Luis H. Martín Arias

Trends in the consumption of attention deficit hyperactivity disorder medications in Castilla y León (Spain): changes in the consumption pattern following the introduction of extended release methylphenidate

Attention deficit hyperactivity disorder (ADHD) is the most diagnosed behavioural disorder in children and adolescents; prevalence has been estimated around 5%. Studies have shown an increase in the use of ADHD medications during the last years. The aim of the present study was to learn the pattern and the evolution of ADHD medication consumption in Castilla y León (Spain).

HMG CoA Reductase Inhibitors and Impotence Two Case Series from the Spanish and French Drug Monitoring Systems

AbstractObjective: HMG CoA Reductase inhibitors, more commonly called statins, are used in the pharmacological management of hyperlipidaemia. At present, the use of these drugs is increasing worldwide. They have been linked to certain adverse drug reactions, including impotence. The aim of the present study is to explore the basis of the association between statin use and impotence using data from spontaneous reports. Method: We analysed the cases of impotence associated with statins that were collected by the Spanish and French pharmacovigilance systems. We used cases of impotence as a numerator and consumption data as a denominator to estimate the cumulative reported incidence of impotence. Results: Thirty-eight cases of impotence associated with statins have been identified in the database of the Spanish pharmacovigilance system; overall, there was a temporal sequence of events in all cases and the adverse reaction disappeared after drug withdrawal in 93% of the cases. Sixteen patients had also been treated with other drugs. In France, 37 cases were collected. In 85% of these cases recovery from the adverse reaction was observed after drug withdrawal; there was a positive rechallenge in five cases, and 15 patients were receiving other drugs at the same time. No significant differences among reported incidences with different statins were found. Conclusion: Considering the widespread use of this drug class and the under-reporting of this particular reaction it could affect a large number of patients. The reaction seems to be reversible in most of the cases after drug withdrawal. Doctors should be aware of this potential adverse reaction when prescribing statins to their patients.

Gastroprotection during the administration of non-steroidal anti-inflammatory drugs. A drug-utilization study.

There has been an increase of anti-ulcer drug consumption in Spain. A high proportion of this consumption may be due to the use of those drugs as gastroprotective agents when co-prescribed with non-steroidal anti-inflammatory drugs (NSAIDs). The aim of this study was to learn how these treatments are being used: the prevalence of use, the type of drug and the main features of patients. A sample of patients going to pharmacies with a NSAID prescription, with or without a gastroprotective agent, was obtained. A survey questionnaire was distributed to learn clinical and demographic data of the patients. Of the 942 patients interviewed, 41.6% were co-treated with a gastroprotective agent in addition to the NSAID. Most of these patients received proton-pump inhibitors and, to a lesser extent, histamine-2-receptor antagonists, antacids and prostaglandin analogues. The use of gastroprotective agents increased with age, treatment duration and illness chronicity; specialists prescribed a higher proportion of those co-treatments than did general practitioners. There was a high prescription rate of gastroprotective agents; in general, these were used according to recommendations. However, the type of gastroprotective agents being used does not seem to be justified by the current guidelines: histamine-2-receptor antagonists and antacid drugs have not proved their efficacy in this indication. The fact that one in four treatments with gastroprotective drugs was issued to patients without associated risk factors identifies a possible problem where an intervention could be appropriate.

DOXAZOSIN AND PRIAPISM

The causal relationship between doxazosin and priapism, in the absence of other alternative causes, was suspected in our patient in view of the temporal sequence of the drug administration, particularly when the dosage had been increased, and the appearance of the condition. Furthermore, prazosin has been associated with priapism, although the dosage used for hypotension differs from that used for BPH. To our knowledge no other cases of priapism following treatment with doxazosin or other new a-1 blockers have been reported. Given the high prevalence of BPH and the widespread use of these medications, priapism may appear more frequently.

Aspirin or Acetaminophen? A Comparison from Data Collected by the Spanish Drug Monitoring System

To characterize and compare the toxicity profiles of aspirin and acetaminophen when used by large populations, all records of adverse drug reactions to these drugs reported to the Spanish Drug Monitoring System from 1982 to 1991 were analyzed. According to these data, aspirin-induced reactions were more serious than those reactions to acetaminophen; the severity of all the reactions in both cases was associated with time of exposure and with the accumulated dose administered. For GI reactions to aspirin no association was found between severity and time of exposure or dose, although an association with age was found. There were no differences between the proportions of deaths, malformations, and renal damage recorded for either of the two groups. Proportions of hematological and hepatic disturbances were greater with acetaminophen. Adverse drug reaction data for aspirin and acetaminophen from spontaneous reporting seem to be consistent with data coming from observational studies.

