The association between calcium dobesilate and pancytopenia in type 2 diabetes: A case report

Turkish Journal of Haematology (Impact Factor: 0.34). 03/2011; DOI: 10.5152/tjh.2011.12
Source: DOAJ
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    ABSTRACT: A study was carried out in Greece with the aim of assessing the prevalence of chronic venous insufficiency (CVI) in Greece and to discuss the role of general practice in the epidemiology, early diagnosis, and initial management of this disease. Design: a prevalence study was carried out in rural Greece between January 17 and December 30, 1997. Setting: 13 GPs, 11 of those working in 13 rural primary health centers, 1 in the University Hospital of Heraklion and 1 private sector from different Greek districts were invited to participate in the study. Participants and methods: patients with the following criteria were entered into the study: weight, pain, cramps, burning, itching, formication and swelling. Complete information about patients' history was collected by the general practitioners (GPs) who used a semi-structured questionnaire. The diagnosis of CVI was established with Doppler ultrasound. Data were based on 6,119 questionnaires and GPs observed 4,502 randomly selected patients. The diagnosis of CVI was established in 993 patients and its prevalence was found to be 11.9% in males and 39.8% in females. Varicose veins were the most frequent clinical finding in patients with vein reflux and diabetes mellitus was the most common co-existing disease in males and hypertension in females. The prevalence of venous insufficiency (VI) appears to be a frequent health problem in general practice in Greece. It requires further investigation in order to explore the observed differences between various groups.
    International angiology: a journal of the International Union of Angiology 04/2002; 21(1):86-92. · 1.01 Impact Factor
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    ABSTRACT: The aim of the present review is to consider the adverse effects and the safety profile of calcium dobesilate. Calcium dobesilate (Doxium) is a veno-tonic drug, which is widely prescribed in more than 60 countries from Europe, Latin America, Asia and the Middle East for three main indications: chronic venous disease, diabetic retinopathy and the symptoms of haemorrhoidal attack. Data sources used for this review comprise the international literature (1970-2003), a postmarketing surveillance (PMS) report for calcium dobesilate from OM Pharma (Geneva, Switzerland) covering the period 1974-1998, and periodic safety update reports (PSUR) covering the period 1995-2003 from the French Regulatory authorities pharmacovigilance database and OM Pharma. Data from the PMS report for 1974-1998 indicated that adverse events with calcium dobesilate did not occur very frequently and had the following distribution in terms of frequency: fever (26%), gastrointestinal disorders (12.5%), skin reactions (8.2%), arthralgia (4.3%), and agranulocytosis (4.3%). No deaths were attributed to calcium dobesilate in the PMS report. Using data on product use in the Swiss Compendium we estimated the prevalence of agranulocytosis to be 0.32 cases/million treated patients, i.e. ten times less than the calculated prevalence of agranulocytosis in the general population. Most adverse events are type B, i.e. rare and unrelated to the pharmacological properties of calcium dobesilate. This review concludes that the risk of an adverse effect with calcium dobesilate 500-1500 mg/day is low and constant over time. The recently raised problem of agranulocytosis (a total of 13 known cases drawn from all data sources) appears to be related to methodological bias. Such a review reinforces the need for a strong international pharmacovigilance organisation using similar methods to detect and analyse the adverse effects of drugs.
    Drug Safety 02/2004; 27(9):649-60. DOI:10.2165/00002018-200427090-00003 · 2.62 Impact Factor
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    ABSTRACT: In the last 20 years, some cases of agranulocytosis associated with calcium dobesilate consumption in Spain have been reported. A high risk of dobesilate-associated agranulocytosis (121 cases per million per year) calculated using both a case-control and a case-population strategy has been published. However few spontaneous reports have been noted in the same period of time. No explanation exists for this disagreement. Estimated incidence rates of agranulocytosis in the IAAAS study and the calculated risk of dobesilate-associated agranulocytosis were used as background risks in a Poisson-based methodology, to calculate the number of coincidental reports of agranulocytosis among patients treated with dobesilate. The influence of treatment duration, notification rate and population characteristics were calculated. During the period 1978-2000, a total of 23 cases would have taken place if the background risk of agranulocytosis were 4.7 per million per year (IAAAS's risk); however, only 9 spontaneous cases of agranulocytosis associated to dobesilate were noted. A simulation showed that with notification rates equal to or higher than 17%, it was not possible to exclude that the 9 cases were false-positives. With notification rates equal or inferior to 16%, it would be unlikely that cases of agranulocytosis were noted in this population with a risk of 4.7 per million per year; therefore, it is necessary to assume a higher agranulocytosis risk. More than 1 case per year could be a false-positive if the background risk of agranulocytosis is 9.5 per million per year, this being the appropriate risk for a population of patients older than 60 years. The duration of treatment beyond 30 days increases the probability of a random coincidence of the intake of drug and an agranulocytosis event. The disagreement between calculated dobesilate-associated agranulocytosis risk and the number of noted spontaneous reports may be explained by at least three different factors: under-reporting, duration of treatment and age of patients. It is possible, with the methodology presented, to estimate the influence of these factors to avoid confusion with possible false-positive cases and then to design the correct prospective trial that can provide the true agranulocytosis risk.
    European Journal of Clinical Pharmacology 04/2003; 58(11):767-72. DOI:10.1007/s00228-002-0550-6 · 2.70 Impact Factor
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