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Grupo de Investigación en Atención Farmacéutica

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GIAF - UGR (CTS 131)

Universidad de Granada
(Facultad de Farmacia)
Campus Universitario de Cartuja

958 24 19 31

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Predictores farmacogenéticos de toxicidad a quimioterapia basada en platino
jueves, 03 de noviembre de 2016

Pharmacogenetic predictors of toxicity to platinum based chemotherapy in non-small cell lung cancer patients.

Pérez-Ramírez C, Cañadas-Garre M, Alnatsha A, Villar E, Delgado JR, Faus-Dáder MJ , Calleja-Hernández MÁ.

Platinum-based chemotherapy is the standard treatment for NSCLC patients with EGFR wild-type, and as alternative to failure to EGFR inhibitors. However, this treatment is aggressive and most patients experience grade 3-4 toxicities. ERCC1, ERCC2, ERCC5, XRCC1, MDM2, ABCB1, MTHFR, MTR, SLC19A1, IL6 and IL16 gene polymorphisms may contribute to individual variation in toxicity to chemotherapy. The aim of this study was to evaluate the effect of these polymorphisms on platinum-based chemotherapy in NSCLC patients. A prospective cohorts study was conducted, including 141 NSCLC patients. Polymorphisms were analyzed by PCR Real-Time with Taqman(®) probes and sequencing. Patients with ERCC1 C118T-T allele (p=0.00345; RR=26.05; CI95%=4.33, 515.77) and ERCC2 rs50872-CC genotype (p=0.00291; RR=4.06; CI95%=1.66, 10.65) had higher risk of general toxicity for platinum-based chemotherapy. ERCC2 Asp312Asn G-alelle, ABCB1 C1236T-TT and the IL1B rs12621220-CT/TT genotypes conferred a higher risk to present multiple adverse events. The subtype toxicity analysis also revealed that ERCC2 rs50872-CC genotype (p=0.01562; OR=3.23; CI95%=1.29, 8.82) and IL16 rs7170924-T allele (p=0.01007; OR=3.19; CI95%=1.35, 7.97) were associated with grade 3-4 hematological toxicity. We did not found the influence of ERCC1 C8092A, ERCC2 Lys751Gln, ERCC2 Asp312Asn, ERCC5 Asp1104His, XRCC1 Arg194Trp, MDM2 rs1690924, ABCB1 C3435T, ABCB1 Ala893Ser/Thr, MTHFR A1298C, MTHFR C677T, IL1B rs1143623, IL1B rs16944, and IL1B rs1143627 on platinum-based chemotherapy toxicity. In conclusion, ERCC1 C118T, ERCC2 rs50872, ERCC2 Asp312Asn, ABCB1 C1236T, IL1B rs12621220 and IL16 rs7170924 polymorphisms may substantially act as prognostic factors in NSCLC patients treated with platinum-based chemotherapy.

Efectividad de un protocolo normalizado de dispensación en farmacia comunitaria
lunes, 10 de octubre de 2016

Effectiveness of a protocolized dispensing service in community pharmacy for improving patient medication knowledge

Abaurre-Labrador R, Maurandi-Guillén MD, García-Delgado P , Moullin JC, Martínez-Martínez F , García-Corpas JP .


Sufficient patient medication knowledge is essential for appropriate use. The dispensing service provided in community pharmacies is one method that may be used to educate patients on their medications.


To compare the effectiveness of protocolized dispensing (following a dispensing protocol that includes standardized patient education), with the effectiveness of traditional dispensing (provision of medication without standardized patient education and information provided only if directly requested), for improving patient medication knowledge.


Pre-post quasi-experimental study of patients or caregivers over 18 years of age requesting one or more medications for their own use or for others. The intervention consisted of using a protocolized process for dispensing medicines in a community pharmacy. The association between the dispensing effectiveness (patient medication knowledge pre and post dispensing) and predictor variables was studied using a multivariate binary logistical regression model.


In total 661 participant medication requests were included in the study. Protocolized dispensing was more effective than traditional dispensing for improving medication knowledge (OR 2.390; 95 % CI 1.373–1.162).


As a means to improve patient medication knowledge it may be recommended that protocolized dispensing processes should be developed, evaluated and implemented with the ultimate aim of improving the appropriate use of medicines.


Community pharmacy services, Dispensing Patient medication knowledge, Spain.


Efectividad y seguridad de genérico de acavir/lamivudine y efavirenz en pacientes vih naïve
jueves, 06 de octubre de 2016

Effectiveness and safety of generic version of abacavir/lamivudine and efavirenz in treatment naïve HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2011–2012."

Jaime Galindo, Pedro Amariles , Héctor F. Mueses-Marín, Jaime A. Hincapié, Sebastián González-Avendaño, Ximena Galindo-Orrego.



Generic drug policies are often associated with concerns about the quality and effectiveness of these products. Phase IV clinical trials may be a suitable design to assess the effectiveness and safety of generic drugs. The objective of this study was to describe the effectiveness and the safety of the generic abacavir/lamivudine and efavirenz in treatment-naïve HIV-infected patients.


A monocentric, nonrandomized, open-label, phase IV study in treatment naïve HIV-infected patients 18 years or older with indication to receive abacavir/lamivudine and efavirenz were recruited from a program that provides comprehensive outpatient consultation and continuing care. The primary end-point was to achieve viral load <40 copies/mL at 12 months after baseline to assess effectiveness. Secondary end-point of the study were 1) to asses increasing in T-CD4 lymphocytes levels as accompaniment to asses effectiveness, and 2) to assess both gastrointestinal, skin, and central nervous system symptoms, and lipid profile, cardiovascular risk, renal, and hepatic function as safety profile. Data were determined at baseline, 3, 6, and 12 months. Close clinical monitoring and pharmaceutical care were used for data collection. Wilcoxon matched-pairs signed-rank test was used to compare proportions or medians.


Sixty patients were invited to participate in the study; 42 were enrolled and 33 completed the follow-up. Of the nine patients excluded from the study, only one was withdrawn due to adverse events. At 12 months, 31 of 42 patients (73.8 % in intention-to-treat analysis) achieved a viral load of HIV1 RNA <40 copies/mL. There was a significant increase (172 cells/mm3) in the median for CD4 T lymphocyte count. The adverse events were mild and met the safety profile for this antiretroviral regimen, mainly of central nervous system symptoms, skin rash, lipid abnormalities, and an increase of 2 % in the median of the percentage of cardiovascular risk.


The clinical outcomes of generic version of abacavir/lamivudine and efavirenz in HIV treatment naïve patients showed the expected safety and effectiveness profile of proprietary ARV drugs.

Trial registration

Registro Público Cubano de Ensayos Clínicos (RPCEC) ID: RPCEC00000202. Registered 19 November 2015.


HIV/AIDS Generic drugs Antiretroviral drugs Phase IV study



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