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6. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials

Author

Baigent, Colin, Bhala, N., Emberson, J., Merhi, A., Abramson, S., Arber, N., Baron, J. A., Bombardier, C., Cannon, C., Farkouh, M. E., Fitzgerald, G. A., Goss, P., Halls, H., Hawk, E., Hawkey, C., Hennekens, C., Hochberg, M., Holland, L. E., Kearney, P. M., Laine, L., Lanas, A., Lance, P., Laupacis, A., Oates, J., Patrono, C., Schnitzer, T. J., Solomon, S., Tugwell, P., Wilson, K., Wittes, J., Adelowo, O., Aisen, P., Al Quorain, A., Altman, R., Bakris, G., Baumgartner, H., Bresee, C., Carducci, M., Chang, D. M., Chou, C. T., Clegg, D., Cudkowicz, M., Doody, L., Miedany, Y. E. l., Falandry, C., Farley, J., Ford, L., Garcia Losa, M., Gonzalez Ortiz, M., Haghighi, M., Hala, M., Iwama, T., Jajic, Z., Kerr, D., Kim, H. S., Kohne, C., Koo, B. K., Martin, B., Meinert, C., Muller, N., Myklebust, G., Neustadt, D., Omdal, R., Ozgocmen, S., Papas, A., Patrignani, P., Pelliccia, Francesco, Roy, V., Schlegelmilch, I., Umar, A., Wahlstrom, O., Wollheim, F., Yocum, S., Zhang, X. Y., Hall, E., Mcgettigan, P., Midgley, R., Moore, R. A., Philipson, R., Curtis, S., Reicin, A., Bond, J., Moore, A., Essex, M., Fabule, J., Morrison, B., Tive, L., Davies, K., and Yau, F.

Subjects
medicine.medical_specialty, Gastrointestinal Diseases, Perforation (oil well), coronary disease, Placebo, anti-inflammatory agents, non-steroidal, blood vessels, Diclofenac, vascular, Internal medicine, medicine, naproxen, Humans, Myocardial infarction, Vascular Diseases, medicine (all), Stroke, ibuprofen, anti-inflammatory, business.industry, Vascular disease, Anti-Inflammatory Agents, Non-Steroidal, General Medicine, Articles, Ibuprofen, medicine.disease, stroke, gastrointestinal, diclofenac, myocardial infarction, cyclooxygenase 2 inhibitors, Heart failure, Anesthesia, Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, gastrointestinal tract, business, anti-inflammatory agents, non-steroidal, gastrointestinal diseases, humans, vascular diseases, medicine.drug
Abstract

BACKGROUND: The vascular and gastrointestinal effects of non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors (coxibs) and traditional non-steroidal anti-inflammatory drugs (tNSAIDs), are not well characterised, particularly in patients at increased risk of vascular disease. We aimed to provide such information through meta-analyses of randomised trials. METHODS: We undertook meta-analyses of 280 trials of NSAIDs versus placebo (124,513 participants, 68,342 person-years) and 474 trials of one NSAID versus another NSAID (229,296 participants, 165,456 person-years). The main outcomes were major vascular events (non-fatal myocardial infarction, non-fatal stroke, or vascular death); major coronary events (non-fatal myocardial infarction or coronary death); stroke; mortality; heart failure; and upper gastrointestinal complications (perforation, obstruction, or bleed). FINDINGS: Major vascular events were increased by about a third by a coxib (rate ratio [RR] 1·37, 95% CI 1·14-1·66; p=0·0009) or diclofenac (1·41, 1·12-1·78; p=0·0036), chiefly due to an increase in major coronary events (coxibs 1·76, 1·31-2·37; p=0·0001; diclofenac 1·70, 1·19-2·41; p=0·0032). Ibuprofen also significantly increased major coronary events (2·22, 1·10-4·48; p=0·0253), but not major vascular events (1·44, 0·89-2·33). Compared with placebo, of 1000 patients allocated to a coxib or diclofenac for a year, three more had major vascular events, one of which was fatal. Naproxen did not significantly increase major vascular events (0·93, 0·69-1·27). Vascular death was increased significantly by coxibs (1·58, 99% CI 1·00-2·49; p=0·0103) and diclofenac (1·65, 0·95-2·85, p=0·0187), non-significantly by ibuprofen (1·90, 0·56-6·41; p=0·17), but not by naproxen (1·08, 0·48-2·47, p=0·80). The proportional effects on major vascular events were independent of baseline characteristics, including vascular risk. Heart failure risk was roughly doubled by all NSAIDs. All NSAID regimens increased upper gastrointestinal complications (coxibs 1·81, 1·17-2·81, p=0·0070; diclofenac 1·89, 1·16-3·09, p=0·0106; ibuprofen 3·97, 2·22-7·10, p

