Ishan Hirji

Incidence of urinary tract infection among patients with type 2 diabetes in the UK General Practice Research Database (GPRD).

The objective of this observational study was to quantify the incidence of urinary tract infections (UTI) among diabetes patients and compare this risk to patients without diabetes. Type 2 diabetes patients and a matched sample of patients without diabetes were identified from GPRD. Patients were followed for 1-year from their study index date until the first record of a UTI or a censored event. The incidence of UTI was 46.9 per 1000 person-years (95% confidence interval (CI) 45.8-48.1) among diabetes patients and 29.9 (95% CI 28.9-30.8) for patients without diabetes. Compared to the non-diabetes patients, the risk of UTI was 1.53 (95% CI 1.46-1.59) for all diabetes patients; and 2.08 (95% CI 1.93-2.24) for patients with previously diagnosed diabetes. In general practice, across gender and age, the risk of developing a UTI is higher for patients with type 2 diabetes compared to patients without diabetes.

Incidence of genital infection among patients with type 2 diabetes in the UK General Practice Research Database.

The objective of this population-based study was to evaluate the incidence of vaginitis (females) and balanitis (males) among a cohort of type 2 diabetes patients and compare this risk to patients without diabetes. The study population included 125,237 female patients and 146,603 males identified from GPRD. All patients were followed for 1-year from their study index date for the first record of an infection or a censored event. Among patients with diabetes the incidence of vaginitis was 21.0/1000PY (95% CI 19.8-22.1) with the risk being 1.81 (95% CI 1.64-2.00) greater that patients without diabetes. The incidence of balanitis among diabetes patients was 8.4/1000PY (95% CI 7.8-9.1) with a relative risk of 2.85 (2.39-3.39) compared to patients without diabetes. Additional analyses were performed by HbA1c level. Results from this large population-based study indicate that patients with diabetes are at an increased risk of being diagnosed with infections of the genital tract and patients with poorly controlled diabetes have higher risks.

Chronic myeloid leukemia (CML): association of treatment satisfaction, negative medication experience and treatment restrictions with health outcomes, from the patient’s perspective

BackgroundThe availability of the tyrosine-kinase inhibitor (TKI), imatinib, and later introduction of second generation TKIs, dasatinib and nilotinib, have not only improved clinical outcomes of patients with chronic myeloid leukemia (CML), but also provide multiple therapeutic options for CML patients. Despite the widespread use of these oral therapies, little is known about the impact of different treatment regimens on patient-reported outcomes (PROs) among CML patients. The objective of this study was to assess the impact of patient-reported treatment restrictions and negative medication experiences (NMEs) on satisfaction and other health outcomes among patients with CML treated with oral TKIs.MethodsParticipants recruited from survey panels and patient networks in the United States (US) and Europe completed an online questionnaire. Respondents included adults (≥18 years) with chronic-phase CML currently on TKI treatment. Study variables included treatment difficulty (i.e., difficulty in following treatment regimens), CML dietary/dosing requirements, NMEs, and validated PROs assessing treatment satisfaction, health-related quality of life (HRQoL), activity impairment, and non-adherence. Structural equation models assessed associations among variables, controlling for covariates.Results303 patients with CML (US n=152; Europe n=151; mean age 51.5 years; 46.2% male) completed the questionnaire. Approximately 30% of patients reported treatment difficulties; treatment difficulty was higher among nilotinib (63.3%) than among dasatinib (2.6%) or imatinib (19.2%) treated patients (p<0.0001). Non-adherence was generally low; however, patients on nilotinib vs. imatinib reported missing doses more often (p<0.05). Treatment satisfaction was associated with significantly increased HRQoL (p<0.05) and lower activity impairment (p<0.01). NMEs were associated with decreased treatment satisfaction (p<0.01) and HRQoL (p<0.05), and greater activity impairment (p<0.01). Higher overall treatment restrictions were associated with greater treatment difficulty (p<0.001), which correlated with non-adherence (p<0.01).ConclusionsTreatment satisfaction and NMEs are important factors associated with HRQoL among patients with CML. Increased treatment restrictions and associated difficulty may affect adherence with TKIs. Choosing a CML treatment regimen that is simple and conveniently adaptable in patients’ normal routine can be an important determinant of HRQoL and adherence.

The relative efficacy of imatinib, dasatinib and nilotinib for newly diagnosed chronic myeloid leukemia: a systematic review and network meta-analysis

ObjectivesDasatinib 100 mg daily and nilotinib 600/800 mg daily have been compared to imatinib as first line treatments for CML in two recent randomised studies. However, no head to head evidence exists of the relative efficacy of dasatinib and nilotinib.MethodsWe conducted a systematic literature review and used the data extracted to perform an indirect comparison meta-analysis of the three interventions.ResultsData from eight clinical studies (3,520 individuals) were included, all of which were of good quality (low risk of bias). At six months, the odds of complete cytogenetic response (CCyR) for dasatinib and nilotinib were approximately three times those for imatinib (range 2.77 to 3.06, all values not significant). At twelve months datatinib and nilotinib were significantly better than imatinib for both CCyR and major molecular response (MMR) (CCyR odds range 2.06 to 2.41, MMR odds range 2.09 to 2.87). At eighteen months dasatinib and nilotinib were again significantly better in terms of CCyR than imatinib (response odds 1.55 to 2.01). When dasatinib and nilotinib were compared to each other, for both clinical endpoints at all time points the response odds were not significantly different.ConclusionsOn the basis of a systematic review of the current literature base, dasatinib 100 mg, nilotinib 600 mg and nilotinib 800 mg should be viewed as equivalent in terms of complete cytogenetic and major molecular response.