Overprescribing proton pump inhibitors

Abstract

In May 2004, the European Clinical Trials Directive came into force. The directive made it mandatory for all clinical drug trials to follow the good clinical practice guidance, and it fuelled existing concerns that financial and organisational constraints were making it almost impossible to conduct independent trials not funded by the drug industry. In the accompanying paper, Berendt and colleagues show that the decrease in the number of new clinical trials registered each year in Denmark began well before 2004, and the decrease was similar for independent and industry sponsored trials.1 In 2006, two years after the enforcement of the EU directive, the number of independent trials actually increased. Similar results have been reported in Sweden, Norway, and Italy.2 The consistency of these findings, despite differences in registration and classification systems, supports their validity and generalisability.So can we feel reassured about the future of independent therapeutic research? Certainly, clinical research not sponsored by the industry is alive and active. Yet, if we consider the role that independent researchers should have in directing therapeutic research towards its primary mission-meeting the needs of patients and health systems-the overall picture is more complex. The data above do not tell us how the relevance and potential impact of the independent trials compare with industry sponsored trials. For instance, the Italian data show that phase III trials, multicentre trials, and international trials are less likely to be independent. 2The trials that showed the efficacy of aromatase inhibitors for early, hormone dependent, postmenopausal breast cancer provide an example of how the aims of industry sponsored trials may differ from those of independent trials. These trials compared the use of aromatase inhibitors with the conventional regimen of five years of tamoxifen.3-6 The first published analyses of these trials, which in two cases were interim analyses that led to the premature cessation and unblinding of the trial, were conducted at median follow-ups of 2.2 to 2.7 years. All four trials found that aromatase inhibitors significantly improved disease-free survival, which is a plausible but not validated surrogate end point for overall survival in early breast cancer. 7 In contrast, no significant effect was seen on overall survival.Because early breast cancer has a long natural history and aromatase inhibitors may have delayed effects, decisions on the use of these drugs in this setting should be based on reliable information on their long term efficacy and safety.8 However, crossover of the control group to aromatase inhibitors in all but one 3 of these studies may hamper their ability to provide this information. 8 Furthermore, for ethical reasons, it is no longer acceptable to conduct a trial in which tamoxifen is given for five years as the control. Consequently, despite the inclusion of more than 20 000 patients in the above trials, aromatase inhibitors are being used to treat early breast c...

Prospective Assessment of Prescribing Pattern of Intravenous Proton Pump Inhibitors in an Indian Tertiary-Care Teaching Hospital

“…2 However, inappropriate use of PPIs has been observed in numerous hospitals worldwide. 3,4 An increase in the prevalence of pneumonia and Campylobacter enteritis, risk of hip fracture and infection with Clostridium difficile, and acute interstitial nephritis and osteoporosis have been reported as consequences of long-term treatment with PPIs. [4][5][6] Furthermore, parenteral PPIs are relatively expensive, and inappropriate use can increase the treatment cost significantly for patients, especially in developing countries.…”

“…3,4 An increase in the prevalence of pneumonia and Campylobacter enteritis, risk of hip fracture and infection with Clostridium difficile, and acute interstitial nephritis and osteoporosis have been reported as consequences of long-term treatment with PPIs. [4][5][6] Furthermore, parenteral PPIs are relatively expensive, and inappropriate use can increase the treatment cost significantly for patients, especially in developing countries. 7 Achieving appropriateprescribing practices regarding parenteral PPIs will be necessary to obviate these issues and challenges.…”

Effets indésirables des inhibiteurs de la pompe à proton : faut-il craindre de les prescrire au long cours ?

“…Si le mécanisme exact n'est pas encore élucidé, ces résultats restent d'un intérêt majeur pour le clinicien, compte tenu du nombre de patients exposés aux IPP sur une longue période et de la part importante de ceux pour lesquels une indication formelle n'est pas posée, sans parler des surcoûts générés pour le système de santé [2].…”

“…1) et la prévalence des traitements de longue durée est en augmentation. Pourtant, une part importante de leur utilisation n'est pas adéquate, cette surconsommation induisant des surcoûts importants et des accidents iatrogènes évi-tables [2].…”

Long-Time Gastric Protection

“…Some manufacters has recommended "manteinance dose" for months and years, this is not convenient. Their sales in USA are $10.billion in 2001 and $ 13.8 billions in 2008, is the drug most sold in the world [1].…”