Published
2013
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18. Effect of Mode of Administration on I–PSS Scores in a Large BPH Patient Population

Author

Garcia-Losa, M., Unda, M., Badia, X., Rodriguez-Alcantara, F., Carballido, J., Dal-Ré, R., and Herdman, M.

Abstract

Objectives:The International Prostate Symptoms Score (I–PSS) was designed to be self–administered to patients with benign prostatic hyperplasia. This study tested for a possible mode of administration effect on the I–PSS and assessed the reliability of the I–PSS over time when modes of administration varied. Methods:Benign prostatic hyperplasia patients over 50 years of age were recruited at 52 Spanish centres. The I–PSS was administered on two occasions 1 month apart. Patients were sequentially classified into groups A–D according to the mode of administration (S = self–administered, I = interview administered) at the two visits (A = S–S, B = S–I, C = I–S, and D = I–I). The intraclass correlation coefficient was used to assess test–retest reliability, and multiple regression analysis was used to test the effects of the mode of administration and the visit number on I–PSS scores. Results:926 patients (mean age 66 years) were evaluated. The mean I–PSSs symptoms score at visit 1 in groups A–D were, respectively, 13.19, 13.57, 12.06, and 12.29. Multiple regression analysis between–group scores were 0.93 points higher when the I–PSS was self–administered and 1.98 points lower at the second visit. The intraclass correlation coefficients were: group A = 0.77, group B = 0.70, group C = 0.67, and group D = 0.76. Conclusions:Interview administration of the I–PSS results in slightly lower scores. The reliability is higher when the same mode of administration is used at two recurrent visits.

Published
2001
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20. Progression of benign prostatic hyperplasia: systematic review of the placebo arms of clinical trials.

Author

Emberton M, Fitzpatrick JM, Garcia-Losa M, Qizilbash N, and Djavan B

Subjects
Adult, Aged, Disease Progression, Humans, Male, Middle Aged, Prostatectomy methods, Prostatic Hyperplasia complications, Prostatic Hyperplasia therapy, Randomized Controlled Trials as Topic, Severity of Illness Index, Placebos therapeutic use, Prostatic Hyperplasia pathology, Urinary Retention etiology
Abstract

Objective: To systematically review the placebo arms of randomized trials of medical therapy for benign prostatic hyperplasia (BPH) and thus estimate rates of progression., Methods: We searched PubMed, the Cochrane Trials Register and the USA Food and Drug Administration website. Retrieved citations were reviewed in two stages: a title and abstract screen, followed by a review of selected full-length articles. The inclusion criterion for studies were trials of BPH with >100 patients in the placebo group., Results: From 1774 citations screened, 16 eligible studies were found with a total of 12 158 patients. The range of mean baseline age was 62.6-66.5 years, for prostate volume 33.9-61.0 mL and for maximum urinary flow 8.6-11.6 mL/s. With studies spanning 12-48 months, the rates of surgery were 1-10% and for acute urinary retention 0.4-6.6%. Most studies showed progression, based on a worsening in clinical outcomes of the change from baseline in prostate volume and maximum urinary flow. Statistical heterogeneity prevented a quantitative synthesis of the data., Conclusion: This systematic review confirms BPH disease progression in the form of increased prostate volume, reduction in maximum urinary flow rate and an increase in the risk of acute urinary retention and surgery. To provide quantitative estimates of effect, access to data from individual participants would be required.

Published
2008
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