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Long-term statin treatment in children with familial hypercholesterolemia: more insight into tolerability and adherence.

Braamskamp MJ, Kusters DM, Avis HJ, Smets EM, Wijburg FA, Kastelein JJ, Wiegman A, Hutten BA - Paediatr Drugs (2015)

Bottom Line: In adults, these agents have been proven to be safe and well tolerated; however, non-adherence is a significant clinical issue.None of the patient characteristics were significantly associated with adherence.Furthermore, statin therapy was well tolerated; only a small minority discontinued therapy because of side effects and the side effects that were reported were mild in nature.

View Article: PubMed Central - PubMed

Affiliation: Department of Vascular Medicine, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands, j.a.braamskamp@amc.uva.nl.

ABSTRACT

Background: Statins are currently the preferred pharmacological therapy in individuals with familial hypercholesterolemia (FH) with the aim to prevent premature atherosclerosis. In adults, these agents have been proven to be safe and well tolerated; however, non-adherence is a significant clinical issue.

Objectives: In this study, we evaluated tolerability and adherence to statin therapy in young adult FH patients 10 years after this was initiated in their childhood.

Methods: A questionnaire including items on medical history, adherence and reasons for discontinuation was sent to 214 young adult FH patients that initiated statin therapy at least 10 years ago. Tolerability was defined as 100% minus the percentage of patients that discontinued statin therapy due to side effects. Adherence was defined as the extent to which patients took their medication as prescribed by their physician. We labelled patients adherent if they took 80% or more of their pills in the month preceding our assessment.

Results: Follow-up was successful in 205 (95.8%) subjects (age 18-30 years). A history of side effects was reported by 40 (19.5%) of the patients, and mainly consisted of muscle complaints and gastrointestinal symptoms. Three patients (1.5%) discontinued statin therapy because of side effects. Rhadbomyolysis or other serious adverse events were not reported. In fact, 169 (82.4%) of 205 patients remained on statin treatment and 78.7% (148 out of 188) were adherent. None of the patient characteristics were significantly associated with adherence.

Conclusions: Individuals with FH who started statin therapy in childhood demonstrated good adherence during ten years of treatment. Furthermore, statin therapy was well tolerated; only a small minority discontinued therapy because of side effects and the side effects that were reported were mild in nature.

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Related in: MedlinePlus

Number of patients that had ever experienced side effects in the last 10 years. Other: frequent urination (2×), weight reduction, hair loss, forgetfulness
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Fig2: Number of patients that had ever experienced side effects in the last 10 years. Other: frequent urination (2×), weight reduction, hair loss, forgetfulness

Mentions: Three out of 205 patients had completely discontinued drug therapy due to side effects; i.e., a tolerability of 98.5 %. All three patients reported a combination of gastro-intestinal symptoms, muscle and joint pain, or headache. Overall, 55 side effects were reported in the last 10 years by 40 subjects (19.5 %), mainly consisting of muscle complaints in 19 patients (9.3 %) and gastrointestinal symptoms in 14 patients (6.8 %) (Fig. 2). No major side effects, such as rhabdomyolysis or elevation of liver enzymes, were reported.Fig. 2


Long-term statin treatment in children with familial hypercholesterolemia: more insight into tolerability and adherence.

Braamskamp MJ, Kusters DM, Avis HJ, Smets EM, Wijburg FA, Kastelein JJ, Wiegman A, Hutten BA - Paediatr Drugs (2015)

Number of patients that had ever experienced side effects in the last 10 years. Other: frequent urination (2×), weight reduction, hair loss, forgetfulness
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4372689&req=5

Fig2: Number of patients that had ever experienced side effects in the last 10 years. Other: frequent urination (2×), weight reduction, hair loss, forgetfulness
Mentions: Three out of 205 patients had completely discontinued drug therapy due to side effects; i.e., a tolerability of 98.5 %. All three patients reported a combination of gastro-intestinal symptoms, muscle and joint pain, or headache. Overall, 55 side effects were reported in the last 10 years by 40 subjects (19.5 %), mainly consisting of muscle complaints in 19 patients (9.3 %) and gastrointestinal symptoms in 14 patients (6.8 %) (Fig. 2). No major side effects, such as rhabdomyolysis or elevation of liver enzymes, were reported.Fig. 2

Bottom Line: In adults, these agents have been proven to be safe and well tolerated; however, non-adherence is a significant clinical issue.None of the patient characteristics were significantly associated with adherence.Furthermore, statin therapy was well tolerated; only a small minority discontinued therapy because of side effects and the side effects that were reported were mild in nature.

View Article: PubMed Central - PubMed

Affiliation: Department of Vascular Medicine, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands, j.a.braamskamp@amc.uva.nl.

ABSTRACT

Background: Statins are currently the preferred pharmacological therapy in individuals with familial hypercholesterolemia (FH) with the aim to prevent premature atherosclerosis. In adults, these agents have been proven to be safe and well tolerated; however, non-adherence is a significant clinical issue.

Objectives: In this study, we evaluated tolerability and adherence to statin therapy in young adult FH patients 10 years after this was initiated in their childhood.

Methods: A questionnaire including items on medical history, adherence and reasons for discontinuation was sent to 214 young adult FH patients that initiated statin therapy at least 10 years ago. Tolerability was defined as 100% minus the percentage of patients that discontinued statin therapy due to side effects. Adherence was defined as the extent to which patients took their medication as prescribed by their physician. We labelled patients adherent if they took 80% or more of their pills in the month preceding our assessment.

Results: Follow-up was successful in 205 (95.8%) subjects (age 18-30 years). A history of side effects was reported by 40 (19.5%) of the patients, and mainly consisted of muscle complaints and gastrointestinal symptoms. Three patients (1.5%) discontinued statin therapy because of side effects. Rhadbomyolysis or other serious adverse events were not reported. In fact, 169 (82.4%) of 205 patients remained on statin treatment and 78.7% (148 out of 188) were adherent. None of the patient characteristics were significantly associated with adherence.

Conclusions: Individuals with FH who started statin therapy in childhood demonstrated good adherence during ten years of treatment. Furthermore, statin therapy was well tolerated; only a small minority discontinued therapy because of side effects and the side effects that were reported were mild in nature.

Show MeSH
Related in: MedlinePlus