Patient-Reported Symptom Burden Following Initiation of Statin Therapy: A Prospective Observational Study

Statins are one of the key drugs used to lower the risk of developing heart disease, but adverse symptoms experienced by the patients post medication are the foremost reason for non-adherence to the treatment. This research work was performed to evaluate the extent, timeline and factors associated with the symptoms reported by patients who were on statins for the first 12 weeks. An observational study was carried out on 248 patients prescribed with statins, among which 232 completed the study. Patients' burden of symptoms was assessed using an eight-questionnaire (score between 0-80) initially and 2-, 4-, 8- and 12-weeks post treatment. Analyses of the data collected were done using paired t-test, linear mixed effects model and multivariable logistic regression analysis using SPSS version 26.0. Of patients, 73.7% experienced one or more clinically significant symptoms in week 12, including, mainly, muscle pain (41.4%), muscle cramps (31.9%) and fatigue (30.6%). Clinically significant worsening was seen in 53.4% of patients, with higher frequency in high intensity versus moderate intensity therapy (67.4% vs 44.3%; p = 0.001). High intensity therapy (OR adjusted 2.58; 95% CI 1.43–4.65), being female (OR adjusted 1.94; 95% CI 1.08–3.49), polypharmacy (OR adjusted 1.87; 95% CI 1.04–3.36), and baseline concerns regarding ADRs (OR adjusted 2.21; 95% CI 1.24–3.94) independently predicted worsening. Modification of therapy occurred in 14.2% of patients, with higher frequency in the group experiencing worsening (23.4% vs 3.7%; p < 0.001). The mean LDL decreased by 42.4%. Burden of symptoms following statins initiation is considerable and front-loaded, and early structured assessment of symptoms can help to maintain therapy for a long time.