4. Materials and Methods
PXE symptoms, cardiovascular or cerebrovascular disease, diabetes
RENAL LITHIASIS, ADVERSE EVENTS, DISEASE, ADVERSE EVENT, DYSLIPIDEMIA, INTERMITTENT CLAUDICATION, BLOOD, HYPERTENSION, DIABETES
Capsules of lansoprazole 30 mg or a placebo were provided by the Pharmacy Service of Hospital Virgen de la Macarena, Sevilla, Spain. The random sequence was created using the software Random Integer Generator (Patients who consented to participate in the trial had 4 visits to the hospital, just before and after the two 8-week periods. At each visit, demographics, clinical and anthropometric data, and the presence of any adverse event were obtained. At the beginning of each 8-week period, a bottle containing 59 capsules of lansoprazole 30 mg or a placebo was given to each patient; the bottle was returned at the end of each period and the capsules were counted.At the first visit, age, sex, date of the first PXE symptoms, skin, vascular and eye stage of the disease, and comorbidities (hypertension, diabetes, dyslipidemia, renal lithiasis, cardiovascular or cerebrovascular disease, intermittent claudication, and any concomitant therapy) were recorded. Body weight, stature, body mass index, blood pressure, and the ankle–brachial index were registered. At each visit, the physical examination, medication, adverse events, and returned pills were recorded.At each visit, after an overnight fast, blood samples were drawn and collected into serum, K2-EDTA, citrate, and citrate-theophylline-adenosine-dipyridamole (CTAD) vacuum tubes (BD Vacutainer; Plymouth, UK). Blood samples were kept on ice and then the K2-EDTA tubes were centrifuged for 15 min at 1750× PPi, TNAP and ENPP1 activities, CXCL4, Osteocalcin, and ENPP1 concentrations were measured as described previously [Hematological and basic biochemistry variables were collected through a clinical autoanalyzer and the Siemens Dimension Vista System Flex analysis system at the clinical laboratory of the Virgen de la Victoria University Hospital in Malaga, Spain.Statistical analyses: These were performed by a statistician not on the research team. The statistical package used was R 3.5.2. Data are shown as mean ± SD, median (IQR) or n (%). A generalized linear mixed-model approach was used to estimate differences between periods of lansoprazole and placebo while accounting for within-subject correlations arising from the crossover design. Study data were collected and managed using REDCap electronic data capture tools hosted at Hospital Regional Universitario de Málaga, Spain [