing 2 common models for management of warfarin therapy; pharmacist-led service versus usual medical care.

Despite a growing body of literature supporting the potential benefit of pharmacist-managed warfarin therapy (PMWT), comprehensive reviews regarding this topic are still lacking. A systematic search of literature was done in Pubmed/Medline, Scopus, Google Scholar, and Cochrane Library from database inception to January 2014. Studies comparing PMWT with usual medical care (UMC) regarding the control of anticoagulation, bleeding and thromboembolic events, mortality, hospitalization, emergency department visit, cost, patients' satisfaction, and quality of life were included. Of 758 potential articles identified, 24 studies (4 randomized controlled trials [RCT] and 20 non-RCT studies) with a population of 11,607 were included. Among non-RCT studies, the percentage of time in the therapeutic range (72.1% vs 56.7%; P = .013), major bleeding events (0.6% vs 1.7%, P < .001), thromboembolic events (0.6% vs 2.9%; P < .001), hospitalization (3% vs 10%; P < .001), emergency department visits (7.9% vs 23.9%; P < .0001) significantly favored PMWT. The study supported PMWT regarding cost saving and patient satisfaction. The results showed that the PMWT model is superior to UMC in managing warfarin therapy based on observational studies. As well, it is comparable to UMC based on RCT studies.

The pattern and risk factors associated with adverse drug reactions induced by Reteplase in patients with acute ST-elevation myocardial infarction: The first report from Iranian population.

OBJECTIVE: Acute myocardial infarction (AMI) is one of the main leading causes of mortality and morbidity. Reteplase is a fibrin-specific thrombolytic which is used in the treatment of AMI. There is a limited number of studies reporting the postmarketing adverse drug reactions (ADRs) induced by reteplase. This study was aimed to examine the reteplase pattern of ADR and its associated risk factors in patients with acute ST-elevation myocardial infarction. METHODS: A cross-sectional, prospective study in an 8-month period was done at the University affiliated referral cardiovascular center. The Naranjo probability scale and World Health Organization criteria for severity of ADRs were used for assessing the ADRs. The linear regression and logistic regression tests were used to evaluate the correlation between ADRs and risk factors. FINDINGS: The all 20 patients who received reteplase during the study period were entered. The majority of patients (n = 17) experienced at least one ADR. The results showed that the incidence of ADRs was mainly associated with gender and age, and the number of ADRs was associated with the history of diabetes and taking anti-diabetic agents. The gender was the main predictor in the occurrence of ADRs (odds ratio: 32, 95% confidence interval: 1.38-737.45; P = 0.030). CONCLUSION: The results showed that gender, age, diabetes mellitus, and using of anti-diabetes medications are the risk factors associated with the incidence of ADRs by reteplase.

A pilot randomized trial of pentoxifylline for the reduction of periprocedural myocardial injury in patients undergoing elective percutaneous coronary intervention.

PURPOSE: Periprocedural myocardial injury (PMI) following percutaneous coronary intervention (PCI) has received great attention due to its significant association with mortality and morbidity. Accordingly, cardioprotection during PCI is one of the important therapeutic concerns. Regarding the potential cardiovascular benefits of pentoxifylline this study was performed to evaluate whether the pretreatment pentoxifylline could reduce PMI in patients who are undergoing elective PCI. METHODS: A randomized clinical trial on 85 patients undergoing elective PCI was performed. The intervention group (n = 41) received 1200 mg pentoxifylline in divided doses plus the standard treatment before PCI, while the control group (n = 44) received the standard treatment. For assessing myocardial damage during PCI, the levels of CK-MB and troponin-I were measured at baseline, 8, and 24 h after the procedure. Then, patients were followed up for a 1-month period regarding the major adverse cardiac effect. RESULTS: Comparing with the control group, no significant change of CK-MB at 8 (p = 0.315) and 24 h (p = 0.896) after PCI was documented in pentoxifylline group. Similarly, no significant change was found in troponin-I at 8 (p = 0.141) and 24 h (p = 0.256) after PCI. CONCLUSIONS: This study could not support the pretreatment with pentoxifylline in the prevention of PMI in patients undergoing elective PCI. However, the trend was toward the potential benefit of pentoxifylline.

Evaluation and monitoring of isotretinoin use in Iran.

BACKGROUND: Isotretinoin (13-cis retinoic acid) is used for treatment of nodular cystic acne unresponsive to conventional therapy. It is an expensive, potent teratogenic drug with serious adverse drug reaction (ADRs). Recently, use of this drug has increased in Iran. To date, there are no published data about the use of isotretinoin in Iran; therefore, this study aims to assess its use in this country. METHODS: This was a prospective, drug utilization evaluation (DUE) study conducted in an institutional community pharmacy affiliated with Tehran University of Medical Sciences (TUMS). Drug prescription, administration, and evaluation of appropriateness were recorded and compared with standard protocols. Collected data were analyzed by SPSS software. RESULTS: A total of 274 outpatients treated with isotretinoin enrolled in the study. Of these, 51.3% were prescribed isotretinoin under the usual recommended daily doses of 0.5mg/kg/day. Data also indicated that 33.5% of the patients were given total doses of less than 100 mg/kg (72.4 ± 17.2 mg/kg) and 12.2% received more than 150 mg/kg. With regards to the teratogenic effects of isotretinoin, only 6.8% of couples simultaneously used two methods of contraception (P = 0.001). In addition, we detected improper use of isotretinoin for mild and moderate acne in about 20% of cases. CONCLUSION: The most important finding of this study is that the doses of isotretinoin are incorrect in many cases. Incorrect dosages would decrease drug efficacy and increase the risk of relapse. In addition, patients have not been adequately counseled about isotretinoin's teratogenicity and the seriousness of its adverse effects.