Trajectories of CKD-MBD biochemical parameters over a 2-year period following diagnosis of secondary hyperparathyroidism: a pharmacoepidemiological study

BMJ Open. 2017 Mar 27;7(3):e011482. doi: 10.1136/bmjopen-2016-011482.

Abstract

Objectives: To define groups of patients according to the changes of biochemical parameters, that is, serum calcium, phosphate and parathyroid hormone (PTH), over a 2-year follow-up period using group-based multi-trajectory modeling (GBMM) among a cohort of dialysis patients with newly diagnosed secondary hyperparathyroidism (SHPT) (ie, PTH≥500 ng/L for the first time) and to compare their patient characteristics and treatments.

Design: Pharmacoepidemiological study.

Setting: In the 12 dialysis units located in the French region of Lorraine.

Participants: A total of 269 dialysis patients with newly diagnosed SHPT were prospectively included from December 2009 to May 2012 and followed-up for 2 years.

Results: We identified four distinct trajectory groups: 'rapid PTH drop' experiencing a rapid and sharp decrease (over weeks) in PTH level associated with decreasing phosphate level within normal range (n=34; 12.7%), 'gradual PTH decrease' experiencing a gradual and continuous decrease (over months) in PTH level and maintaining phosphate at a middle level throughout the study (n=98; 36.4%), 'slow PTH decrease with high phosphate' experiencing a slow decrease in PTH level associated with a relatively high phosphate level (n=105; 39.0%) and 'uncontrolled SHPT' with high levels of PTH and phosphate throughout the study (n=32; 11.9%). Patients in the 'uncontrolled SHPT' group were significantly (p<0.00001) younger than patients in other groups. Kidney Disease Improving Global Outcomes (KDIGO) targets for PTH, phosphate and calcium were reached simultaneously for 14.9% of patients at baseline and 16.7% at the end of the study. Patients were given cinacalcet more frequently at months 3 and 6 in the 'rapid PTH drop' and at month 24 in the 'uncontrolled SHPT' groups.

Conclusions: Over 2 years following a new SHPT diagnosis, a younger age and a higher rate of alkaline phosphatase were associated to a continuous uncontrolled SHPT. Patients with the lowest PTH at the end of the follow-up tended to receive more often cinacalcet.

Trial registration number: ClinicalTrials.gov number, NCT02888639, post results.

MeSH terms

  • Adult
  • Alkaline Phosphatase / metabolism*
  • Calcimimetic Agents / therapeutic use*
  • Calcium / metabolism*
  • Chronic Kidney Disease-Mineral and Bone Disorder / drug therapy
  • Chronic Kidney Disease-Mineral and Bone Disorder / epidemiology
  • Chronic Kidney Disease-Mineral and Bone Disorder / metabolism*
  • Chronic Kidney Disease-Mineral and Bone Disorder / physiopathology
  • Cinacalcet / therapeutic use*
  • Female
  • Follow-Up Studies
  • France / epidemiology
  • Humans
  • Hyperparathyroidism, Secondary / epidemiology
  • Hyperparathyroidism, Secondary / metabolism*
  • Hyperparathyroidism, Secondary / physiopathology
  • Male
  • Models, Biological
  • Parathyroid Hormone / metabolism*
  • Pharmacoepidemiology*
  • Prospective Studies
  • Reference Standards
  • Renal Dialysis
  • Treatment Outcome

Substances

  • Calcimimetic Agents
  • Parathyroid Hormone
  • Alkaline Phosphatase
  • Calcium
  • Cinacalcet

Associated data

  • ClinicalTrials.gov/NCT02888639