Background/Purpose:   Allopurinol is a cornerstone therapy in gout management.  Despite this, allopurinol use is suboptimal as providers often fail to follow the treat-to-target paradigm endorsed as a best practice in gout.  We conducted a large cluster-randomized study to examine the impact of a pharmacist-driven intervention to optimize allopurinol therapy in gout. 

Methods:    Medical offices in the Kaiser Permanente Southern California health system were cluster randomized (n = 103 clusters) to deliver either a pharmacist-led intervention or usual care to patients receiving new allopurinol prescriptions.  The intervention allowed the study pharmacist to assume responsibility for most elements of allopurinol prescribing.  Patient outreach was conducted primarily via telephone interactive voice recognition (IVR) system to assess adherence, encourage serum urate (sUA) and other gout-related lab monitoring, provide patient-focused gout education, and adjust allopurinol dosing.  Primary outcomes were achievement of a sUA <6.0 mg/dl and allopurinol treatment adherence at one year.  Patients were considered adherent if the proportion of days covered (PDC), based on allopurinol prescription fills, was ≥ 0.8. Treatment (n=77) and control (n=147) patients without a follow-up sUA were assumed not to have reached sUA goal (i.e. non-responder imputation).

Results:   Usual care (n=782) and intervention (n=630) patients were similar in age, sex, mean household income, BMI, baseline sUA (mean 8.4 mg/dl in both groups), creatinine, and starting allopurinol dose (mean 188 mg/day in both groups).  Intervention patients were more often Caucasian (45% vs. 38%) and less often reported Asian race (20% vs. 26%) than those receiving usual care (p=0.01). The proportion achieving sUA goal, 1-year adherence, ending allopurinol dose, and changes in sUA are shown in the Table.  The intervention met all primary outcomes and showed significant improvements compared to usual care. With a mean of 2.4 (±2.4) IVR/pharmacist contacts, intervention patients were approximately 3-times more likely than usual care patients to receive allopurinol dose escalation (32% vs. 12%, p<0.001).

Conclusion:   A relatively simple intervention leveraging ambulatory pharmacists and automated telephone technology led to improved treatment adherence and achievement of sUA goal in gout patients initiating allopurinol.  However, almost 7 of 10 intervention patients failed to achieve a sUA < 6.0 mg/dl. Thus, while this light-touch, low-tech intervention was effective for some patients, additional efforts will be needed to optimize allopurinol administration in gout care.