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Reason for request
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Clinical Benefit
| Moderate |
In the absence of demonstrated efficacy with all of the statins, the actual benefit of CHOLESTAGEL “co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) as adjunctive therapy to diet to provide an additive reduction in low-density lipoprotein cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone” is moderate. In view of the possible consequences on the absorption of other medicinal products potentially used in combination, particularly those with a narrow therapeutic margin, “in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia”, the actual benefit of CHOLESTAGEL is moderate. |
| Substantial |
" As monotherapy as an adjunct to diet for reduction of elevated total cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well-tolerated” the actual benefit of CHOLESTAGEL is substantial. |
Clinical Added Value
| no clinical added value |
“Co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) as adjunctive therapy to diet to provide an additive reduction in low-density lipoprotein cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone”, CHOLESTAGEL does not provide any improvement in actual benefit (IAB V) in the treatment strategy for these patients. “As monotherapy as an adjunct to diet for reduction of elevated total-cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well-tolerated”, CHOLESTAGEL does not provide any improvement in actual benefit (IAB V) in the treatment strategy for these patients. “In combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia”, CHOLESTAGEL does not provide any improvement in actual benefit (IAB V) by comparison with QUESTRAN. |