Trends in the consumption of antidepressants in Castilla y León (Spain). Association between suicide rates and antidepressant drug consumption

To learn the evolution of antidepressant and lithium use in Castilla y León (Central Spain) and its relationship with suicide rates.

Gynaecomastia Associated with Proton Pump Inhibitors A Case Series from the Spanish Pharmacovigilance System

AbstractObjective: Proton pump inhibitors (PPIs) are widely used in the management of peptic ulcer and related symptoms. They have been linked to certain endocrine adverse reactions, including gynaecomastia. The aim of the present study is to investigate the association between the use of PPIs and the development of gynaecomastia. Methods: Reports of cases of gynaecomastia that had putatively been induced by PPIs and that had been collected by the Spanish Pharmacovigilance System via the ‘yellow card’ scheme, were analysed. Reporting odds ratios (RORs) were calculated as a measure of disproportionality. Results: Twenty-four cases of gynaecomastia associated with PPIs were identified in the database of the Spanish Pharmacovigilance System. Overall, there was a clear temporal sequence of events in all cases and the adverse effect disappeared after drug withdrawal in most of the cases; 14 patients were also receiving other drugs at the time of the adverse effect. The ROR for omeprazole exposure versus no exposure, but not that for other PPIs, showed a statistically significant elevation (ROR adjusted for age 5.23; 95% CI 3.32, 8.26). Conclusion: Considering the widespread use of PPIs, gynaecomastia may affect a large number of patients. In most cases, the condition seems to be reversible with drug withdrawal. Doctors should be aware of this potential adverse reaction when prescribing PPIs to their patients over long periods of time.

Strontium ranelate may cause alopecia

From May 2005 to January 2008, the Spanish pharmacovigilance system received 56 reports in which strontium ranelate, a drug intended for the treatment of osteoporosis, was associated with different adverse reactions; five of them (8.9%) were reports of alopecia (table⇓; figure⇓). From the start of pharmacovigilance activities in Spain in 1982 up to January 2008, 102 540 reports were collected, of which 393 (0.4%) were cases of alopecia; the corresponding reports for postmenopausal women were 39 640, of which 205 (0.5%) cases were of alopecia. Alopecia in case 3 (see table). This was accompanied by some features compatible with …

Utilisation of Lipid-Lowering Drugs in Spain between 1986 and 1998

AbstractObjective: To investigate the pattern of use of lipid-lowering drugs in Spain between 1986 and 1998, with particular emphasis on the impact of drug utilisation following the marketing of statins in Spain. Design: Information on drug utilisation was obtained from the ECOM (Especialidades Consumo de Medicamentos) database of the Spanish Ministry of Health, which contains the number of packages sold in community pharmacies and charged to the National Health System. Data were expressed in defined daily doses (DDD) per 1000 inhabitants per day. Main Outcomes and Results: The use of lipid-lowering drugs increased from 2.45 DDD/1000 inhabitants/day (1986) to more than 19.3 DDD/1000 inhabitants/ day (1998). Over the period studied, fibrates (until 1995), and statins (thereafter), were the most widely used lipid-lowering drugs. The consumption of probucol and other lipid-lowering drugs, including fixed-dose combinations, decreased during this period. Conclusion: The consumption of lipid-lowering drugs has increased dramatically in Spain during the last few years. This increase did not seem to be directly influenced by the information derived from important clinical trials. The introduction of statins has markedly modified the pattern of use of lipid-lowering drugs in Spain. Some indicators point to a greater rationality in the consumption of these drugs.

Emergency contraceptive pill safety profile. Comparison of the results of a follow-up study to those coming from spontaneous reporting

The emergency contraceptive pill (ECP) containing levonorgestrel is dispensed without a prescription in Spain since 2009. An easy access could diminish unwanted pregnancies; however, there is a risk of misuse and, in any case, of developing some adverse events. The aim of the present study is to further learn the adverse effects of this ECP.